HOKLAS 007 Annex II
Management System Checklist
The laboratory shall complete the following checklist, which will be
used for the assessment of the laboratory’s conformity with HKAS
and HOKLAS accreditation requirements.
The checklist consists of questions based on the requirements of
HKAS 002, HKAS Supplementary Criteria No. 6, HOKLAS
Supplementary Criteria No. 33 and HOKLAS 003. For further
information, please refer to the corresponding document and
clause as listed in the second column.
The laboratory shall indicate in the ‘QM Clause’ column, for every
question, the clause(s) in its quality manual, operation procedures
manual or other related document which can demonstrate the
laboratory’s conformity with the requirement.
The columns headed ‘*’ and ‘OK’ are for internal use of HKAS
Executive.
A softcopy of this completed checklist shall be provided to HKAS
Executive by email or other means.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements
Organisation
Is your laboratory or the organisation of which it is part an entity that can be held
legally responsible?
003 4.1.1
Is it the responsibility of your laboratory to carry out its testing and calibration
activities in such a way as to meet the requirements of HOKLAS 003 and to satisfy
the needs of the customer, the regulatory authorities or organisations providing
recognition?
003 4.1.2
Does your management system cover work carried out in the laboratory’s
permanent facilities, at sites away from your permanent facilities, or in associated
temporary or mobile facilities?
003 4.1.3
If your laboratory is part of an organisation performing activities other than testing
and/or calibration, are the responsibilities of key personnel in the organisation that
have an involvement or influence on the testing and/or calibration activities of your
laboratory defined in order to identify potential conflicts of interest?
003 4.1.4
Does your laboratory
- have managerial and technical personnel who, irrespective of other
responsibilities, have the authority and resources needed to carry out their
duties, including the implementation, maintenance and improvement of the
management system, and to identify the occurrence of departures from the
management system or from the procedures for performing tests and/or
calibrations, and to initiate actions to prevent or minimise such departures?
003 4.1.5a
- have arrangements to ensure that its management and personnel are free from
any undue internal and external commercial, financial and other pressures and
influences that may adversely affect the quality of their work?
003 4.1.5b
- have policies and procedures to ensure the protection of its customers’
confidential information and proprietary rights, including procedures for
protecting the electronic storage and transmission of results?
003 4.1.5c
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements (continued)
Organisation (Cont’d)
Does your laboratory
- have policies and procedures to avoid involvement in any activities that would
diminish confidence in your competence, impartiality, judgment or operational
integrity?
003 4.1.5d
- define your organisation and management structure, your place in any parent
organisation, and the relationships between quality management, technical
operations and support services?
003 4.1.5e
- specify the responsibility, authority and interrelationships of all personnel who
manage, perform or verify work affecting the quality of the tests and/or
calibrations?
003 4.1.5f
- provide adequate supervision of testing and calibration staff, including trainees,
by persons familiar with methods and procedures, purpose of each test and/or
calibration, and with the assessment of the test or calibration results?
003 4.1.5g
- have technical management which has overall responsibility for the technical
operations and the provision of the resources needed to ensure the required
quality of laboratory operations?
003 4.1.5h
- appoint a member of staff as quality manager (however named) who,
irrespective of other duties and responsibilities, has defined responsibility and
authority for ensuring that the management system is implemented and followed
at all times; and has direct access to the highest level of management at which
decisions are made on laboratory policy or resources?
003 4.1.5i
- appoint deputies for key managerial personnel?
003 4.1.5j
- ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the objectives of the
management system?
003 4.1.5k
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements (continued)
Organisation (Cont’d)
Do the top management ensure that appropriate communication processes are
established within the laboratory and that communication takes place regarding the
effectiveness of the management system?
003 4.1.6
Management System
Has your laboratory established, implemented and maintained a management
system appropriate to the scope of its activities?
003 4.2.1
Has your laboratory documented its policies, systems, programmes, procedures and
instructions to the extent necessary to assure the quality of the test and/or
calibration results?
003 4.2.1
Is the system’s documentation communicated to, understood by, available to, and
implemented by the appropriate personnel?
003 4.2.1
Are your laboratory’s management system policies related to quality, including a
quality policy statement defined in a quality manual (however named)?
003 4.2.2
Are the overall objectives established and reviewed during management review?
003 4.2.2
Is the quality policy statement issued under the authority of the top management?
003 4.2.2
Does the quality policy statement include at least the following:
- the laboratory management’s commitment to good professional practice and to
the quality of its testing and calibration in servicing its customers?
003 4.2.2a
- the management’s statement of the laboratory’s standard of service?
003 4.2.2b
- the purposes of the management system related to quality?
003 4.2.2c
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements (continued)
Management System (Cont’d)
Does the quality policy statement include at least the following: (cont’d)
- a requirement that all personnel concerned with testing and calibration activities
within the laboratory familiarise themselves with the quality documentation and
implement the policies and procedures in their work?
003 4.2.2d
- the laboratory management’s commitment to comply with HOKLAS 003 and to
continually improve the effectiveness of the management system?
003 4.2.2e
Does the quality manual include or make reference to the supporting procedures
including technical procedures?
003 4.2.3
Do the top management provide evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness?
003 4.2.3
Do the top management communicate to the organisation the importance of
meeting customer requirements as well as statutory and regulatory requirements?
003 4.2.4
Does the quality manual outline the structure of the documentation used in the
management system?
003 4.2.5
Are the roles and responsibilities of technical management and the quality
manager, including their responsibility for ensuring compliance with HOKLAS
003, defined in the quality manual?
003 4.2.6
Do the top management ensure that the integrity of the management system is
maintained when changes to the management system are planned and
implemented?
003 4.2.7
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Document Control
General
Has your laboratory established and maintained procedures to control all
documents that form part of its management system (internally generated and from
external sources), such as regulations, standards, other normative documents, test
and/or calibration methods, as well as drawings, software, specifications,
instructions and manuals?
003 4.3.1
Document approval and issue
Are all documents issued to personnel in the laboratory as part of the management
system reviewed and approved for use by authorised personnel prior to issue?
003 4.3.2.1
Is a master list or an equivalent document control procedure identifying the current
revision status and distribution of documents in the management system
established and readily available to preclude the use of invalid and/or obsolete
documents?
003 4.3.2.1
Does the procedure adopted ensure that:
- authorised editions of appropriate documents are available at all locations where
operations essential to the effective functioning of the laboratory are performed?
- documents are periodically reviewed and, where necessary, revised to ensure
continuing suitability and compliance with applicable requirements?
003
4.3.2.2a
003
4.3.2.2b
Does the procedure adopted ensure that:
- invalid or obsolete documents are promptly removed from all points of issue or
use, or otherwise assured against unintended use?
- obsolete documents retained for either legal or knowledge preservation purposes
are suitably marked?
003
4.3.2.2c
003
4.3.2.2d
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Document approval and issue (Cont’d)
Are management system documents generated by the laboratory uniquely
identified?
003 4.3.2.3
Does such identification include the date of issue and/or revision identification,
page numbering, the total number of pages or a mark to signify the end of the
document, and the issuing authority(ies)?
003 4.3.2.3
Document changes
Are changes to documents reviewed and approved by the same function that
performed the original review unless specifically designated otherwise?
003 4.3.3.1
Do the designated personnel have access to pertinent background information upon
which to base their review and approval?
003 4.3.3.1
Where practicable, are the altered or new text identified in the document or the
appropriate attachments?
003 4.3.2.2
If your laboratory’s documentation control system allows for the amendment of
documents by hand pending the re-issue of the documents, are the procedures and
authorities for such amendments defined?
003 4.3.2.3
Is a revised document formally re-issued as soon as practicable?
003 4.3.2.3
Have procedures been established to describe how changes in documents
maintained in computerised systems are made and controlled?
003 4.3.2.4
Review of requests, tenders and contracts
Has your laboratory established and maintained procedures for the review of
requests, tenders or contracts?
003 4.4.1
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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- the requirements, including the methods to be used, are adequately defined,
documented and understood (see 5.4.2 of HOKLAS 003)?
003 4.4.1a
●
- the laboratory has the capability and resources to meet the requirements?
003 4.4.1b
●
- the appropriate test and/or calibration method is selected and capable of meeting
the customers’ requirements (see 5.4.2 of HOKLAS 003)?
003 4.4.1c
●
Are, if any, differences between the request or tender and the contract resolved
before any work commences?
003 4.4.1
Is each contract acceptable both to the laboratory and the customer?
003 4.4.1
Are records of reviews, including any significant changes, maintained?
003 4.4.2
Are records also maintained of pertinent discussions with a customer relating to the
customer’s requirements or the results of the work during the period of execution
of the contract?
003 4.4.2
Does the review also cover any work that is subcontracted by the laboratory?
003 4.4.3
Is the customer informed of any deviation from the contract?
003 4.4.4
If a contract needs to be amended after work has commenced, is the same contract
review process repeated and are, if any, amendments communicated to all affected
personnel?
003 4.4.5
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements (continued)
Review of requests, tenders and contracts (Cont’d)
Do the policies and procedures for these reviews leading to a contract for testing
and/or calibration ensure that:
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Subcontracting of tests and calibrations
When your laboratory subcontracts work whether because of unforeseen reasons
(e.g. workload, need for further expertise or temporary incapacity) or on a
continuing basis (e.g. through permanent subcontracting, agency or franchising
arrangements), is this work placed with a competent subcontractor?
