RECOGNITION of TEST
LABORATORIES
FEBRUARY 2006
Rule Note
NR 462 DTE R01 E
17 bis, Place des Reflets – La Défense 2 – 92400 Courbevoie
Postal Address : 92077 Paris La Défense Cedex
Tel. 33 (0) 1 42 91 52 91 – Fax. 33 (0) 1 42 91 53 20
Email : [email protected]
Web : http://www.veristar.com
MARINE DIVISION
GENERAL CONDITIONS
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RULE NOTE NR 462
Recognition of Test Laboratories
February 2006
Section 1
RECOGNITION OF TEST LABORATORY
1
General
1.1
1.2
1.3
1.4
1.5
1.6
1.7
2
4
Organization
Management system
Testing standards and procedures
Review of request for testing
Subcontracting
Complaints
Nonconforming testing
Corrective and preventive actions
Technical records
Management review
Technical requirements
3.1
3.2
3.3
3.4
3.5
3.6
2
Scope
Principles
Application
Attendance to tests
Assessment
Certificate of recognition
Use of BV’s logo or marks
Management requirements
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
3
3
5
Personnel
Testing conditions
Testing methods
Testing equipment
Test items
Reports
Bureau Veritas
February 2006
NR 462, Sec 1
SECTION 1
1
1.1
RECOGNITION OF TEST LABORATORY
General
1.4
Scope
1.1.1 This Rule Note gives the requirements for the recognition of a test laboratory by Bureau Veritas Marine Division
(BV).
1.1.2 The recognition is restricted to given types of product
and given testing standards or testing procedures used for
conformity assessment made by BV.
1.1.3 The test laboratory can be an independent test laboratory or a test laboratory being part of a manufacturing
plant.
1.2
Principles
1.2.1 This Rule Note is based on the principles derived
from the standard ISO/IEC 17025:2005 “General requirements for the competence of testing and calibration laboratories”.
1.3
Application
1.3.1 Application for recognition is to be made using the
appropriate form obtained from the Bureau Veritas local
office.
1.4.1 In general, the recognition procedure does not prevail on the requirements for attendance to tests in accordance with the applicable procedure for the conformity
assessment of the product.
Unless otherwise agreed as per [1.4.2], each test included
in the scope of the recognition is to be made in the presence of a surveyor to BV. The details about attendance to
the tests (witnessing and hold points) is generally agreed in
a document “Inspection and Testing Plan” established by
the test laboratory for each type of tests.
1.4.2 For some types of tests and for test laboratories operating a certified Quality Management System (ISO 9001),
the recognition procedure can include an agreement for a
non-systematic attendance to the tests (like attendance to a
given number of tests for a given time interval). Such recognition is designated as a “BV Mode I” recognition.
Where the tests are carried out without attendance of a BV
surveyor, the tests report issued by the laboratory is to
include a statement making reference to the recognition
certificate like “The tests were carried out in accordance
with the alternative survey conditions agreed within the
scope of BV recognition certificate number ...”.
1.3.2 The typical information and documentation to be
submitted in duplicate copies is given below :
1.5
• Name, site address of the laboratory and contact details,
1.5.1
• Outline of laboratory, organization and management
structure,
• List of typical products or types of products subject to
the tests concerned,
• Detailed list of the testing standards concerned,
• Experience in the performance of these testing standards,
• List of the laboratory staff with their name, qualification,
experience and training,
Attendance to tests
Assessment
Initial assessment
An initial assessment of the test laboratory will be performed by BV based on the requirements of this Rule Note
and the testing standards included in the scope of the recognition.
Where the test laboratory operates a Quality Management
System certified to ISO 9001 standard by an accredited
body, BV will take into consideration this certification to set
up the scope of the initial assessment.
• Copy
of
certificates
or
letter
of
recognition/approval/accreditation by other bodies, if any,
An assessment report will be issued by BV.
• Copy of certificates for Quality Management System
certification (ISO 9001) if any,
1.5.2
• Quality manual and/or documented procedures and
instructions, etc.,
Intermediate assessment
A planning with a time interval to carry out intermediate
assessment will be agreed with the test laboratory.
