SADCAS POLICY ISO/IEC 17020:2012 TRANSITION

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1 SADCAS POLICY ISO/IEC 17020:2012 TRANSITION Prepared by: SADCAS Approved by: SADCAS CEO Approval Date: Effective Date: Page 1 of 11

2 Table of Contents Page 1. INTRODUCTION TRANSITION TO ISO/IEC 17020: General Transition Plan SADCAS Assessment for Purposes of Transition Nonconformities against New Standard ISO/IEC Accreditation Certificate and Schedule End of Transition CHANGES IN REQUIREMENTS... 5 APPENDIX A: SUMMARY OF CHANGES.6 APPENDIX B CROSS REFERENCE.7 Page 2 of 11

3 1. INTRODUCTION ISO/IEC 17020:2012: Conformity assessment General criteria for the operation of various types of bodies performing inspection was published on 1 March On 18 July 2012, the International Laboratory Accreditation Cooperation (ILAC) published a resolution on the transition period for the implementation of ISO/IEC 17020:2012. The resolution is as follows: The ILAC membership agrees to a three year transition period for the implementation of ISO/ IEC 17020: 2012 Conformity assessment Requirements for the operation of various types of inspection bodies performing inspection, from the date of publication of the English language version of the standard. The standard was published on 1 March 2012, therefore the three year transition period will conclude on 1 March The resolution was posted on the SADCAS website soon after publication by ILAC. The ILAC document number IAF/ILAC A4: 2004 Guidance on the application of ISO/IEC is no longer applicable to accreditations in accordance with ISO/IEC 17020:2012 but still applies to the inspection bodies that are currently in process for accreditation against ISO/IEC :1998. The guidance document IAF/ILAC A4 is being revised in line with the new standard for inspection bodies ISO/IEC 17020:2012. For the purpose of this transition policy document, the definitions in ISO/IEC Conformity assessment Vocabulary and general principles apply. 2. TRANSITION TO ISO/IEC General Any applications for accreditation in accordance with ISO/IEC submitted to SADCAS after 1 October 2012 shall be based on the latest version of the standard ISO/IEC 17020: For inspection bodies whose applications were received before 1 October 2012 and are already being processed by SADCAS, the following shall apply: SADCAS shall not conduct assessments against the new standard ISO/IEC 17020:2012 before 31 March Between 1 October 2012 and 31 March 2013, SADCAS will continue to undertake assessments against the old standard ISO/IEC 17020:1998 unless the inspection body explicitly requests that assessment be against the new standard ISO/IEC 17020:2012. This request should be made when scheduling the assessment. After 31 March 2013, all assessments shall be conducted against the new standard ISO/IEC 17020:2012. Page 3 of 11

4 All nonconformities raised during the transition period against the requirements of the new standard ISO/IEC 17020:2012, that are also nonconformities against the old standard ISO/IEC 17020:1998 will require corrective actions from the inspection body. Refer to 2.4 It is important that inspection bodies that have already applied for accreditation from SADCAS and have not yet implemented the new standard do so as soon as possible. SADCAS expects inspection bodies to establish an action plan for implementation of this transition from the old version of the standard ISO/IEC 17020:1998 to the new version ISO/IEC 17020: Transition Plan Inspection bodies that have already applied for accreditation from SADCAS and whose application is progressing through the accreditation process shall provide SADCAS with a transition plan The transition plan shall demonstrate that the inspection body has analyzed the new standard and its implication for their management system and operations and shall enable the inspection body to effectively implement all the changes needed to comply with the new standard ISO/IEC 17020:2012 before 1 March 2015, the date set by ILAC As a minimum the transition plan shall include: All specific actions to be taken to implement the changes; The timelines and milestones for completion of actions; The persons responsible for the actions; Means of monitoring progress and completion of the actions Inspection bodies that have already applied for accreditation from SADCAS and whose application is progressing through the accreditation process shall provide SADCAS with the transition plan before 1 March SADCAS Assessment for Purposes of Transition During transition process, and after the inspection body has submitted its transition plan, SADCAS shall review the plan to verify that the inspection body has analyzed the impact of the new standard ISO/IEC 17020:2012 on its system and has developed the action plan. Refer to Implementation of the transition plan shall be verified during assessments undertaken after 31 March 2013 when SADCAS shall review the changes in the documented system and progress in the implementation of the transition plan Nonconformities against New Standard ISO/IEC 17020: Nonconformities raised against the requirements of the new standard ISO/IEC 17020:2012 that are not nonconformities against the old version of the standard ISO/IEC 17020:1998 shall be recorded as observations to highlight the gap identified. The inspection body shall have until 1 September 2014 to Page 4 of 11