003 4.5.1
Does your laboratory advise the customer of the arrangement in writing and, when
appropriate, gain the approval of the customer, preferably in writing?
003 4.5.2
Is your laboratory responsible to the customer for the subcontractor’s work, except
in the case where the customer or a regulatory authority that specifies which
subcontractor is to be used?
003 4.5.3
Does your laboratory maintain a register of all subcontractors that it uses for tests
and/or calibrations and a record of the evidence of compliance with HOKLAS 003
for the work in question?
003 4.5.4
Purchasing services and supplies
Does your laboratory have a policy and procedure(s) for the selection and
purchasing of services and supplies it uses that affect the quality of the tests and/or
calibrations?
003 4.6.1
Do procedures exist for the purchase, reception and storage of reagents and
laboratory consumable materials relevant for the tests and calibrations?
003 4.6.1
Does your laboratory ensure that purchased supplies and reagents and consumable
materials that affect the quality of tests and/or calibrations are not used until they
have been inspected or otherwise verified as complying with standard
specifications or requirements defined in the methods for the tests and/or
calibrations concerned?
003 4.6.2
Do these services and supplies used comply with specified requirements?
003 4.6.2
Are records of actions taken to check compliance maintained?
003 4.6.2
●
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Purchasing services and supplies (Cont’d)
Do purchasing documents, for items affecting the quality of laboratory output
contain data describing the services and supplies ordered?
003 4.6.3
Are purchasing documents reviewed and approved for technical content prior to
release?
003 4.6.3
Does your laboratory evaluate suppliers of critical consumables, supplies and
services which affect the quality of testing and calibration, and maintain records of
these evaluations and list those approved?
003 4.6.4
Service to the customer
Does your laboratory afford customers or their representatives’ cooperation to
clarify the customer’s request and to monitor your laboratory’s performance in
relation to the work performed and ensure confidentiality to other customers?
003 4.7.1
Does your laboratory seek feedback, both positive and negative, from its
customers? Are the feedback used and analysed to improve the management
system, testing and calibration activities and customer service?
003 4.7.2
Complaints
Does your laboratory have a policy and procedure for the resolution of complaints
received from customers or other parties?
003 4.8
Are records maintained of all complaints and of the investigations and corrective
actions taken by the laboratory?
003 4.8
Control of nonconforming testing and/or calibration work
Does your laboratory have a policy and procedures that shall be implemented when
any aspect of its testing and/or calibration work, or the results of this work, do not
conform to your own procedures or the agreed requirements of the customer?
003 4.9
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Control of nonconforming testing and/or calibration work (Cont’d)
Do the policy and procedures ensure that
- responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of test
reports and calibration certificates, as necessary) are defined and taken when
nonconforming work is identified?
003 4.9.1a
- an evaluation of the significance of the nonconforming work is made?
003 4.9.1b
●
- correction is taken immediately, together with any decision about the
acceptability of the nonconforming work?
003 4.9.1c
●
- where necessary, the customers are notified and work is recalled?
003 4.9.1d
-
- the responsibility for authorising the resumption of work is defined ?
003 4.9.1e
Where the evaluation indicates that the nonconforming work could recur or that
there is doubt about the compliance of the laboratory’s operations with its own
policies and procedures, are the corrective action procedures given in 4.11 of
HOKLAS 003 promptly followed?
003 4.9.2
Improvement
Does your laboratory continually improve the effectiveness of its management
system through the use of quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management review?
003 4.10
Corrective action
Has your laboratory established a policy and procedure and designated appropriate
authorities for implementing corrective action when nonconforming work or
departures from the policies and procedures in the management system or technical
operations have been identified?
003 4.11.1
●
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Does the procedure for corrective action start with an investigation to determine
the root cause(s) of the problem?
003 4.11.2
●
Where corrective action is needed, does your laboratory identify potential
corrective actions?
003 4.11.3
●
Does your laboratory select and implement the action(s) most likely to eliminate
the problem and to prevent recurrence?
003 4.11.3
●
Are corrective actions to a degree appropriate to the magnitude and the risk of the
problem?
003 4.11.3
●
Does your laboratory document and implement any required changes resulting
from corrective action investigations?
003 4.11.3
●
Does your laboratory monitor the results to ensure that the corrective actions taken
have been effective?
003 4.11.4
●
Where the identification of nonconformities or departures casts doubts on your
laboratory’s compliance with its own policies and procedures, or on its compliance
with this document, does your laboratory ensure that the appropriate areas of
activity are audited in accordance with 4.14 of HOKLAS 003 as soon as possible?
003 4.11.5
OK
QM Clause
Remarks / Questions to be asked at laboratory
Management requirements (continued)
Corrective action (Cont’d)
Preventive action
Are needed improvement and potential sources of nonconformities, either technical
or concerning the management system, identified?
003 4.12.1
When improvement opportunities are identified or if preventive action is required,
are action plans developed, implemented and monitored to reduce the likelihood of
the occurrence of such nonconformities and to take advantage of the opportunities
for improvement?
003 4.12.1
Do procedures for preventive actions include the initiation of such actions and
application of controls to ensure that they are effective?
003 4.12.2
●
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Control of records
Has your laboratory established and maintained procedures for identification,
collection, indexing, access, filing, storage, maintenance and disposal of quality
and technical records?
003 4.13.1
Do quality records include reports from internal audits and management reviews as
well as records of corrective and preventive actions?
003
4.13.1.1
Are all records legible and stored and retained in such a way that they are readily
retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss?
003
4.13.1.2
Have retention times of records been established?
003
4.13.1.2
Are all records held secure and in confidence?
003
4.13.1.3
Does your laboratory have procedures to protect and back-up records stored
electronically and to prevent unauthorised access to or amendment of these
records?
003
4.13.1.4
Does your laboratory retain records of original observations, derived data and
sufficient information to establish an audit trail, calibration records, staff records
and a copy of each test report or calibration certificate issued, for a defined period?
003
4.13.2.1
●
Do the records for each test or calibration contain sufficient information to
facilitate, if possible, identification of factors affecting the uncertainty and to
enable the test or calibration to be repeated under conditions as close as possible to
the original?
003
4.13.2.1
●
Do the records include the identity of personnel responsible for the sampling,
performance of each test and/or calibration and checking of results?
003
4.13.2.1
Are observations, data and calculations recorded at the time they are made and
identifiable to the specific task?
003
4.13.2.2
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Control of records (Cont’d)
When mistakes occur in records, is each mistake crossed out, not erased, made
illegible or deleted, and the correct value entered alongside?
003
4.13.2.3
Are all such alterations to records signed or initialled by the person making the
correction?
003
4.13.2.3
In the case of records stored electronically, are equivalent measures taken to avoid
loss or change of original data?
003
4.13.2.3
Internal audits
Does your laboratory periodically, and in accordance with a predetermined
schedule and procedure, conduct internal audits of its activities to verify that its
operations continue to comply with the requirements of the management system
and HOKLAS 003?
003 4.14.1
Does the internal audit programme address all elements of the management system,
including the testing and/or calibration activities?
003 4.14.1
Is it the responsibility of the quality manager to plan and organise audits as
required by the schedule and requested by management?
003 4.14.1
Are such audits carried out by trained and qualified personnel who are, wherever
resources permit, independent of the activity to be audited?
003 4.14.1
When audit findings cast doubt on the effectiveness of the operations or on the
correctness or validity of the laboratory’s test or calibration results, does your
laboratory take timely corrective action, and notify customers in writing if
investigations show that the laboratory results may have been affected?
003 4.14.2
Are the area of activity audited, the audit findings and corrective actions that arise
from them recorded?
003 4.14.3
Do follow-up audit activities verify and record the implementation and
effectiveness of the corrective action taken?
003 4.14.4
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
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Remarks / Questions to be asked at laboratory
Management requirements (continued)
Management reviews
Does your laboratory’s top management, in accordance with a predetermined
schedule and procedure, periodically conduct a review of your laboratory’s
management system and testing and/or calibration activities to ensure their
continuing suitability and effectiveness, and to introduce necessary changes or
improvements?
003 4.15.1
Does the review take account of:
- the suitability of policies and procedure?
003 4.15.1
- reports from managerial and supervisory personnel?
003 4.15.1
- the outcome of recent internal audits?
003 4.15.1
- corrective and preventive actions?
003 4.15.1
- the results of interlaboratory comparisons or proficiency tests?
003 4.15.1
- changes in the volume and type of the work?
003 4.15.1
- customer’s feedback?
003 4.15.1
- complaints?
003 4.15.1
- recommendations for improvement?
003 4.15.1
- other relevant factors, such as quality control activities, resources and staff
training?
003 4.15.1
Are findings from management reviews and the actions that arise from them
recorded?
003 4.15.2
Does the management ensure that those actions are carried out within an
appropriate and agreed timescale?
003 4.15.2
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
Technical requirements
General
Many factors determine the correctness and reliability of the tests and/or calibrations
performed by a laboratory. These factors include contributions from:
-
003 5.1.1
human factors (5.2)
accommodation and environmental conditions (5.3)
test and calibration methods and method validation (5.4)
equipment (5.5),
measurement traceability (5.6)
sampling (5.7),
the handling of test and calibration items (5.8)
003 5.1.2
●
Does your laboratory management ensure the competence of all who operate
specific equipment, perform tests and/or calibrations, evaluate results and sign test
reports and calibration certificates?
