SADCAS POLICY ISO/IEC 17020:2012 TRANSITION
|
|
- Letitia Green
- 6 years ago
- Views:
Transcription
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 The ILAC document number IAF/ILAC A4: 2004 Guidance on the application of ISO/IEC is no longer applicable to accreditations in accordance with ISO/IEC 17020:2012 but still applies to the inspection bodies that are currently in process for accreditation against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
SANAS Transition Policy: ISO/IEC 17020: 2012
SANAS Transition Policy: ISO/IEC 17020: 2012 CONTENTS 1 Introduction 2 Transition to ISO/IEC 17020 3 Specific changes in requirements Appendix A: Summary of changes Appendix B: Cross References: ISO/IEC
More informationREQUIREMENTS FOR ACCREDITATION OF INSPECTION BODIES
NATIONAL CENTRE FOR ACCREDITATION REQUIREMENTS FOR ACCREDITATION OF INSPECTION BODIES according to SM SR EN ISO/IEC 17020:2013 Code DR-OI-07 Edition 2 Page 1/15 Approved by Technical Certification Committee
More informationGuidance on the Application. of ISO / IEC Accreditation International Association for Certifying Bodies
Accreditation International Association for Certifying Bodies Guidance on the Application of ISO / IEC 17020 Guidance on the Application of ISO/IEC 17020 Page 1 of 16 Introduction This guidance document
More information4. General requirements 4.1 Impartiality and independence F Organisation s SANAS No/s. Date/s of evaluation
Generic Checklist for Accreditation of Measurements and Verification of Energy Savings Inspection Bodies to ISO/IEC 17020: 2012 incorporating TR 81: Technical Requirements for the application of SANS/ISO/IEC
More informationSANAS Accr. No/s. F Date/s of evaluation
ISO/IEC 17020: 2012 Generic Checklist for Accreditation of Various Types of Bodies Performing Inspection to ISO/IEC 17020:2012, incorporating TR 80: Technical Requirements for Inspection Bodies in the
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 15189 Third edition 2012-11-01 Medical laboratories Requirements for quality and competence Laboratoires de biologie médicale Exigences concernant la qualité et la compétence
More informationAccreditation Criteria for In-service Inspection of Lifting Equipment
Accreditation Criteria for In-service Inspection G-24/02 Issue Date: 08/07/08 1 INTRODUCTION 1.1 This document has been produced by the Pakistan National Accreditation Council (PNAC) in conjunction with
More informationAccreditation Criteria for In-service Inspection of Lifting Equipment
1 INTRODUCTION 1.1 This document has been produced by the Pakistan National Accreditation Council (PNAC) in conjunction with the PNAC Sectoral Committee for Inspection Bodies. It provides guidance to those
More informationGreen Product Mark Certification Scheme
Green Product Mark Certification Scheme www.tuv.com FOREWORD Product environmental labels are claims regarding the environmental impact of a product. They provide information about the product s overall
More informationGeneral Accreditation Criteria Inspection. ISO/IEC Standard Application Document
General Accreditation Criteria Inspection ISO/IEC 17020 Standard Application Document January 2018 Copyright National Association of Testing Authorities, Australia 2015 This publication is protected by
More informationThe new ISO/IEC 17025:2017
The new ISO/IEC 17025:2017 By Dr. George Anastasopoulos Director, Conformity assessment, IAS Email: ganastasopoulos@iasonline.org Introduction - Background information ISO/IEC 17025 was first issued in
More informationDEPARTMENT OF LABOUR TR 85-03
DEPARTMENT OF LABOUR TR 85-03 DEPARTMENT OF LABOUR (DOL) AND SANAS TECHNICAL REQUIREMENTS FOR THE APPLICATION OF SANS/ISO/IEC 17020: 2012 IN THE REGULATORY ASSESSMENT OF LIFT, ESCALATOR AND PASSENGER CONVEYOR
More informationInter American Accreditation Cooperation IAAC APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS
