ACCREDITATION REQUIREMENTS

Transcription

1 ACCREDITATION REQUIREMENTS Prepared by: Technical Manager Approved by: Chief Executive Officer Approval Date: Effective Date:

2 Table of Contents 1. PURPOSE AND SCOPE COMPLIANCE WITH REQUIREMENTS ACCREDITATION PROCESS Application and Document Review Application Documentation review Selection of assessors Assessment Pre-assessment Initial assessment Witnessing associated with application for accreditation Proficiency testing (PT)/ Inter-laboratory comparison (ILC) Traceability Surveillance assessment Extraordinary assessment Re-assessment Extension of accreditation Access to premises and availability of documents Disclosure requirements Assessment report Accreditation Decision Issuance of Certificate Suspension of Accreditation Withdrawal of Accreditation APPEAL ACCREDITATION FEES OBLIGATIONS FOR ACCREDITATION REFERENCES APPENDIX - AMENDMENT RECORD Page 2 of 27

3 1. PURPOSE AND SCOPE Accreditation will be granted to all organizations that fully meet the accreditation requirements. This document describes the conditions which have to be fulfilled by accredited organizations and by organizations applying for accreditation. 2. COMPLIANCE WITH REQUIREMENTS Organizations accredited by SADCAS shall at all times comply with the relevant international standards requirements listed below, ILAC and IAF requirements, SADCAS general and specific requirements and shall institute all prescribed corrective actions in the time limits determined by SADCAS. Type of Accreditation Requirements Calibration and testing laboratories ISO/IEC : General requirements for the competence of testing and calibration laboratories Medical laboratories ISO : Medical laboratories Particular requirements for quality and competence Certification bodies for management systems ISO/IEC : Conformity assessment Requirements for bodies providing audit and certification of management systems : Conformity assessment Requirements for bodies certifying products, processes and services : Conformity assessment General requirements for bodies operating certification of persons Certification bodies for product ISO/IEC certification Certification bodies for personnel ISO/IEC certification Inspection Bodies ISO/IEC : General criteria for the operation of various types of bodies performing inspection The applicable standards may be purchased from the respective countries National Standards Bodies or from the International Organization for Standardization (ISO). All accredited organizations or applicant organizations must use the current versions of all requirements documents. SADCAS will notify organizations about new versions of these documents and where necessary transition arrangements. General Requirements SADCAS TR 01: Part 1 - Conditions for the use of SADCAS Accreditation Mark SADCAS TR 01: Part 2 - Use of Combined Marks SADCAS AP 02 - SADCAS Accreditation Fees SADCAS AP 12: Part 1 - Accreditation Process for Testing/Calibration/Medical Laboratories SADCAS AP 12: Part 2 - Accreditation of Inspection Bodies Operating in the Regulatory / Voluntary Area All SADCAS documents can be downloaded from the website: Page 3 of 27

4 3. ACCREDITATION PROCESS The SADCAS Accreditation Process is outlined in SADCAS AP 12: Part 1 Accreditation Process for Testing/Calibration/Medical Laboratories; SADCAS AP 12: Part 2 Accreditation of Inspection Bodies Operating in the Regulatory/Voluntary Area and TPA J01: Guidelines for SADCAS/SANAS Joint Assessments under the Twinning Partnership Arrangements. 3.1 Application and Document Review Application The applicant is required to fill an application form SADCAS F 43 (a/b/c/d/e/f/g/h) as relevant and submit it with the up to date quality manual and other relevant information described in the application form to SADCAS office in Gaborone, Botswana. The application form is available from SADCAS or from the NAFP office in each Member State and can be downloaded from the website: Information on participation in Proficiency Testing Schemes/Inter Laboratory Comparisons (applicable to testing/calibration laboratories) The information on PT/ILC participation shall be provided on the relevant section of the application form. The results on PT/ILC participation shall be submitted to SADCAS at least one month before the scheduled date of the initial assessment. If the laboratory used internal methods, the validation reports shall be also submitted with the application form. If the laboratory applied for interpretation and evaluation of the results of tests analysis, a description of the analysis and all documentation on which the interpretation and evaluation are based on, shall be enclosed with the application form. Participation in PT schemes ILC is a prerequisite for accreditation Methods (applicable only for laboratories) The laboratories shall preferably use standard methods. New versions of standard methods shall be implemented within six (6) months after their publication unless otherwise specified by the regulatory authorities. If the laboratory uses a modified standard method (smaller changes/modifications in a standard method) the changes shall be written in the laboratory s procedure. The changes shall be validated and the validation report shall document that the results (including the corresponding measurement uncertainty) are the same as with the standard method. Where a modified standard method is used, the test report/calibration certificate shall indicate so. If another principle of measurement is used and/or a matrix is changed compared to the standard method, the method shall be defined as an internal method. Internal methods based on standard methods are methods where the laboratory has made some changes to the standard method and where the validation data shall show that the modified method does not give the same result (including the corresponding measurement uncertainty) as when using the standard method. All modifications from the standard method shall be described in the laboratory s own procedure. Page 4 of 27

