Title: How to assess a PQS testing laboratory Table of Content

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2 Version: Effective date: 08/07/2004 Page: 2 of 22 Table of Content 1.0 Purpose Scope Responsibility Documentation required Procedure Assessment Register Make initial inquiries and check ISO/IEC accreditation Send assessment information pack Information dossier Evaluate facilities and expertise ISO/IEC accreditation: ILAC accreditation: References: Facilities and CVs: On-site inspection Evaluation results Distribution... 9 Annex 1 Definitions Annex 2 References Annex 3 Standard letter A: Assessment information pack Annex 4 Standard letter B: Request for missing information Annex 5 Standard letter C: Request for reference Annex 6 Standard letter D: Request for laboratory inspection visit Annex 7 Model checklist for a laboratory inspection visit Annex 8 Evaluation checklist Annex 9 Standard letter E: Assessment rejection Annex 10 Standard letter F: Acceptance Annex 11 Format for listing a PQS-assessed testing laboratory on the PQS website REVISION HISTORY FORM... 22

3 Version: Effective date: 08/07/2004 Page: 3 of 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 specification 1. 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 assessment 2. 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.

4 Version: Effective date: 08/07/2004 Page: 4 of 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-SG s 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.

5 Version: Effective date: 08/07/2004 Page: 5 of 22 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 accredited? no yes PQS Secretariat sends Approval Information Pack Laboratory responds Facilities and expertise suitable? no yes Check against current list at On-site inspection optional yes Accreditation body an ILAC signatory? no On-site inspection essential Accept laboratory yes Laboratory acceptable? no 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.

6 Version: Effective date: 08/07/2004 Page: 6 of Make initial inquiries and check ISO/IEC 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 laboratory s 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 laboratories 3. 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 results 4. If initial enquires show that a laboratory is not ISO/IEC 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 laboratory s 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: ISO/IEC accreditation: Check that the ISO/IEC accreditation is valid. Only laboratories that have a valid accreditation can be considered for assessment. 3 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 31 st December Quoted from the introduction to ISO/IEC 17025:1999.

7 Version: Effective date: 08/07/2004 Page: 7 of ILAC accreditation: Check whether the accreditation body that issued the ISO/IEC accreditation is an ILAC signatory. The International Laboratory Accreditation Cooperation (ILAC) arrangement came into effect on 31st January 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 ILAC s 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 years 5. Other accreditation bodies may have different arrangements 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 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) 5 See ILAC-G10:1996 Harmonised Procedures for Surveillance and Reassessment of Accredited Laboratories.

8 Version: Effective date: 08/07/2004 Page: 8 of 22 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 and 5.2.3) - checking of results and calculations. (ISO 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.

9 Version: Effective date: 08/07/2004 Page: 9 of 22 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.

10 Version: Effective date: 08/07/2004 Page: 10 of 22 Annex 1 Definitions 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. ILAC-13:1996 The Role of Testing and Laboratory Accreditation in International Trade. ILAC-G10:1996 Harmonised Procedures for Surveillance and Reassessment of Accredited Laboratories. ILAC-G15:2001 Guidance for Accreditation to ISO/IEC ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. The ILAC Mutual Recognition Arrangement. WHO/EPI/LHIS/97.03 EPI Performance Specifications and Test Procedures - Annex 1: Testing institutions. February 1999 revision.

11 Version: Effective date: 08/07/2004 Page: 11 of 22 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/ > 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: < Performance specification(s) description and reference, including revision ref.> <Product verification protocol(s) description and reference, including revision ref.> Full Quality Assurance < Performance specification(s) description and reference, including revision ref.> <Product verification protocol(s) description and reference, including revision ref.> 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;

12 Version: Effective date: 08/07/2004 Page: 12 of 22 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 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 laboratory s 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.

