ACCREDITATION PROCESS FOR TESTING/ CALIBRATION/ MEDICAL LABORATORIES

Transcription

1 Document No: SADCAS AP 12: Part 1 Issue No: 4 ACCREDITATION PROCESS FOR TESTING/ CALIBRATION/ MEDICAL LABORATORIES Prepared by: Technical Manager Approved by: Chief Executive Officer Approval Date: Effective Date:

2 Table of Contents 1. PURPOSE AND SCOPE GENERAL APPLICATION PRE-ASSESSMENT ASSESSMENTS SURVEILLANCE RE-ASSESSMENT SCOPE EXTENSIONS SCOPE OF ACCREDITATION TIMESCALE FOR ACCREDITATION PROCESS COMPLAINTS, APPEALS AND DISPUTES OBLIGATIONS AND DUTIES OF ACCREDITED FACILITIES SUSPENSION OF ACCREDITATION WITHDRAWAL OF ACCREDITATION REDUCTION OF SCOPE OF ACCREDITATION REFERENCES APPENDIX - AMENDMENT RECORD Page Page 2 of 19

3 1. PURPOSE AND SCOPE This document outlines the process and assessment techniques used in the accreditation of testing/ calibration and medical laboratories in accordance with ISO/IEC and ISO respectively, SADCAS requirements as well as the International Laboratory Accreditation Cooperation (ILAC) requirements. 2. GENERAL 2.1 One of the functions of SADCAS is to assess and accredit the competence of testing/calibration/medical laboratories to carry out specified tests/calibrations. Each applicant laboratory provides basic information to SADCAS on its activities on SADCAS F 43(a): Application for accreditation of calibration laboratories/ SADCAS F 43(b): Application for accreditation of testing laboratories/ SADCAS F 43(c): Application for accreditation of medical laboratories, staff in SADCAS F 43 (f): Application for approval of personnel i.e. nominated representative and technical signatory in the case of testing and calibration laboratories and only nominated representative in the case of medical laboratories together with the laboratory s quality manual. Assessment of the competence of a testing/calibration/medical laboratory is carried out through a review of documentation, visits to the laboratory s central administrative office and other locations and witnessing of activities. 2.2 The purpose of the assessment is to determine whether a testing/calibration/medical laboratory complies with the requirements of the relevant international accreditation standard applicable to their field and type of tests/calibration and SADCAS Requirements and Guidance documents. Relevant documents, procedures and application forms are available on the SADCAS website Note: Guidance for the implementation of a medical laboratory accreditation system are provided in ILAC G 26: 07:2012 whilst Guidelines for forensic science both of which are available from the ILAC website Accreditation of a testing/calibration/medical laboratory is a voluntary activity. Testing/ calibration/medical laboratories from the public/private sector that want to recognize the competence of their organization to carry out specific tasks can submit an application for accreditation to SADCAS. 2.4 SADCAS uses Technical Assessors (TAs) with the relevant specialist knowledge to evaluate the competence of the CABs to perform the tests/calibration for which accreditation is sought. The assessment team is required by SADCAS to maintain confidentiality, and to sign SADCAS F 45 (a): Nondisclosure/confidentiality statement specifying the need to declare any potential conflict of interest. Their activities will be confined to assess the testing/calibration/medical laboratories activities for compliance with the respective requirements and reporting their findings to the laboratory and to SADCAS. Page 3 of 19