IAAC APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS CLASSIFICATION This document is classified as an IAAC Mandatory Document AUTHORIZATION Issue Nº: 01 Prepared by: Laboratories
More informationSampling for Assessment
Page of 4 208-0-6 Prepared by: Getnet Tsigemelak Position: Quality Manager Signature: Approved by: Araya Fesseha Position : Director General Signature: Contents: Page 0. Introduction.... Purpose and Scope...2
More informationManagement System Manual International Compliance Group
Granting, refusing, maintaining, renewing, suspending, restoring or withdrawing certification. Page 1-1 Initial certification audit General - ICG s auditing work is conducted in two stages: Stage 1 and
More informationQP 02 Audit and Certification Procedure
1. AUDIT PROGRAMME [9.1.1] The audit programme shall be conducted in stages within a 3-year certification cycle as follows; Initial audit: Two stage process Surveillance audit: Conducted in the first and
More informationISO/IEC INTERNATIONAL STANDARD. Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
INTERNATIONAL STANDARD ISO/IEC 17011 First edition 2004-09-01 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies Évaluation de la conformité Exigences
More informationMeasuring Instruments Directive 2014/32/EU Assessment of Notified Bodies in Charge of Type Examination Presumption of Conformity based on EN 17065
WELMEC 8.5, 2017 Measuring Instruments Directive 2014/32/EU Assessment of Notified Bodies in Charge of Type Examination Presumption of Conformity based on EN 17065 For information: This guide is available
More informationISO9001:2008 SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM SYSTEM KARAN ADVISER & INFORMATION CENTER
SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM WWW.SYSTEMKARAN.COM 1 www.systemkaran.org Foreword... 5 Introduction... 6 0.1 General... 6 0.2 Process approach... 6 0.3 Relationship
More informationSampling for Assessment
Page of 4 208-0-6 Prepared by: Getnet Tsigemelak Position: Quality Manager Signature: Approved by: Araya Fesseha Position : Director General Signature: Contents: Page 0. Introduction.... Purpose and Scope...2
More informationApplication of ISO/IEC 17020:2012 AS IB C1. of inspection bodies. for accreditation. specific criteria
specific criteria for accreditation of inspection bodies Application of ISO/IEC 17020:2012 AS IB C1 1 2 specific criteria for accreditation of inspection bodies Application of ISO/IEC 17020:2012 ILAC P15
More informationSpecification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry
Addendum 1 June 2010 Effective Date: December 1, 2010 Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry ANSI/API SPECIFICATION Q1 EIGHTH EDITION, DECEMBER 2007
More informationGeneral Accreditation Guidance. ISO/IEC 17025:2017 Gap analysis. April 2018
General Accreditation Guidance Gap analysis April 2018 Copyright National Association of Testing Authorities, Australia 2018 This publication is protected by copyright under the Commonwealth of Australia
More informationAccreditation Criteria for In-service Inspection of Pressure Systems/Equipments
1. Introduction 1.1 This document has been produced by the Pakistan National Accreditation Council (PNAC) in conjunction with the PNAC Sectoral Committee for Inspection Bodies. It provides guidance to
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 28003 First edition 2007-08-01 Security management systems for the supply chain Requirements for bodies providing audit and certification of supply chain security management
More informationEA Procedure and Criteria. For the Evaluation of Conformity. Assessment Schemes by EA. Accreditation Body Members
Schemes by EA Accreditation Body Members Publication Reference EA-1/22 A: 2016 EA Procedure and Criteria For the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members PURPOSE This
