Quality Management in Photovoltaics

Size: px
Start display at page:

Download "Quality Management in Photovoltaics"

Transcription

1 Quality Management in Photovoltaics Quality Control Training Manual for Manufacturers Peter F. Varadi PV GAP Geneva, Switzerland Ram n Dominguez Dominguez and Associates Rockville, Maryland, USA Deborah McGlauflin Insights in Action, Inc. Annapolis, Maryland, USA

2 Copyright 2001 The International Bank for Reconstruction and Development / THE WORLD BANK 1818 H Street, N.W. Washington, D.C , USA All rights reserved Manufactured in the United States of America First printing January 2001 The findings, interpretations, and conclusions expressed in this book are entirely those of the authors and should not be attributed in any manner to the World Bank, to its affiliated organizations, or to members of its Board of Executive Directors or the countries they represent. The World Bank does not guarantee the accuracy of the data included in this publication and accepts no responsibility for any consequence of their use. The boundaries, colors, denominations, and other information shown on any map in this volume do not imply on the part of the World Bank Group any judgment on the legal status of any territory or the endorsement or acceptance of such boundaries. The material in this publication is copyrighted. The World Bank encourages dissemination of its work and grants permission to reproduce this work.

3 Table of Contents Preface... ix Acknowledgments... xi Chapter 1: Quality in Manufacturing General Concepts Introduction The Photovoltaic (PV) Industry Pilot Program Design Elements of a Quality System Quality Manufacturing Process Standards for the Performance of Products Testing Laboratories Auditing by an Outside Organization Global Approval Program for PV (PV GAP) Why Is a Global Approval Program for PV Needed? The Elements of the PV GAP Approval System PV GAP Administered by a Globally Accepted Approval Body Globally Utilized PV Quality Mark and Seal The Evolution and Merits of Quality Systems ISO Standards for Quality in Manufacturing What Is ISO 9000? Your Company s Quality System Requirements Definitions ISO Documentation Levels ISO Quality Definitions The Fundamentals of Quality Management (ISO 4.1) What Does Quality Mean for Your Business? Management Responsibility The Role of the Management Representative Management Reviews Homework Assignment Day One Chapter 2: ISO 9000 Standards Quality in Manufacturing Procedures and Planning (ISO 4.2) Standard General Description Standard Quality System Procedures Standard Quality Planning Contract Review Process (ISO 4.3) Design Control (ISO 4.4) Suggested Process for Establishing Design Control Procedures to Control and Verify the Design of Products Document and Data Control (ISO 4.5) Control of Quality Records (ISO 4.16) Case Study No Purchasing (ISO 4.6) iii

4 2.7.1 Purchasing Data Evaluation of Subcontractors Product Tracking and Verification Inventory Control Case Study No Control of Customer-Supplied Products (ISO 4.7) Product Identification and Traceability (ISO 4.8) Homework Assignment Day Two Chapter 3: ISO 9000 Standards, Continued Process Control (ISO 4.9) Inspection and Testing (ISO 4.10) Incoming Inspection In-process Inspection and Testing Final Inspection and Testing Control of Inspection, Measuring, and Test Equipment (ISO 4.11) Inspection and Test Status (ISO 4.12) Control of Nonconforming Products (ISO 4.13) Corrective and Preventive Action (ISO 4.14) Corrective Actions Preventive Actions Training (ISO 4.18) Handling, Storage, Packaging, Preservation, and Delivery (ISO 4.15) Handling Storage Packaging Preservation Delivery Case Study No Servicing (ISO Planning and Scheduling Servicing Activities Spare Parts Availability and Management Servicing Instructions and Records Case Study No Statistical Data (ISO 4.20) Non-Numerical Methods Numerical Methods Description of Non-Numerical Methods Description of Numerical Methods Homework Assignment Day Three Chapter 4: PV Standards Existing Standards for PV What is a Standard? Why Are Standards Needed? iv

5 4.2 How Are Standards Established? National or Regional Standards Case Study No Global/International Standards for PV (IEC Standards) The Two Categories of IEC standards for PV PV GAP Recommended Specifications (PVRS) Case Study No The Development of a Charge Controller for Navigational Aids Work Item Initiated by PV GAP When There Are No Standards Certifiable PV Standards Is a Technical Standard Enough? What is a Certifiable Standard? What is in a Detail Specification? Time Required to Complete the BDS Intermediate Tests and Final Product Test Incoming Inspection and Tests Intermediate Testing Final Inspection and Testing Case Study No Testing Laboratories Purpose of Testing Laboratory Quality Systems Accreditation Process Why Is It Necessary to Have an Accredited Testing Laboratory Do the Tests? The Importance of Reciprocity Chapter 5: The Qualification Process Quality Audits (ISO 4.17) The Internal Audit The External Audit Noncompliance The Steps to ISO 9000 Qualification Preliminary Stage Setting up the Quality System The Certification Process IECQ/PV GAP Approval Process How Does the IECQ Approval Process Work? What Are the Steps a Manufacturer Must Take to Get IECQ Approval for Its Products? What Does the SI Then Do? Withdrawal or Suspension of Approval The PV GAP Approval Process Recognition PV GAP Mark and Seal How Can People Recognize Quality Products? What Is the Benefit of a PV Quality Mark/Seal? PV Manufacturer s Identification Number The Cost of PV GAP Licensing v

