SOP How To Assess A PQS Testing Laboratory

SOP No FCH/ IVB/QSS/PQS/007
Date of issue: 08/07/2004
Version: 01.05
Effective date: 08/07/2004
Title: How to assess a PQS testing laboratory
Revision Date:
06/01/2007
Page: 2 of 22
Table of Content
1.0 Purpose.......................................................................................................................... 3
2.0 Scope............................................................................................................................. 3
3.0 Responsibility ............................................................................................................... 3
4.0 Documentation required................................................................................................ 4
5.0 Procedure ...................................................................................................................... 4
5.1
Assessment Register ........................................................................................... 5
5.2
Make initial inquiries and check ISO/IEC 17025 accreditation ......................... 6
5.3
Send assessment information pack ..................................................................... 6
5.4
Information dossier ............................................................................................. 6
5.5
Evaluate facilities and expertise.......................................................................... 6
5.5.1
ISO/IEC 17025 accreditation:..................................................................... 6
5.5.2
ILAC accreditation: .................................................................................... 7
5.5.3
References:.................................................................................................. 7
5.5.4
Facilities and CVs:...................................................................................... 7
5.6
On-site inspection ............................................................................................... 8
5.7
Evaluation results................................................................................................ 8
6.0 Distribution ................................................................................................................... 9
Annex 1 Definitions....................................................................................................... 10
Annex 2 References ....................................................................................................... 10
Annex 3 Standard letter A: Assessment information pack ............................................ 11
Annex 4 Standard letter B: Request for missing information........................................ 13
Annex 5 Standard letter C: Request for reference ......................................................... 14
Annex 6 Standard letter D: Request for laboratory inspection visit .............................. 16
Annex 7 Model checklist for a laboratory inspection visit ............................................ 17
Annex 8 Evaluation checklist ........................................................................................ 18
Annex 9 Standard letter E: Assessment rejection .......................................................... 19
Annex 10 Standard letter F: Acceptance ....................................................................... 20
Annex 11 Format for listing a PQS-assessed testing laboratory on the PQS website .... 21
REVISION HISTORY FORM ......................................................................................... 22
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1.0 Purpose
Before a product or device can be added to the PQS database, it must be verified.
Verification establishes whether a specific product from a specific manufacturer satisfies
the requirements of the relevant PQS performance specification1. There are three distinct
methods:
1. Type-examination.
2. Independent type-testing.
3. Full Quality Assurance.
An accredited testing laboratory is an organization that can perform one or more of the
functions outlined above. In addition it must be able to demonstrate its competency by
conforming to appropriate internationally or nationally accepted standards or codes of
practice and must be able to show to a competent third-party accreditation body that it
does so; usually by peer assessment2.
All independent type-testing must be carried out by an accredited testing laboratory. In
addition accredited testing laboratories may sometimes be employed to carry out typeexamination or full quality assurance of PQS products. This SOP describes how to assess
whether a testing laboratory has the relevant competencies. Laboratories that satisfy the
assessment process may then be accepted by WHO to test specific categories of PQS
products.
The procedures set out in this SOP will be followed by the PQS Secretariat (Secretariat),
by the PQS Steering Group (PQS-SG) and by any WHO employee or consultant
appointed to inspect a testing laboratory.
2.0 Scope
This SOP is applicable whenever a testing laboratory is being considered for assessment
under the PQS initiative.
3.0 Responsibility
Responsibilities and tasks will be assigned as follows:
1. The PQS Secretariat (Secretariat) will identify potentially suitable testing
laboratories and will send out an assessment information pack.
1
Refer to SOP No FCH/ IVB/ATT/VML/004: How to develop and publish a PQS product verification
protocol.
2
Adapted from Testing, Quality Assurance, Certification and Accreditation. ILAC-I2:1994.
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2. The Secretariat will analyze the information dossier supplied by the testing
laboratory. If the dossier is satisfactory, the Secretariat may then arrange for a
suitably qualified WHO employee or consultant to visit the laboratory.
3. Based upon the visit report, the Secretariat will make a recommendation to the
PQS Steering Group (PQS-SG).
4. The PQS-SG will direct the Secretariat whether or not to accept the test
laboratory.
5. The Secretariat will notify the test laboratory of the PQS-SGs decision.
4.0 Documentation required

