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4.3 Document control
4.4 Review of requests, tenders and
contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
No significant change
4.7 Service to the customer
HOKLAS
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4.7.1 The laboratory shall afford clients
be willing to cooperate with customers or
their representatives cooperation to
clarify the client’s request and to monitor
in clarifying the customer’s request and
in monitoring the laboratory’s
performance….clientscustomers.
Commentary
HOKLAS
003
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Edition
1. There is no significant difference in the
requirement, except that a laboratory
should show willingness to cooperate.
2. The HKAS policy in this regard is given in
HKAS 002 cl. 9.2.3, which remains
unchanged.
HOKLAS
003
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4.7.2 The laboratory shall seek feedback, both
positive and negative, from its customers.
The feedback shall be used and analysed to
improve the management system, testing
and calibration activities and customer
service.
Note Examples of the types of feedback
include customer satisfaction surveys and
review of test or calibration reports with
customers.
Commentary
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From recommendation to requirement
4.8 Complaints
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No significant change
4.9 Control of nonconforming testing and/or
calibration work
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4.9.1 ….
Edition
c) Corrective actions are Correction is taken
immediately, together with any decision
about the acceptability of the
nonconforming work;
Commentary
HOKLAS
003
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(ISO9000 Quality management systems –
Fundamentals and vocabulary)
1. Corrective action – action to eliminate the
cause of a detected nonconformity, or other
undesirable situation.
2. Correction – action to eliminate a detected
nonconformity. (A correction can be made
in conjunction with a corrective action, i.e.
both may be needed.)
Commentary
HOKLAS
003
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Edition
3. Corrective action is required only in
situations described in clause 4.9.2, i.e.
nonconforming work could recur.
4. Corrective action requirements given in
clause 4.11. (Corrective action is taken to
prevent recurrence whereas preventive action is
taken to prevent occurrence. The only difference is
the time when the action is taken – after or before
occurrence of nonconformity.)
Commentary
HOKLAS
003
8th
Edition
5. Past assessment experience indicates that
laboratories seldom identify the occurrence
of nonconforming work. HOKLAS policy
clarifies and gives examples of common
nonconforming work, and highlights the
necessity to adhere to the requirements
given in clause 4.9.1.
Commentary
HOKLAS
003
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Edition
6. Initiation is needed when any aspect of a
laboratory’s testing and/or calibration work,
or the results of this work, do not conform
to its own procedures or the agreed
requirements of the customer.
4.10 Improvement
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The laboratory shall continually improve the
effectiveness of its management system
through the use of the quality policy, quality
objectives, audit results, analysis of data,
corrective and preventive actions and
management review.
Commentary
HOKLAS
003
8th
Edition
1. A new requirement.
2. The aim is to increase the probability of
enhancing the satisfaction of customers
(perception of the degree to which
customer’s requirements have been
fulfilled) and other interested parties.
3. Continual improvement = recurring
activity to increase the ability to fulfil
requirement (ISO 9000 definition).
Commentary
HOKLAS
003
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Edition
4. Effectiveness – extent to which planned
activities are realised and planned results
achieved.
5. Not continuous, but continual.
6. Applies to management system but should
be focused on aspects related to quality and
technical management.
4.11 Corrective action
HOKLAS
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No significant change
4.12 Preventive action
HOKLAS
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4.12.1 Needed improvement and potential
sources of nonconformances
nonconformities, either technical or
concerning the quality management system,
shall be identified. If When improvement
opportunities are identified or if preventive
action is required, …
Commentary
HOKLAS
003
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1. Stress the importance of improvement
opportunities (versus potential
nonconformities).
2. No significant change.
4.13 Control of records
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Commentary
1. No significant change
2. HKAS policy updated and clarified.
3. LIMS – validated and meet requirements of this
section.
4. Retention periods of equipment records and
training records
4.14 Internal audits
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No significant change
4.15 Management reviews
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4.15.1 In accordance with a …., the
laboratory’s executive top management
and …review of the laboratory’s quality
management system …The review shall
take account of:
- …
- recommendations for improvement;
- ….
Commentary
HOKLAS
003
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Edition
1. Included a new review item
2. Stress the importance of improvement
5.1 General
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No significant change
5.2 Personnel
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5.2.2 …The effectiveness of the training
actions taken shall be evaluated.
Commentary
Not just provide the training but its
effectiveness is required to be evaluated
by, for example, competence assessment.
Already a HKAS policy. Hence, not new.
Commentary
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1. HKAS policy – The continuing competence
of technical personnel shall be assessed
regularly and records of such assessment
shall be kept.
2. Contract Staff - ..training required for
contract staff irrespective of duration of
contract and whether full-time or part-time
basis
5.3 Accommodation and environmental
conditions
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No significant change
Commentary
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• HKAS policy – It should be emphasized that
it is the responsibility of the laboratory to
ensure that its operation is in compliance
with all applicable regulations, particularly
those related to laboratory safety.
• HKAS is not a regulatory authority and
assessments will not cover regulatory
requirements. Assessors may give general
safety advice but should not be regarded as
meeting the relevant regulatory
requirements.
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5.4 Test and calibration methods and method
validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.10 Reporting of results
No significant change
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5.9 Assuring the quality of test and
calibration results
5.9.2 Quality control data shall be analysed
and, where they are found to be outside predefined criteria, planned action shall be
taken to correct the problem and to prevent
incorrect results from being reported.
Commentary
HOKLAS
003
8th
Edition
1. Imply in last edition but now stating it
explicitly.
2. Not entirely new. Some HOKLAS
Supplementary Criteria already stated
this explicitly, e.g. No. 6, 8, 12, 20, 21, 22.