6 5.5 The Costs and Benefits of Quality Who Benefits from ISO 9000 Implementation? Appendix 1. Pilot Training Schedule Appendix 2. Example of a Standard Quality Plan Appendix 3. IEC Standards Possibly Useful for PV Appendix 4. Publications Issued by IEC TC Appendix 5. PV GAP Recommended Specifications (PVRS) Appendix 6. Example of a Certifiable Standard and PVRS Appendix 7. Supervising Inspectorates Appendix 8. Provisional List of Testing Laboratories Glossary of Terms Bibliography List of Figures Figure 1.1. How ISO, IEC, and IECQ Are Related... 3 Figure 1.2. Elements of the Global Approval Program for PV (PV GAP)... 9 Figure 1.3. Quality System Documentation Control Figure 1.4. Procedure to Elaborate a Quality Statement Figure 2.1. Nonstandard Product Purchase Order Procedure Figure 2.2. Design Review Figure 2.3. Documentation Control Figure 2.4. Sample Controller Flow Chart Figure 2.5. Why Use Purchasing Specifications? Figure 2.6. Sample Tags and Labels Figure 3.1. Process Control Figure 3.2. Handling a Nonconforming Product Figure 3.3. Training Figure 3.4. Cause-and-Effect Diagram Figure 3.5. Sample Flow Chart Figure 3.6. Sample Pareto Charts Figure 3.7. Sample Histograms Figure 3.8. Performance Charts Figure 3.9. Scatter Diagrams Figure Statistical Tools for Problem-Solving Figure Control Charts Figure 4.1. Relationship between PV GAP, IEC, and IECQ Figure 4.2. PV GAP Recommended Specifications Figure 4.3. When No Published Standard Is Available Figure 5.1. Internal Audits Figure 5.2. Top Reasons for Noncompliance Figure 5.3. The Road to ISO Figure 5.4. ISO Procedures and Processes Figure 5.5. The IECQ System vi

7 Figure 5.6. The Steps a Manufacturer Must Take to Get IECQ Approval for Its Products Figure 5.7. Quality Mark and Quality Seal Figure 5.8. The Importance of Quality Marks and Quality Seals Figure 5.9. PV GAP Licensing List of Tables Table 1.1. The Rewards of Quality... 8 Table 1.2. A Comparison of the ISO 9000 Standards Table 1.3. Elements of ISO Table 3.1. Steps to Make a Control Chart Table 5.1. Most Common Reasons for Noncompliance during ISO 9001 Audits Table 5.2. Areas of Relevance of the Various ISO Requirements (ISO 9001) Table 5.3. The Voice of the Customer Table 5.4. Results that Speak for Themselves Table 5.5. Comparison of Quality Systems List of Boxes Box 1.1. The PV GAP Mission Statement... 6 Box 3.1. Rules for Brainstorming Box 4.1. Advantages of Having Global Standards Box 5.1 Self-Audit Exercise List of Forms Form Statement of Commitment to Quality Form Management Representative Form Sample Organizational Chart Form Job Description Form Management Representative Responsibility Checklist Form Annual Review of the Quality System and Its Impacts on the Company and the Company s Products and Customer Relations Form Work Flow Diagram Form Sample Documentation of the Steps in the Work Flow Process Form Instructions for the Use of the Quality System Procedures Form Quality Planning Checklist Form Contract Order, Review,Verification, and Validation Form Form Form for Quality Control of Design Procedures Form Design Review,Verification, and Validation Form Form Document Flow and Control Form Form Materials Control Data Form Form for Qualifying Outside Vendors/Products and Tracking and Verification Form Customer-Supplied Product Tracking and Verification Form Product Tracking and Verification Form Product Tracking Form Process Control Form Form for Monitoring Production Process Form Procedure and Schedule for Equipment Maintenance Form Documentation for Receiving, In-Process, and Final Inspection and Testing Form Procedures for Quality Control of Measurement and Test Equipment vii

8 Form Form for Product Status, Disposition, and Corrective/Preventive Action Form Corrective Action Request Form Sample Component/Product Handling Form Form Audit Planning Form Internal Audit Report Form Training Documentation Form Form Servicing Documentation Form viii

9 Preface Photovoltaic (PV) products are manufactured in many countries and sold all over the world. Most work well and are very reliable, with the result that industry market growth is higher now than at any time in the last 15 years. Although there are no worldwide statistics, product failures are probably less than 5 percent of total shipments, and the quality of modules produced by the major manufacturers is outstanding. PV product failures are predominantly attributable to manufacturers and systems integrators in developing countries, although some developing countries have much higher product quality than others. Even though the overwhelming majority of PV companies deploy quality systems, it is necessary to bring those that do not up to the level of the rest of the PV industry to avoid jeopardizing customer confidence in the quality and reliability of PV products. The purpose of this training manual is to establish global quality standards and to begin to help everyone in the industry meet them. This will not happen overnight, and some very real barriers must be addressed. Good quality is always cheaper in the end, however, and companies that strive for it can expect to be rewarded with greater profits. Other industries have faced similar challenges and have created some solutions that the PV industry can study and adopt. Today the globally accepted system for a quality management of the manufacturing process is the ISO 9000 standard. It is generic and, therefore, is used in many industries. At present, a few PV manufacturers primarily larger and older ones meet the ISO 9000 standard, but many do not. Of the latter, many simply may not know about the standard, but others think that the ISO 9000 system is too technical and expensive to be practical for small and medium-size companies to implement. Recognizing that this is a valid concern and that the original ISO 9000 documentation was far from user-friendly, the Global Approval Program for Photovoltaics (PV GAP) has developed this manual to spell out in simple terms what is required by the ISO 9000 standard and to provide forms that PV companies can refer to, to easily and inexpensively install a quality manufacturing management system without having to hire an extensive staff. PV GAP was established by the PV industry to establish a uniform approach to quality assurance. This training manual, Quality Management in Photovoltaics, is part of that effort and was prepared for the World Bank. It builds on an earlier manual that PV GAP developed under a contract from the Energy and Atmosphere Programme of the United Nations Development Programme that focused on one key requirement of the ISO 9000 standard the development of a quality process manual. This training manual completes the picture by explaining all the ISO 9000 requirements and giving companies the tools they need to comply with them fully, but with an economy of effort. It describes how the PV GAP system uses the established International Electrotechnical Commission Quality Assurance System for Electronic Components (IECQ). The manual also introduces the PV quality Mark and Seal and explains how they help ix