5 If the laboratory uses a withdrawn standard method that means the method is defined as an internal method based on the withdrawn standards. The laboratories shall document this procedure. If the laboratory uses an earlier version of a standard method longer than six (6) months after it is revised and if it is agreed by SADCAS, the method shall be defined as an internal method based on the earlier version Normative documents (applicable only for certification and inspection bodies) A normative document may be a national, regional or international standard/guide, national law or regulation, government guidance or other documents that are accepted by interested parties. The applicant shall indicate the normative document used for certification/ inspection purposes. SADCAS may require that the applicant make available a copy of this document with the application form to SADCAS Documentation Review The SADCAS appointed Lead Assessor will conduct a desk review of the application form and all documents received. Once SADCAS has confirmed that the applicant s documented quality management system addresses all the requirements, an onsite assessment will be scheduled with the organization. A desk review report shall be made available to the organization within one month from receipt of complete documents. In cases where additional information is requested, the deadline may be extended. The initial assessment of the laboratory should be arranged within 3 months after the facility has addressed the issues raised in the document review report. The SADCAS Technical Manager will make the assessment arrangements with the organization and the assessment team Selection of assessors SADCAS contracts on a need basis a number of qualified and registered assessors and experts. For each application, SADCAS will select from the register of assessors, the appropriate assessors and experts and make the proposition to the organization. SADCAS shall provide the organization with an opportunity to object to the proposed assessment team on the basis of objective evidence of a conflict of interest. If the applicant rejects SADCAS proposed assessment team or a team member, this shall be explained and SADCAS shall evaluate if the reasons are acceptable and propose changes to the assessment team composition. Communication between the applicant organization and assessors during the whole application process shall be done through SADCAS. 3.2 Assessment The assessment (Pre-assessment, initial assessment, surveillance assessment, and reassessments) will be undertaken by at least two assessors appointed by SADCAS: the Lead assessor; and the Technical Page 5 of 27

6 assessor/expert. The number of assessors varies according to the scope of accreditation. The lead assessor is responsible for evaluating the quality management system and the Technical assessor/expert for all technical aspects. For this the technical assessor/expert shall witness the performance of selected technical activities. If the organization has some satellite laboratories in different locations, accreditation is only addressed for the laboratory specified in the application form. The assessment will be done in the agreed time between SADCAS and the organization. The applicant will be informed about the onsite assessment visit in suitable time. Documentation and premises shall be accessible by SADCAS personnel and assessors/experts engaged by SADCAS and accepted by the organization Pre-assessment Prior to embarking on the formal accreditation process, organizations that seek accreditation may voluntarily request SADCAS to conduct a pre-assessment. The purpose of a pre-assessment is to evaluate readiness for accreditation. Pre-assessments may however be compulsory for new organizations seeking accreditation depending on the regulator s conditions of acceptance. During a pre-assessment the assessors shall undertake a pre-assessment of the applicant s quality management system, premises, the equipment and competence of personnel involved. After such a visit, a short report will be presented to the applicant. The possible result of the pre-assessment is: The initial assessment be conducted; Corrective actions are necessary and the applicant confirms when they will be ready for an assessment; Assessment cannot be conducted. SADCAS will deliver to the applicant organization a report within 2 weeks after the pre-assessment Initial assessment Where decision is to conduct an initial assessment, then this shall be conducted onsite at the applicant s premises. The assessment team shall visit the main office and all other premises where key activities are performed. The initial assessment assesses the organization s competence to perform specific task for which accreditation is sought. The onsite assessment shall consist of the following steps: An opening meeting, chaired by the SADCAS Lead Assessor and attended by the SADCAS assessment team members, the applicant organization s management, management representative, personnel involved in the areas to be accredited as identified by the applicant organization. In this meeting the SADCAS Lead Assessor explains the assessment activities and the final plan for the conduct of the assessment is made. Page 6 of 27

7 An assessment of the applicant s quality management system to ensure compliance with requirements is undertaken by the SADCAS assessment team who shall also assess the implementation of the system and witness technical activities (see 3.2.3). The assessment covers all aspects of the organization s scope of application. During the assessment, the applicant shall make available key personnel to give required information or complimentary explanations to the assessors. Assessors shall have access to all documents related to the quality management system. The assessors shall record all nonconformities raised during the assessment and inform the applicant about them at the assessment closing meeting A closing meeting shall be held at the end of the onsite assessment and is chaired by the SADCAS Lead Assessor and attended by the SADCAS assessment team members, the applicant organization s management, management representative and personnel involved in the areas assessed as identified by the applicant organization. The purpose of the closing meeting is to inform the applicant organization of the outcome of the assessment including the nonconformities raised during the onsite assessment. The applicant organization shall have the opportunity to seek clarification and ask questions. After completion of the onsite assessment, the applicant organization shall be invited to identify and propose corrective action, within one (1) month after the assessment, to address the raised nonconformities and to clear them within three (3) months after the assessment Witnessing associated with application for accreditation For laboratories, selected tests/calibrations and/or sampling are witnessed during the onsite assessment. Witnessing takes place at every location where testing/calibration are undertaken. For certification/ inspection bodies, witnessing of activities to be accredited are normally performed within the scope of accreditation. However, if some of the normative documents are regarded, based on technical grounds, as belonging to the same group, then one witnessing may be valid for the whole group of normative documents. Witnessing takes place at every location visited. For management system certification, the accreditation scope is defined by the standard and the specific industrial sector. Before accreditation is granted for the industrial sector, a certification audit shall be witnessed in that sector Proficiency testing (PT)/ Inter Laboratory comparisons (ILC) Participation in PT schemes/inter Laboratories Comparisons is a prerequisite for accreditation. It is the laboratory s responsibility to identify relevant PT schemes/ilcs to participate in. The information on PT/ILC participation shall be provided on the relevant section of the application form. The results on PT/ILC participation shall be submitted to SADCAS at least one month before the scheduled date of the initial assessment. Frequency of participation in PT schemes/ilcs shall be appropriate to the Page 7 of 27