Associated documents: Refer to the following:
SOP No FCH/ IVB/QSS/PQS/001: How to develop and publish a PQS product
performance specification.
SOP No FCH/ IVB/QSS/PQS/002: How to review and revise a PQS product
performance specification.
SOP No FCH/ IVB/QSS/PQS/003: How to withdraw a PQS product performance
specification.
SOP No FCH/ IVB/QSS/PQS/004: How to develop and publish a PQS product
verification protocol.
SOP No FCH/ IVB/QSS/PQS/005: How to review and revise a PQS product
verification protocol.
SOP No FCH/ IVB/QSS/PQS/006: How to withdraw a PQS product verification
protocol.
SOP No FCH/ IVB/QSS/PQS/008: How to re-evaluate PQS-assessed testing
laboratory.
5.0 Procedure
Each of the following task headings includes (in brackets) a description of the person or
group responsible for the task. Refer to Annex 1 for the definitions of certain critical
terms used in this SOP. Figure 1 outlines the procedure described in detail below.
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Figure 1 Procedure for pre-qualifying a testing laboratory

Start
Make initial
contact
Test laboratory may apply to WHO

or WHO may invite applications
Laboratory
ISO/IEC 17025
accredited?
no
yes
PQS Secretariat
sends Approval
Information Pack
Laboratory
responds
Facilities
and expertise
suitable?
no
yes
Check against current
list at www.ilac.org
On-site inspection
optional
Accept
laboratory
yes
yes
Accreditation
body an ILAC
signatory?
Laboratory
acceptable?
no
no
On-site inspection
essential
Reject
laboratory
5.1
Assessment Register (Secretariat): The Secretariat will establish and maintain a
register of testing laboratories which includes a comprehensive list of testing laboratories
and which records details of every application for assessment. Copies of all
correspondence with testing laboratories will be kept in the register.
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5.2
Make initial inquiries and check ISO/IEC 17025 accreditation (Secretariat):
Candidate testing laboratories may formally apply to WHO for assessment. Alternatively
WHO may choose to make the initial contact. The initial inquiry will establish the
laboratorys accreditation arrangements and its general area of expertise. No testing
laboratory will be accepted to carry out type-examination, independent type-testing or
full quality assurance unless it is already accredited in accordance with ISO/IEC
17025:1999 General requirements for the competence of testing and calibration
laboratories3. This document sets out all of the requirements that testing and calibration
laboratories have to meet to demonstrate that they operate a quality system, are
technically competent, and are able to generate technically valid results4. If initial
enquires show that a laboratory is not ISO/IEC 17025 accredited then it must be rejected.
5.3
Send assessment information pack (Secretariat): All testing laboratories that are
considered for assessment will be sent an assessment information pack by the Secretariat.
This will contain, as a minimum, the following information:
PQS performance specification(s) and PQS verification protocol(s) relevant to the
laboratorys expertise;
a covering letter outlining the assessment process and listing the information
required from the testing laboratory. In addition the letter will set out formal
terms and conditions. Standard letter A will be used as the basis for this
correspondence (Annex 3).
5.4
Information dossier (Testing laboratory): All testing laboratories who seek
assessment will submit an information dossier to the Secretariat. This must contain all
the information requested in standard letter A. The Secretariat will screen the dossier for
completeness before it is evaluated. If the dossier is incomplete the laboratory will be
contacted in writing and will be given a single opportunity to provide the missing
information or material. Standard letter B will be used for this purpose (Annex 4). If,
after a reasonable period has elapsed, the laboratory fails to supply the missing
information, the dossier will be automatically rejected.
5.5
Evaluate facilities and expertise (Secretariat): Completed information dossiers
will be evaluated. The key checks will be as follows:
5.5.1 ISO/IEC 17025 accreditation: Check that the ISO/IEC 17025 accreditation is
valid. Only laboratories that have a valid accreditation can be considered for assessment.
Under the terms of the ILAC agreement, laboratories operating under earlier standards (ISO/IEC Guide 25
and/or EN45001) were required to comply with ISO/IEC 17025:1999 by 31st December 2002.
4
Quoted from the introduction to ISO/IEC 17025:1999.
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5.5.2 ILAC accreditation: Check whether the accreditation body that issued the
ISO/IEC 17025 accreditation is an ILAC signatory. The International Laboratory
Accreditation Cooperation (ILAC) arrangement came into effect on 31st January 2001.