003 5.2.1
●
When using staff who are undergoing training, is appropriate supervision
provided?
003 5.2.1
●
Are personnel performing specific tasks qualified on the basis of appropriate
education, training, experience and/or demonstrated skills, as required?
003 5.2.1
●
Has the management of your laboratory formulated the goals with respect to the
education, training and the skills of the laboratory personnel?
003 5.2.2
●
Does your laboratory have a policy and procedures for identifying training needs
and providing training of personnel?
003 5.2.2
●
Does your laboratory take account of these factors in developing test and
calibration methods and procedures, in the training and qualification of personnel,
and in the selection and calibration of the equipment it uses?
Personnel
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Is the training programme relevant to present and anticipated tasks of the
laboratory?
003 5.2.2
●
Is the effectiveness of the training actions taken evaluated?
003 5.2.2
●
Does your laboratory use only personnel who are employed by, or under contract
to, your laboratory?
003 5.2.3
Where contracted and additional technical and key support personnel are used,
does your laboratory ensure that such personnel are supervised and competent and
that they work in accordance with your laboratory’s management system?
003 5.2.3
Does your laboratory maintain current job descriptions for managerial, technical
and key support personnel involved in tests and/or calibrations?
003 5.2.4
Does your laboratory management authorise specific personnel to perform
particular types of sampling, test and/or calibration, to issue test reports and
calibration certificates, to give opinions and interpretations and to operate
particular types of equipment?
003 5.2.5
Does your laboratory maintain records of the relevant authorisation(s),
competence, educational and professional qualifications, training, skills and
experience of all technical personnel, including contracted personnel?
003 5.2.5
Is this information readily available and does it include the date on which
authorisation and/or competence is confirmed?
003 5.2.5
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Personnel (Cont’d)
●
Accommodation and environmental conditions
Do your laboratory facilities for testing and/or calibration, including but not limited
to energy sources, lighting and environmental conditions, facilitate correct
performance of tests and/or calibrations?
003 5.3.1
●
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Does your laboratory ensure that the environmental conditions do not invalidate the
results or adversely affect the required quality of any measurement?
003 5.3.1
●
Is particular care taken when sampling and tests and/or calibrations are undertaken
at sites other than a permanent laboratory facility?
003 5.3.1
●
Are the technical requirements for accommodation and environmental conditions
that can affect the results of tests and calibrations documented?
003 5.3.1
●
Does your laboratory monitor, control and record environmental conditions as
required by relevant specifications, methods and procedures or where they
influence the quality of the results?
003 5.3.2
●
Is due attention paid, for example, to biological sterility, dust, electromagnetic
disturbances, radiation, humidity, electrical supply, temperature, and sound and
vibration levels, as appropriate to the technical activities concerned?
003 5.3.2
●
Are tests and calibrations stopped when the environmental conditions jeopardise
the results of the tests and/or calibrations?
003 5.3.2
●
Are there effective separations between neighbouring areas in which there are
incompatible activities?
003 5.3.3
●
Are measures taken to prevent cross-contamination?
003 5.3.3
●
Are access to and use of areas affecting the quality of the tests and/or calibrations
controlled?
003 5.3.4
●
Does your laboratory determine the extent of control based on its particular
circumstances?
003 5.3.4
●
Are measures taken to ensure good housekeeping in the laboratory?
003 5.3.5
●
Are special procedures prepared where necessary?
003 5.3.5
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Accommodation and environmental conditions (Cont’d)
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Does your laboratory use appropriate methods and procedures for all tests and/or
calibrations within its scope, including sampling, handling, transport, storage and
preparation of items to be tested and/or calibrated, and, where appropriate, an
estimation of the measurement uncertainty as well as statistical techniques for
analysis of test and/or calibration data?
003 5.4.1
●
Does your laboratory have instructions on the use and operation of all relevant
equipment, and on the handling and preparation of items for testing and/or
calibration, or both, where the absence of such instructions could jeopardise the
results of tests and/or calibrations?
003 5.4.1
●
Are all instructions, standards, manuals and reference data relevant to the work of
the laboratory kept up to date and made readily available to personnel (see 4.3 of
HOKLAS 003)?
003 5.4.1
●
Does deviation from test and calibration methods occur only if the deviation has
been documented, technically justified, authorised, and accepted by the customer?
003 5.4.1
●
Does your laboratory use test and/or calibration methods, including methods for
sampling, which meet the needs of the customer and which are appropriate for the
tests and/or calibrations it undertakes?
003 5.4.2
●
Are methods published in international, regional or national standards preferably
used?
003 5.4.2
●
Does your laboratory ensure that it uses the latest valid edition of a standard unless
it is not appropriate or possible to do so?
003 5.4.2
●
When necessary, is the standard supplemented with additional details to ensure
consistent application?
003 5.4.2
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Test and calibration methods and method validation
General
Selection of methods
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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When the customer does not specify the method to be used, does your laboratory
select appropriate methods that have been published either in international,
regional or national standards, or by reputable technical organisations, or in
relevant scientific texts or journals, or as specified by the manufacturer of the
equipment?
003 5.4.2
●
Are laboratory-developed methods or methods adopted by the laboratory used only
if they are appropriate for the intended use and only if they are validated?
003 5.4.2
●
Is the customer informed as to the method chosen?
003 5.4.2
Does your laboratory confirm that it can properly operate standard methods before
introducing the tests or calibrations?
003 5.4.2
●
If the standard method changes, is the confirmation repeated?
003 5.4.2
●
Does your laboratory inform the customer when the method proposed by the
customer is considered to be inappropriate or out of date?
003 5.4.2
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Selection of methods (Cont’d)
Laboratory-developed methods
Is the introduction of test and calibration methods developed by the laboratory for
its own use a planned activity and assigned to qualified personnel equipped with
adequate resources?
003 5.4.3
●
Are plans updated as development proceeds and effective communication amongst
all personnel involved ensured?
003 5.4.3
●
Non-standard methods
When it is necessary to employ methods not covered by standard methods, are
these subject to agreement with the customer and do they include a clear
specification of the customer’s requirements and the purpose of the test and/or
calibration?
003 5.4.4
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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003 5.4.4
●
Does your laboratory validate non-standard methods, laboratory-designed/
developed methods, standard methods used outside their intended scope, and
amplifications and modifications of standard methods to confirm that the methods
are fit for the intended use?
003 5.4.5.2
●
Is the validation as extensive as is necessary to meet the needs of the given
application or field of application?
003 5.4.5.2
●
Does your laboratory record the results obtained, the procedure used for the
validation, and a statement as to whether the method is fit for the intended use?
003 5.4.5.2
●
Are the range and accuracy of the values obtainable from validated methods (e.g.
the uncertainty of the results, detection limit, selectivity of the method, linearity,
limit of repeatability and/or reproducibility, robustness against external influences
and/or cross-sensitivity against interference from the matrix of the sample/test
object), as assessed for the intended use, relevant to the customers’ needs?
003 5.4.5.3
●
If your laboratory is a calibration laboratory, or a testing laboratory performing its
own calibrations, does it have and apply a procedure to estimate the uncertainty of
measurement for all calibrations and types of calibrations?
003 5.4.6.1
●
If your laboratory is a testing laboratory, does it have and apply procedures for
estimating uncertainty of measurement?
003 5.4.6.2
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Non-standard methods (Cont’d)
Has the method developed been validated appropriately before use?
Validation of methods
Estimation of uncertainty of measurement
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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In cases where the nature of the test method preclude rigorous, metrologically and
statistically valid, calculation of uncertainty of measurement, does your laboratory
at least attempt to identify all the components of uncertainty and make a reasonable
estimation, and ensure that the form of reporting of the result does not give a
wrong impression of the uncertainty?
003 5.4.6.2
●
Is reasonable estimation based on knowledge of the performance of the method and
on the measurement scope and make use of, for example, previous experience and
validation data?
003 5.4.6.2
●
When estimating the uncertainty of measurement, are all uncertainty components
which are of importance in the given situation, taken into account using appropriate
methods of analysis?
003 5.4.6.3
●
003 5.4.7.1
●
- computer software developed by the user is documented in sufficient detail and
suitably validated as being adequate for use?
003
5.4.7.2a
●
- procedures are established and implemented for protecting the data and include,
but not be limited to, integrity and confidentiality of data entry or collection,
data storage, data transmission and data processing?
003
5.4.7.2b
●
- computers and automated equipment are maintained to ensure proper
functioning and are provided with the environmental and operating conditions
necessary to maintain the integrity of test and calibration data?
003
5.4.7.2c
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Estimation of uncertainty of measurement (Cont’d)
Control of data
Are calculations and data transfers subject to appropriate checks in a systematic
manner?
When computers or automated equipment are used for the acquisition, processing,
recording, reporting, storage or retrieval of test or calibration data, does your
laboratory ensure that:
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Is your laboratory furnished with all items of sampling, measurement and test
equipment required for the correct performance of the tests and/or calibrations
(including sampling, preparation of test and/or calibration items, processing and
analysis of test and/or calibration data)?
003 5.5.1
●
In those cases where the laboratory needs to use equipment outside its permanent
control, does it ensure that the requirements of HOKLAS 003 are met?
003 5.5.1
●
Are equipment and its software used for testing, calibration and sampling capable
of achieving the accuracy required and comply with specifications relevant to the
tests and/or calibrations concerned?