10 customers distinguish high-quality PV components and systems from those of poor or unknown quality while, at the same time, they help the PV manufacturers who are qualified and licensed to use them be more globally competitive. x

11 Acknowledgments The following people deserve special thanks for contributing sections of the text or reviewing drafts, or both: Mr. Harvey Berman, Joe Chiaramonte, Regi Sam, Rich Lap, and others; Underwriters Laboratories; IECQ US National Supervising Inspectorate; Melville, New York Mr. M. M. Bhardwaj; REIL, India Dr. Anil Cabraal, the World Bank Dr. Harvey Forest and Mr. John Wohlgemuth: Solarex, USA Mr. Enno Heijndermans: The World Bank Mr. Philippe Jacquin: Erik Lysen, and Bernard McNelis; IEA/PVPS/ Task III Mr. Richard Kay: IECQ Secretary, Switzerland Mr. Wim J. van Nes: Novem, the Netherlands Dr. Markus G. Real: Alpha Real AG, Switzerland Mr. Hidenori Shimizu: JQAO, Japan Dr. K. S. Srinivas: MNES, India xi

12

Quality Management in Photovoltaics

Quality Management in Photovoltaics Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Quality Management in Photovoltaics Quality Control Manual for Manufacturers Peter F.

More information

Quality management systems Guidelines for the application of ISO 9001:2008 in local government

Quality management systems Guidelines for the application of ISO 9001:2008 in local government Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 18091 First edition 2014-02-15 Quality management systems Guidelines for the application of ISO 9001:2008 in local government Systèmes de management

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 18091 First edition 2014-02-15 Quality management systems Guidelines for the application of ISO 9001:2008 in local government Systèmes de management de la qualité Lignes directrices

More information

ISO 9001:2000 Making the Transition

ISO 9001:2000 Making the Transition ISO 9001:2000 Making the Transition ISO 9001:2000 Making the Transition Annette Dennis McCully Debra L. Reese Excerpts from interviews conducted by the author with Garnett Davis and William Poliseo published

More information

Report on the Observance of Standards & Codes (ROSC) Accounting & Auditing (A&A)

Report on the Observance of Standards & Codes (ROSC) Accounting & Auditing (A&A) Public Disclosure Authorized Public Disclosure Authorized Report on the Observance of Standards & Codes (ROSC) Accounting & Auditing (A&A) Public Disclosure Authorized MODULE B: INSTITUTIONAL FRAMEWORK

More information

Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry

Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry ANSI/API SPECIFICATION Q1 EIGHTH EDITION, DECEMBER 2007 EFFECTIVE DATE: JUNE 15, 2008 CONTAINS API MONOGRAM

More information

Provläsningsexemplar / Preview. Third edition

Provläsningsexemplar / Preview. Third edition Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 15378 Third edition 2015-10-01 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008,

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 30301 First edition 2011-11-15 Information and documentation records Requirements Information et documentation Systèmes de gestion des documents d'activité Exigences Reference

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 22313 First edition 2012-12-15 Societal security Business continuity management systems Guidance Sécurité sociétale Systèmes de management de la continuité d activité Lignes

More information

ACCREDITATION CRITERIA FOR FABRICATOR INSPECTION PROGRAMS FOR WOOD WALL PANELS AC196. April 2017 (Effective June 1, 2017) PREFACE

ACCREDITATION CRITERIA FOR FABRICATOR INSPECTION PROGRAMS FOR WOOD WALL PANELS AC196. April 2017 (Effective June 1, 2017) PREFACE ACCREDITATION CRITERIA FOR FABRICATOR INSPECTION PROGRAMS FOR WOOD WALL PANELS April 2017 (Effective June 1, 2017) PREFACE The attached accreditation criteria have been issued to provide all interested

More information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 29001 Third edition 2010-06-01 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL SPECIFICATION ISO/TS 22163 First edition 2017-05 Railway applications Quality management system Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements

More information

INTERNATIONAL STANDARD

INTERNATIONAL 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 information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 29001 First edition 2003-09-15 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply

More information

INTERNATIONAL STANDARD

INTERNATIONAL 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 information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 29001 Third edition 2010-06-01 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply

More information

Current Quality. Culture. Mini Paper IE 361

Current Quality. Culture. Mini Paper IE 361 Current Quality Culture Mini Paper IE 361 I. Introduction ISO 9001 The International Organization for Standardization (ISO) was established in 1946 to promote the development of standardization and related

More information

SUPPLIER SURVEY FORM Instructions

SUPPLIER SURVEY FORM Instructions SUPPLIER SURVEY FORM Instructions 1. The following Supplier Survey was developed by Vishay Measurements Group, Inc. to assess and document the capability of its supplier base. 2. The Supplier Survey is

More information

THE CERTIFIED SUPPLIER

THE CERTIFIED SUPPLIER THE CERTIFIED SUPPLIER QUALITY PROFESSIONAL HANDBOOK Mark Allen Durivage, editor ASQ Quality Press Milwaukee, Wisconsin Table of Contents List offigures and Tables Preface Acknowledgments xi xv xvii Part

More information

Quality assured. Solar photovoltaics is used around the world to provide. PV GAP global quality label based on IECEE certification

Quality assured. Solar photovoltaics is used around the world to provide. PV GAP global quality label based on IECEE certification Over the past five years, the PV GAP quality label has grown from an idea to a sought-after industry standard. Four of the major PV manufacturers have now been awarded PV GAP status. Markus Real, Pierre

More information

Quality management systems Requirements

Quality management systems Requirements INTERNATIONAL STANDARD ISO 9001 Fifth edition 2015-09-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2015(E) ISO 2015 ISO 9001:2015(E)

More information

SUPPLY AND INSTALLATION OF TURBINES AND GENERATORS CONTRACT SCHEDULE 8 QUALITY MANAGEMENT TABLE OF CONTENTS

SUPPLY AND INSTALLATION OF TURBINES AND GENERATORS CONTRACT SCHEDULE 8 QUALITY MANAGEMENT TABLE OF CONTENTS SUPPLY AND INSTALLATION OF TURBINES AND GENERATORS CONTRACT SCHEDULE 8 QUALITY MANAGEMENT TABLE OF CONTENTS 1 INTERPRETATION... 1 1.1 Definitions... 1 2 QUALITY MANAGEMENT SYSTEM... 2 2.1 Quality Management

More information

PROPOSED NEW SECTIONS FOR WHO GOOD MANUFACTURING PRACTICES (GMP): MAIN PRINCIPLES FOR PHARMACEUTICAL PRODUCTS DRAFT FOR COMMENT

PROPOSED NEW SECTIONS FOR WHO GOOD MANUFACTURING PRACTICES (GMP): MAIN PRINCIPLES FOR PHARMACEUTICAL PRODUCTS DRAFT FOR COMMENT August 2010 RESTRICTED PROPOSED NEW SECTIONS FOR WHO GOOD MANUFACTURING PRACTICES (GMP): MAIN PRINCIPLES FOR PHARMACEUTICAL PRODUCTS DRAFT FOR COMMENT Please address any comments on this draft guideline

More information

Quality Management Systems for the Food Industry

Quality Management Systems for the Food Industry Quality Management Systems for the Food Industry Quality Management Systems for the Food Industry A guide to ISO 9001/2 Andrew Bolton Quality Management Consultant Tunbridge Wells, UK A Chapman & Hall

More information

INS QA Programme Requirements

INS QA Programme Requirements Specification Date: 20/3/17 INS QA Programme Requirements UNCONTROLLED WHEN PRINTED Author: J Cooch AUTHORISATION Date: 20/3/17 A Brown Owner: J Cooch (Signature) N.B. only required for hard copy If issued

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 15378 Fourth edition 2017-09 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing

More information

Guidance on the Application. of ISO / IEC Accreditation International Association for Certifying Bodies

Guidance 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 information

PROOF/ÉPREUVE A ISO INTERNATIONAL STANDARD. Environmental management systems Specification with guidance for use

PROOF/ÉPREUVE A ISO INTERNATIONAL STANDARD. Environmental management systems Specification with guidance for use INTERNATIONAL STANDARD ISO 14001 First edition 1996-09-01 Environmental management systems Specification with guidance for use Systèmes de management environnemental Spécification et lignes directrices

More information

INTERNATIONAL STANDARD

INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 30300 First edition 2011-11-15 Information and documentation records Fundamentals and vocabulary Information et documentation Systèmes de gestion des documents d activité Principes

More information

Quality management systems Requirements

Quality management systems Requirements Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 9001 Fifth edition 2015-09-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 2015

More information

Medical devices Quality management systems Requirements for regulatory purposes

Medical devices Quality management systems Requirements for regulatory purposes Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 13485 Third edition 2016-03-01 Medical devices Quality management systems Requirements for regulatory purposes Dispositifs médicaux Systèmes de

More information

Educational organizations Management systems for educational organizations Requirements with guidance for use

Educational organizations Management systems for educational organizations Requirements with guidance for use INTERNATIONAL STANDARD ISO 21001 First edition 2018-05 Educational organizations Management systems for educational organizations Requirements with guidance for use Organismes d'éducation/formation Systèmes

More information

Information technology Security techniques Information security management systems Requirements

Information technology Security techniques Information security management systems Requirements INTERNATIONAL STANDARD ISO/IEC 27001 Second edition 2013-10-01 Information technology Security techniques Information security management systems Requirements Technologies de l information Techniques de