Its stated aim is to develop a global network of mutually recognized and accredited
testing and calibration laboratories that can be relied upon to provide accurate results so
that products can be tested once and accepted everywhere. As of December 2003 forty
five laboratory accreditation bodies had become signatories to the ILAC arrangement.
All these signatories have been peer-reviewed and have been shown to meet ILACs
criteria for competence. If the accreditation body is an ILAC signatory it may be
unnecessary to carry out an inspection of the laboratory, although an inspection is still
advisable. If the accreditation body is not an ILAC signatory, then an inspection is
essential. Laboratories that are accredited by ILAC signatories should receive a
surveillance visit every 12 to 18 months and a reassessment visit every 4 to 5 years5.
Other accreditation bodies may have different arrangements.
5.5.3 References: Check the references listed in the information dossier using standard
letter C and the attached questionnaire (Annex 5). There should be a minimum of at least
three replies.
5.5.4 Facilities and CVs: Check the information in the dossier to establish whether the
testing laboratory has adequate facilities and suitably qualified personnel to perform the
tests shown in the product verification protocol(s) attached to the assessment information
pack. An acceptable laboratory will:
Have the testing equipment described in paragraphs 1.3, 1.5, 1.6, 1.7, 1.8 and 1.9
of EPI Performance Specifications and Test Procedures - Annex 1: Testing
institutions February 1999 revision.
(not specifically covered by ISO 17025)
Have a laboratory structure and management system that is clearly defined and
which is organized in such a way that the integrity of its staff and operation can be
judged.
(ISO Section 4 Management requirements)
Employ suitably qualified laboratory staff, experienced and technically competent
for the work to be undertaken.
(ISO Section 5.2 Personnel)
Use laboratory equipment required for testing against the appropriate WHO
product verification protocol and which is properly installed, maintained and
calibrated. Adequate records of calibration and servicing must be maintained.
(ISO section 5.4 Test and calibration methods and method validation)
See ILAC-G10:1996 Harmonised Procedures for Surveillance and Reassessment of Accredited

Laboratories. www.ilac.org
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Have a testing environment and laboratory suitable for the tests undertaken.
(ISO section 5.3 Accommodation and environmental conditions)
Employ laboratory practices that are demonstrable and meet WHO
requirements, such as:
- sample identification; (ISO Section 5.7 Sampling)
- test methods and procedures; (ISO Section 5.4)
- supervision of staff; (ISO 5.2.1 and 5.2.3)
- checking of results and calculations. (ISO 4.12.2.1 to .3)
Operate a secure laboratory record system containing full details of all tests
undertaken.
(ISO Section 4.3 Document control)
Supply test reports and documents which are accurate, clear and unambiguous and
contain all the relevant information.
(ISO section 5.10 Reporting the results)
The above requirements are those identified as being the optimum requirement;
nevertheless, failure to fully comply will not preclude consideration.
If an inspection is necessary the Secretariat will write to the laboratory using standard
letter D (Annex 6).
5.6
On-site inspection (Secretariat/consultant): If an on-site inspection is indicated,
the Secretariat will arrange for a suitably qualified member of staff, or for a consultant, to
visit the testing laboratory. Annex 7 gives a model checklist for such an inspection. The
appointed staff member or consultant will prepare a brief trip report setting out his/her
observations and conclusions.
5.7
Evaluation results (Secretariat): The Secretariat will prepare a brief report and
recommendation on the evaluated testing laboratory, appending the on-site inspection
report where relevant. This document will be submitted to the PQS-SG. Annex 8 shows
a checklist which may be used to record the results of the evaluation.
5.8
Acceptance (PQS-SG): The PQS-SG, will review the report and recommendation
and will direct the Secretariat whether or not to add the testing laboratory to the list of
accepted testing bodies.
5.9
Publication (Secretariat): If the PQS-SG rejects the laboratory, it will be notified
of this decision using standard letter E (Annex 9). If the PQS-SG accepts the laboratory
will be notified in writing using standard letter F (Annex 10). A copy of the relevant
letter will also be sent to UNICEF-SD and a further copy will be filed in the
Prequalification Register.
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Relevant details of every accepted testing laboratory will be published electronically in