8 scope of accreditation and consistent with the PT/ILC plan. The PT/ILC plan shall cover all the accredited activities and shall be accomplished in a period not exceeding one accreditation cycle. Laboratories are encouraged to use PT schemes/ilcs providers which comply with the requirements of ISO 17043: Conformity assessment General requirements for proficiency testing. For testing areas where PT schemes/ ILCs are not available, the laboratory shall undertake other actions to ensure satisfactory control of the test method s traceability e.g. comparisons with other testing laboratories and/ or certified reference materials. SADCAS requirements for participation in PT are outlined in SADCAS TR 04 Proficiency Testing and other Comparison Requirements for Calibration Laboratories and in SADCAS TR 08 Proficiency Testing and other Comparison Programmes Requirements for Testing and Medical Laboratories. SADCAS maintains links to PT service providers on the website Traceability Traceability for calibration Equipment and reference standards used by calibration laboratories and having an impact on the accuracy and validity of measurement result shall be calibrated by: a) A National Metrology Institute (NMI) whose service is suitable for the intended need and belongs to the CIPM MRA and are signatories to its Mutual Recognition Agreement (MRA) amongst NMIs and who have approved CMCs within the BIPM Key Comparison Database (KCDB) which includes the range and uncertainty for each listed service. b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement or by Regional Arrangements recognized by ILAC whose service is suitable for the appropriate calibration. c) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA. The National Metrology Institute shall have participated in the SADC Cooperation in Metrology (SADCMET) through which SADC countries that are not yet signatory to the CIPM can get their traceability. The acceptance of other NMIs other than those of the CIPM MRA partners shall be at the discretion of SADCAS Chief Executive Officer after due consultation of the appropriate Advisory Committee subject to satisfactory evidence of the technical competence of the laboratory using appropriate methods as outlined in the technical procedures. d) A calibration laboratory whose service is suitable for the intended need but not covered by the ILAC Arrangement or by regional arrangements recognized by ILAC. Page 8 of 27

9 For options c) and d) appropriate evidence for the technical competence of the laboratory and claimed metrological traceability shall include the following: - Record of calibration method validation; - Procedures for estimation of uncertainty ; - Documentation for traceability of measurements; - Documentation for assuring the quality of calibration results; - Documentation for the competence of staff; - Documentation for accommodation and environmental conditions; and - Audits of the calibration laboratory. Options a) and b) above are the preferred options for metrological traceability. Options c) and d) are only applicable when options a) and b) are not possible Traceability for Testing/Medical Laboratories Equipment and instruments used by testing/medical laboratories and having a significant impact on the measurements results shall be calibrated by one of the process defined in Where traceability as stated above is not technically possible or reasonable or available, the testing/ medical laboratories and client and other interested parties may agree to using reference materials /certified reference materials as outlined in Traceability for Inspection Bodies Equipment used by inspection bodies and having significant impact on measurement results shall be calibrated. SADCAS accepts evidence of traceability as outlined in Where traceability as stated above is not technically possible or reasonable or available, the inspection body and client and other interested parties may agree to using reference materials /certified reference materials as outlined in Traceability provided from reference materials and certified reference materials When the conformity assessment bodies use reference materials (RM)/certified reference materials (CRM) to establish traceability then (a) The RM/ CRM must be produced by a NMI, and covered by BIPM/KCDB ; or (b) The RM/CRM must be produced by Reference Materials Producer (RMP) which is accredited by any accreditation body which is signatory to the ILAC Mutual Recognition Arrangement or by a recognized regional cooperation (APLAC/EA/IAAC) Mutual Recognition Arrangement for RMP in the accredited scope. Note: For use of RM/CRM, ISO Guide 33: Reference materials Good practice in using reference materials may be referred. Page 9 of 27