003 5.5.2
●
Are calibration programmes established for key quantities or values of the
instruments where these properties have a significant effect on the results?
003 5.5.2
●
Before being placed into service, is equipment (including that used for
sampling)calibrated or checked to establish that it meets the laboratory’s
specification requirements and complies with the relevant standard specifications?
003 5.5.2
●
Is equipment checked and/or calibrated before use (see 5.6 of HOKLAS 003)?
003 5.5.2
●
Is equipment operated by authorised personnel?
003 5.5.3
●
Are up-to-date instructions on the use and maintenance of equipment (including
any relevant manuals provided by the manufacturer of the equipment) readily
available for use by the appropriate laboratory personnel?
003 5.5.3
●
Are each item of equipment and its software used for testing and calibration and
significant to the result, when practicable, uniquely identified?
003 5.5.4
●
Are records maintained of each item of equipment and its software significant to
the tests and/or calibrations performed?
003 5.5.5
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Equipment
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Equipment (Cont’d)
Do the records include at least the following:
003 5.5.5
- the identity of the item of equipment and its software?
003 5.5.5a
- the manufacturer’s name, type identification, and serial number or other unique
identification ?
003 5.5.5b
- checks that equipment complies with the specification (see 5.5.2 of
HOKLAS003)?
003 5.5.5c
- the current location, where appropriate?
003 5.5.5d
- the manufacturer’s instructions, if available, or reference to their location ?
003 5.5.5e
- dates, results and copies of reports and certificates of all calibrations,
adjustments, acceptance criteria, and the due date of next calibration?
003 5.5.5f
- the maintenance plan, where appropriate, and maintenance carried out to date?
003 5.5.5g
- any damage, malfunction, modification or repair to the equipment?
003 5.5.5h
Does your laboratory have procedures for safe handling, transport, storage, use and
planned maintenance of measuring equipment to ensure proper functioning and in
order to prevent contamination or deterioration?
003 5.5.6
Is equipment that has been subjected to overloading or mishandling, gives suspect
results, or has been shown to be defective or outside specified limits, taken out of
service?
003 5.5.7
Is it isolated to prevent its use or clearly labelled or marked as being out of service
until it has been repaired and shown by calibration or test to perform correctly?
003 5.5.7
Does your laboratory examine the effect of the defect or departure from specified
limits on previous tests and/or calibrations and institute the “Control of
nonconforming work” procedure (see 4.9 of HOKLAS 003)?
003 5.5.7
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Equipment (Cont’d)
Whenever practicable, is all equipment under the control of the laboratory and
requiring calibration labelled, coded or otherwise identified to indicate the status of
calibration, including the date when last calibrated and the date or expiration
criteria when recalibration is due?
003 5.5.8
When, for whatever reason, equipment goes outside the direct control of the
laboratory, does your laboratory ensure that the function and calibration status of
the equipment are checked and shown to be satisfactory before the equipment is
returned to service?
003 5.5.9
●
When intermediate checks are needed to maintain confidence in the calibration
status of the equipment, are these checks carried out according to a defined
procedure?
003 5.5.10
●
Where calibrations give rise to a set of correction factors, does your laboratory
have procedures to ensure that copies (e.g. in computer software) are correctly
updated?
003 5.5.11
Is test and calibration equipment, including both hardware and software,
safeguarded from adjustments which would invalidate the test and/or calibration
results?
003 5.5.12
●
Is all equipment used for tests and/or calibrations, including equipment for
subsidiary measurements (e.g. for environmental conditions) having a significant
effect on the accuracy or validity of the result of the test, calibration or sampling
calibrated before being put into service?
003 5.6.1
●
Does your laboratory have an established programme and procedure for the
calibration of its equipment?
003 5.6.1
●
Measurement traceability
General
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Measurement traceability (Cont’d)
Specific requirements
Calibration
003 5.6.2
003 5.6.2.1
If your laboratory is a calibration laboratory, is the programme for calibration of
equipment designed and operated so as to ensure that calibrations and
measurements made by the laboratory are traceable to the International System of
Units (SI) (Système International d’unitè )?
003
5.6.2.1.1
●
A calibration laboratory establishes traceability of its own measurement standards
and measuring instruments to the SI by means of an unbroken chain of calibrations
or comparisons linking them to relevant primary standards of the SI units of
measurement. The link to SI units may be achieved by reference to national
measurement standards. National measurement standards may be primary
standards, which are primary realisations of the SI units or agreed representations
of SI units based on fundamental physical constants, or they may be secondary
standards which are standards calibrated by another national metrology institute.
003
5.6.2.1.1
●
When using external calibration services, is traceability of measurement assured by
the use of calibration services from laboratories that can demonstrate competence,
measurement capability and traceability?
003
5.6.2.1.1
●
Do the calibration certificates issued by these laboratories contain the measurement
results, including the measurement uncertainty and/or a statement of compliance
with an identified metrological specification (see 5.10.4.2 of HOKLAS 003)?
003
5.6.2.1.1
●
- the use of certified reference materials provided by a competent supplier to give
a reliable physical or chemical characterisation of a material?
003
5.6.2.1.2
●
- the use of specified method and/or consensus standards that are clearly
described and agreed by all parties concerned?
003
5.6.2.1.2
●
Do calibrations that currently cannot be strictly made in SI units provide
confidence in measurements by establishing traceability to appropriate
measurement standards such as:
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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003
5.6.2.1.2
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Measurement traceability (Cont’d)
Calibration (Cont’d)
Does your laboratory participate in a suitable programme of interlaboratory
comparisons where possible?
●
Testing
If your laboratory is a testing laboratory, do the requirements given in 5.6.2.1 of
HOKLAS 003 apply for measuring and test equipment with measuring functions
used, unless it has been established that the associated contribution from the
calibration contributes little to the total uncertainty of the test result?
003
5.6.2.2.1
●
When this situation arises, does your laboratory ensure that the equipment used can
provide the uncertainty of measurement needed?
003
5.6.2.2.1
●
Where traceability of measurements to SI units is not possible and/or not relevant,
are the same requirements for traceability to, for example, certified reference
materials, agreed methods and/or consensus standards, as for calibration
laboratories (see 5.6.2.1.2 of HOKLAS 003) complied with?
003
5.6.2.2.2
●
Does your laboratory have a programme and procedure for the calibration of its
reference standards?
003 5.6.3.1
●
Are reference standards calibrated by a body that can provide traceability as
described in 5.6.2.1 of HOKLAS 003?
003 5.6.3.1
●
Are such reference standards of measurement held by the laboratory used for
calibration only and for no other purpose, unless it can be shown that their
performance as reference standards would not be invalidated?
003 5.6.3.1
Are reference standards calibrated before and after any adjustment?
003 5.6.3.1
Reference standards and reference materials
●
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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003 5.6.3.2
●
Are internal reference materials checked as far as is technically and economically
practicable?
003 5.6.3.2
●
Are checks needed to maintain confidence in the calibration status of reference,
primary, transfer or working standards and reference materials carried out
according to defined procedures and schedules?
003 5.6.3.3
●
Does your laboratory have procedures for safe handling, transport, storage and use
of reference standards and reference materials in order to prevent contamination or
deterioration and in order to protect their integrity?
003 5.6.3.4
●
Does your laboratory have a sampling plan and procedures for sampling when it
carries out sampling of substances, materials or products for subsequent testing or
calibration?
003 5.7.1
●
Are sampling plan as well as the sampling procedure available at the location
where sampling is undertaken?
003 5.7.1
●
Are sampling plans, whenever reasonable, based on appropriate statistical
methods?
003 5.7.1
●
Does the sampling process address the factors to be controlled to ensure the
validity of the test and calibration results?
003 5.7.1
●
Where the customer requires deviations, additions or exclusions from the
documented sampling procedure, are these recorded in detail with the appropriate
sampling data and included in all documents containing test and/or calibration
results, and communicated to the appropriate personnel?
003 5.7.2
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Measurement traceability (Cont’d)
Reference standards and reference materials (Cont’d)
Are reference materials, where possible, traceable to SI units of measurement, or to
certified reference materials?
Sampling
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Does your laboratory have procedures for recording relevant data and operations
relating to sampling that forms part of the testing or calibration that is undertaken?
003 5.7.3
●
Do these records include the sampling procedure used, the identification of the
sampler, environmental conditions (if relevant) and the diagrams or other
equivalent means to identify the sampling location as necessary and, if appropriate,
the statistics the sampling procedures are based upon?
003 5.7.3
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Sampling (Cont’d)
Handling of test and calibration items
Does your laboratory have procedures for the transportation, receipt, handling,
protection, storage, retention and/or disposal of test and/or calibration items,
including all provisions necessary to protect the integrity of the test or calibration
item, and to protect the interests of the laboratory and the customer?
003 5.8.1
Does your laboratory have a system for identifying test and/or calibration items?
003 5.8.2
Is the identification retained throughout the life of the item in the laboratory?
003 5.8.2
Is the system designed and operated so as to ensure that items cannot be confused
physically or when referred to in records or other documents?
003 5.8.2
Does the system, if appropriate, accommodate a sub-division of groups of items
and the transfer of items within and from the laboratory?
003 5.8.2
When there is doubt as to the suitability of an item for test or calibration, or when
an item does not conform to the description provided, or the test or calibration
required is not specified in sufficient detail, does your laboratory consult the
customer for further instructions before proceeding and record the discussion?