4 2.5 A five year accreditation cycle is applicable to all testing/calibration/medical laboratories which have applied for accreditation to SADCAS. 3. APPLICATION A testing/calibration/medical laboratory wishing to be accredited submits directly to SADCAS duly completed SADCAS F 43(a): Application for accreditation of calibration laboratories/ SADCAS F 43(b): Application for accreditation of testing laboratories/ SADCAS F 43(c): Application for accreditation of medical laboratories together with the laboratory s quality manual, duly completed SADCAS F 43 (f): Application for approval of personnel i.e. nominated representative and technical signatory in the case of testing/calibration laboratories and only nominated representative in the case of medical laboratories and duly signed SADCAS F 44: SADCAS accreditation agreement. 3.1 Upon receipt of the above documents, SADCAS will undertake the following: (v) Review the application form for completeness; Confirm the detailed list of fields and type of tests/calibration for which the organization is seeking accreditation; In the case of multi-standard accreditation (refer to clause 5.5), confirm the multistandard accreditation for which the organization is seeking accreditation; Confirm the different locations from which the testing/calibration service is managed and the activities which are carried out at each of these locations; Seek agreement with the applicant on the appointment of the assessment team and assessment dates. SADCAS will send notification of the proposed assessment team to the laboratory. Rejection of assessors will only be considered if there is a conflict of interest. In this case the laboratory shall provide SADCAS with clear and valid reasons for the rejection of the assessor in writing within seven (7) working days of receipt of the notification. The SADCAS Technical Manager will decide whether a change of assessor is warranted or not. If the laboratory has good reason to reject an assessor and no other assessor is available from the SADC region to carry out the assessment, SADCAS may opt to use competent assessors from other accreditation bodies outside the region. In this case the laboratory will be liable for the full costs covering travel and subsistence (accommodation meals and incidental) of the assessor. 3.2 Prior to any work being carried out, SADCAS will provide the organization with a quotation detailing the cost of the application and/or pre-assessment and initial assessment. If acceptable, the applicant signs and returns duly signed quotation to SADCAS. Acceptance of the quotation is required in order to proceed to the next stage of the assessment process. Annual accreditation fees will also be quoted and invoiced on a pro-rata basis. Page 4 of 19

5 3.3 The SADCAS Policy Manual (SADCAS PM 01) and all other SADCAS accreditation documents applicable to the testing/calibration/medical laboratories are available on the SADCAS website The testing/calibration/medical laboratories quality manual and procedures will be reviewed for compliance with the applicable standard(s), SADCAS technical requirements and guidance documents. 3.5 On completion of the document review, a report on the relevant document review report for testing/calibration/medical laboratories SADCAS F 61 (a-1): Document review report for laboratories ISO/IEC and SADCAS F 61 (a-3): Document review for medical laboratories ISO will be issued to the laboratory. The report will contain comments on any nonconformity, areas which are not addressed, areas where actions are needed, areas where there are concerns or weaknesses and a recommendation on the way forward. A maximum period of six (6) months is allowed for applicant organization to address the findings. Failure to address the findings within the 6-months period may lead to a repeat of the entire process should the applicant decide to continue seeking accreditation. The Lead Assessor (LA) shall use the appropriate checklist as a guide in reviewing the quality documentation. 3.6 The initial assessment of the Laboratory shall be arranged within three (3) months after the facility has addressed the issues raised in the document review report. 4. PRE-ASSESSMENT 4.1 Pre-assessment is an optional stage. The laboratory that seeks accreditation may voluntarily request SADCAS to conduct a pre-assessment to assess their readiness for accreditation. Preassessment is carried out on-site by the Lead/Technical Assessor The pre-assessment can be carried out at a specified location (generally the central office) of the testing/calibration/medical laboratories to: (v) (vi) discuss any findings related to the documentation; seek further information on the quality system; briefly examine the systems which have been established and implemented; discuss any arrangements which have been made to include multiple locations, subcontracted activities, etc. within the quality system; agree the proposed scope(s) of accreditation; determine whether any further technical assessors/experts will be required The pre-assessment visit will normally be completed within one (1) day. Note: No technical assessment of the laboratory s technical capabilities of competencies will be conducted during the pre-assessment. Page 5 of 19