More information

NUMBER OF EMPLOYEES TOTAL ENGINEERING MANUFACTURING QUALITY SUPPLIER IN-HOUSE SPECIAL PROCESS CAPABILITIES

NUMBER OF EMPLOYEES TOTAL ENGINEERING MANUFACTURING QUALITY SUPPLIER IN-HOUSE SPECIAL PROCESS CAPABILITIES Kearfott/ACA SUPPLIER QUALITY SYSTEM SURVEY SUPPLIER NAME SUPPLIER CODE DATE ADDRESS & ZIP CODE AREA CODE & PHONE QUALITY MANAGEMENT (NAME & TITLE) PRODUCT LINE (DESCRIBE) NUMBER OF EMPLOYEES TOTAL ENGINEERING

More information

IECRE OPERATIONAL DOCUMENT

IECRE OPERATIONAL DOCUMENT IECRE OD-405-2 Edition 1.0 2016-09-26 IECRE OPERATIONAL DOCUMENT IEC System for Certification to Standards relating to Equipment for use in Renewable Energy applications (IECRE System) IECRE Quality System

More information

Quality management Guidelines for quality plans

Quality 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 information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 14067 First edition 2018-08 Greenhouse gases Carbon footprint of products Requirements and guidelines for quantification Gaz à effet de serre Empreinte carbone des produits Exigences

More information

QUALITY CONTROL MANUAL

QUALITY CONTROL MANUAL QUALITY CONTROL MANUAL Page 1 of 10 TABLE OF CONTENTS CONTENTS PAGE General Information 3 Statement of Policy and Authority 3 Control of the QC Manual (Section I) 4 Responsibility of Key Personnel (Section

More information

ISO INTERNATIONAL STANDARD. Quality systems Medical devices Guidance on the application of ISO and ISO 13488

ISO INTERNATIONAL STANDARD. Quality systems Medical devices Guidance on the application of ISO and ISO 13488 INTERNATIONAL STANDARD ISO 14969 First edition 1999-06-01 Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488 Systèmes qualité Dispositifs médicaux Lignes directrices

More information

INTERNATIONAL STANDARD

INTERNATIONAL 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 information

Part 1: Life cycle governance

Part 1: Life cycle governance INTERNATIONAL STANDARD ISO 16530-1 First edition 2017-03 Petroleum and natural gas industries Well integrity Part 1: Life cycle governance Pétrole et industries du gaz naturel Intégrité du puits Partie

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 16106 First edition 2006-03-01 Packaging Transport packages for dangerous goods Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings Guidelines

More information

IECQ PUBLICATION IECQ IEC Quality Assessment System for Electronic Components (IECQ System)

IECQ PUBLICATION IECQ IEC Quality Assessment System for Electronic Components (IECQ System) IECQ 03-2 Edition 2.1 2013-02 IECQ PUBLICATION IEC Quality Assessment System for Electronic Components (IECQ System) Rules of Procedure Part 2: IECQ Approved Process Scheme IECQ 03-2:2013(E) THIS PUBLICATION

More information

Contents. Part I Business-Integrated Quality Systems. Part II Integrated Planning. Preface... xi

Contents. Part I Business-Integrated Quality Systems. Part II Integrated Planning. Preface... xi Contents Preface... xi Part I Business-Integrated Quality Systems 1 Organizational Structures... 3 General Theory of Organization Structure... 5 The Functional/Hierarchical Structure... 6 Matrix Organizations...

More information

QUALITY ASSURANCE MANUAL CHAPTER COVER. PAG # 1 of 1 REVISION DATE 05/27/2014 FLUID FILTRATION MANUFACTURING CORPORATION UNCONTROLLED COPY

QUALITY ASSURANCE MANUAL CHAPTER COVER. PAG # 1 of 1 REVISION DATE 05/27/2014 FLUID FILTRATION MANUFACTURING CORPORATION UNCONTROLLED COPY COVER 1 of 1 UNCONTROLLED COPY 1. 1 of 3 1. SCOPE OF APPLICATION 1.1 General This manual establishes requirements for FLUID FILTRATION Quality Assurance System. The system has been designed to provide

More information

ISCC 204 AUDIT REQUIREMENTS AND RISK MANAGEMENT. Version 3.0

ISCC 204 AUDIT REQUIREMENTS AND RISK MANAGEMENT. Version 3.0 ISCC 204 AUDIT REQUIREMENTS AND RISK MANAGEMENT Version 3.0 II Copyright notice 2016 ISCC System GmbH This ISCC document is protected by copyright. It is freely available from the ISCC website or upon

More information

QUALITY MANUAL QM0492 ISO SUPPLEMENT III

QUALITY MANUAL QM0492 ISO SUPPLEMENT III QUALITY MANUAL QM0492 ISO 13485 SUPPLEMENT III REV. ORIG Foreword This document defines the quality management system requirements to be applied when processing product for clients within the medical sector

More information

OWNER USER INTEGRITY MANAGEMENT SYSTEM WRITTEN DESCRIPTION CHECKLIST AB-512(b)

OWNER USER INTEGRITY MANAGEMENT SYSTEM WRITTEN DESCRIPTION CHECKLIST AB-512(b) Company Name: Written Description of QMS Title and Rev. Status: Person who is responsible for preparing the owner s QMS written description: Name: Title: Telephone No.: ( ) Fax No.: ( ) Cell No.: ( ) E-Mail:

More information

Successful Project Management. Third Edition

Successful Project Management. Third Edition Successful Project Management Third Edition Successful Project Management Third Edition Larry Richman Some material in this course has been adapted from Project Management Step-by-Step, by Larry Richman.