More informationREVISION OF ISO/IEC GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
REVISION OF ISO/IEC 17025 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES Presented August 10, 2017 to Environmental Measurement Symposium Warren Merkel, Co-convenor ISO/CASCO
More informationVERTICAL ASSESSMENT INSPECTION ISO/IEC 17020:2012
VERTICAL ASSESSMENT INSPECTION ISO/IEC 17020:2012 Organisation s SANAS No/s. Date/s of evaluation Name of Organisation Organisation Representative Area/Field of Accreditation as per schedule of accreditation
More informationISO/IEC INTERNATIONAL STANDARD. Conformity assessment General requirements for proficiency testing
INTERNATIONAL STANDARD ISO/IEC 17043 First edition 2010-02-01 Conformity assessment General requirements for proficiency testing Évaluation de la conformité Exigences générales concernant les essais d'aptitude
More informationNLECTC-National Ballistic-resistant Body Armor Inspection Scheme
Subject: 23 Feb 2018 1 Scope The National Law Enforcement and Corrections Technology Center-National (NLECTC-National) is a program of the U.S. Department of Justice (DOJ), Office of Justice Programs (OJP),
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Third edition 2000-12-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2000(E) ISO 2000 PDF disclaimer
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Third edition 2000-12-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2000(E) ISO 2000 Contents Page
More informationNew ISO/IEC 17025:2017 Update Course (based on DIS Version) Dr. George Anastasopoulos Director, Conformity Assessment ISO/CASCO WG 44 Member
:2017 Update Course (based on DIS Version) Dr. George Anastasopoulos Director, Conformity Assessment ISO/CASCO WG 44 Member About IAS 1975 IAS established March 2002 IASbecomes a nonprofit, public benefit
More informationFinal Document. 18 September 2014
IMDRFIMDSAP WG/N11FINAL:2014 International Medical Device Regulators Forum Final Document Title: MD SAP Assessment and Decision Process for the Recognition of an Auditing Organization Authoring Group:
More informationGuidelines for the assessment of the appropriateness of small interlaboratory comparisons within the process of laboratory accreditation
Publication Reference EA-4/21 INF: 2018 Guidelines for the assessment of the appropriateness of small interlaboratory comparisons within the process of laboratory accreditation PURPOSE This paper provides
More informationCO-ORDINATION OF NOTIFIED BODIES PPE Regulation 2016/425 RECOMMENDATION FOR USE
CO-ORDINATION OF NOTIFIED BODIES PPE Regulation 2016/425 PPE-R/00.018 Version 1 RECOMMENDATION FOR USE Number of pages: 5 Approval stage : Approved on : Origin : Horizontal Committee, C2D Ad hoc group
More informationPRESENTATION OVERVIEW
Conformance and Interoperability (C&I) Validation Workshop for EAC Region Laico Regency Hotel, Nairobi, Kenya 21st 23rd October 2015 PART 2 Requirements for Accreditation Bodies and Testing Laboratories
More informationCRITERIA FOR THE ACCREDITATION OF INSPECTION BODIES PERFORMING INSPECTION IN TERMS OF THE PRESSURE VESSELS/BOILERS REGULATIONS IN ZIMBABWE
CRITERIA FOR THE ACCREDITATION OF INSPECTION BODIES PERFORMING INSPECTION IN TERMS OF THE PRESSURE VESSELS/BOILERS REGULATIONS IN ZIMBABWE Prepared by: SADCAS based on Advisory Committee for Inspection
More informationNLECTC-National Ballistic-resistant Body Armor Inspection Scheme
Subject: 6 Oct 2016 1 Scope The National Law Enforcement and Corrections Technology Center-National (NLECTC-National) is a program of the U.S. Department of Justice (DOJ), Office of Justice Programs (OJP),
More informationOP-19 (9) Certification Process & Decision
OP-19 (9) Certification Process & Decision Purpose: To provide guidance on certification granting and decision making process. Scope: Guidelines for all kind of audits that comes under the ISO 22000 standards.