6 4.1.3 The laboratory may need to make changes to its policies, procedures and practices in order that the organizations documented system complies with the requirements of the relevant standard Once all the findings raised during the pre-assessment have been effectively cleared, SADCAS will arrange the initial on-site assessment of the laboratory within 6 months. 5. ASSESSMENTS 5.1 Prior to Assessment Prior to assessment, the laboratory will provide SADCAS with a list of current personnel, the fields and types of tests/calibration and the locations (however named) at which they are currently operating. The Technical Manager (TM) will determine, in conjunction with the organization, when and which locations and personnel will be subject to on-site assessment (see 6.4) as part of the planning process An assessment schedule and a quotation will be forwarded to the laboratory in advance of the assessment; written acceptance of the quotation will be required before a visit can be undertaken The time required for assessment, surveillance and re-assessment will be dependent on the complexity of the laboratory, the geographical spread of its activities, the structure of the quality system, the proposed scope(s) of accreditation and where relevant, the combination of multi-standards for accreditation. 5.2 Initial Assessment The nature of the initial assessment will depend on the schedule of accreditation required by the testing/calibration/medical laboratory and the complexity of the quality system that is being operated. However, the following elements will be covered: Central office assessment; Assessment of multiple locations (however named and where applicable); On-site assessments of testing/calibration/medical laboratories activities. Note: On-site assessment is a mandatory requirement for an initial assessment The SADCAS assessment team will hold an opening meeting with the applicant laboratory. Refer to SADCAS F 46(a): On-site assessment Opening Meeting Agenda The SADCAS assessment team will seek to establish through objective evidence and by using various techniques that: The quality system is appropriate to the testing/calibration/medical laboratories needs, organizational arrangements and methods of operation, including multiple location activities and number of personnel; Page 6 of 19

7 All of the requirements of the relevant standard applicable to their field of activities have been satisfactorily addressed; The testing/calibration/medical laboratories have implemented all the requirements of the quality system effectively; The operational, administrative and technical procedures used to support the quality manual are complete, technically valid and appropriate The following techniques will be employed to establish that procedures are being correctly and fully implemented: Questioning of management and staff who have an involvement in or bearing upon the quality of tests/calibration activities; Examination of records; Examination of the suitability, maintenance, calibration, control and use of all equipment used for testing/calibration/medical laboratories activities; and Examination of the arrangements for exercising control over sub-contractors and suppliers All fields and types of testing/calibration activities will be subject to an office assessment and technical review. The team will assess the technical competence of personnel related to the type of tests/calibration covered by the schedule. This will be done through: The examination of the records outlined above; Discussions with staff supervisors and manager; Assessment of the performance of the staff whilst conducting scheduled activities (see 5.6); and Assessment of calibration certificates /test reports issued by the laboratory The Assessor shall record all the information gathered during the assessment on the relevant SADCAS forms provided for this purpose. The records shall be sufficiently comprehensive as to allow for an independent expert serving on the Accreditation Approvals Committee to reach the same conclusion The team will report the findings raised during the on-site assessment on the nonconformity, corrective action and clearance report form SADCAS F 61 (b) and will need to agree on the nature and classification of the nonconformity. Each form shall be signed by the Assessor and the organization s representative. If the team could not reach a decision about a finding, the matter shall be referred to SADCAS for clarification After each number of the assessment team has completed their respective assignment, they shall hold a private meeting to summarize their conclusions and contribute to a coordinated view on the status of the applicant laboratory s system The team, together with the laboratory s representative will agree on the draft schedule of accreditation during the closing meeting. Page 7 of 19

8 A summary of the assessment report [SADCAS F 61(c)] will be provided to the testing/ calibration/ medical laboratory during a closing meeting held with the applicant Laboratory. Refer to SADCAS F 46 (b): Onsite Assessment Closing Agenda. Where corrective action by the laboratory is required [SADCAS F 61(b)], the applicant organization shall be invited to identify and propose corrective actions to address the raised nonconformities within one (1) month after the assessment and have corrective action cleared within three (3) months after the assessment. In most cases evidence can be provided by post/fax/ although there may be situations where additional visits to the CAB will be required. If an additional visit for clearing of findings is recommended by the assessment team, it will be at cost to the organization. SADCAS will review the evidence provided and decide upon its acceptability When all corrective actions have been completed and approved by the assessment team, the SADCAS Accreditation Approvals Committee (AAC) will review the assessment documentation and decide whether to support the recommendation made by the team. If the AAC is satisfied, accreditation will be granted and a SADCAS certificate and schedule of accreditation will be issued. The AAC meetings shall be held as necessary without undue delay to the accreditation decision making process. The AAC should be held within two (2) weeks after the review of the file. Note: The Certificate and schedule of accreditation shall not be issued if there are any outstanding fees. 5.3 Multi-Location Laboratories An applicant that operates from a central laboratory through a number of locations may seek a single accreditation provided that the conditions specified in the relevant standard are fulfilled. Groups of medical laboratories operating under the same quality system are allocated individual accreditation numbers, and each satellite laboratory shall be individually assessed Laboratories shall under no circumstances franchise their accredited activities to other laboratories/ organizations On application, the laboratory must indicate the number and range of locations being operated. All locations will be visited during the initial assessment, thereafter, SADCAS will visit selected locations taking into account: (v) (vi) (vii) The results of internal audits from central laboratory and locations; The results of management reviews; Variations in the size of locations; Complexity of the quality system; Complexity of the locations; Variations in working practices including, where applicable, equipment used; Variations in activities undertaken e.g. types of testing/calibration activities. Page 8 of 19