More information

Guidelines for auditing management systems

Guidelines 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 information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 29001 Third edition 2010-06-01 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply

More information

Forum on Regional Cooperation: Developing Quality Infrastructure for Photovoltaic Energy Generation

Forum on Regional Cooperation: Developing Quality Infrastructure for Photovoltaic Energy Generation Forum on Regional Cooperation: Developing Quality Infrastructure for Photovoltaic Energy Generation Santiago, Chile 13-14 September 2017 a) IEC technical standards for PV systems b) IECRE Certification

More information

IPD Quality Management System Supplier Questionnaire Instructions

IPD Quality Management System Supplier Questionnaire Instructions IPD Quality Management System Supplier Questionnaire Instructions 1. The following Supplier Questionnaire was developed by Industrial Parts Depot (IPD) to assess and document the capability of its supplier

More information

INTERNATIONAL STANDARD

INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 9001 Fourth edition 2008-11-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2008(E) ISO 2008 PDF disclaimer

More information

Information technology Security techniques Information security management systems Requirements

Information technology Security techniques Information security management systems Requirements INTERNATIONAL STANDARD ISO/IEC 27001 Second edition 2013-10-01 Information technology Security techniques Information security management systems Requirements Technologies de l information Techniques de

More information

Accepting Supplier ISO 9000 Quality Programs

Accepting Supplier ISO 9000 Quality Programs Accepting Supplier ISO 9000 Quality Programs IEEE Subcommittee on Qualification October 7-8, 2004 Leigh A. Aparicio PSE Technical Leader aparicio@epri.com Project Overview ISO 9000 Phase I Initiated in

More information

HFI Fluid Power Products Quality Manual Revision # 5 dated 02/07/10. HFI FLUID POWER PRODUCTS A Division of Hydraulic Fittings, Inc.

HFI Fluid Power Products Quality Manual Revision # 5 dated 02/07/10. HFI FLUID POWER PRODUCTS A Division of Hydraulic Fittings, Inc. HFI FLUID POWER PRODUCTS A Division of Hydraulic Fittings, Inc. ISO9001-2008 QUALITY MANUAL SCOPE HFI Fluid Power Products is a full line stocking distributor/manufacturer for both hydraulic and pneumatic

More information

SHORT ANSWER QUESTIONS (KEY) UNIT- I

SHORT ANSWER QUESTIONS (KEY) UNIT- I SHORT ANSWER QUESTIONS (KEY) UNIT- I 1. Define quality. Quality is the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. 2. What do you mean by quality

More information

ISO Information and documentation Management systems for records Fundamentals and vocabulary

ISO Information and documentation Management systems for records Fundamentals and vocabulary Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 30300 First edition 2011-11-15 Information and documentation records Fundamentals and vocabulary Information et documentation Systèmes de gestion

More information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 16949 Second edition 2002-03-01 Quality management systems Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part

More information

ISO INTERNATIONAL STANDARD. Specification for security management systems for the supply chain

ISO INTERNATIONAL STANDARD. Specification for security management systems for the supply chain INTERNATIONAL STANDARD ISO 28000 First edition 2007-09-15 Specification for security management systems for the supply chain Spécifications pour les systèmes de management de la sûreté pour la chaîne d'approvisionnement

More information

Air Monitoring Directive Chapter 5: Quality System

Air Monitoring Directive Chapter 5: Quality System Air Monitoring Directive Chapter 5: Quality System Version Dec 16, 2016 Amends the original Air Monitoring Directive published June, 1989 Title: Air Monitoring Directive Chapter 5: Quality System Number:

More information

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS TECHNICAL SAFETY BC Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS Date: October 12, 2017 Controlled Document: MAN-4018-02 MAN-4018-02 Page 1 of 27 Contents 1.0 Introduction...

More information

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS BRITISH COLUMBIA SAFETY AUTHORITY Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS Date: April 25, 2017 Controlled Document: MAN-4018-01 MAN-4018-01 Page 1 of 27 Contents Contents...

More information

Successful Project Management. Second Edition

Successful Project Management. Second Edition Successful Project Management Second Edition Successful Project Management Second Edition Larry Richman Material in this course has been adapted from Project Management Step-by-Step, by Larry Richman.

More information

Proprietary Document Disclosure Restricted To Employees and Authorized Holders

Proprietary Document Disclosure Restricted To Employees and Authorized Holders Revision Level: A Page 1 o f 33 Revision Level: A Page 2 o f 33 (This page left blank intentionally.) Revision Level: A Page 3 o f 33 S i g n a t u r e P a g e Reviewed By Management Representative: 1

More information

CERTIFICATION OF OFF-GRID RENEWABLE ENERGY SYSTEMS September 29, 2001

CERTIFICATION OF OFF-GRID RENEWABLE ENERGY SYSTEMS September 29, 2001 CERTIFICATION OF OFF-GRID RENEWABLE ENERGY SYSTEMS September 29, 2001 Written by JP Ross, Consultant to Center for Resource Solutions Introduction The rate of dissemination of off-grid renewable energy

