SOP N : FCH/ IVB/ATT/VML/008 Version n : Page: 1 of 16. Name Date Signature. ATT Coordinator ACCESS TO TECHNOLOGIES

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1 STANDARD OPERATING PROCEDURE SOP N : FCH/ IVB/ATT/VML/008 Version n : Page: 1 of 16 1 st edition : 08/07/2004 Effective date : 08/07/2004 Revision date : DD/MM/YYYY HOW TO RE-EVALUATE A PQS-ASSESSED TESTING LABORATORY Name Date Signature Authorised by: ATT Coordinator Reviewed by: Group Leader Checked by: Original prepared by: ACCESS TO TECHNOLOGIES 1 of 16

2 Version: Effective date: 08/07/2004 Page: 2 of 16 Table of Content 1.0 Purpose Scope Responsibility Documentation required Procedure Assessment Register Obtain annual report from testing laboratory Review annual report from testing laboratory Review user reports Evaluate need for reassessment inspection Reassessment inspection Annual report to PQS-SG Distribution... 3 Annex 1 Definitions... 3 Annex 2 References... 3 Annex 3 Standard letter A: Annual report reminder... 3 Annex 4 Standard form for annual re-evaluation report... 3 Annex 5 Standard letter B: Request for laboratory reassessment inspection visit... 3 Annex 6 Model checklist for a laboratory reassessment visit... 3 Annex 7 Standard letter C: Loss of PQS-assessed status... 3 Annex 8 Standard letter D: Changes to assessment status... 3 Annex 9a Website entry: withdrawing PQS-assessed status... 3 Annex 9b Website entry: amending service details... 3 Annex 9c Website entry: updating an un-amended entry... 3 REVISION HISTORY FORM of 16

3 Version: Effective date: 08/07/2004 Page: 3 of Purpose This SOP describes how to carry out an annual re-evaluation of a testing laboratory that has been accepted in accordance with the procedures set out in SOP No FCH/ IVB/ATT/ /00X: How to assess a PQS testing laboratory. It sets out the grounds for disqualifying any laboratory that has failed to perform adequately and it describes the disqualification procedure. 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 disqualification. 3.0 Responsibility Responsibilities and tasks will be assigned as follows: 1. The PQS Secretariat (Secretariat) will carry out an annual review of the performance of each PQS-assessed testing laboratory, will arrange a reassessment visit where warranted, and will identify laboratories that have failed to perform adequately. The Secretariat will then prepare a report for the PQS Steering Group (PQS-SG). 2. Based on the report, the PQS-SG will direct the Secretariat either to disqualify a test laboratory, to amend the list of assessed services, or to maintain the assessment status unaltered. 3. If a decision is taken to disqualify the laboratory, the Secretariat will notify the test laboratory of the PQS-SG s decision. 4. The Secretariat will make amendments to the website to take account of the PQS- SG s decisions. 4.0 Documentation required Associated documents: Refer to the following: SOP No FCH/ IVB/ATT/VML/007: How to assess a PQS 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. 3 of 16

4 Version: Effective date: 08/07/2004 Page: 4 of 16 Figure 1 Annual review procedure for re-assessing a testing laboratory Start annual report received from laboratory? no Send reminder yes Record non-compliance no Report satisfactory? yes Report received? yes no no Reassessment inspection required? no Have adverse user reports been received? yes yes Carry out reassessment inspection Maintai n PQS-assessed status yes Inspection report favourable? no Cancel PQS-assessed status 5.1 Assessment Register (Secretariat): The Secretariat will file all reports and correspondence arising from the annual review in the assessment register. 5.2 Obtain annual report from testing laboratory (Secretariat): Every 12 months PQS-assessed testing laboratories are required: to communicate 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 1. A laboratory that fails to do this will be sent a single reminder letter. If a 1 See SOP No FCH/ IVB/ATT/VML/007: How to assess a PQS testing laboratory. Annex 3. 4 of 16