10 3.2.6 Surveillance assessment After granting accreditation SADCAS shall undertake periodical surveillances at the applicant s premises in order to have confidence that the organization always fulfills the accreditation requirements. SADCAS shall plan the surveillance on-site assessments of accredited conformity assessment bodies taking account other surveillance activities. The first surveillance assessment shall be undertaken not more than twelve (12) months after accreditation. Thereafter, surveillance visits are scheduled annually throughout the accreditation cycle of five (5) years. The surveillance activities will vary based on the experience of each organization. It can vary between assessment visits to document review of different aspects together with witnessing tests analyses, verification or practical work. SADCAS is free to choose the activities to be witnessed. Conformity assessment bodies shall be invited to identify and propose corrective actions on the findings raised within one month after the assessment Extraordinary assessment SADCAS may conduct extraordinary assessments when it is considered necessary. The accredited organization shall be informed of such an assessment and the scope, and reasons thereof Reassessment An accreditation is valid for five (5) years provided that all requirements are fulfilled during the period. Reassessments will be conducted at the end of an assessment cycle i.e. every five years. The reassessment will be a complete assessment covering the organization s scope of accreditation including elements of relevant standards and will be as comprehensive as the initial assessment. The results of inter laboratory comparisons are assessed as one part in the consecutive surveillance and renewal. The organization shall submit applications forms and the quality manual. A review of the full documentation shall be undertaken prior to the on-site assessment. Conformity assessment bodies shall be invited to identify and propose corrective actions on the findings raised within one (1) month after the assessment, to address the nonconformity and to have the corrective action cleared within three (3) months after the assessment Extension of accreditation Accredited organization can at any time apply for extension of its accreditation scope to SADCAS. Extensions of accreditation scope may be: Testing or Calibration new methods, parameters or standards Inspection within new area Page 10 of 27

11 Certification according to new standards or new industrial sectors Inclusion of new locations/ geographical area Extensions of accreditation follow the same process as for initial assessment. The applicant is required to fill an application form SADCAS F 43 (a/b/c/d/e/f/g/h) as applicable and submit it with the relevant information directly to SADCAS office in Gaborone, Botswana. The application form could be downloaded from the website or availed upon request from the SADCAS/NAFP office. Application for extension should be made at least six (6) weeks prior to onsite visit. SADCAS can assess the extension of accreditation scope at the same time as the surveillance assessment or separately. The scheduled time will be agreed with the applicant. If the application is received by SADCAS six (6) weeks before a surveillance visit, the application for extension will be assessed during the planned visit Access to premises and availability of documents Applicant organizations/ accredited organizations are obliged to give SADCAS and its accepted assessors access to their premises and to all relevant documentation required for the assessment. Records shall be retained in a suitable way for ready access to SADCAS and organization s needs. Facilities shall retain records for at least 5 years unless otherwise required by law. Certification bodies records shall be retained for a period as defined in the accreditation standard or as decided by the country s laws Disclosure requirements Applicant organizations/ accredited organizations shall at all times keep SADCAS updated on any changes which may influence the organization s ability to comply with the terms and conditions of accreditation. The organization shall inform SADCAS immediately if there are any changes in: a) Its legal, commercial ownership or organization s status and contact details b) Organization, top management and key personnel c) Main policies d) Essential calibration and testing equipment, instruments and premises. Such changes shall be approved by SADCAS. e) Substantial changes in national, regional or international standard methods f) Scope of accreditation etc Assessment report After each assessment, the Lead assessor with inputs from the assessment team members shall submit the assessment report to SADCAS within one (1) week after the assessment. The report shall include all inputs and recommendations from the assessment team. SADCAS shall verify the content of the report and still remain responsible for the adequacy of the assessment report. SADCAS will wait for the applicant/accredited organization s corrective actions report within the deadline. Upon Page 11 of 27

12 submission, the report will be reviewed by the SADCAS Technical Manager and submitted to the SADCAS Approvals Committee for accreditation decision. The assessment report shall at least include the following: a) Unique identification of the conformity assessment body; b) Date(s) of the on-site assessment; c) Name(s) of the assessor(s) and/or experts involved in the assessment; d) Unique identification of all premises assessed; e) Proposed scope of accreditation that was assessed; f) The assessment report; g) A statement on the adequacy of the internal organization and procedures adopted by conformity assessment bodies to give confidence in its competence, as determined through its fulfillment on the requirements for accreditation; h) Information on the resolution of all nonconformities; i) Any further information that may assist in determining fulfillment of requirements and the competence of the conformity assessment bodies; and j) Where applicable, summary of the results of proficiency testing or other comparisons conducted by the conformity assessment bodies and any actions taken as a consequence of the results. 3.3 Accreditation Decision The SADCAS Accreditation Approvals Committee will determine from the information submitted by the assessment team that a thorough assessment has been carried out correctly and decide on the accreditation status. The Accreditation Approvals Committee shall look at the inputs, i.e. assessment report, the nonconformities raised and recommendations made by the assessment team and will make its decision. The accreditation Approvals Committee decision could be: a) Accreditation granted in accordance with the application; b) Parts of the application accredited; c) Accreditation is rejected; d) Accreditation is rejected; e) Accreditation scope is reduced; f) Accreditation is withdrawn; g) Accreditation is continued. SADCAS will communicate the Accreditation Approval Committee s decision to the applicant/ accredited organization, in writing. Should the decision of the Accreditation Approvals Committee be to grant accreditation, the applicant is issued with a SADCAS Certificate of Accreditation which shall include a schedule of accreditation detailing the scope of accreditation. Page 12 of 27