More information

ISO Environmental management systems Requirements with guidance for use

ISO Environmental management systems Requirements with guidance for use INTERNATIONAL STANDARD Environmental management systems Requirements with guidance for use ISO 14001 Third edition 2015-09-15 Systèmes de management environnemental Exigences et lignes directrices pour

More information

ABENGOA INABENSA ABENGOA INABENSA. General Operating Procedure POG Page 2 of 9. Translation control table. Revision: 02

ABENGOA INABENSA ABENGOA INABENSA. General Operating Procedure POG Page 2 of 9. Translation control table. Revision: 02 Page 2 of 9 Translation control table General Operating Procedure Revision: E00 Date: 21.08.15 Translated by: Adrienne Chaballe Revised by: María Dolores Cubiles Pérez Title: The only version of this document

More information

International Electrotechnical Commission (IEC) is based in Geneva, Switzerland Technical Committee 82 SOLAR PHOTOVOLTAIC ENERGY SYSTEMS

International Electrotechnical Commission (IEC) is based in Geneva, Switzerland Technical Committee 82 SOLAR PHOTOVOLTAIC ENERGY SYSTEMS International Electrotechnical Commission (IEC) is based in Geneva, Switzerland Technical Committee 82 SOLAR PHOTOVOLTAIC ENERGY SYSTEMS The secretariat for TC 82 rests in the US. The secretary is Howard

More information

Systems and software engineering Content of life-cycle information items (documentation)

Systems and software engineering Content of life-cycle information items (documentation) INTERNATIONAL STANDARD ISO/IEC/ IEEE 15289 Third edition 2017-06 Systems and software engineering Content of life-cycle information items (documentation) Ingénierie des systèmes et du logiciel Contenu

More information

ISO INTERNATIONAL STANDARD. Event sustainability management systems Requirements with guidance for use

ISO INTERNATIONAL STANDARD. Event sustainability management systems Requirements with guidance for use INTERNATIONAL STANDARD ISO 20121 First edition 2012-06-15 Event sustainability management systems Requirements with guidance for use Systèmes de management responsable appliqués à l'activité événementielle

More information

Desk Audit of. Based on Federal Transit Administration (FTA) Quality Assurance and Quality Control Guidelines FTA-IT

Desk Audit of. Based on Federal Transit Administration (FTA) Quality Assurance and Quality Control Guidelines FTA-IT Desk Audit of Based on Federal Transit Administration (FTA) Quality Assurance and Quality Control Guidelines FTA-IT-90-5001-02.1 Reviewed by: Element Requirements Applicable 1. Is a quality policy defined

More information

Steel and steel products Inspection documents

Steel and steel products Inspection documents Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 10474 Second edition 2013-07-01 Steel and steel products Inspection documents Aciers et produits sidérurgiques Documents de contrôle Reference

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 45001 First edition 2018-03 Occupational health and safety management systems Requirements with guidance for use Systèmes de management de la santé et de la sécurité au travail

More information

ISO/TS TECHNICAL SPECIFICATION

ISO/TS TECHNICAL SPECIFICATION TECHNICAL SPECIFICATION ISO/TS 16949 Third edition 2009-06-15 Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 15378 First edition 2006-03-01 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing

More information

ISO/IEC INTERNATIONAL STANDARD. Information technology Security techniques Guidelines for information security management systems auditing

ISO/IEC INTERNATIONAL STANDARD. Information technology Security techniques Guidelines for information security management systems auditing INTERNATIONAL STANDARD ISO/IEC 27007 First edition 2011-11-15 Information technology Security techniques Guidelines for information security management systems auditing Technologies de l'information Techniques

More information

MEMORANDUM of UNDERSTANDING

MEMORANDUM of UNDERSTANDING MEMORANDUM of UNDERSTANDING between The INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) and The INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY (OIML) concerning LIAISONS and COLLABORATION BETWEEN BOTH ORGANIZATIONS

More information

Supplier Questionnaire and On-site Supplier Evaluation

Supplier Questionnaire and On-site Supplier Evaluation Supplier Questionnaire and On-site Supplier Evaluation GENERAL EVALUATION INSTRUCTIONS Purpose Application This On-site Supplier Evaluation (OSE) is to assess the supplier's ability to produce a quality

More information

INTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS UNIFORM EVALUATION SERVICES

INTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS UNIFORM EVALUATION SERVICES INTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS UNIFORM EVALUATION SERVICES EVALUATION CRITERIA FOR STRUCTURAL STEEL APPROVED FABRICATOR INSPECTION PROGRAMS 1.0 PURPOSE EC 020-2014 (Adopted

More information

ISO/IEC/ IEEE Systems and software engineering Content of life-cycle information items (documentation)

ISO/IEC/ IEEE Systems and software engineering Content of life-cycle information items (documentation) INTERNATIONAL STANDARD This is a preview - click here to buy the full publication ISO/IEC/ IEEE 15289 Third edition 2017-06 Systems and software engineering Content of life-cycle information items (documentation)

More information

Sampler For the PMBOK Guide 5 th Edition. Summary Edition For the PMBOK Guide Fourth Edition

Sampler For the PMBOK Guide 5 th Edition. Summary Edition For the PMBOK Guide Fourth Edition Sampler For the PMBOK Guide 5 th Edition Summary Edition For the PMBOK Guide Fourth Edition SamplerBy Projerra Management Inc. For the PMBOK Fourth Edition THANK YOU Thank you for downloading the VisuAL