.pdf format on the PQS website in the format shown in Annex 11. In addition
notification of publication will be posted on the TechNet21 and SIGN e-forums.
6.0 Distribution
This SOP is to be distributed to the following individuals and groups:
PQS Secretariat;
all members of the PQS Steering Group;
any WHO employee or consultant who is appointed to inspect a testing
laboratory.
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Annex 1 Definitions
email
IEC
ILAC
in writing
ISO
QA
Correspondence by electronic mail. A hard copy will be kept on

file.
International Electro-technical Commission
International Laboratory Accreditation Cooperation
Where the phrase in writing is used this means correspondence be
transmitted by mail or by fax. A hard copy will be kept on file.
International Standards Organization
Quality Assurance.
Annex 2 References
ILAC-12:1994 Testing, Quality Assurance, Certification and Accreditation.

www.ilac.org
ILAC-13:1996 The Role of Testing and Laboratory Accreditation in International
Trade. www.ilac.org
ILAC-G10:1996 Harmonised Procedures for Surveillance and Reassessment of
Accredited Laboratories. www.ilac.org
ILAC-G15:2001 Guidance for Accreditation to ISO/IEC 17025. www.ilac.org
ISO/IEC 17025:1999 General requirements for the competence of testing and
calibration laboratories. www.iso.org
The ILAC Mutual Recognition Arrangement. www.ilac.org
WHO/EPI/LHIS/97.03 EPI Performance Specifications and Test Procedures Annex 1: Testing institutions. February 1999 revision.
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Annex 3 Standard letter A: Assessment information pack