003 5.8.3
Upon receipt of the test or calibration item, are abnormalities or departures from
normal or specified conditions, as described in the test or calibration method
recorded?
003 5.8.3
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Does your laboratory have procedures and appropriate facilities for avoiding
deterioration, loss or damage to the test or calibration item during storage, handling
and preparation?
003 5.8.4
●
Are handling instructions provided with the item followed?
003 5.8.4
●
When items have to be stored or conditioned under specified environmental
conditions, are these conditions maintained, monitored and recorded?
003 5.8.4
●
Where a test or calibration item or portion of an item is to be held secure, does
your laboratory have arrangements for storage and security that protect the
condition and integrity of the secured items or portions concerned?
003 5.8.4
●
Does your laboratory have quality control procedures for monitoring the validity of
tests and calibrations undertaken?
003 5.9.1
●
Are the resulting data recorded in such a way that trends are detectable and, where
practicable, statistical techniques are applied to the reviewing of the results?
003 5.9.1
●
- regular use of certified reference materials and/or internal quality control using
secondary reference materials?
003 5.9.1a
●
- participation in interlaboratory comparison or proficiency-testing programmes?
003 5.9.1b
●
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Handling of test and calibration items (Cont’d)
Assuring the quality of test and calibration results
Is this monitoring planned and reviewed and does it include, but not be limited to,
the following:
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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- replicate tests or calibrations using the same or different methods?
003 5.9.1c
●
- retesting or recalibration of retained items?
003 5.9.1d
●
- correlation of results for different characteristics of an item?
003 5.9.1e
●
Are quality control data analysed and, where they are found to be outside
pre-defined criteria, does planned action taken to correct the problem and to
prevent incorrect results from being reported?
003 5.9.2
●
Are the results of each test, calibration, or series of tests or calibrations carried out
by the laboratory reported accurately, clearly, unambiguously and objectively, and
in accordance with any specific instructions in the test or calibration methods?
003 5.10.1
●
Are the results reported, usually in a test report or a calibration certificate, and do
they include all the information requested by the customer and necessary for the
interpretation of the test or calibration results and all information required by the
method used?
003 5.10.1
●
Does this information normally include that required by 5.10.2, and 5.10.3 or
5.10.4 of HOKLAS 003?
003 5.10.1
In the case of tests or calibrations performed for internal customers, or in the case
of a written agreement with the customers and the results are reported in a
simplified way, is any information listed in 5.10.2 to 5.10.4 of HOKLAS 003,
which is not reported to the customer, readily available in the laboratory which
carried out the tests and/or calibrations?
003 5.10.1
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Assuring the quality of test and calibration results (Cont’d)
Is this monitoring planned and reviewed and does it include, but not be limited to,
the following: (cont’d)
Reporting the results
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Reporting the results (Cont’d)
Does each test report or calibration certificate include at least the following
information, unless the laboratory has valid reasons for not doing so?
- a title (e.g. “Test Report” or “Calibration Certificate”)?
- the name and address of laboratory, and location where the tests and/or
calibrations were carried out, if different from the address of the laboratory?
003
5.10.2a
003
5.10.2b
- unique identification of the test report or calibration certificate (such as serial
number), and on each page an identification in order to ensure that the page is
recognised as a part of the test report or calibration certificate, and a clear
identification of the end of the test report or calibration certificate?
003
5.10.2c
-- the name and address of the customer?
003
5.10.2d
- identification of the method used?
003
5.10.2e
- a description of, the condition of, and unambiguous identification of the item(s)
tested or calibrated?
003
5.10.2f
- the date of receipt of test or calibration item(s) where this is critical to the
validity and application of the results, and the date(s) of performance of the test
or calibration?
003
5.10.2g
- reference to the sampling plan and procedures used by the laboratory or other
bodies where these are relevant to the validity or application of the results?
003
5.10.2h
- the test or calibration results with, where appropriate, the units of measurement?
003
5.10.2i
- the name(s), function(s) and signature(s) or equivalent identification of
person(s) authorising the test report or calibration certificate?
003
5.10.2j
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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*
OK
QM Clause
Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Reporting the results (Cont’d)
Does each test report or calibration certificate include at least the following
information, unless the laboratory has valid reasons for not doing so? (cont’d)
- where relevant, a statement to the effect that the results relate only to the items
tested or calibrated?
003
5.10.2k
In addition to the requirements listed in 5.10.2 of HOKLAS 003, do test reports,
where necessary for the interpretation of the test results, include the following:
- deviations from, additions to, or exclusions from the test method, and
information on specific test conditions, such as environmental conditions?
003
5.10.3.1a
- where relevant, a statement of compliance/non-compliance with requirements
and/or specifications?
003
5.10.3.1b
- where applicable, a statement on the estimated uncertainty of measurement,
information on uncertainty is needed in test reports when it is relevant to the
validity or application of the test results, when a customer’s instruction so
requires, or when the uncertainty affects compliance to a specification limit?
003
5.10.3.1c
- where appropriate and needed, opinions and interpretations (see 5.10.5 of
HOKLAS 003)?
003
5.10.3.1d
- additional information which may be required by specific methods, customers
or groups of customers?
003
5.10.3.1e
In addition to the requirements listed in 5.10.2 and 5.10.3.1of HOKLAS 003, do
test reports containing the results of sampling include the following, where
necessary for the interpretation of test results:
- the date of sampling?
003
5.10.3.2a
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Reporting the results (Cont’d)
In addition to the requirements listed in 5.10.2 and 5.10.3.1of HOKLAS 003, do
test reports containing the results of sampling include the following, where
necessary for the interpretation of test results: (cont’d)
- unambiguous identification of substance, material or product sampled
(including the name of manufacturer, the model or type of designation and serial
numbers as appropriate)?
003
5.10.3.2b
- the location of sampling, including any diagrams, sketches or photographs?
003
5.10.3.2c
- a reference to the sampling plan and procedures used?
003
5.10.3.2d
- details of any environmental conditions during sampling that may affect the
interpretation of the test results?
003
5.10.3.2e
- any standard or other specification for the sampling method or procedure, and
deviations, additions to or exclusions from the specification concerned?
003
5.10.3.2f
In addition to the requirements listed in 5.10.2 of HOKLAS 003, do calibration
certificates include the following, where necessary for the interpretation of
calibration results:
- the conditions (e.g. environmental) under which the calibrations were made that
have an influence on the measurement results?
003
5.10.4.1a
- the uncertainty of measurement and/or a statement of compliance with an
identified metrological specification or clauses thereof?
003
5.10.4.1b
- evidence that the measurements are traceable?
003
5.10.4.1c
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Reporting the results (Cont’d)
Does the calibration certificate relate only to quantities and the results of functional
tests?
003
5.10.4.2
If a statement of compliance with a specification is made, does this identify which
clauses of the specification are met or not met?
003
5.10.4.2
When a statement of compliance with a specification is made omitting the
measurement results and associated uncertainties, does your laboratory record
those results and maintain them for possible future reference?
003
5.10.4.2
When statements of compliance are made, is the uncertainty of measurement taken
into account?
003
5.10.4.2
When an instrument for calibration has been adjusted or repaired, are the
calibration results before and after adjustment or repair, if available, reported?
003
5.10.4.3
Does calibration certificate (or calibration label) exclude any recommendation on
the calibration interval except where this has been agreed with the customer, unless
this requirement is superseded by legal regulations?
003
5.10.4.4
When opinions and interpretations are included, does your laboratory document the
basis upon which the opinions and interpretations have been made?
003 5.10.5
Are opinions and interpretations clearly marked as such in a test report?
003 5.10.5
When the test report contains results of tests performed by subcontractors, are these
results clearly identified?
003 5.10.6
Does the subcontractor report the results in writing or electronically?
003 5.10.6
When your laboratory subcontracts a calibration, does the laboratory performing
the work issue the calibration certificate to your laboratory?
003 5.10.6
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
Technical requirements (continued)
Reporting the results (Cont’d)
In the case of transmission of test or calibration results by telephone, telex,
facsimile or other electronic or electromagnetic means, are the requirements of
HOKLAS 003 met (see also 5.4.7 of HOKLAS 003)?
003 5.10.7
Is the format designed to accommodate each type of test or calibration carried out
and to minimise the possibility of misunderstanding or misuse?
003 5.10.8
Are material amendments to a test report or calibration certificate after issue made
only in the form of a further document, or data transfer, which includes the
statement:
003 5.10.9
●
“Supplement to Test Report [or Calibration Certificate], serial number...[or
as otherwise identified]”, or an equivalent form of wording?
Do such amendments meet all the requirements of HOKLAS 003?
003 5.10.9
When it is necessary to issue a complete new test report or calibration certificate, is
this uniquely identified and does it contain a reference to the original that it
replaces?
003 5.10.9
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations
The obligations of an accredited organisation
After obtaining accreditation, will your laboratory at all times:(a) comply with the accreditation criteria, including accreditation regulations
specified in HKAS 002 and HOKLAS Supplementary Criteria No.33,
technical and non-technical requirements and other conditions as specified by
HKAS Executive under your terms of accreditation;
002 5.1a
(b) represent honestly and truthfully to any person concerned that it is only
accredited for activities stated in the scope of accreditation;
002 5.1b
(c) pay such fees and charges as determined by HKAS Executive;
002 5.1c
(d) endeavour to ensure the accreditation granted by HKAS is not used in a
misleading manner;
002 5.1d
(e) be a legal entity; and
002 5.1e
(f) conform with the Business Registration Ordinance (Cap 310)?