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 21001 First edition 2018-05 Educational organizations Management systems for educational organizations Requirements with guidance for use Organismes d'éducation/formation Systèmes

More information

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS

Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS BRITISH COLUMBIA SAFETY AUTHORITY Welding Performance Qualification Test Administrators GUIDE FOR APPLICANTS Prepared by: Ed Hurd P.Eng. Provincial Safety Manager, Boilers Date: March 2, 2012 Controlled

More information

ISO/IEC INTERNATIONAL STANDARD. Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies

ISO/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 information

Steel and steel products Inspection documents

Steel and steel products Inspection documents INTERNATIONAL STANDARD ISO 10474 Second edition 2013-07-01 Steel and steel products Inspection documents Aciers et produits sidérurgiques Documents de contrôle Reference number ISO 10474:2013(E) ISO 2013

More information

Rules for Planning and Conducting Audits

Rules for Planning and Conducting Audits Rainforest Alliance Rules for Planning and Conducting Audits Farms and producer groups involved in crop and cattle production April, 2018 Version 1 More information? For more information about the Rainforest

More information

SCC Requirements and Guidance for Calibration and Measurement Traceability in Testing Laboratories

SCC Requirements and Guidance for Calibration and Measurement Traceability in Testing Laboratories Accreditation Services SCC Requirements and Guidance for Calibration and Measurement Traceability in Testing Laboratories 2017-07-06 Standards Council of Canada 55 Metcalfe Street, Suite 600 Ottawa, ON

More information

Quality Manual. ISO 9001:2008 Standard. Issue No - 3. April

Quality Manual. ISO 9001:2008 Standard. Issue No - 3. April Quality Manual ISO 9001:2008 Standard Issue No - 3 April - 2010 COPYRIGHT: Renaissance Services-CSG owns the copyright of this document. It may not be copied, reproduced or transmitted in any form without

More information

GoldSRD Audit 101 Table of Contents & Resource Listing

GoldSRD Audit 101 Table of Contents & Resource Listing Au GoldSRD Audit 101 Table of Contents & Resource Listing I. IIA Standards II. GTAG I (Example Copy of the Contents of the GTAG Series) III. Example Audit Workprogram IV. Audit Test Workpaper Example V.

More information

Sýnishorn. Medical devices Quality management systems Requirements for regulatory purposes

Sýnishorn. Medical devices Quality management systems Requirements for regulatory purposes INTERNATIONAL STANDARD ISO 13485 Third edition 2016-03-01 Medical devices Quality management systems Requirements for regulatory purposes Dispositifs médicaux Systèmes de management de la qualité Exigences

More information

Food safety management systems Guidance on the application of ISO 22000

Food safety management systems Guidance on the application of ISO 22000 Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 22004 First edition 2014-09-01 Food safety management systems Guidance on the application of ISO 22000 Systèmes de management de la sécurité des

More information

Earthworks QA/QC Plan Sample

Earthworks QA/QC Plan Sample Earthworks QA/QC Plan Sample Selected pages (not a complete plan) Part 1: Project Specific Quality Plan Part 2: Quality Manual Part 3: Submittal Forms Part 4: Inspection Checklist Forms Contact: FirstTimeQuality

More information

ROTEK. IIInnInstI Instrument Corp. ISO 9001 Quality System Manual

ROTEK. IIInnInstI Instrument Corp. ISO 9001 Quality System Manual ROTEK IIInnInstI Instrument Corp. ISO 9001 Quality System Manual QSM900100-01 REV O MANUAL NO: 10 ISSUED TO: Rotek Web Site DATE OF ISSUE: 17 July 2002 APPROVALS: ORIGINATOR: Lawrence E. Weissbach Lawrence

More information

USACE NAVFAC Sample QA/QC Plan 20 selected pages (out of )

USACE NAVFAC Sample QA/QC Plan 20 selected pages (out of ) USACE NAVFAC Sample QA/QC Plan 20 selected pages (out of ) Part 1: Project Specific Quality Plan Part 2: Quality Manual Part 3: Submittal Forms Contact: First Time Quality 410 451 8006 Pat [Pick the date]

More information

Guide for the preparation of quality programs for licensing of companies performing BPE regulated work.

Guide for the preparation of quality programs for licensing of companies performing BPE regulated work. Labour and Advanced Education Guide for the preparation of quality programs for licensing of companies performing BPE regulated work. Company Name: QC Program issue#: Revision# Overview: 1. This guideline

More information

ISO 9001: 2008 Engineering Design Construction Quality Management System Sample - Selected pages (not a complete plan)

ISO 9001: 2008 Engineering Design Construction Quality Management System Sample - Selected pages (not a complete plan) ISO 9001: 2008 Engineering Design Construction Quality Management System Sample - Selected pages (not a complete plan) Part 1: Project-Specific Quality Plan Part 2: Company Quality Manual Part 3: Submittal

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 22000 Second edition 2018-06 Food safety management systems Requirements for any organization in the food chain Systèmes de management de la sécurité des denrées alimentaires

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 5667-24 First edition 2016-04-01 Water quality Sampling Part 24: Guidance on the auditing of water quality sampling Qualité de l eau Échantillonnage Partie 24: Lignes directrices

More information