More informationVersion 2 November Code of Practice. Consignment Based Conformity Assessment (CBCA) Services
Code of Practice Consignment Based Conformity Assessment (CBCA) Services November 2012 PREFACE Many developed countries have strong National Standards and Technical Regulations supported internally with
More informationGuidelines for auditing management systems
INTERNATIONAL STANDARD ISO 19011 Third edition 2018-07 Guidelines for auditing management systems Lignes directrices pour l'audit des systèmes de management Reference number ISO 19011:2018(E) ISO 2018
More informationMicrogeneration Installation Standard: MCS 001. MCS Contractor certification Scheme requirements Issue 3.0
Microgeneration Installation Standard: MCS 001 MCS Contractor certification Scheme requirements Issue 3.0 This Microgeneration Installation Standard is the property of Department of Energy and Climate
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Quality management systems Requirements Systèmes de management de la qualité Exigences Fourth edition 2008-11-15 Reference number ISO 9001:2008(E) ISO 2008 PDF disclaimer
More informationAccreditation Process Requirements
SAAS Accreditation Process Requirements Work Instructions for Accreditation Auditors, Procedures 311 and 314 Social Accountability Accreditation Services, June 2010 Accreditation Process and Policies SAAS
More informationMicrogeneration Installation Standard: MCS 001. MCS Contractor certification scheme requirements Issue 2.5
Microgeneration Installation Standard: MCS 001 MCS Contractor certification scheme requirements Issue 2.5 This Microgeneration Installation Standard is the property of Department of Energy and Climate
More informationGUIDANCE FOR ADDRESSING AND CLEARING NONCONFORMITIES
GUIDANCE FOR ADDRESSING AND CLEARING NONCONFORMITIES Prepared by : Technical Manager Approved by : Chief Executive Officer Date of Approval: 2016-06-15 Effective Date: 2016-06-15 Table of Contents 1. PURPOSE
More informationBINDT AUDIT PROCEDURE CONFORMITY ASSESSMENT AND CERTIFICATION/VERIFICATION OF MANAGEMENT SYSTEMS
Certification Services Division Midsummer House Riverside Way, Bedford Road Northampton, NN1 5NX United Kingdom Tel: +44(0)1604-438-300. E-mail: pcn@bindt.org CP14 ISSUE 6 DATED 1 st OCTOBER 2017 IMPLEMENTATION
More informationVendor Qualification Survey
1200 West 96 th St Minneapolis, MN 55431 Ph: 952-888-7900 Fax: 952-888-2719 Vendor Qualification Survey Vendor Information Company Name: Date: Address: City: Phone Number: email address: Product or Service
More informationEA-7/04 Legal Compliance as a part of accredited ISO 14001: 2004 certification
Publication Reference EA-7/04 Legal Compliance as a part of Accredited ISO 14001: 2004 certification PURPOSE The text of this document has been produced by a working group in the European co-operation
More informationILAC Mutual Recognition Arrangement: Policy and Management ILAC-P4:06/2017
ILAC Mutual Recognition Arrangement: Policy and Manag ement ILAC-P4:06/ /2017 ILAC International Laboratory Accreditation Cooperation ILAC is the international authority on laboratory, inspection body,
More informationISO /TS 29001:2010 SYSTEMKARAN ADVISER & INFORMATION CENTER SYSTEM KARAN ADVISER & INFORMATION CENTER
SYSTEM KARAN ADVISER & INFORMATION CENTER PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES -- SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS -- REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
More informationCMI Guidance Document
CMI Guidance Document for Product Quality Plan Requirements Reference CMI-GD-PQP This document has been produced by the Administration Department of CertMark International (CMI). For technical information
More informationQuality management Guidelines for quality plans
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 10005 ISO/TC 176/SC 2 Secretariat: BSI Voting begins on: 2018 03 13 Voting terminates on: 2018 05-08 Quality management Guidelines for quality plans Management
More informationIAF MLA Document. Guidance for the Exchange of Documentation among MLA Signatories for the Assessment of Conformity Assessment Bodies.