13 Version: Effective date: 08/07/2004 Page: 13 of 22 Annex 4 Standard letter B: Request for missing information Dear Sirs, Application for assessment of an independent testing laboratory under the PQS 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,

14 Version: Effective date: 08/07/2004 Page: 14 of 22 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,

15 Version: Effective date: 08/07/2004 Page: 15 of 22 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? years Yes No... Type of product Purpose of test 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: Yes No... Yes No (very poor) (excellent) Quality of laboratory management: Quality of staff responsible for testing: Quality and accuracy of test report(s): Other comments:

16 Version: Effective date: 08/07/2004 Page: 16 of 22 Annex 6 Standard letter D: Request for laboratory inspection visit Dear Sirs, Application for assessment of an independent testing laboratory under the PQS initiative: Request for inspection visit 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 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,

17 Version: Effective date: 08/07/2004 Page: 17 of 22 Annex 7 Model checklist for a laboratory inspection visit 6 Inspection checklist for: <name of testing laboratory> Checklist prepared by: Checklist completed by (a) : : <name> <name> Date of inspection: <dd.mm.yy> 1. Test equipment (b) : Comments: <item to be inspected> <item to be inspected> <item to be inspected> <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 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: +43 C 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 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.

18 Version: Effective date: 08/07/2004 Page: 18 of 22 Annex 8 Evaluation checklist Evaluation checklist for: <name of testing laboratory> Checklist completed by: <name> Date: <dd.mm.yy> 1. Is laboratory ISO/IEC accredited? Yes No (letter of rejection issued <dd.mm.yy>) 2. Date of next re-assessment <dd.mm.yy> 3. Name of accreditation body <name> 4. Is accreditation body an ILAC signatory? Yes No 5. If the answer to Q4 is no, is the accreditation body acceptable? Yes No 6. Details of references: Ref recd. Date Mean overall result (scale of 0-5) <name> <dd.mm.yy> <name> <dd.mm.yy> <name> <name> <dd.mm.yy> <dd.mm.yy> <name> <dd.mm.yy> 7. Was an on-site inspection necessary? Yes No (go to Q9) 8. If the answer to Q7 is yes has an on-site inspection been carried out? Yes on <dd.mm.yy> No Who carried out the on-site inspection? Has an inspection report <name> been submitted? Yes on <dd.mm.yy> No Is the inspection report appended to this checklist? Yes 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: <list performance specs and verification procedures> Full Quality Assurance: <list performance specs and verification procedures> 10. General comments: <summarise results of examination> 11. Is acceptance of this laboratory recommended? Yes No 12. Which services should be accepted? Type-examination: Type-testing: Full Quality Assurance: <list performance specs and verification procedures> <list performance specs and verification procedures> <list performance specs and verification procedures>

19 Version: Effective date: 08/07/2004 Page: 19 of 22 Annex 9 Standard letter E: Assessment rejection Dear Sirs, Application for assessment of an independent testing laboratory under the PQS system initiative 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 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,

20 Version: Effective date: 08/07/2004 Page: 20 of 22 Annex 10 Standard letter F: Acceptance Dear Sirs, Application for assessment of an independent testing laboratory under the PQS system initiative Your reference: <reference> We refer to your letter dated <dd.mm.yy> enclosing the information dossier requested in our letter dated <dd.mm.yy>. 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 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,

21 Version: Effective date: 08/07/2004 Page: 21 of 22 Annex 11 Format for listing a PQS-assessed testing laboratory on the PQS website PQS record for assessed independent testing laboratory 1. LABORATORY NAME: <name> 2. Assessment date: <dd.mm.yy> 3. Last re-evaluation date: <dd.mm.yy> 4. Next re-evaluation date <dd.mm.yy> 5. MAILING ADDRESS <address> Telephone no. <number> Fax no. <number> address <address> Website: <address> Contact name: <name> 6. ASSESSED SERVICES: Type-examination <list performance specs and verification procedures> Type-testing Full Quality Assurance <list performance specs and verification procedures> <list performance specs and verification procedures> 7. SHIPPING ADDRESS <address> Telephone no. <number> Fax no. <number> address <address> Website: <address> Contact name: <name> 8. DOCUMENTATION REQUIRED FOR SENDING EQUIPMENT FOR TESTING <full description of shipping documents required>

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