002 5.1f
For any customers for which your laboratory performs any accredited activity, does
your laboratory maintain for such activity a quality standard which is in conformity
with the accreditation criteria as set by HKAS?
002 5.2
Will your laboratory maintain the same quality standard at all times, no matter
whether or not the HKAS accreditation symbol is used in the report or certificate
covering the result of such activity?
002 5.2
When making any statement in relation to your laboratory’s accreditation status in
situation where non-accredited activities are mentioned, will your laboratory
ensure that such a statement is accompanied by a statement indicating which
activities are not accredited?
002 5.3
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
The obligations of an accredited organisation (Cont’d)
Does your laboratory aware of the following accreditation regulation:
002 5.4
“Upon termination of accreditation for all activities of an organisation as specified
in a certificate of accreditation, the organisation shall return such certificate of
accreditation to HKAS Executive forthwith.”?
Will your laboratory cooperate with HKAS Executive and its assessment teams and
provide them with full support during an on-site assessment and in any other
situation such as to provide all necessary information for assessment of the
laboratory’s competence and its conformity with the accreditation criteria?
002 5.5
Upon the request of HKAS Executive, will your laboratory provide HKAS
Executive with a copy of the documentary standard for which it seeks HKAS
accreditation for use during the assessment?
002 5.5
Does your laboratory ensure that it will use its accreditation status only in a manner
that will not bring HKAS or any of its accreditation schemes into disputes and will
not make any statement regarding its accreditation status that HKAS Executive
may reasonably consider it to be misleading?
002 5.6
Does your laboratory maintain complete integrity and impartiality in all
circumstances? Does your laboratory issue and implement a pertinent code of
conduct for all its directors, officers, employees and other personnel involved in its
operation? Will the authorised representative report any impropriety or unlawful
act of the laboratory or any iniquitous management and/or staff to HKAS
Executive? Will the authorised representative further report immediately any
corrupt practice to the ICAC (or similar authority or the police when outside the
jurisdiction of the HKASR)?
002 5.7
Will your laboratory notify HKAS Executive within one calendar month if a new
authorised representative has been appointed?
002 5.8
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
The obligations of an accredited organisation (Cont’d)
Will the authorised representative or in his absence, other responsible person of the
laboratory inform HKAS Executive in writing immediately of any changes or
intended changes in the laboratory’s circumstances which may affect its
conformity with relevant accreditation criteria?
002 5.9
Does your laboratory
confidentiality:
002 5.10
implement
the
following
HKAS
regulation
on
“An accredited organisation shall pay due regard to the confidentially of its
customer’s information and shall make internal rules and guidelines in order to
ensure protection of its customer’s information. Confidential information about a
particular customer shall not be disclosed to a third party without the consent of the
customer, except where the law requires such information to be so disclosed.
However, an applicant organisation or an accredited organisation shall allow
HKAS Executive to examine all its records which are relevant to the scope of
accreditation in order to assess its competence and compliance with the relevant
accreditation criteria. An applicant organisation and an accredited organisation
shall obtain consent from their customers for the disclosure of any relevant
information to HKAS.”?
Does your laboratory ensure that no unofficial contact with assessors, technical
experts and/or AAB members will be made on any matter relating to or in
connection with the assessment of any activity for the purpose of granting or
maintaining accreditation?
002 5.11
Are all communications concerning the laboratory’s assessment make between the
authorised representative or his/her representative or its chief executive or his/her
representative and HKAS Executive?
002 5.11
Does your laboratory have a clear policy in writing concerning the provision or
receipt of advantages by its staff? Does the policy document contain a statement
notifying its staff the law under Section 9 of the Prevention of Bribery Ordinance
(Cap. 201)? Does your laboratory further ensure that the policy is made known to
all its staff members?
002 5.12
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
The obligations of an accredited organisation (Cont’d)
Does your laboratory have a policy and procedure in writing for handling and
resolving complaints, disputes and appeals made to it by its customers or other
parties?
002 5.13
Does your laboratory keep records of all complaints, disputes and appeals and
actions taken for a minimum of 3 years and make available to HKAS Executive for
inspection upon request?
002 5.13
Where a complaint, dispute or appeal received from your customers or other parties
raise any doubt on your compliance with your polices or procedures, will your
laboratory ensure that the relevant areas of its accredited activities are promptly
audited?
002 5.14
If a complaint, dispute or appeal received from your customers or other parties
relating to any of your accredited activities is not satisfactorily resolved within 60
days from the date of receipt, will your laboratory notify HKAS Executive in
writing of this matter?
002 5.15
Is your laboratory aware that any concerned party may lodge complaints with
HKAS on any of your accredited activities?
002 5.16
Is your laboratory aware of the following HKAS regulation?
Upon the request of HKAS Executive, an accredited organisation shall confirm the
authenticity or otherwise of a report, certificate or other document purporting to
have been issued by it for an accredited activity. Where such a report, certificate
or document is found to be a forged document, the organisation shall cooperate
with HKAS Executive in the investigation of its cause and taking mutually
agreeable steps to prevent recurrence.
002 5.17
An accredited organisation shall not provide certification service to any other party
for any standard used by HKAS as accreditation criteria. HKAS Executive will
take immediate action to suspend the accreditation of an accredited organisation in
violation of this requirement.
002 5.18
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Use of HKAS accreditation symbols and claims of accreditation status
Does your laboratory implement the following HKAS regulation:“An accredited organisation may use the relevant HKAS accreditation symbol as
described in HKAS Supplementary Criteria No. 1 and claim its accreditation status
provided that the following conditions are complied with:-
(a) all advertising and promotional materials (including letterheads) shall not, in
the opinion of HKAS Executive, give a false or misleading impression
regarding the accreditation status of the organisation;
002 8.1a
(b) HKAS Supplementary Criteria No. 1 and requirements relevant to the
accreditation scheme concerned as described in the relevant specific
regulations, are conformed with at all times; and
002 8.1b
(c) any statement made by the organisation in connection with its accreditation
status shall not, in the opinion of HKAS Executive, give a false or misleading
impression to any third party of its accreditation status.”?
002 8.1c
Is your laboratory aware of that an organization shall not allow its accreditation be
used to imply that any subject of its accredited activities, for example, a product,
process, system or person is approved by HKAS or HKAS Executive and shall take
suitable actions to stop any incorrect reference to accreditation.
002 8.2
Does your laboratory ensure that its customers, on receiving any report or
certificate which bears a HOKLAS accreditation symbol are aware that the subject
of the activity (e.g. the sample, instrument, product, design or system tested,
calibrated, certified or inspected) as referred to in such report or certificate is in no
way approved nor disapproved by HKAS or HKAS Executive?
002 8.2
Upon termination of the accreditation of any activities carried out by an accredited
laboratory, whether or not voluntarily made, will your laboratory immediately
remove all reference to the accreditation status of the laboratory in any report,
certificate, letterhead, brochure and advertising material?
002 8.3
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HKAS
Has your laboratory documented the code of conduct within its management
system for stating its policies on impartiality, confidentiality, professionalism,
integrity, conflict of interest, and the organisation’s commitment to complying with
the Prevention of Bribery Ordinance (Cap 201) of Hong Kong or applicable laws
and regulations of the country where the accredited organisation is located?
Does the code of conduct cover at least the following aspects:
HKAS SC-06
2.1
(a) acceptance of advantage;
HKAS SC-06
2.2a
(b) offer of advantage;
HKAS SC-06
2.2b
(c) entertainment;
HKAS SC-06
2.2c
(d) compliance with laws of Hong Kong or of relevant jurisdictions;
HKAS SC-06
2.2d
(e) compliance with relevant requirements of applicable professional standards;
HKAS SC-06
2.2e
(f) conflict of interest;
HKAS SC-06
2.2f
(g) use of company assets;
HKAS SC-06
2.2g
(h) confidentiality of company information;
HKAS SC-06
2.2h
(i) outside employment;
HKAS SC-06
2.2i
(j) relationship with customers, suppliers and contractors;
HKAS SC-06
2.2j
(k) procedures for reporting suspected violation and established mechanism for
the prompt and fair adjudication of alleged violations; and
HKAS SC-06
2.2k
(l) disciplinary actions to be taken against violations.
HKAS SC-06
2.2l
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HKAS (Cont’d)
Does your laboratory determine the contents of the code of conduct in accordance
with its circumstances to ensure that all personnel working for it act lawfully,
ethically, professionally, and honestly and protect the impartiality, independence
and integrity of the organisation?
Does your laboratory ensure that all personnel including its directors, staff and
other personnel working for it understand and practise the code of conduct?
HKAS SC-06
2.3
HKAS SC-06
3.1
Has your laboratory provided training to all personnel as part of the orientation
training when they join the organisation and refresher training to all personnel
periodically thereafter?
HKAS SC-06
3.2
Does your laboratory periodically remind all personnel working for it the code of
conduct?
HKAS SC-06
3.3
Is the code of conduct accessible to all personnel working for the organisation?
HKAS SC-06
3.4
Is the authorised representative aware that he/she shall report any impropriety or
unlawful act of the organisation or any iniquitous management and/or staff to
HKAS Executive in accordance with HKAS 002 clause 5.7?