9 5.3.4 It will normally not be necessary to witness the full range of scopes for each selected location once accredited SADCAS will seek to establish through objective evidence and by using various techniques that: All locations are operating under the same quality system; All locations are included in the internal audit programme and central review process All locations must be working to the same requirements and may be subject to assessment on a sampling basis as part of the accreditation process to provide evidence of the operation and effectiveness of the system During the central laboratory assessment SADCAS may need to see records of activities, which are being carried out at different locations If SADCAS observes non-compliance at the central laboratory or at any one of the locations of a laboratory with multiple locations, the corrective action procedure shall apply to all locations where applicable. In the event that the results of any of the assessments of sample locations reveal that there is a significant weakness or inconsistency in the application of the quality system, SADCAS will review the assessment programme and may increase the number of locations to be assessed Failure by one location to comply with SADCAS requirements may lead to removal of the location from the schedule of accreditation. If the cause of non-compliance is the lack of central control then the corporate accreditation will be subject to be reviewed by SADCAS and may lead to suspension or withdrawal of accreditation from all locations Generally, each location from which a laboratory is operating will be visited at least once during the assessment cycle SADCAS must be advised of any changes to location addresses and activities, see SADCAS F 44: Accreditation agreement. The establishment of any new locations from which the laboratory proposes to offer an accredited service must be notified to SADCAS before these can be included in the scope of accreditation. The need for assessment of the new location will be reviewed, the schedule of accreditation will be amended as appropriate and the location will be included in the programme of surveillance and re-assessment. 5.4 Multi-Standard Assessment A laboratory who wishes to be assessed to two (2) or more accreditation standards may be assessed to multiple standards at the same assessment, using one Lead Assessor knowledgeable in the multi-standards for which accreditation is sought, together with the required technical assessors. Page 9 of 19

10 5.4.2 Where the scope applied for falls under different programmes (e.g. testing in accordance with ISO/IEC and ISO for medical laboratories), the accreditation application forms and approval of personnel forms of the different programmes must be completed in full, although only one copy of all the information required must be submitted to SADCAS. Each applicant organization also provides completed SADCAS checklists appropriate to its scope of application and Multi-Standard combination indicating where the requirements are addressed in their system The application forms are forwarded to the Technical Manager, who will process the application form as described in Clause 3 of this document It is important for the organization to ensure that the applicable Multi-Standards are fully addressed in their documented system to ensure that all the requirements are fully addressed. If the documented system does not address the applicable Multi-Standards fully additional time may be required for the document review and assessment. An integrated management system is preferred The normal application and assessment process is followed, as described in Clauses 3 to 5, with a pre-assessment which may be mandatory for a multi-standard assessment. 5.5 Witnessing of activities Witnessing of activities is an essential part of the SADCAS assessment of laboratory applicable to their field of operation. This is particularly important to determine the competency of the analysts/technician/metrologist when the laboratory is performing activities and where the personnel professional judgement is crucial to the outcome of tests/calibration results When deciding on the number of witnessing activities needed the following aspects will be considered by SADCAS: (v) (vi) The fields and types of tests/calibration on the accreditation schedule; The testing/calibration/medical laboratory s procedures for selecting, training, authorising and monitoring staff, having regard to the qualifications and experience required for different fields and types of tests/calibration; The internal auditing arrangements of the testing/calibration/medical laboratory; The locations from which the personnel operate; Any statutory requirements; The extent to which analysts/technician/metrologist are required to exercise professional judgement When deciding on the types of tests/calibration to be witnessed account will be taken of the following: Types of tests/calibration covered by the testing/calibration activities; Skills needed by analysts/technician/metrologist; Page 10 of 19