13 3.4 Issuance of Certificate An accredited facility may only issue a SADCAS certificate for the type and range of activities for which accreditation has been granted and which is listed on the accompanying schedule of accreditation. The certificate shall include the following information: a) The SADCAS accreditation mark; b) SADCAS name; c) Name of accredited facility; d) Unique accreditation number; e) Premises from which key activities are performed and which are covered by the accreditation; f) Details of the scope of accreditation: Tests or types of tests performed and materials or products tested. Where appropriate, the methods used (for testing/medical laboratories). For calibration laboratories to include: The types of measurements performed; The calibration and measurements capabilities (CMC) expressed as uncertainty of measurement; The measurement range; and Additional parameters where applicable, e.g. frequency of applied voltage. For inspection bodies to include: The field of inspection; The type of inspection: and Range of inspection. g) Statement of conformity and reference to the standards/other normative documents; h) Contact details of the accredited facility; i) Personnel approved; j) Validity of accreditation of 5 years; k) Effective date of granting accreditation; l) Date of expiry of certificate i.e. the date of issue of certificate; and m) Signature of the SADCAS Chief Executive Officer. Status of accreditation SADCAS shall make publicly available on the website the current status of the accreditation it has granted to conformity assessment bodies. Upon accreditation, the organization has the right to use SADCAS accreditation mark within the scope of accreditation. Use of the SADCAS accreditation mark shall be in accordance with SADCAS TR 01: Part 1 Conditions for use of SADCAS Accreditation Mark and SADCAS TR 01: Part 2 Use of Combined Marks. Page 13 of 27

14 When an amendment/change has been made to the current schedule of accreditation of an accredited conformity assessment body after an AAC meeting, the revised schedule of accreditation shall be issued with a new number of issue and new date of issue. 3.5 Suspension of Accreditation An accreditation can be suspended or withdrawn if the accreditation requirements are no longer met or by request from the accredited body it feels that it cannot fulfill accreditation requirements e.g. changes in locations, lost of key staff, etc. This has to be done in writing and according to the requirements described in the requirement document for technical area. SADCAS may suspend an accreditation if the nonconformities are not corrected within the agreed time limit or if the requirements are not fulfilled. Examples of serious deficiencies that can lead to suspension are as follows: No traceability to measurements standards Loss of key staff (Signatories) Unacceptable results from tests analyses, verification, inter laboratory comparisons Non competence of key personnel after personnel change Lack of performance of corrective actions within the time limit Mistakes by performance of test/calibrations/certifications/inspections that show serious errors in the quality system Misuse of the accreditation Non follow-up of relevant requirements Nonpayment of accreditation fees Failure to notify SADCAS of changes affecting the organizations accreditation status SADCAS may suspend an accreditation for a limited period or the applicant could ask for voluntary suspension of accreditation. SADCAS will determine if the suspension will be the totality or part of the accreditation scope. Suspension shall be for a period of up to six months. During the suspension period the organization shall not offer accredited services for the suspended activities. All tests/calibration, certification or inspection reports listed in under the accreditation schedule shall not be issued within the area where the suspension has been raised. The organization shall inform affected customers about the suspension and its consequences. The accreditation will be reinstated by the SADCAS Accreditation Approvals Committee when the organization has demonstrated that the conditions are fulfilled within the time limit and satisfy the accreditation requirements. However, if the nonconformities are not corrected within the time limit, SADCAS Accreditation Approvals Committee shall terminate the accreditation. The procedure for suspension /reinstatement of an accredited facility is outlined in SADCAS TR 06 Suspension and Reinstatement of Accredited Organizations. Page 14 of 27

15 3.6 Withdrawal of Accreditation If SADCAS accreditation is withdrawn, a written notification will be sent to the organization. The applicant has a right to comment on the withdrawal within one [1] month. After this period, if the comments are not pertinent, SADCAS shall decide to withdrawn the accreditation and the organization s name will be removed from the list of accredited organizations on the SADCAS website. The organization is required to return to SADCAS the accreditation certificate and the accreditation documents. If the organization s comments are pertinent, the decision will be re-submitted to the SADCAS Accreditation Approvals Committee. If parts of the accreditation are withdrawn, the applicant shall hand over to SADCAS the relevant accreditation documents for destruction or alteration. The organization shall no longer carry out accredited activities within the withdrawn areas and must inform the concerned customers about it and its consequences. A copy of the information shall be sent to SADCAS. Where accreditation has been withdrawn paid fees will not be refunded. 4. APPEAL The organization can make an appeal on SADCAS accreditation decision in. The organization shall submit its appeal in writing attention of the Chief Executive Officer (CEO), within three months of the cause of appeal. The CEO shall forward the appeal to the Appeals Committee for investigation and decision. The appeal shall be handled in accordance with SADCAS AP 08 Customer Feedback Handling Procedure. Throughout the investigation of an appeal, all decisions made prior to the appeal stand. The decision of the Appeals Committee is final and shall not be open for further appeal. 5. ACCREDITATION FEES Applicant accredited organizations are obliged to pay fees specified in SADCAS AP 02 SADCAS Accreditation Fees. The current rates are published on the SADCAS website: 6. OBLIGATIONS FOR ACCREDITATION An organization accredited by SADCAS shall sign SADCAS F 44 Accreditation Agreement which details the obligations of the accredited conformity assessment body and of SADCAS with regard to accreditation. The agreement covers all aspects that the accredited conformity assessment body must comply with in order to maintain accreditation including: Agreement to adapt to changes in the requirements for accreditation, Page 15 of 27