HKAS SC-06
3.5
Does your laboratory periodically review the code’s suitability and adequacy; and
implement improvement as appropriate?
HKAS SC-06
3.6
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS
Is your laboratory aware of the following accreditation regulation on accreditation
procedure:
“An assessment team may require a laboratory to demonstrate a test, a calibration
or other laboratory activities as part of an assessment. It may also require the
laboratory to participate in proficiency testing in order to evaluate its standard and
competence. The specific laboratory activities to be demonstrated will be
selected from those covered in the proposed scope of accreditation at the discretion
of the assessment team.”?
HOKLAS
SC-33
2.1
Is your laboratory aware of the following accreditation regulation on accreditation
procedure:
“HKAS Executive shall conduct a reassessment on the accredited activities of a
laboratory:(a) within twelve months after the date of the notification letter in which HKAS
Executive has granted the accreditation to the laboratory;
(b) every two years after the due date of the first reassessment or at such time
intervals as specified for the Monitoring Plan adopted by the laboratory;
(c) at such other times as may be specified in the terms of accreditation;
HOKLAS
SC-33
2.2a
HOKLAS
SC-33
2.2b
HOKLAS
SC-33
2.2c
(d) upon notification by the authorised representative, or in his absence, other
responsible person of an accredited laboratory, of any change in the structure
and circumstances of the laboratory since the last assessment or reassessment
and in the opinion of HKAS Executive, such change may affect the
laboratory’s competence or conformity with the accreditation criteria; and
HOKLAS
SC-33
2.2d
HKAS Executive may, at its discretion, vary the reassessment schedule.
HOKLAS
SC-33
2.2
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following accreditation regulation on accreditation
procedure: (cont’d)
“HKAS Executive shall conduct a surveillance visit to an accredited laboratory if
neither reassessment, assessment for extension of accreditation, nor surveillance
visit to it has been conducted within the past twelve months’ period or at such time
intervals as specified for the Monitoring Plan adopted by the laboratory. HKAS
Executive may, at its discretion, vary the surveillance visit schedule.”?
Is your laboratory aware of the following HKAS regulation:
“Upon granting of accreditation for a test category to a laboratory, HKAS
Executive shall issue to it a certificate of HOKLAS accreditation for such test
category.”?
Does your laboratory at all times comply with the following HOKLAS
accreditation criteria?
HKAS002, HOKLAS003, relevant HOKLAS Supplementary Criteria and relevant
HKAS Supplementary Criteria.
Does your laboratory ensure that its accreditation status will not use in a way that
may be interpreted by any person that any product, material or any other subject of
an activity for which HOKLAS accreditation has been granted has been approved
or disapproved by HKAS or HKAS Executive? Will your laboratory further
endeavour to ensure that no person use any certificate, report, statement or
documentation issued by it for such activity in a misleading manner?
HOKLAS
SC-33
2.3
HOKLAS
SC-33
2.4
HOKLAS
SC-33
3.1
HOKLAS
SC-33
3.2
Is your laboratory aware of the following HKAS regulation on cooperation:
“A laboratory accredited under HOKLAS shall afford its customers or their
representative reasonable cooperation to monitor the laboratory’s performance (in
so far as to their respective contracts are concerned). This cooperation shall
include:
(a) to perform any reasonable check tests or calibrations or checks for other
laboratory activities, including to prepare, pack and dispatch the test pieces,
samples and other items for such check activities, which serve to verify its
capability or standard of service as requested by the customer; and
HOKLAS
SC-33
3.3a
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation on cooperation:
(cont’d)
(b) to allow each of its customers or their representatives reasonable access to the
laboratory in order to observe any test, calibration or other activity performed
by it for the customer. However, the laboratory shall ensure that the
confidentiality of its other customers will be protected and their information
will not be divulged to any third party (subject to clause 5.10 of HKAS 002).”?
HOKLAS
SC-33
3.3b
For avoidance of doubt, the laboratory may also take reasonable steps to
protect its proprietary information and agree with its customers the cost the
customers have to pay to the laboratory for performing or taking part in such
monitoring activities.
Is your laboratory aware of the following HKAS regulation on subcontracting:
“If an accredited laboratory intends to subcontract any part of its activities to which
HOKLAS accreditation has been granted, it shall ensure that the activities of the
laboratory to which the activities will be subcontracted have been accredited by
HKAS or an accreditation body recognised by HKAS under a mutual recognition
arrangement. A list of such accreditation bodies is available at the HKAS website.
The accredited laboratory shall notify its customer concerned in writing of its
intention to subcontract the activities and the extent of such subcontract. It shall
obtain agreement from the customer regarding such arrangement and shall further
keep records of such agreement. In the report or certificate, the accredited
laboratory shall identify the activities performed and the results obtained by such
subcontractor.”?
HOKLAS
SC-33
3.4
Does your laboratory take part in proficiency testing (PT) programmes which are
relevant to its scope of accreditation organised or specified by HKAS Executive
unless it can demonstrate to HKAS Executive that it has already participated in
alternative programmes which are acceptable to HKAS Executive?
HOKLAS
SC-33
3.5
Is the performance of your laboratory in any proficiency testing activity relevant to
its scope of accreditation acceptable to HKAS Executive?
HOKLAS
SC-33
3.5
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation on proficiency testing:
“An applicant laboratory shall have taken part in appropriate proficiency testing
activity(ies), representative of each test area of the laboratory’s scope of
accreditation to demonstrate its competence in each test area, and obtain
satisfactory result before initial accreditation or accreditation extended to a new
test area will be granted.”?
HOKLAS
SC-33
3.6
Does your laboratory establish a one-year PT participation plan with the coverage
being representative and adequate to demonstrate your laboratory’s competence in
performing tests under its scope of accreditation?
HOKLAS
SC-33
3.7
Where suitable PT programme does not exist or is not practical, has your
laboratory included suitable alternative means aiming to demonstrate the
laboratory’s competence in the plan?
HOKLAS
SC-33
3.7
Has the plan been regularly reviewed and updated where necessary (for example,
in response to changes of the scope of accreditation, staffing, methodology,
instrumentation, and other factors that may affect the quality of the laboratory’s test
or calibration results)?
HOKLAS
SC-33
3.7
Has any change to the plan been documented and justified?
HOKLAS
SC-33
3.7
When the laboratory updates its PT plan, does your laboratory ensure its continual
suitability in relation to its scope of accreditation?
HOKLAS
SC-33
3.7
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation on proficiency testing:
“Records of PT participation for the past four years shall be available to show that
the laboratory participated in PT activities representative of the accredited
tests/calibration activities under each test area of its scope of accreditation. PT
activities participated to represent a group of tests in a test area are expected to
vary in subsequent cycles.
It should be noted that the necessary level of
participation in PT for certain technical disciplines may be specifically defined in
the relevant HOKLAS Supplementary Criteria. Where defined, the laboratory
shall ensure that the planned participation fulfils the respective PT requirements as
stated in the relevant supplementary criteria.
Where more stringent PT
requirements are stipulated in the relevant supplementary criteria, the more
stringent requirements shall be followed.”?
Is your laboratory aware of the following HKAS regulation on proficiency testing:
“An assessment team shall determine the adequacy of the PT participation plan and
the appropriateness of any PT activities and may, at its discretion, require the
laboratory to participate in other forms of PT activity so as to evaluate its
competence in performing specific tests, calibrations or other laboratory activities.
Where an applicant or an accredited laboratory is unable to participate in any
appropriate PT activity because it fails to identify a suitable PT programme, it shall
demonstrate to the satisfaction of the assessment team that it has taken all
reasonable steps to identify such PT programme and any justification to use
alternative suitable means shall be documented. In this clause, PT activity
includes any international, regional and national interlaboratory comparisons as
well as measurement audits and check samples acceptable to HKAS.”?
HOKLAS
SC-33
3.8
HOKLAS
SC-33
3.9
Where the performance of an accredited laboratory in a PT activity is
unsatisfactory, has your laboratory investigated the cause and take effective
corrective actions?
HOKLAS
SC-33
3.10
Are relevant records of corrective actions kept?
HOKLAS
SC-33
3.10
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Clause
*
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Are the actions taken effective to achieve satisfactory performance in PT activity
for the test in question?
HOKLAS
SC-33
3.10
If the laboratory cannot rectify the unsatisfactory PT performance for an accredited
activity within a reasonable timeframe (e.g. three months), has your laboratory
notified HKAS Executive in writing of the actions taken to address the problem
and the measures taken to deal with request for the problematic activity?
HOKLAS
SC-33
3.10
Is your laboratory aware of the following HKAS regulation on approved signatory:
HOKLAS
SC-33
3.11
“An applicant laboratory shall nominate persons to HKAS Executive for signing
endorsed reports and certificates for every test, calibration or other activity in the
scope of accreditation. Accreditation for such activity will not be granted unless
HKAS Executive is satisfied that at least one nominee meets the requirements for
approved signatories as laid down in the accreditation criteria. An accredited
laboratory shall maintain at least one approved signatory for each accredited
activity. Additional persons may be nominated by an accredited laboratory to
HKAS Executive for approval as approved signatories at any time.”?
Is your laboratory aware of the following HKAS regulation on approved signatory:
“An accredited laboratory shall inform HKAS Executive of any change in the
availability and duties of any of its HOKLAS approved signatories. HKAS shall
withdraw the approval concerning such approved signatory who no longer meets
the requirements for approved signatories as laid down in the accreditation criteria.