IAF MLA Document Guidance for the Exchange of Documentation among MLA Signatories for the Assessment of Conformity Assessment Bodies Issue 3 (IAF ML 1:2016) Issue 3 Guidance for the Exchange of Documentation
More informationOverview of Good Food Laboratory Practices
Overview of Good Food Laboratory Practices Dr. Anne Bridges Technical Director, AACC International International Workshop & Training Program On Good Food Laboratory Practices Jointly Organized By Food
More informationDutch Accreditation Council (RvA) Explanatory notes on EN-ISO/IEC 17025
Dutch Accreditation Council (RvA) Explanatory notes on EN-ISO/IEC 17025 Document code: RvA-T015-UK Version 6, 13-4-2018 Rv A explanatory notes describe the policy and/or the procedures of the Rv A concerning
More informationCorrelation Matrix & Change Summary
The correlation matrix compares the new requirements of ISO 9001:2015 to the requirements of ISO 9001:2008, and provides a summary of the changes. Correlation Matrix & Change Summary Introduction Correlation
More informationGeneral requirements for the competence of testing and calibration laboratories. In this presentation:
General requirements for the competence of testing and calibration laboratories ISO/IEC 17025:2017 In this presentation: Explanation New requirement Interpretation / Examples / Questions Agenda Welcome
More informationGUIDE 60 Conformity assessment Code of good practice
GUIDE 60 Conformity assessment Code of good practice Second edition 2004 ISO 2004 PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may
More informationICC-ES Requirements for Quality Documentation and Inspection of Manufacturing Facilities
ICC-ES Requirements for Quality Documentation and Inspection of Manufacturing Facilities Quality Control Department ICC Evaluation Service, Inc. January 2011 Agenda AC10 AC304 Changes to AC304 Summary
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 19011 Second edition 2011-11-15 Guidelines for auditing management systems Lignes directrices pour l audit des systèmes de management Reference number ISO 19011:2011(E) ISO 2011
More informationIECEx OPERATIONAL DOCUMENT
IECEx OD 314-3 Edition 2.0 2018-10 IECEx OPERATIONAL DOCUMENT IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres (IECEx System) IECEx Certified Service Facilities
More informationDECISION TO ACCREDIT
DECISION TO ACCREDIT Determine the requirements of the regulator, legislation and customer s needs prior to deciding on the standard to implement. Process is based on the following: Top management s decision
More informationEA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members
Publication Reference EA-1/22 A-AB: 2014 EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA PURPOSE This document contains the procedure and criteria to be applied by EA
More informationAPLAC GUIDANCE ON REFERENCE MATERIAL USE AND PRODUCTION
APLAC GUIDANCE ON REFERENCE MATERIAL USE AND PRODUCTION Issue 6 Issue Date: 2018/02 Page 1 of 18 PURPOSE Reference Materials (RMs) are used in all stages of the measurement process, for method validation,
More informationTitle Procedure for setting up the accreditation of new conformity assessment schemes
Title Procedure for setting up the accreditation of new conformity assessment schemes Reference PG-13-01 Revision 1 Date 09-04-2018 NOTE: The present document represents the English version of document
More information25 D.L. Martin Drive Mercersburg, PA (717)
QUALITY MANUAL D. L. MARTIN CO. 25 D.L. Martin Drive Mercersburg, PA 17236 (717) 328-2141 Revision 14 August 2012 Michael A. White Manager, QA & Engineering D.L. Martin Co. Quality Manual UNCONTROLLED
More informationSYSTEMKARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM ISO9001:
SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM ISO9001:2015 WWW.SYSTEMKARAN.ORG 1 WWW.SYSTEMKARAN.ORG Foreword... 5 Introduction... 6 0.1 General... 6 0.2 Quality management principles...
More informationProcedures: QP 4 through QP 8, QP 16, QP 17, and QP 19
SRI Quality System Registrar Procedures: QP 4 through QP 8, QP 16, QP 17, and QP 19 Booklet Version 171122 Revision Date QP 4.0 Pre-Audit Registration Procedures 15 11/07/15 QP 5.0 On-Site Audit Procedure
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationJOB DESCRIPTION: LEAD ASSESSOR
Page of 6 203-2-29 Prepared by: Mulugeta Mekonnen Signature: Approved by: Araya Fesseha Signature: CONTENTS Purpose and scope... 2 2 References... 2 3 Selection Criteria... 2 4 Training... 3 5 Responsibilities...