Dear Sirs,
Application for assessment of an independent testing laboratory under the PQS
initiative: Information dossier
We refer to your <letter/fax/email> dated <dd.mm.yy> in which you expressed an
interest in offering the following testing services: (Strike out items that do not apply)
type-examination;
independent type-testing;
full quality assurance
We enclose the relevant performance specification(s) and product verification
protocol(s) relating to the range of products that we consider you may be qualified to
evaluate: (Strike out items that do not apply)
Type-examination:
< Performance specification(s) description and reference, including revision ref.>
<Product verification protocol(s) description and reference, including revision ref.>
Independent type-testing:
Full Quality Assurance
We also attach <paragraphs 1.3, 1.5, 1.6, 1.7, 1.8 and 1.9 from EPI Performance
Specifications and Test Procedures - Annex 1: Testing institutions> setting out some key
items of test equipment that will be required for the specific purposes described.
If you wish to be considered for assessment you must provide us with an information
dossier containing the following:
full details of accreditation under ISO/IEC 17025, including next reassessment date;
full details of your accreditation body;
the names and contact details of at least five well-established organizations that have
used your testing services during the past three years.
full details of the laboratory facilities and equipment that are relevant to the enclosed
performance specification(s) and product verification procedure(s);
full details of your quality system;
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CVs for the personnel who would carry out the work prescribed above;
Confirmation of the range of products you would be able to test, classified by type of
service (e.g. Type-examination, Independent type-testing or Full Quality Assurance);
If your response to this letter is satisfactory we may wish to inspect your laboratory and
to interview key members of staff before we can confirm acceptance under the PQS
initiative. We also refer you to the general terms and conditions attached to this letter.
Yours faithfully,
TERMS AND CONDITIONS
1. Examination of information dossier: The information dossier will be screened by WHO for
completeness prior to its evaluation. The dossier can be rejected on grounds of incompleteness.
Complete dossiers will be retained for evaluation purposes. Incomplete dossiers may be retained for
record purposes.
2. Evaluation results: Completed dossiers will be evaluated. WHO will then write to the testing
laboratory confirming EITHER: that the application for is unsuccessful, OR: that WHO wishes to
make an inspection of the laboratory before reaching a final decision, OR that WHO proposes to
accept the testing laboratory as being suitable to carry out the tasks specified in the letter.
3. Meaning of PQS-assessed status: The conferment of PQS-assessed status means that WHO considers
the testing laboratory to be technically capable of carrying out certain specified work on its behalf.
WHO does not undertake that the testing laboratory will be commissioned to carry out any such work.
4. Payment for testing services: WHO does not itself undertake to pay for testing services. In most
instances testing fees will be paid by the manufacturer of the product under test.
5. Re-evaluation: The testing laboratory will be subjected to a WHO review once a year. Once every 12
months testing laboratories will be required to submit evidence of periodic surveillance or
reassessment of any relevant accreditations or certifications, including ISO/IEC 17025 accreditation,
together with details of any changes in facilities or personnel which may have an impact on the quality
of the service offered by the laboratory.
6. Periodic inspections: Laboratories will also be subject to monitoring and reassessment visits by
WHO. The purpose of periodic monitoring and reassessment is to determine whether a laboratory is
continuing to comply with required procedures. Such surveillance visits will usually be undertaken
and completed within one day.
7. Withdrawal of qualification: If PQS-assessed status is withdrawn the reason for this will be
communicated to the laboratory by the WHO. It will be necessary to make formal application for
reinstatement. This application must detail the corrective actions taken to warrant the laboratorys requalification.
8. Confidentiality undertaking: WHO will treat, and will require evaluators of information dossiers to
treat all information to which they will gain access during the evaluation, or otherwise in connection
with the discharge of their responsibilities in regard to the assessment of testing laboratories as
confidential. In addition, the evaluators of information dossiers will be required to sign a Declaration
of Interest. A sample of the confidentiality and declaration of interest undertaking for evaluators of
information dossiers can be obtained on request. If based on this Declaration of Interest, it is felt that
there is no risk of real or perceived conflict of interest and it is thus deemed appropriate for evaluators
to undertake this work, they will discharge their functions exclusively as advisers to WHO.
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Annex 4 Standard letter B: Request for missing information

Dear Sirs,
initiative: Information dossier
Your reference: <reference>
We refer to your letter dated <dd.mm.yy> enclosing the information dossier requested in
our letter dated <dd.mm.yy>.
We have now made a preliminary examination of the dossier and find that the following
material is missing:
<list missing information>
If we do not receive the missing items by <dd.mm.yy> we will reject your application.
You will receive no further correspondence from us.
If you have any queries, please contact us as soon as possible.
Yours faithfully,
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Annex 5 Standard letter C: Request for reference

Dear Sirs,
<Name of testing laboratory>: Request for reference
WHO is evaluating <name of testing laboratory> for its suitability to carry out
independent testing of the following types of product that are used in the Expanded
Programme for Immunization:
<list generic product types>
The laboratory has given the name of your organization as a reference. We would be
most grateful if you would complete the attached questionnaire and return it to us within
the next four weeks. Your reply will be treated as confidential and will be used solely for
our own internal evaluation of the named testing laboratory.
Please use the other comments section to highlight any issues that are not covered
elsewhere by the questionnaire. We recognize that the response to questionnaires of this
type can be somewhat subjective. If you would like to send us additional material to
support your observations and conclusions we would be grateful to receive it.
Yours faithfully,
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Annex 5 (cont) Standard letter C: Reference questionnaire