HKAS Executive may suspend the accreditation of a laboratory for a test,
calibration or other laboratory activity if it does not have any approved signatory
for such activity and has failed to obtain approval from HKAS Executive for a new
signatory within three months from the date when it ceased to have any approved
signatory for such activity.”?
HOKLAS
SC-33
3.12
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Will the authorised representative of your laboratory, within 14 days from the
effective date of any suspension or termination (voluntarily or by HKAS
Executive), identify the customers to whom the laboratory has issued results for
tests, calibrations or other activities which are found to be unreliable because of the
deficiencies discovered during the investigation of the suspension and termination,
and inform them that the results are unreliable?
Is your laboratory aware of the following HKAS regulation on suspension:
“Upon suspension of accreditation, a laboratory shall provide to HKAS Executive
an action plan to solve the concerns related to the suspended activity(ies) within
four weeks from the date of notice of suspension. Such actions shall be taken to the
satisfaction of HKAS Executive within one year from the effective date of
suspension.”
Is your laboratory aware of the following HKAS regulation on suspension and
termination:
HOKLAS
SC-33
4.1
HOKLAS
SC-33
4.1
002 2.10
“HKAS Executive may publish information relating to any suspension and
termination of accreditation granted by HKAS in any HKAS publications and in the
website of HKAS.”?
Is your laboratory aware of the following HKAS regulation:
“An accredited laboratory may display the appropriate HOKLAS accreditation
symbol in a report or certificate issued by it for reporting the result(s) of an activity
accredited under HOKLAS. Such a document is referred to hereafter as a
HOKLAS endorsed report or certificate.”?
HOKLAS
SC-33
5.1
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Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
(a) the HOKLAS accreditation symbol (which includes the HKAS logo, the logo
of the relevant scheme, the laboratory’s registration number and
identification code of the accreditation programme) at the top right hand
corner of the front page. ;
(b)
HOKLAS
SC-33
5.2a
on the same page the following statement (except as specified in (d) below):(i) for non-medical laboratories
“HKAS has accredited this laboratory (Reg. No. HOKLAS 999) under
HOKLAS for specific laboratory activities as listed in the HOKLAS directory
of accredited laboratories.”
HOKLAS
SC-33
5.2.b(i)
Is your laboratory aware of the following HKAS regulation on the use of HKAS
accreditation symbols and claims of accreditation status (cont’d):
(b)
on the same page the following statement (except as specified in (d) below):(cont’d)
(ii) for reports and certificates showing calibration results
“HKAS has accredited this laboratory (Reg. No. HOKLAS 999) under
HOKLAS for specific calibration activities as listed in the HOKLAS directory
of accredited laboratories. The results shown in this report (or certificate,
where appropriate) are traceable to the International System of Units (S.I.) or
recognised measurement standards.”
HOKLAS
SC-33
5.2.b(ii)
The word “this laboratory” in the first sentence of the above statement may be
replaced by the full identity of the laboratory as listed in the scope of
accreditation. When the statement is used alone to claim a laboratory’s
accreditation status without displaying the accreditation symbol (See clause
5.3), the same words shall be replaced by the full identity, registration number
and identification code of the accreditation programme (in form of e.g., ABC
Testing Limited, Registration Number HOKLAS 999 and the appropriate
Identification Code such as “TEST”, “CAL” etc.).
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation:
“For reports and certificates issued for internal use and where it is technically not
possible or very difficult to display the accreditation symbol on a report or
certificate, claiming of accreditation status may be made with the statements in 5.2
(b) without displaying the accreditation symbol. Such claim without displaying
the accreditation symbol is subject to prior written agreement by HKAS Executive.
The laboratory should note that an endorsed report or certificate shall bear the
accreditation symbol. It should also note that if it selects to claim the
accreditation status with one of the statements in 5.2(b) without displaying the
accreditation symbol, requirements that govern the issue of HOKLAS endorsed
report as detailed in this document and HKAS 002 shall also apply to such reports
or certificates.”
Clause
OK
QM Clause
Remarks / Questions to be asked at laboratory
HOKLAS
SC-33
5.2.c
HOKLAS
SC-33
5.3
Does your laboratory ensure that the term “HOKLAS”, the HOKLAS accreditation
symbol and/or a statement claiming accreditation status under HOKLAS will not
use in any report or certificate of laboratory activities except as described above in
clause 5.2 and 5.3?
HOKLAS
SC-33
5.4
Does your laboratory ensure that the form, size, colour and usage of the HOKLAS
accreditation symbol are in accordance with HKAS Supplementary Criteria No. 1?
HOKLAS
SC-33
5.5
Is your laboratory aware of the following HKAS regulation:
HOKLAS
SC-33
5.6
“A HOKLAS endorsed report or certificate shall be signed by a HOKLAS
approved signatory of the issuing laboratory. For printed reports or certificates,
such signature shall be made in hand-written form. For reports or certificates in
an electronic form, the electronic signature shall be in a form acceptable under the
Electronic Transactions Ordinance (Cap. 553). The full name of the approved
signatory (as in his/her identify document such as identity card or passport) shall be
clearly shown alongside the signature.
*
Other arrangements of signing HOKLAS endorsed reports or certificates may be
acceptable subject to agreement from HKAS Executive. When determining the
acceptability of such an arrangement, HKAS Executive will consider all pertinent
factors such as the reliability of the arrangement in ensuring proper and traceable
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Remarks / Questions to be asked at laboratory
authorisation by approved signatories and the demand of users of the accredited
service.”
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation:
“A HOKLAS endorsed report or certificate may contain signatures of others
provided that one of the laboratory’s HOKLAS approved signatory has signed the
report or certificate. Where signatures other than the approved signatory also
appear on the report or certificate, the capacity of the one who signed (such as his
capacity as the quality manager) shall appear on the report or certificate.”?
HOKLAS
SC-33
5.7
Does HOKLAS endorsed report or certificate issued by your laboratory contain
only the results of the tests, calibrations or other laboratory activities for which
your laboratory is holding valid HOKLAS accreditation?
HOKLAS
SC-33
5.8
Is your laboratory aware of the following HKAS regulation:
HOKLAS
SC-33
5.9
“The results of any activity which has not been accredited (whether obtained by the
laboratory or its subcontractor) can only be included in a HOKLAS endorsed
report or certificate if HKAS Executive has explicitly approved such inclusion in
writing. The HOKLAS endorsed report or certificate which contains the said
results shall clearly state therein that the activities are not covered by the
laboratory’s HOKLAS accreditation.”?
Does your laboratory keep at least one exact copy of the test report or certificate
for any accredited activities issued by it for record? Does your laboratory also
keep such copies of report or certificate, all original observations and records in
relation to any accredited activity performed by it for a period of not less than three
years or for a period specified by the HKAS Executive?
HOKLAS SC
No.33
5.10
Does your laboratory ensure that each HOKLAS endorsed report/certificate, or any
report/certificate with the accreditation status claimed, comply with all relevant
accreditation criteria as specified by HKAS Executive from time to time?
HOKLAS
SC-33
5.11
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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QM Clause
Remarks / Questions to be asked at laboratory
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation:
“An accredited laboratory may issue a HOKLAS endorsed report or certificate
which extends the results of a test, a calibration or another laboratory activity on a
sample or samples to the properties or qualities of the inspected lot, batch or
consignment from which the sample(s) was drawn provided that:
(a) the accredited laboratory’s scope of accreditation covers the sampling
involved; and
HOKLAS
SC-33
5.12a
(b) the sample or samples concerned were taken by staff of the accredited
laboratory using the accredited sampling procedure.”?
HOKLAS
SC-33
5.12b
Is your laboratory aware of the following HKAS regulation:
“A HOKLAS endorsed report or certificate may include statements in
amplification of results reported therein provided that:(a) where a sample, batch or consignment is tested, calibrated or examined to
specification requirements such statements shall be limited to information as to
whether or not the sample, batch or consignment conforms to the specification
requirements and the manner or degree in which it departs from such
specification requirements;
HOKLAS
SC-33
5.13a
(b) where a sample is not tested, calibrated or examined to specification
requirements such statements shall be limited to explanation of the results as is
necessary for interpretation of their meaning; and
HOKLAS
SC-33
5.13b
(c) where an instrument or measuring device is calibrated such statements shall be
limited to:-
HOKLAS
SC-33
5.13c
(i) the uncertainty to be associated with its use, or
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Remarks / Questions to be asked at laboratory
(ii) the information referred to in (a) or (b) above as appropriate.”?
HKAS Regulations (continued)
Specific regulations for HOKLAS (Cont’d)
Is your laboratory aware of the following HKAS regulation:
“Opinions or interpretation for which a laboratory is not accredited for providing
can only be included in a HOKLAS endorsed report or certificate if HKAS
Executive has given its approval for such inclusion in writing. An endorsed
report or certificate containing such opinions or interpretations shall in all cases
clearly state that the laboratory is not accredited for providing such opinions or
interpretation.”?
Is your laboratory aware of the following HKAS regulation:
“Application for any accreditation from HKAS shall be made in appropriate forms.
These forms can be downloaded at the HKAS website.”?
HOKLAS
SC-33
5.14
HOKLAS
SC-33
6.1
End
∗ Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.
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