This document provides a toolkit of documentation for an ISO 9001:2015 quality management system. It contains 74 documents organized into sections covering the requirements of ISO 9001, including document control, quality policy, risk management, purchasing, production, nonconformities, internal audits, and management review. The documentation is numbered and includes procedures, appendices, checklists, and records to implement each process of the quality management system.
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ISO 9001 Documentation
This document provides a toolkit of documentation for an ISO 9001:2015 quality management system. It contains 74 documents organized into sections covering the requirements of ISO 9001, including document control, quality policy, risk management, purchasing, production, nonconformities, internal audits, and management review. The documentation is numbered and includes procedures, appendices, checklists, and records to implement each process of the quality management system.
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ISO
9001:2015 Premium Documentation Toolkit
Note: The documentation should preferably be implemented in the order in which it is listed here.
Doc. ISO 9001 Mandatory
No. Name of Document Code Clause document 1 00 Procedure for Document and Record Control 7.5 2 00.1 Appendix 1 List of Internal Documents 3 00.2 Appendix 2 List of External Documents 4 00.3 Appendix 3 List of Types of Records Appendix 4 Registry of Records for Detention/ Central 5 00.4 Archive 6 01 Project Plan 7 02 Quality Policy 5.2 8 02.1 Appendix 1 Quality Objectives 6.2 9 03 Quality Manual Procedure for Determining Context of the Organization 10 04 4.1; 4.2 and Interested Parties 11 04.1 Appendix 1 List of Interested Parties 4.2 12 04.2 Appendix 2 Conformance Evaluation Record 4.2 13 04.3 Appendix 3 Scope of the Quality Management System 4.3 14 05 Procedure for Competence, Training and Awareness 7.1.2; 7.2; 7.3 15 05.1 Appendix 1 Training Program 7.2 16 05.2 Appendix 2 Training Record 7.2 17 05.3 Appendix 3 Record of Attendance 7.3 18 06 Procedure for Addressing Risks and Opportunities 6.1 19 06.1 Appendix 1 Registry of Key Risks and Opportunities 6.1 20 06.2 Appendix 2 Procedure for FMEA Risk Assessment 6.1 21 06.3 Appendix 3 FMEA Risks Assessment Record 6.1 22 07 Sales Procedure 8.2 23 07.1 Appendix 1 Customer Requirement Review Checklist 8.2.2; 8.2.3 24 07.2 Appendix 2 Registry of Customer Complaints 8.2 25 08 Procedure for Design and Development 8.3 26 08.1 Appendix 1 Project Task 8.3.2; 8.3.3 * 27 08.2 Appendix 2 Project Plan and Review 8.3.2; 8.3.4; 28 08.3 Appendix 3 Change Review Record 8.3.6 29 08.4 Appendix 4 Design Review Minutes 8.3.5 30 09 Procedure for Purchasing and Evaluation of Suppliers 8.4 31 09.1 Appendix 1 Checklist for Evaluation of Suppliers 8.4.1 * 32 09.2 Appendix 2 List of Approved Suppliers 8.4.1
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33 09.3 Appendix 3 Registry of Complaints about Suppliers 8.4
34 09.4 Appendix 4 Request and Order for Purchasing 8.4.1 35 10 Procedure for Production and Service Provision 8.5 36 10.01 Appendix 1 Product Specification 8.5.1 37 10.02 Appendix 2 Record of Product/Service Conformance 8.5.1 38 10.03 Appendix 3 Quality Plan 8.5.1 Appendix 4 Notification to a Customer about Changes 39 10.04 8.5.3 * on his Property 40 10.05 Appendix 5 Record of Traceability 8.5.2; 8.6 * Appendix 6 Production/Service Change Review 41 10.06 8.5.6 Record 42 10.07 Appendix 7 Production Plan 8.1 43 10.08 Appendix 8 Production Registry 8.5 44 10.09 Appendix 9 Procedure for Manufacturing 8.5 * 45 10.10 Appendix 10 Procedure for Construction Process 8.5 * 46 10.11 Appendix 11 Procedure for Food Processing 8.5 * 47 10.12 Appendix 12 Procedure for Software Development 8.5 * 48 10.13 Appendix 13 Procedure for Transportation Services 8.5 * Appendix 14 Procedure for Production of Chemical 49 10.14 8.5 * Products Appendix 15 Procedure for Manufacturing of 50 10.15 8.5 * Electrical and Optical Equipment Appendix 16 Procedure for Production of Machinery 51 10.16 8.5 * and Equipment 52 10.17 Appendix 17 Procedure for Production of Metals 8.5 * Appendix 18 Procedure for Production of Rubber and 53 10.18 8.5 * Plastics Appendix 19 Procedure for Wholesale and Retail 54 10.19 8.2 * Operations 55 11 Warehousing Procedure 8.5.4 Appendix 1 Record of Warehousing Temperature 56 11.1 8.5.4 Control Procedure for Management of Nonconformities and 57 12 8.7; 10.2 Corrective Actions 58 12.1 Appendix 1 Non-Conformity Record 8.7; 10.2.2 59 12.2 Appendix 2 Corrective Action Record 10.2.2 Appendix 3 Registry and Status of Nonconformities 60 12.3 10.2.2 and Corrective Actions Procedure for Equipment Maintenance and Measuring 61 13 7.1.5 Equipment
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62 13.1 Appendix 1 List of Equipment 7.1.5
Appendix 2 Plan for Preventive Maintenance of 63 13.2 7.1.5 Equipment 64 13.3 Appendix 3 Maintenance and Calibration Record 7.1.5.2 65 14 Procedure for Measuring Customer Satisfaction 9.1.2 66 14.1 Appendix 1 Customer Satisfaction Questionnaire 9.1.2 67 14.2 Appendix 2 Report of Customer Satisfaction 9.1.2 68 14.3 Appendix 3 Monitoring of Customer Satisfaction 9.1.2 69 15 Procedure for Internal Audit 9.2 70 15.1 Appendix 1 Internal Audit Checklist 71 15.2 Appendix 2 Internal Audit Program 9.2.2 72 15.3 Appendix 3 Internal Audit Report 9.2.2 73 16 Procedure for Management Review 9.3 74 16.1 Appendix 1 Matrix of Key Performance Indicators 9.1.3 75 16.2 Appendix 2 Data Analysis Report 9.1.3 76 16.3 Appendix 3 Management Review Minutes 9.3.3
*The listed documents are not mandatory if the corresponding processes dont exist in the organization.