5 Version: Effective date: 08/07/2004 Page: 5 of 16 response is not received within the stated time, this will constitute grounds for disqualification. Standard letter A (Annex 3) should be used for this purpose. 5.3 Review annual report from testing laboratory (Secretariat): The Secretariat will review the testing laboratory s annual report. The standard form shown in Annex 4 will be used to record the details. 5.4 Review user reports (Secretariat): The content of any reports received from users of the testing laboratory will also be summarised on the standard form shown in Annex 4. The annual report and this form will be filed in the assessment register. 5.5 Evaluate need for reassessment inspection (Secretariat): If the annual report is unsatisfactory and/or if adverse reports have been received from users this may justify a reassessment inspection of the laboratory. If reassessment is not needed then the Secretariat will recommend that the laboratory retains its PQS-assessed status for another 12 months see Reassessment inspection (Secretariat/consultant): If a reassessment inspection is indicated, the Secretariat will arrange for a suitably qualified member of staff, or for a consultant, to visit the testing laboratory. Standard letter B will be used to make the arrangements (Annex 5) and Annex 6 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 Annual report to PQS-SG (Secretariat): The Secretariat will prepare an annual report on all the PQS-assessed testing laboratories, appending the reassessment inspection reports where relevant, and recommending which laboratories should retain PQS-assessed status and which should be disqualified. This document will be submitted to the PQS-SG. Grounds for disqualification include the following: loss of ISO/IEC accreditation; bankruptcy, receivership, corruption or other financial irregularity; evidence of collusion between testing laboratory and product manufacturer(s); loss of key testing facilities; loss of key personnel; unsatisfactory service (reported by users); unsatisfactory test reports; The annual report will also indicate whether any of the assessed services need to be amended. Grounds for amending the list of services include the following: loss or addition of key testing facilities; loss or addition of key personnel; unsatisfactory service in certain areas (reported by users) 5 of 16

6 Version: Effective date: 08/07/2004 Page: 6 of Acceptance (PQS-SG): The PQS-SG will review the annual report and recommendations and will direct the Secretariat whether to retain or disqualify each PQSassessed laboratory. 5.9 Publication (Secretariat): If the PQS-SG disqualifies a testing laboratory it will be notified of this decision using standard letter C (Annex 7). Notification is to be by letter, fax or by . A copy of the relevant letter will also be sent to UNICEF-SD and a further copy will be filed in the Prequalification Register. The relevant PQS website entry will be overwritten with the words PQS-ASSESSED STATUS WITHDRAWN ON <DD.MM.YY> as shown in Annex 9a. The overwritten entry will remain on the website for a minimum period of six months, after which it will be deleted. At the discretion of the PQS-SG or the Secretariat, notification of withdrawal may also be posted on the TechNet21 and SIGN e-forums. If the PQS-SG maintains PQS-assessed status, but with changes to the list of assessed services, the testing laboratory it will be notified of this decision using standard letter D (Annex 8). The letter allows an opportunity for further discussion with the laboratory. After these discussions have taken place, or after the cut-off date if no discussions take place, the PQS website entry will be updated as shown in Annex 9b. If the PQS-SG maintains PQS-assessed status unaltered, the PQS website entry will be updated as shown in Annex 9c. 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. 6 of 16

7 Version: Effective date: 08/07/2004 Page: 7 of 16 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. 7 of 16

8 Version: Effective date: 08/07/2004 Page: 8 of 16 Annex 3 Standard letter A: Annual report reminder Dear Sirs, Assessment of an independent testing laboratory under the PQS initiative: Annual report We write to remind you of item 6 of the Terms and Conditions for assessment under the PQS initiative. This states the following: 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. Your annual report is now overdue. If you wish to remain on the PQS-assessed register please send us your report by. Yours faithfully, 8 of 16

9 Version: Effective date: 08/07/2004 Page: 9 of 16 Annex 4 Standard form for annual re-evaluation report Annual re-evaluation checklist for: <name of testing laboratory> Checklist completed by: Date of assessment: Date of last re-evaluation: ANNUAL REPORT DETAILS 1. Annual report received from testing laboratory? Yes No Follow up letter issued 2. Is laboratory still ISO/IEC accredited? Yes No Letter of disqualification issued 3. Date of next re-assessment 4. Name of accreditation body 5. Is accreditation body an ILAC signatory? Yes No 6. If the answer to Q4 is no, is the accreditation body acceptable? Yes No 7. Other information: <summarize other information in annual report> USER REPORT DETAILS 8. User name Date Summary ON-SITE REASSESSMENT DETAILS 9. Was an on-site reassessment necessary? Yes No (go to Q11) 10. If the answer to Q10 is yes has an on-site reassessment been carried out? Yes on No Who carried out the on-site reassessment? Has an inspection report been submitted? Yes on No Is the inspection report appended to this checklist? Yes No (an inspection report is mandatory) RECOMMENDATIONS 11. Should PQS-assessed status be retained? Yes No Letter of disqualification issued 12. Changes needed to list of assessed services? Yes No Type-examination: Type-testing: Full Quality Assurance: <list changes> <list changes> <list changes> 9 of 16