16 Provision of the necessary cooperation to SADCAS to enable it to verify the fulfillment of the requirements for accreditation in all the premises where the conformity assessment body s activities take place, Provision of information, documents and records as necessary for the assessment and maintenance of accreditation, Provision of documents that provide insight into the level of independence and impartiality of the conformity assessment body from its related bodies where applicable, Arranging for witnessing of conformity assessment body services when requested by SADCAS, Follow SADCAS TR 01: Part 1 Conditions for the use of SADCAS Accreditation Mark and SADCAS TR 01: Part 2 Use of Combined Marks, Pay accreditation fees as determined by SADCAS, Advise SADCAS without delay for any significant changes relevant to its accreditation relating to: Its legal, commercial ownership or organization status; Organization, top management and key personnel; Main policies ; Resources and premises; Scope of accreditation, etc. 7. REFERENCES SADCAS AP 02 SADCAS Accreditation Fees SADCAS AP 08 Customer Feedback Handling Procedure SADCAS AP 12: Part 1 Accreditation Process for Testing/Calibration/Medical Laboratories SADCAS AP 12: Part 2 Accreditation of Inspection Bodies Operating in the Regulatory/ Voluntary Areas SADCAS AP 14 Accreditation Decision Making Process SADCAS AP 18: Criteria for Extraordinary Assessments SADCAS TR 01: Part 1 Conditions for the use of SADCAS Accreditation Marks SADCAS TR 01: Part 2 Use of Combined Marks SADCAS TR 04 Proficiency Testing and other Comparison Programmes Requirements for Calibration Laboratories SADCAS TR 06 Suspension and Reinstatement of Accredited Organizations SADCAS TR 08 Proficiency Testing and other Comparison Programmes Requirements for Testing and Medical Laboratories SADCAS TR 09 Criteria for Performing Calibration and Intermediate Checks on Equipment used in Accredited Facilities Page 16 of 27

17 SADCAS F 43 (a) Application for Accreditation of Calibration Laboratory SADCAS F 43 (b) Application for Accreditation of Testing Laboratory SADCAS F 43 I Application for Accreditation of Medical Laboratory SADCAS F 43 (d) Application for Accreditation of Certification Bodies for Management Systems SADCAS F 43 (e) Application for Accreditation of Certification Bodies for Products SADCAS F 43 (f) Application for Approval of Personnel SADCAS F 43 (g) Application for Accreditation of Certification Bodies for Personnel SADCAS F 43 (h) Application for Accreditation of Inspection Bodies SADCAS F 44 SADCAS Accreditation Agreement TPA J01-01 Guidelines for SADCAS/SANAS Joint Assessments under the Twinning Partnership Arrangement ILAC P 9: ILAC Policy for Participation in Proficiency Testing Activities ILAC P 10: ILAC Policy on the Traceability of Measurement Results ILAC P 14: ILAC Policy for Uncertainty in Calibration ISO 15189: Medical laboratories Particular requirements for quality and competence, ISO/IEC 17020: General criteria for the operation of various types of bodies performing inspection ISO/IEC 17021: Conformity assessment Requirements for bodies providing audit and certification of management systems ISO/IEC 17024: Conformity assessment General requirements for bodies operating certification of persons ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories ISO/IEC 17065: Conformity assessment Requirements for bodies certifying products, processes and services ISO/IEC 17043: Conformity assessment General requirements for proficiency testing ISO Guide 33: Reference materials Good practice in using reference materials Page 17 of 27

18 APPENDIX AMENDMENT RECORD Change Revision Effective Approved by Status Clause/ Date Page Description of Change Sub clause Issue CEO Issue Paragraph 1, line 2: Deleted /guides Table, row 4 : Deleted Guide 65 and substitute with Paragraph 2, line 1: Deleted guides General Requirements: Added bullet 5 which reads SADCAS AP 12: Part 1 Accreditation Process for Testing/Calibration/Medical Laboratories; SADCAS AP 12: Part 2 - Accreditation of Inspection Bodies Operating in the Regulatory/Voluntary Area 4 3 Deleted SADCAS AP 10 and TPA J01-01 and substituted with SADCAS AP 12: Part 1 Accreditation Process for Testing/Calibration/ Medical Laboratories; SADCAS AP 12:Part 2 Accreditation of Inspection Bodies Operating in the Regulatory/Voluntary Area and TPA J Paragraph 3, line 1: Deleted /guide Paragraph 1, line 4: Deleted be in line with accepted rules for each testing area and substituted with at least once a year Inserted new Paragraph 3 which reads SADCAS requirements for participation in PT are outlined in SADCAS TR 04 Proficiency Testing and other Comparison Requirements for Calibration Laboratories and in SADCAS TR 08 Proficiency Testing and other Comparison Programmes Requirements for Testing and Medical Laboratories Deleted clause in its entirety and substituted with clause Traceability Traceability for calibration Equipment and reference standards used by calibration laboratories and having an impact on the accuracy and validity of measurements results shall be calibrated by: a) A National Metrology Institute whose service is suitable for the intended need and is covered CEO Page 18 of 27