11 Any statutory requirements; The extent to which analysts/technician/metrologist are required to exercise professional judgement As a minimum, one analyst/technician/metrologist carrying out tests/calibration will be witnessed on-site for the fields and types of tests/calibration on the accreditation schedule When deciding on which analysts/technician/metrologist will be witnessed account will be taken of: (v) New recruits or new authorisations; Qualifications and experience; Location; Any statutory requirements; The extent to which analysts/technician/ metrologist are required to exercise professional judgement If none of the analysts/technician/metrologist can cover the entire scope of a specific field, then more than one analyst/metrologist will be witnessed for that field. Where there is any evidence, which casts doubt on the competence of laboratory s staff, the sample size of analysts/technician/metrologist witnessed on-site may be increased It will be necessary to examine equipment and documentation, such as procedures and instructions, records, reports and planning arrangements. If an analyst/technician/metrologist operates in different locations, this examination will be arranged at a mutually acceptable location SADCAS assessors will ensure that their role during witnessing of activities is one of observer and they will not influence the activity being performed. The team will be looking to see that as a minimum: (v) (vi) (vii) (viii) (ix) The analyst/technician/metrologist has the competence for the test/calibration performed; The analyst/technician/metrologist s competence is consistent with the records; The analyst/technician/metrologist has been supplied with all necessary documented testing/calibration methods and procedures; The procedures are up-to-date; the analyst/technician/metrologist implements the procedure in full and correctly i.e. no short-cuts, no personalised application where it is not permissible to do so; records of all observations are made while on-site as required by the procedure; Records clearly identify what has been inspected, using what method/procedure, and when; All records are signed/initialled, stamped, as applicable; All findings that indicate immediate or urgent action are reported as required to the customer whilst on site; Page 11 of 19

12 (x) (xi) Reports comply with the laboratory requirements, the relevant standard [ISO/IEC 17025, ISO 15189] and/or as amplified by the relevant guidance documents; Facilities and equipment are fit for the analyst/technician/metrologist purpose. 6 SURVEILLANCE 6.1 General Following accreditation, SADCAS will check for continuing compliance with accreditation requirements by carrying out surveillance visits to a laboratory. The first surveillance assessment is undertaken not more than 12 months after accreditation thereafter annually throughout the accreditation cycle The level of sampling of locations and analysts/technicians/metrologists will depend on performance over the assessment cycle, the extent of any changes, which have taken place, and the level of confidence, which can be placed in the performance measures, and control systems of the laboratory. 6.2 Surveillance Surveillance visits will be planned to cover the whole of the schedule of accreditation over the assessment cycle. SADCAS shall plan the surveillance visits of accredited laboratory taking into account other surveillance activities. Any revisions to the quality system will be reviewed during these visits. Extensive changes may require additional assessment time A report will be provided to the facility at the time of the surveillance. Where corrective action is required, the facility shall be invited to identify and propose corrective action, within one month after the surveillance assessment, address the nonconformity and to have the corrective action cleared within three (3) months after the assessment In most cases evidence can be provided by /fax/post although there may be situations where additional visits to the laboratory may be required. SADCAS will review the evidence provided and decide upon its acceptability. 6.3 Multi-Location Laboratories For multi-location laboratories the central quality system and technical requirements will be subject to surveillance with the first surveillance being undertaken not more than 12 months after accreditation thereafter annually throughout the accreditation cycle. It is anticipated that, in addition to the central laboratory, at least one location will be visited each year, with a visit to each location generally taking place over the assessment cycle. However, the level of sampling of locations and analysts/technicians/metrologists will depend on performance over the assessment cycle, the extent of any changes which have taken place and the level of confidence which can be placed in the performance measures and control systems of the laboratory. Page 12 of 19