5 implement corrective actions and provide SADCAS with corrective action report. SADCAS shall verify these actions before 1 October 2014 and take its decision before 1 November If by 1 November 2014 SADCAS cannot confirm compliance with the new version of the standard ISO/IEC 17020:2012, then accreditation against ISO/IEC 17020:1998 shall be suspended on 1 March No accreditation against ISO/IEC 17020:2012 shall be granted Nonconformities raised against the old version of the standard ISO/IEC 17020:1998 shall be dealt with in accordance with the SADCAS normal processes and must be cleared within the set timelines before accreditation can be granted Accreditation Certificate and Schedule The accreditation certificate and schedule shall be adapted to reflect accreditation against the new standard ISO/IEC 17020:2012 after assessment against the new standard has been successfully completed and a decision has been taken to that effect by the Accreditation Approvals Committee The inspection body accreditation reference numbers shall remain the same The date on the certificate will be the date of decision to grant accreditation against the new standard. The cycle shall remain as five years End of Transition The three year transition period will conclude on 1 March 2015 and all inspection bodies are expected to be in full compliance with the new standard ISO/IEC 17020:2012 and have new accredited certificates issued If by 1 November 2014 SADCAS cannot confirm compliance with the new version of the standard ISO/IEC 17020:2012, then accreditation against ISO/IEC 17020:1998 shall be suspended on 1 March No accreditation against ISO/IEC 17020:2012 shall be granted. 3. CHANGES IN REQUIREMENTS 3.1 Appendix A of this document summarizes the significant changes in the new standard ISO/IEC 17020: This summary does not contain all the changes made. The inspection body is responsible to investigate which all the changes in the new standard ISO/IEC 17020: 2012 and their impact. 3.2 Appendix B contains the cross references between the new standard ISO/IEC 17020: 2012 and the old standard ISO/IEC 17020: 1998 and the guidance document IIAF/ILAC A4. Page 5 of 11

6 APPENDIX A: SUMMARY OF CHANGES Clause ISO/IEC 17020: Impartiality and independence Details of changes Identification of risks to IB s impartiality 4.2 Confidentiality Legally enforceable commitments 5.1 Administrative requirements Adequate provision (e.g. insurance or reserves) 6.1 Personnel Define and document the competence requirements for all personnel SADCAS explanation Considered a new requirement, management system documentation must be revised to address the identification of risks and actions taken to minimize/eliminate the risk Legally enforceable commitments can be, for example, contractual agreements. See note in 17020:2012 How are liabilities covered arising from its operations? Not only insurance The competence requirements can be part of the job description or other documentation. 7.1 Inspection methods and procedures 8 Management system requirements 8.8 Preventive actions Relevant knowledge of significance of deviations found with regard to the normal use of the products, the operation of the processes and the delivery of services Documented procedures for selecting, training, formally authorizing, and monitoring inspectors and other personnel Inform the client if the inspection method proposed by the client is considered to be inappropriate Traceable to performing inspector(s) Inspection report/certificate shall include all of the following: a) to g) 7.5 Complaints and appeals and 7.6 Complaints and appeals process Management system options A or B available Preventive actions procedure required Personnel must understand the value chain of the product inspected. Records must include a formal declaration of competence, see clause as well Evidence of customer interaction required, formal or informal Traceability Inspection report/certificate to be revised to comply with clause Additional and new requirements, management system to be updated accordingly Selection of management system options A or B and system revised accordingly New to management system Page 6 of 11