19 Revision Status Page Clause/ Sub clause Change Description of Change by the CIPM MRA. In SADC region the following SADC Countries National Metrology Institutes are signatory to the CIPM MRA: Botswana, Mauritius, Namibia, South Africa, Seychelles, Zambia and Zimbabwe) Approved by Effective Date b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement or by Regional Arrangements recognized by ILAC whose service is suitable for the appropriate calibration) c) A National Metrology Institute whose service is suitable for the intended need but not covered by the CIPM MRA. The National Metrology Institute shall have participated in the SADC Cooperation in Metrology (SADCMET) through which SADC countries that are not yet signatory to the CIPM can get their traceability. Calibration certificates issued by the National Metrology Institute shall provide sufficient information regarding the process of calibration Traceability for Testing a) Equipment and instruments used by testing/medical laboratories and having a significant impact on the measurements results shall be calibrated by one of the process defined in ) b) If the calibration is not a dominant factor in the testing result, traceability does not need to be demonstrated but the laboratory shall have quantitative evidence to demonstrate that the calibration contributes insignificantly to the measurement results and the measurement uncertainty of the test Traceability provided from reference materials and certified reference material) a) Testing/medical laboratories shall have a programme and procedure for the calibration of the reference materials. Page 19 of 27

20 Revision Status Clause/ Page Sub clause Change Description of Change Issue 3 8 b) Reference materials used by testing/medical laboratories shall be inspected, verified as complying with standards specifications/ requirements defined in the methods for the tests and/or calibrations concerned. Approved by Effective Date c) Reference materials shall be, where possible, traceable to SI units of measurements. They shall be calibrated by one of the process defined in d) Where calibrations cannot be made to SI units, testing/medical laboratories shall provide confidence in measurements results by the use of certified reference materials provided by a competent supplier and/or to other specified methods or consensus standards. To maintain confidence in the calibration status, intermediate checks need to be performed by all accredited facilities. SADCAS requirements are outlined in SADCAS TR 09 Criteria for Performing Calibration and Intermediate Checks on Equipment used in Accredited Facilities Inserted new Paragraph 2 which reads SADCAS shall plan the surveillance on-site assessments of accredited conformity assessment bodies taking into account other surveillance activities Inserted new Paragraph 4 which reads Conformity assessment bodies shall identify and propose corrective actions about the findings raised within one month after the assessment Paragraph 2, line 2: Deleted SADCAS F 43 (a-f) and substituted with SADCAS F43 (a/b/c/d/e/f/g/h) Paragraph 2, line 3: Deleted or through the National Accreditation Focal Point in each member state. Page 20 of 27

21 Revision Status Clause/ Page Sub clause Change Description of Change Issue Deleted bullets a) to j) and substituted with: a) Unique identification of the conformity assessment body b) Date of(s) of the on-site assessment; c) Name(s) of the assessor(s) and/or experts involved in the assessment; d) Unique identification of all premises e) Proposed scope of accreditation that was assessed; f) The assessment report; g) A statement on the adequacy of the internal organization and procedures adopted by conformity assessment bodies to give confidence in its competence, as determined through its fulfillment on the requirements for accreditation; h) Information on the resolution of all nonconformities; i) Any further information that may assist in determining fulfillment of requirements and the competence of the conformity assessment bodies; and j) Where applicable, summary of the results of proficiency testing or other comparisons conducted by the Conformity Assessment Bodies and any actions taken as a consequence of the results (f): Deleted terminated and substituted with withdrawn At the end of Paragraph 2: added: Should the decision of the Accreditation Approvals Committee be to grant accreditation, the applicant is issued with a SADCAS Certificate of Accreditation which shall include a schedule of accreditation detailing the scope of accreditation Deleted a) to g) and substituted with: a) The SADCAS accreditation mark; b) SADCAS name; c) Name of accredited facility; d) Unique accreditation number; e) Premises from which key activities are performed key activities are performed and which are covered by the accreditation ; f) Details of the scope of accreditation; Approved by Effective Date Page 21 of 27