13 6.4 On-site Assessment of testing/calibration/medical laboratories On-site assessment of a laboratory will be carried out at each surveillance visit where practicable. The same criteria used for assessment will be considered when determining the number and type of tests/calibration, and the personnel to be witnessed. The laboratory shall inform SADCAS if a site is not available for the scheduled surveillance visit The applicant organization shall be invited to identify and propose corrective actions to address the raised nonconformities within one (1) month after the assessment and have corrective action cleared within three (3) months after the assessment. 7 RE-ASSESSMENT 7.1 A re-assessment is conducted at least 6 months prior to the start of each new 5 year accreditation cycle. Re-assessment visits will involve a comprehensive re-examination of the laboratory s quality system and testing/calibration activities and will be similar in format and content to the initial assessment. The same criteria used for assessment will be considered when determining the number and type of tests/calibration, and the personnel to be assessed. The laboratory shall submit an application form and quality manual. A review of the full documentation shall be undertaken prior to the on - site assessment. 7.2 The applicant organization shall be invited to identify and propose corrective actions to address the raised nonconformities within one (1) month after the assessment and have corrective action cleared within three (3) months after the assessment. 8 SCOPE EXTENSIONS 8.1 Following receipt of an application for extension to scope, SADCAS will determine whether or not there is a need for a central laboratory and/or location assessment and/or on-site assessments of a laboratory to take place. Factors which will be taken into consideration will be the: Existing scope of accreditation; Analysts/technicians/metrologists competencies within scopes; The range of scopes; The location at which the extension to scope is sought. 8.2 Where possible and desirable, any additional work will be carried out at the next surveillance or re-assessment visit; where necessary, additional visits will be arranged. The estimated effort required for subsequent surveillance and reassessment will be reviewed and may be revised. Page 13 of 19

14 9 SCOPE OF ACCREDITATION 9.1 It is SADCAS policy to define the scope(s) of a laboratory s accreditation as precisely as possible. Laboratories will therefore be asked to specify in detail the field, type and range of tests/calibration for which accreditation is sought and the locations at which these activities are to be carried out. The scope(s) will be agreed as far as possible before the assessment in order to determine the extent of the assessment activities. Following successful assessment, the scope, including standard specifications, methods and procedures relevant to the tests/calibration concerned will be identified on the accreditation Schedule. 9.2 Following accreditation, the Schedule is considered to be in the public domain unless otherwise requested by the laboratory for legitimate reasons and will form the basis of SADCAS publication Directory of Accredited Organizations. 10 TIMESCALE FOR ACCREDITATION PROCESS 10.1 SADCAS makes every effort to ensure that all applications are processed as efficiently as possible. The time taken to process an application depends on a number of factors, some of which are outside the control of SADCAS. The timing is dependent on: (v) The quality of the applicant s documentation and the extent to which it complies with SADCAS requirements. A delay can occur due to insufficient documented procedures and submission of inadequate Quality Manuals; The availability of suitable assessors; The level of implementation of the system and available evidence of technical competence How efficiently the applicant organization clears the nonconformities after the initial assessment; The availability of the resources within SADCAS. 11 COMPLAINTS, APPEALS AND DISPUTES 11.1 Complaints, appeals and disputes will be handled in accordance with the SADCAS AP 08: Customer feedback handling procedure. 12 OBLIGATIONS AND DUTIES OF ACCREDITED FACILITIES 12.1 The obligations and duties of an accredited facility are captured in the SADCAS F 44: Accreditation agreement. All applicant organizations need to familiarize themselves with the content of this document. Page 14 of 19

15 13 SUSPENSION OF ACCREDITATION 13.1 The SADCAS TR 06 covers suspension and reinstatement of accreditation If the laboratory is to perform any activity in the suspended scope during the suspension period, they must inform SADCAS at their earliest opportunity for arrangements for a re-instatement assessment. 14. WITHDRAWAL OF ACCREDITATION 14.1 The SADCAS TR 06 covers withdrawal of accreditation If the laboratory accreditation is withdrawn, the laboratory shall submit a new application for accreditation to SADCAS should they want to continue. 15. REDUCTION OF SCOPE OF ACCREDITATION A laboratory may apply to SADCAS to have their scope of accreditation reduced at any time. An application for the reduction in scope may be for a number of reasons such as lack of access to the expertise needed for the scope, insufficient applications in the scope, etc. If the laboratory fails to meet the requirements for accreditation for the tests methods already accredited including competence of personnel, SADCAS shall reduce the scope of accreditation to exclude those test methods. SADCAS will update the certificate and schedule of accreditation accordingly and publish the amended version on the SADCAS website. 16. REFERENCES ILAC G19: Guidelines for forensic science laboratories ILAC G26: Guidance for the implementatio0n of a medical laboratory SADCAS F 43(a) - Application for accreditation of calibration laboratories SADCAS F 43(b) - Application for accreditation of testing laboratories SADCAS F 43(c) - Application for accreditation of medical laboratories SADCAS F 43 (f)- Application for approval of personnel SADCAS F 44 - Accreditation agreement SADCAS F 45 (a)- Nondisclosure/confidentiality statement Assessors/experts SADCAS F 46 (a) On-site Assessment Opening Meeting Agenda SADCAS F 46 (b) On-site Assessment Closing Meeting Agenda SADCAS F 61 (a-1) Document review report for laboratories ISO/IEC SADCAS F 61 (a-3) Document review report for medical laboratories ISO/IEC Page 15 of 19