More informationKENYA ACCREDITATION SERVICE
KENAS-GUD-033 01 17/02/2016 17/03/2016 GUD 1 of 6 Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this Document. Name Job Title / Role Signature
More informationILAC P10 TRACEABILITY
ACTIVITY 1.3 TRAINING SESSION FOLLOWING THE FINDINGS FROM PREVIOUS ACTIVITIES: ILAC P10 TRACEABILITY Maria Pia Toni Slide 1 of XX REFERENCE ILAC P10:2013 ILAC Policy on the Traceability of Measurement
More informationISO 9001: 2000 (December 13, 2000) QUALITY MANAGEMENT SYSTEM DOCUMENTATION OVERVIEW MATRIX
In completing your Documented Quality Management System Review, it is important that the following matrix be completed and returned to us as soon as possible. This will save time during the review and
More informationKENYA ACCREDITATION SERVICE
KENAS-TS-OP-005 03 17/08/2018 17/09/2018 OP 1 of 7 Approval and Authorization Completion of the following signature blocks signifies the review and approval of this Document. Name Job Title / Role Signature
More informationIMDRF. Final Document. Regulatory Authority Assessor Competence and Training Requirements. IMDRF MDSAP Work Group
IMDRF/ WG /N6 FINAL:2013 IMDRF International Medical Device Regulators Forum Final Document Title: Authoring Group: Regulatory Authority Assessor Competence and Training Requirements IMDRF MDSAP Work Group
More informationIIW Manufacturer Certification Scheme for the Management of Quality in Welding
IIW Manufacturer Certification Scheme for the Management of Quality in Welding ANBCC s Assessment of Manufacturers of Welded Products Copyright EWF 2008 IIW MCS IIW Manufacturer Certification Scheme for
More informationSOLAR KEYMARK SPECIFIC SCHEME RULES ANNEX E: FACTORY PRODUCTION CONTROL INFORMATIVE BASED ON ISO 9001 STANDARD COVERING THE PRODUCTION LINE
SOLAR KEYMARK SPECIFIC SCHEME RULES ANNEX E: FACTORY PRODUCTION CONTROL INFORMATIVE BASED ON ISO 9001 STANDARD COVERING THE PRODUCTION LINE 1. General This annex specifies the requirements for the Factory
More informationQuality System ACCREDITATION For the Clinical Laboratories
Quality System ACCREDITATION For the Clinical Laboratories A NEW PERSPECTIVE BY: Accreditation Commission For Conformity Assessment Bodies (ACCAB) 1 Objective What are Standards? Voluntary & Mandatory
More informationIAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Template report for the peer evaluation of an Accreditation Body based on
IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Template report for the peer evaluation of an Accreditation Body based on ISO/IEC 17011:2017 IAF/ILAC-A3:01/2018 Copyright IAF/ILAC
More informationIAF Guidance on the Application of ISO/IEC Guide 66
IAF GD 6:2003 In terna tion a l A ccred itation Forum,In c. IAF Guidance Document IAF Guidance on the Application of ISO/IEC Guide 66 General Requirements for Bodies Operating Assessment and Certification/registration
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9000 Third edition 2005-09-15 Quality management systems Fundamentals and vocabulary Systèmes de management de la qualité Principes essentiels et vocabulaire Reference number
More informationIECEE OPERATIONAL DOCUMENT
IECEE OD-4001 Edition 1.34 20138-06xx06-05 IECEE OPERATIONAL DOCUMENT IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE System) Factory Surveillance Report
More informationSupplier Quality Manual
Supplier Quality Manual February 2010 Page 1 of 6 Table of Contents 1.0 Purpose 2.0 Scope 3.0 Quality System Requirements 4.0 Supplier Assessments 5.0 Advance Product Quality Planning 6.0 First Article
More information25 D.L. Martin Drive Mercersburg, PA (717)
EMS MANUAL D. L. MARTIN CO. 25 D.L. Martin Drive Mercersburg, PA 17236 (717) 328-2141 Revision 13 January 2017 Kip Heefner Environmental Management Representative Daniel J. Fisher President & CEO D.L.