10 Version: Effective date: 08/07/2004 Page: 10 of 16 Annex 5 Standard letter B: Request for laboratory reassessment inspection visit Dear Sirs, Assessment of an independent testing laboratory under the PQS initiative: Request for reassessment inspection visit Following receipt of your annual report on we have now carried out a preliminary reassessment of your laboratory. The reassessment has raised a number of concerns and we would therefore like to arrange a visit to your facility. 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, 10 of 16

11 Version: Effective date: 08/07/2004 Page: 11 of 16 Annex 6 Model checklist for a laboratory reassessment visit 2 Reassessment checklist for: <name of testing laboratory> Checklist prepared by: Checklist completed by (a) : : Date of inspection: 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 2 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. 11 of 16

12 Version: Effective date: 08/07/2004 Page: 12 of 16 procedure (or those that are relevant). Annex 7 Standard letter C: Loss of PQS-assessed status Dear Sirs, Assessment of an independent testing laboratory under the PQS system initiative: Loss of PQS-assessed status arising from annual reassessment We have now carried out the annual reassessment of your laboratory and regret to inform you that we will be withdrawing your facility from the database of PQS-assessed independent testing laboratories with immediate effect. The reasons we have taken this action are as follows: <briefly list reasons> If you wish to do so you may submit a formal application for reinstatement. This application must detail the corrective actions that you have taken to warrant the laboratory s re-qualification. Unless and until we receive an application for reinstatement we regret that we are unable to enter into any further correspondence on this matter. Yours faithfully, 12 of 16

13 Version: Effective date: 08/07/2004 Page: 13 of 16 Annex 8 Standard letter D: Changes to assessment status Dear Sirs, Assessment of an independent testing laboratory under the PQS system initiative: Changes arising from annual reassessment We have now carried out the annual reassessment of your laboratory and write to advise you that we propose to amend the list of services for which your laboratory is PQSassessed. The list of changes and the reasons for making them are as follows: <briefly list changes and the reasons for making them> If you wish to discuss these changes please contact us before. If we have not heard from you by this date your website entry will be altered as indicated. Yours faithfully, 13 of 16

14 Version: Effective date: 08/07/2004 Page: 14 of 16 Annex 9a Website entry: withdrawing PQS-assessed status PQS record for assessed independent testing laboratory PQS-ASSESSED STATUS WITHDRAWN ON <DD.MM.YY> 1. LABORATORY NAME: 2. Assessment date: 3. Last re-evaluation date: 4. Next re-evaluation date 5. MAILING ADDRESS <address> 6. DOCUMENTATION REQUIRED FOR SENDING EQUIPMENT FOR TESTING <full description of shipping documents required> Annex 9b Website entry: amending service details Record for PQS-assessed independent testing laboratory 7. LABORATORY NAME: 8. Assessment date: 9. Last re-evaluation date: update this field 10. Next re-evaluation date update this field 11. MAILING ADDRESS <address> Telephone no. <number> Fax no. <number> address <address> Website: <address> Contact name: 12. ASSESSED SERVICES: 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> 13. SHIPPING ADDRESS <address> Telephone no. <number> Fax no. <number> address <address> Website: <address> Contact name: 14. DOCUMENTATION REQUIRED FOR SENDING EQUIPMENT FOR TESTING <full description of shipping documents required> Amend these entries as required 14 of 16

15 Version: Effective date: 08/07/2004 Page: 15 of 16 Annex 9c Website entry: updating an un-amended entry Record for PQS-assessed independent testing laboratory 15. LABORATORY NAME: 16. Assessment date: 17. Last re-evaluation date: update this field 18. Next re-evaluation date update this field 19. MAILING ADDRESS <address> 20. DOCUMENTATION REQUIRED FOR SENDING EQUIPMENT FOR TESTING <full description of shipping documents required> 15 of 16

16 Version: Effective date: 08/07/2004 Page: 16 of 16 REVISION HISTORY FORM (Form number: FCH/IVB /ATT/GEN/F002) SOP Number Date of original version: REVISIONS Date Reason Authorized by (Signature and Name) 16 of 16