7 APPENDIX B CROSS REFERENCE Foreword Foreword Introduction Introduction 1. Scope 1. Scope 2. Normative references 3. terms and definitions 2. Definitions 4. General requirements 4. Independence, impartiality and integrity 4.1 Impartiality and Independence General New requirement, identify risk New requirement, minimize risk New requirement, management commitment Annex A 4.2 Independence a) Type A Inspection Body b) Type B Inspection Body c)type C Inspection Body 4.2 Confidentiality 5. Confidentiality New requirement, legally enforceable arrangements Additional; customer notification IAF/ILAC A4: 5. Confidentiality New requirement 5. Structural requirements 5.1 Administrative requirements 3. Administrative requirements Not only liability insurance Organization and management 6. Organization and management & & IAF/ILAC A4: 6.3a Resource requirements 6.1 Personnel 8 Personnel New requirement. Competence & 8.2 Page 7 of 11

8 6.1.3 Expanded. Knowledge of value chain ISO/IEC 17020: 2012 ISO/IEC 17020:1998/IAF/ILAC A4: New requirement. Formally authorizing Alternative. On site observation unless? Expanded. Records required Expanded. All personnel impartial Confidentiality 6.2 Facilities and equipment 9. Facilities and equipment Additional requirement for competent and safe 9.1 & IAF/ILAC A4: 9.1a manner Expanded. Significant influence defined and 9.4 uniquely identified Additional. Significant influence, calibrate Additional notes on adequacy of software Expanded. Examine effects on defects 9.14 and action Sub contracting 14 Sub contracting See Notes 14.1, 14.2 & IAF/ILAC A4: 14.2a Expanded. Customer informed? Process requirements 10. Inspection methods and procedures 7.1 Inspection methods and procedures Additional. Customer informed if considered 10.1 & IAF/ILAC A4: 10.1a inappropriate Page 8 of 11

9 See Notes on Standard and Non standard method 10.3 & IAF/ILAC A4: 10.3a New. Use of information from other parties Handling inspection items and samples 11. Handling inspection samples and items Expanded. IB establish preparation Inspection records 12. Records See also & New. Traceability to performing inspector 7.4 Inspection reports and inspection certificates 13. Inspection reports and inspection certificates Additional requirements New requirement, report/certificate Additional requirements Complaints and appeals 15. Complaints and appeals Additional requirements 15.1 & New requirement, availability New requirement New requirement New requirement 7.6 Complaints and appeals procedure 15. Complaints and appeals Additional requirement New requirement New requirement New requirement New requirement 8. Management system requirements 7. Quality System 8.1 Options New System option for Inspection Body Option A Page 9 of 11

10 8.1.3 Option B New 8.2 General Management System Documentation (option A) & New requirement New requirement 8.3 Control of documents (option A) 7.6 Control of documents Additional requirement Control of records (option A) 12. Records ISO/IEC 17020: 2012 ISO/IEC 17020:1998/IAF/ILAC A4: Management review (option A) 7.9 Management review General New requirement New requirement Review inputs New requirement IAF/ILAC A4: 7.9a Review outputs New requirement 8.6 Internal audits (option A) 7.7 Internal audits Additional requirement Additional requirement Additional requirement Additional requirement 8.7 Corrective actions (option A) 7.8 Corrective actions Additional requirement Additional requirement Additional requirement Additional requirement 8.8 Preventive actions (option A) New New requirement New requirement New requirement Annex A (normative) Independence requirements for inspection bodies A.1 Requirements for Inspection Bodies (Type A) Annex A (normative) A.1 Requirements for Inspection Bodies (Type B) Annex B (normative Page 10 of 11

11 A.1 Requirements for Inspection Bodies (Type C) Annex C (normative Annex b (informative) optional elements of inspection Appendix 3: Elements of Inspection Reports and reports and certificates inspection certificates IAF/ILAC A4: 2004 Guidance on the Application of ISO/IEC Page 11 of 11

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