22 Revision Status Clause/ Page Sub clause Change Description of Change Issue g) Statement of conformity and reference to the standards/other normative documents; h) Validity of accreditation of 5 years; i) Effective date of granting accreditation i.e. the date of issue of certificate; j) Date of expiry of certificate; and k) Signature of the SADCAS Chief Executive Officer. After k) added: Status of accreditation SADCAS shall make publicly available on the website the current status of the accreditation it has granted by to conformity assessment bodies. At end of clause 3.4 added new paragraph which reads When an amendment/change has been made to the current schedule of accreditation of an accredited conformity assessment body after an AAC meeting, the revised schedule of accreditation shall be issued with a new issue number and new date of issue. Approved by Effective Date Paragraph 1, line 1: Deleted termination and substitute with withdrawn Clause title: deleted Termination and substituted with Withdrawal Paragraph 1, line 1 & 3 and paragraph 2, line 1 & 3: Deleted terminated and substituted with withdrawn Paragraph 1, line 2: Deleted termination and substituted with the withdrawal Last sentence: Deleted terminated and substituted with withdrawn 14 5 At end of sentence added: The current rates are published on the SADCAS website: Issue Paragraph 2 line 1: Deleted have one (1) month and substituted with be invited Paragraph 2 line 2: Inserted within one (1) month after the assessment between action and to Paragraph 2 line 3:Inserted to between and and clear CEO Page 22 of 27

23 Revision Status Page Change Clause/ Description of Change Sub clause Paragraph (a): Deleted sentence in its entirety and substitute with A National Metrology Institute whose service is suitable for the intended need and belongs to the CIPM MRA and are signatories to its Mutual Recognition Agreement (MRA) amongst NMIs and who have approved CMCs within the BIPM Key Comparison Database (KCDB) which includes the range and uncertainty for each listed service. In SADC region the following SADC Countries National Metrology Institutes are signatory to the CIPM MRA: Botswana, Mauritius, Namibia, South Africa, Seychelles, Zambia and Zimbabwe. Approved by Effective Date CEO After Paragraph(c): Inserted additional paragraph reading Options a) and b) above are the preferred options for metrological traceability. Option c) is only applicable when options a) and b) are not possible. 9 and and Paragraphs 4: Inserted be invited to between shall and identify Paragraph (f): Elaborated on (f) by adding the following: Tests or types of tests performed and materials or products tested. Where appropriate, the methods used (for testing/medical laboratories). For calibration laboratories to include: The types of measurements performed; The calibration and measurements capabilities (CMC) expressed as uncertainty of measurement; The measurement range; and Additional parameters where applicable, e.g. frequency of applied voltage. For inspection bodies to include: The field of inspection; The type of inspection: and Range of inspection. Added new (h) which reads contact details of the accredited facility Added new (i) which reads Personnel approved and renumbered all subsequent clauses accordingly. Page 23 of 27

24 Revision Status Page Issue 5 8 and 9 Change Clause/ Description of Change Sub clause Deleted sub clause in its entirety and substituted with the following: Equipment and reference standards used by calibration laboratories and having an impact on the accuracy and validity of measurement result shall be calibrated by: a) A National Metrology Institute (NMI) whose service is suitable for the intended need and belongs to the CIPM MRA and are signatories to its Mutual Recognition Agreement (MRA) amongst NMIs and who have approved CMCs within the BIPM Key Comparison Database (KCDB) which includes the range and uncertainty for each listed service. The acceptance of other NMIs other than those of the CIPM MRA partners shall be at the discretion of SADCAS Chief Executive Officer after due consultation of the appropriate Advisory Committee. b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement or by Regional Arrangements recognized by ILAC whose service is suitable for the appropriate calibration. c) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA. The National Metrology Institute shall have participated in the SADC Cooperation in Metrology (SADCMET) through which SADC countries that are not yet signatory to the CIPM can get their traceability. d) A calibration laboratory whose service is suitable for the intended need but not covered by the ILAC Arrangement or by regional arrangements recognized by ILAC. For options c) and d) appropriate evidence for the technical competence of the laboratory and claimed metrological traceability shall include the following: - Record of calibration method validation; Approved by Effective Date CEO Page 24 of 27

25 Revision Status Page Clause/ Sub clause Change Description of Change - Procedures for estimation of uncertainty ; - Documentation for traceability of measurements; - Documentation for assuring the quality of calibration results; - Documentation for the competence of staff; - Documentation for accommodation and environmental conditions; and - Audits of the calibration laboratory. Approved by Effective Date CEO Options a) and b) above are the preferred options for metrological traceability. Options c) and d) are only applicable when options a) and b) are not possible Deleted title of sub clause and substituted with Traceability for Testing/Medical Laboratories 17 7 Added to list of references ILAC P 9: ILAC Policy for Participation in Proficiency Testing Activities; ILAC P 10: ILAC Policy on the Traceability of Measurement Results; and ILAC P 14: ILAC Policy for Uncertainty in Calibration Issue nd paragraph Inserted subject to satisfactory evidence of the technical competence of the laboratory using appropriate methods as outlined in the technical procedures after Advisory Committee Issue st Sentence Deleted 1 st sentence and substituted with The information on PT/ILC participation shall be provided on the relevant section of the application form. The results on PT/ILC participation shall be submitted to SADCAS at least one month before the scheduled date of the initial assessment. CEO CEO After 4 th sentence added new sentence which reads The initial assessment of the laboratory should be arranged within 3 months after the facility has addressed the issues raised in the document review report Page 25 of 27