Reference questionnaire for: <name of testing laboratory>
Questionnaire completed by:
....................
On behalf of:
....................
Date:
1. For how long have you used
the testing laboratory?
2. Will you continue to use the
laboratory?
....................
If no, please say why:

3. What types of product have
been tested for you and for
what purpose?
4. Where tests generally

completed on time?
If no, please comment:
5. Where tests generally
completed on budget?
If no, please comment
6. Please rank the following
qualities on a scale of 0-4:
Quality of test facilities:
years
Yes
No
....................
Type of product
Purpose of test
Yes
No
....................
Yes
No
....................
0
1
2
3
4
(very poor)
(excellent)
Quality of laboratory
management:
Quality of staff responsible
for testing:
Quality and accuracy of test
report(s):
Other comments:
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Annex 6 Standard letter D: Request for laboratory inspection visit

Dear Sirs,
initiative: Request for inspection visit
We have now made a full examination of your dossier and would like to arrange a visit to
your laboratory.
In particular we wish to inspect the following:
<list facilities of interest>
We would also like to interview the following people:
<list key staff members identified during the review of CVs>
The visit should take no more than one working day. We propose to send <name and
details of staff member or consultant> and we suggest <give alternative dates>. Please
advise whether this is convenient and confirm that the relevant members of staff will be
available for interview. If the proposed dates are inconvenient, please contact us to
arrange an alternative time.
Yours faithfully,
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Annex 7 Model checklist for a laboratory inspection visit6

Inspection checklist for: <name of testing laboratory>
Checklist prepared by:
<name>
Checklist completed by (a): :
<name>
Date of inspection:
<dd.mm.yy>
1. Test equipment (b):
Comments:
<item to be inspected>
2. Personnel (c):
Comments:
<staff member>
<staff member>
<staff member>
<staff member>
3. Reports (d):
Comments:
Sample type-examination
report
Sample independent typetesting report
Sample Full Quality
Assurance report
4. Overall assessment of the
Comments
facility:
General organization
Quality of buildings
Quality of test equipment
Quality of record-keeping
Orderliness
Cleanliness
Quality of senior staff
Quality of technical staff
Other comments:
Notes:
(a) The inspector should have a reference copy of ISO/IEC 17025 available during the inspection.
(b) Make a list of items to be inspected, based on the performance specifications and product verification
protocols attached to the assessment information pack for example: +43C test chamber.
(c) By reference to the CVs already supplied interview members of staff with the relevant key skills.
(d) Ask to see sample test reports for relevant products and for all three different types of verification
procedure (or those that are relevant).
6
As the laboratory will already be ISO 17025-accredited, the purpose of the exercise is NOT to carry out
an in-depth global inspection. It should only be necessary to look at facilities, to interview staff that are
directly relevant to PQS activities and to gain a general overall impression of the facility and its
management.
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Annex 8 Evaluation checklist

Evaluation checklist for: <name of testing laboratory>
Checklist completed by:
Date:
1. Is laboratory ISO/IEC
17025 accredited?
2. Date of next re-assessment
3. Name of accreditation body
4. Is accreditation body an
ILAC signatory?
5. If the answer to Q4 is no,
is the accreditation body
acceptable?
6. Details of references:
<name>
<name>
<name>
<name>
<name>
7. Was an on-site inspection
necessary?
8. If the answer to Q7 is yes
has an on-site inspection
been carried out?
Who carried out the on-site
inspection?
Has an inspection report
been submitted?
Is the inspection report
appended to this checklist?
<name>
<dd.mm.yy>
Yes
No
<dd.mm.yy>
<name>
Yes
Yes
Ref recd.
No
(letter of rejection issued <dd.mm.yy>)
No
Date
<dd.mm.yy>
<dd.mm.yy>
<dd.mm.yy>
<dd.mm.yy>
<dd.mm.yy>
Yes
Yes
on <dd.mm.yy>
No
Mean overall result (scale of 0-5)
(go to Q9)
No
<name>
Yes
Yes
on <dd.mm.yy> No
No (an inspection report is mandatory)
9. What services have been

offered by the laboratory?
Type-examination:
<list performance specs and verification procedures>
Type-testing:
Full Quality Assurance:
10. General comments: <summarise results of examination>
11. Is acceptance of this
laboratory recommended?
Yes
12. Which services should be

accepted?
Type-examination:
Type-testing:
Full Quality Assurance:

No
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Annex 9 Standard letter E: Assessment rejection

Dear Sirs,
system initiative
We have now evaluated the dossier and regret to inform you that we are unable to
recommend your laboratory for inclusion on the database of PQS-assessed independent
testing laboratories. A summary of the reasons for this decision are as follows:
<reason>
<reason>
We thank you for your application. We regret that we are unable to enter into any
further correspondence on this matter.
Yours faithfully,
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Annex 10 Standard letter F: Acceptance

Dear Sirs,
system initiative
OPTION:
We also refer to our inspection visit on <dd.mm.yy>.
We have now completed our evaluation and are pleased to inform you that your
laboratory has been recommended for inclusion on the database of PQS-assessed
independent testing laboratories to carry out the following work:
<list items>
We draw your attention again to the terms and conditions set out in the assessment
information pack sent to you on <dd.mm.yy>. These terms and conditions apply to all
independent testing laboratories listed in the PQS database. Note particularly the
requirement to inform us of the periodic renewal of any relevant accreditations or
certifications, including your ISO/IEC 17025 accreditation, together with details of any
changes in facilities or personnel which may have an impact on the quality of the service
offered by your laboratory.
Yours faithfully,
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Annex 11 Format for listing a PQS-assessed testing laboratory on the PQS website
PQS record for assessed independent testing laboratory
1.
2.
3.
4.
5.
LABORATORY NAME:
<name>
Assessment date:
<dd.mm.yy>
Last re-evaluation date:
<dd.mm.yy>
Next re-evaluation date
<dd.mm.yy>
MAILING ADDRESS
<address>
Telephone no.
<number>
Fax no.
<number>
Email address
<address>
Website:
<address>
Contact name:
<name>
6. ASSESSED SERVICES:
Type-examination
Type-testing
Full Quality Assurance
7. SHIPPING ADDRESS
<address>
Telephone no.
<number>
Fax no.
<number>
Email address
<address>
Website:
<address>
Contact name:
<name>
8. DOCUMENTATION REQUIRED FOR SENDING EQUIPMENT FOR TESTING
<full description of shipping documents required>

SOP How To Assess A PQS Testing Laboratory

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SOP How To Assess A PQS Testing Laboratory

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SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

4.0 Documentation required

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Figure 1 Procedure for pre-qualifying a testing laboratory

Test laboratory may apply to WHO

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

See ILAC-G10:1996 Harmonised Procedures for Surveillance and Reassessment of Accredited

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Relevant details of every accepted testing laboratory will be published electronically in

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Correspondence by electronic mail. A hard copy will be kept on

ILAC-12:1994 Testing, Quality Assurance, Certification and Accreditation.

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 3 Standard letter A: Assessment information pack

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 4 Standard letter B: Request for missing information

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 5 Standard letter C: Request for reference

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 5 (cont) Standard letter C: Reference questionnaire

If no, please say why:

4. Where tests generally

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 6 Standard letter D: Request for laboratory inspection visit

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 7 Model checklist for a laboratory inspection visit6

Checklist completed by (a): :

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 8 Evaluation checklist

(letter of rejection issued <dd.mm.yy>)

Mean overall result (scale of 0-5)

9. What services have been

12. Which services should be

<list performance specs and verification procedures>

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 9 Standard letter E: Assessment rejection

SOP No FCH/ IVB/QSS/PQS/007

Date of issue: 08/07/2004

Annex 10 Standard letter F: Acceptance

SOP No FCH/ IVB/QSS/PQS/007