16 SADCAS F 61(b) - Conformity assessment body Nonconformity, corrective and clearance report SADCAS F 61 (c)- Assessment recommendation report SADCAS F 91 (a) Accreditation Approvals Committee Assessment packs Testing/Calibration Laboratories Accreditation Programme SADCAS F 91 (b) Accreditation Approvals Committee Assessment packs Medical Laboratories Accreditation Programme SADCAS F 93 Completeness check of application and Resource review SADCAS AP 08 - Customer feedback handling procedure SADCAS PM 01 - SADCAS Policy Manual SADCAS TR 06 - Suspension and Reinstatement of Accredited Organizations Page 16 of 19

17 APPENDIX - AMENDMENT RECORD Revision Status Page Clause/ Sub clause Change Description of Change Approved by Effective Date Issue CEO Issue Line 1: Deleted F 42 and substituted with F 61 (b) Line 4: Inserted be Invited between shall and identify Line 1: Inserted be Invited between shall and identify 7.2 Line14: Inserted be Invited between shall and identify Issue Added new sub- clause 3.6 which reads The initial assessment of the Laboratory shall be arranged within three (3) months after the facility has addressed the issues raised in the document review report. CEO CEO CEO CEO CEO At end of paragraph added 2 new sentences which read The AAC meetings shall be held as necessary without undue delay to the accreditation decision making process. The AAC should be held within two (2) weeks after the review of the file Deleted 2 nd sentence and substituted with Where corrective action is required, the facility shall be invited to identify and propose corrective action, within one month after the surveillance assessment, address the nonconformity and to have the corrective action cleared within three (3) months after the assessment At end of paragraph added new sentence which reads The laboratory shall submit an application form and quality manual. A review of the full documentation shall be undertaken prior to the on - site assessment. CEO CEO CEO Page 17 of 19

18 Revision Status Page Clause/ Subclause Change Description of Change Issue Line 2: Added SADCAS F 61 (a-1): Document review report for laboratories ISO/IEC and SADCAS F 61 (a-3): Document review for medical laboratories ISO between laboratories and will Approved by Effective Date CEO Title added OF ACCREDITATION and amended contents page accordingly Line 1 Deleted applicant body and substitute with laboratory 15 New Clause 15 Added new Clause 15 entitled: Reduction of Scope of Accreditation which reads A laboratory may apply to SADCAS to have their scope of accreditation reduced at any time. An application for the reduction in scope may be for a number of reasons such as lack of access to the expertise needed for the scope, insufficient applications in the scope, etc. If the laboratory fails to meet the requirements for accreditation for the tests methods already accredited including competence of personnel, SADCAS shall reduce the scope of accreditation to exclude those test methods. SADCAS will update the certificate and schedule of accreditation accordingly and publish the amended version on the SADCAS website. 15 Renumbered Clause 16 Amended contents page accordingly Added to the references the following: SADCAS F 91 (a) Accreditation Approvals Committee Assessment packs Testing/Calibration Laboratories Accreditation Programme SADCAS F 91 (b) Accreditation Approvals Committee Assessment packs Medical Laboratories Accreditation Programme SADCAS F 93 Completeness check of application and Resource review SADCAS F 61 (a-1): Document review report for laboratories ISO/IEC Page 18 of 19

19 Revision Status Page Clause/ Subclause Change Description of Change Approved by Effective Date SADCAS F 61 (a-3): Document review for medical laboratories ISO Page 19 of 19