• Record formats used,
Usually at least one annual assessment will be applied.
• Details of subcontracting, if any,
The time interval is generally agreed with a due date plus or
minus three months.
• Detailed list of equipment used.
February 2006
Bureau Veritas
3
NR 462, Sec 1
1.6
Certificate of recognition
1.6.1
2.2
Initial certificate
Upon satisfactory completion of the recognition procedure,
a certificate of recognition on appropriate form will be
issued by BV to the test laboratory.
Management system
2.2.1 The test laboratory is to have a documented policy,
programmes, procedures, instructions etc. covering the
scope of the testing activities and at least the following :
•
code of conduct,
The certificate will be issued with a validity period and will
be subject to the intermediate assessment programme
agreed between BV and the test laboratory.
•
training programme for the personnel involved in testing
activities (operators, technicians, engineers etc.),
•
maintenance and calibration of testing equipment,
1.6.2
•
monitoring/supervision and verification to ensure compliance with testing procedures,
•
recording and reporting of testing activities,
•
control of subcontracted activities,
•
process of complaints, corrective actions, preventive
actions, maintenance and control of documents.
Modification of a certificate
Upon request of the test laboratory, modifications of the
scope of the recognition can be agreed with BV.
1.6.3
Renewal of a certificate
Upon request of the test laboratory, renewal of the certificate of recognition can be agreed with BV.
where considered necessary by Bureau Veritas, a certificate
may be cancelled. The reasons may be typically :
2.2.2 The policy is to state clearly that the testing activities
are allways to be carried out in accordance with the applicable standard or method as per the customer’s requirements.
• where the laboratory fails to inform of any alteration of
the conditions of the recognition,
2.3
1.6.4
Cancellation of a certificate
• where the intermediate assessment has not been applied
by the test laboratory in the agreed time interval,
• where deficiencies are found during the intermediate
assessment and appropriate corrective action is not
taken,
• where deficiencies are found during further attendance
to tests and appropriate action is not taken.
A test laboratory whose recognition has been cancelled
may apply for a re-assessment by BV who may restore the
recognition.
1.7
Use of BV’s logo or marks
The BV’s agreement will be given in writing with the necessary conditions to be complied with.
2.1
2.3.1 The test laboratory shall make the necessary arrangement to have the testing standards covering the scope of the
recognition.
2.3.2 A periodical review is to be organized in order to
maintain in force updated testing standards and corresponding procedures, work instructions etc.
Obsolete documents are to be identified and marked in
order to prevent from their use, as relevant.
2.4
Review of request for testing
2.4.1 The procedure for the review of the request for testing
shall ensure that :
1.7.1 The laboratory may apply in writing for the use of
BV’s logo or marks and shall give details about the intended
use (type of use, model of media used etc.).
2
Testing standards and procedures
Management requirements
•
the requirements including the selection of the test sample and the testing methods to be used are adequately
defined,
•
the test laboratory has the capability and resources to
meet the requirements,
•
the appropriate test method is selected to meet the
requirements,
Any changes are to be agreed between the test laboratory
and the applicant.
Organization
2.1.1 The organization and management structure of the
test laboratory is to be defined.
2.5
2.1.2 The test laboratory shall demonstrate that the organization ensures the independence and impartiality of the
testing activities.
2.5.1 A procedure for subcontracted testing activities is to
be in place and shall reflect the requirements of this Rule
Note or equivalent.
2.1.3 The responsibilities, authorities and relationships of
the personnel involved in work that might affect the quality
of the tests are to be specified.
2.5.2 A list of subcontractors used for testing activities is to
be maintained with a record of evidence of compliance
with these requirements.
4
Bureau Veritas
Subcontracting
February 2006
NR 462, Sec 1
2.6
ble standard or where the test laboratory considers that they
can influence the results.
Complaints
2.6.1 Records of the complaints received from customers
or other parties are to be maintained as well as investigations and corrective actions taken by the test laboratory.
2.7
3.3
Testing methods
3.3.1 The testing method detailed in the applicable testing
standard is to be used.
Nonconforming testing
2.7.1 A procedure for nonconforming testing is to be in
place and shall ensure that appropriate actions are defined
and taken.