More informationLEAD EVALUATOR TRAINING COURSE CASE STUDIES
1 Only 2 CAB files were selected those of the CAB s witnessed - for review. 2 The transition of CAB s to an updated standard ISO 15189:2012 was not reviewed by the APLAC evaluator and it was noted (by
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD FDIS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories Exigences générales concernant la compétence des laboratoires d'étalonnages et
More informationPrinciples of the Railway Industry Supplier Qualification Scheme
RISQS/001 Issue 1.2 Date: December 2015 Principles of the Railway Industry Supplier Qualification Scheme Copyright 2013 Rail Safety and Standards Board Limited. This document is subject to copyright protection.
More informationSTATIONARY SOURCE AUDIT SAMPLE PROGRAM [VOLUME 1, MODULE 2] GENERAL REQUIREMENTS FOR AN ACCREDITOR OF STATIONARY SOURCE AUDIT SAMPLE PROVIDERS
[V1M2-2009]-Rev0.2 STATIONARY SOURCE AUDIT SAMPLE PROGRAM [VOLUME 1, MODULE 2] GENERAL REQUIREMENTS FOR AN ACCREDITOR OF STATIONARY SOURCE AUDIT SAMPLE PROVIDERS TNI Standard P.O. Box 2439 Weatherford,
More informationGeneral Accreditation Criteria Equipment assurance, in-house calibration and equipment verification
General Accreditation Criteria Equipment assurance, in-house calibration and equipment verification January 2018 Copyright National Association of Testing Authorities, Australia 2009 This publication is
More informationIAF Mandatory Document. for the Audit and Certification of a Management System Operated by a Multi-Site Organization (IAF MD 1:2018)
IAF Mandatory Document IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization Issue 2 (IAF MD 1:2018) Issued: 29 January 2018 Application Date:
More informationIAF Mandatory Document. Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries. Issue 2 IAF MD 12:2016
IAF Mandatory Document Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries Issue 2 IAF MD 12:2016 2016 Issue 2 Accreditation Assessment of Conformity Page 2 of
More informationGuidelines for auditing management systems
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 19011 Third edition 2018-07 Guidelines for auditing management systems Lignes directrices pour l'audit des systèmes de management Reference number
More informationIATF - International Automotive Task Force IATF 16949:2016 Frequently Asked Question (FAQ)
:2016 Frequently Asked Question (FAQ) :2016 1 st Edition was published in October 2016. In response to questions from the IATF recognized certification bodies and stakeholders, the following questions
More informationReport. Sectorial scheme for accreditation of notified bodies under Directive 2008/57/EC HARMONISED REQUIREMENTS
European Railway Agency Report Report Sectorial scheme for accreditation of notified bodies under Directive 2008/57/EC HARMONISED REQUIREMENTS Elaborated by Validated by Approved by Name Luca TRINCA, Irugo
More informationClause Map IATF 16949:2016 to ISO/TS 16949:2009
Table of Contents Table of Contents Foreword Foreword + Foreword Automotive QMS Standard + History + Goal + 0.5 Goal of this Technical Specification + Remarks for Certification + Remarks for Certification
More informationPart II: Requirements for the Management of Schemes
Version 6.4 Contact address: Global Food Safety Initiative Foundation c/o The Consumer Goods Forum 22/24 rue du Gouverneur Général Eboué 92130 Issy-les-Moulineaux FRANCE Secretariat email: gfsinfo@theconsumergoodsforum.com
More informationGuidelines for the monitoring and reporting of the operation of quality systems by RMOs
Guidelines for the monitoring and reporting of the operation of quality systems by RMOs Version 3 Contents Title Page 1. Introduction... 1 2. Review Guidelines... 1 3. Requirements for the QS... 3 3.1.
More information