3.3.2 Where the method to be used is a non-standard
method, the procedure developed is to be validated appropriately before use. The validation process is to be documented.
2.8
3.3.3 Where necessary, interlaboratory comparisons can be
necessary to give evidence that the method used is appropriate.
Corrective and preventive actions
2.8.1 Corrective actions shall be based on investigation to
determine the cause of the problem, shall be selected,
implemented and monitored in order to prevent recurrence.
2.8.2 Preventive actions are to be taken, implemented and
monitored where improvement opportunities are detected.
2.9
Technical records
2.9.1 The records are to be legible and made in any appropriate media.
2.9.2 Retention time of records are to be in accordance
with the applicable requirements.
3.3.4 Procedures for the estimation of uncertainty of measurement are to be available and applied, as appropriate.
3.3.5 Procedure for the control of data covering the data
entry, storage, transmission, and processing are to be available and applied.
3.4
Testing equipment
3.4.1 The test laboratory is to be equiped with the necessary items for sampling, measurement and testing for the
correct performance of the tests.
2.9.3 Records are to be stored in a way compatible with
the retention time to ensure their legibility.
3.4.2 Before being placed into service, equipment is to be
calibrated in accordance with the relevant specification or
standard, as appropriate.
2.10 Management review
A programme and a procedure for the calibration of equipment are to be available and applied.
2.10.1 Laboratory’s top management is to conduct periodical management review of the system and testing activities
in order to introduce necessary changes and improvements.
Equipment requiring calibration is to bear a mark to indicate the status of calibration, date of last calibration and
expiration criteria.
3
3.4.3 A procedure for handling, transport, storage, use and
maintenance of measuring equipment is to be available and
applied.
3.1
Technical requirements
Personnel
3.1.1 The test laboratory is responsible for the qualification
and training of its personnel operating specific equipment,
performing test, evaluating results and signing reports.
3.1.2 The personnel is to have an adequate experience and
be familiar with the operation of any necessary equipment.
3.1.3 The personnel undergoing training is to be supervised
by confirmed personnel.
3.1.4 Where appropriate, qualification is to be verified by
certification.
3.2
Testing conditions
3.4.4 Each item of equipment used for testing is to be identified, as far as practicable.
3.4.5 Equipment that has been considered defective for
whatever reason is to be clearly marked to prevent from its
use.
3.5
Test items
3.5.1 A procedure covering the transportation, receipt,
handling, storage and disposal of the test item with all provisions necessary to protect the integrity of the test item is to
be available and applied.
3.2.1 The facilities are to be such as to facilitate correct
performance of the tests.
3.5.2 The test laboratory is to have procedures to take samples for testing covering the sampling plan, withdrawal,
preparation and identification of sample, as appropriate and
in accordance with the applicable requirements.
3.2.2 The test laboratory shall monitor, control and record
environmental conditions in accordance with the applica-
3.5.3 A system of identification of the test item and test
sample is to be in place to ensure their traceability.
February 2006
Bureau Veritas
5
NR 462, Sec 1
3.6
Reports
3.6.1 The results of each test are to be reported by the test
laboratory in accordance with the requirements of the testing standard.
3.6.2 Usually the test report is to include the following
information :
• a title
• the name and address of the laboratory and the location
where the tests were carried out , as appropriate,
• unique identification number of the test report,
• name and address of the customer,
• identification of the test method used,
• description, condition and identification of the item
tested,
6
•
date of receipt of the test item, as necessary, relevant
sampling information, and date of performance of the
test,
•
test results with the measurement units, and estimated
measurement uncertainty, as appropriate,
•
any deviations, additions or exclusions from the test
method,
•
a statement of compliance/non compliance with the
requirements, as appropriate,
•
opinions and interpretations, as appropriate.
3.6.3 It is reminded that where the tests are carried out
without attendance of a BV surveyor, the tests report issued
by the laboratory is to include a statement making reference
to the recognition certificate like “The tests were carried out
in accordance with the alternative survey conditions agreed
within the scope of BV recognition certificate number ...”.
Bureau Veritas
February 2006