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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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Bogdan Bătrânu
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100% found this document useful (1 vote)
1K views3 pages

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.

Uploaded by

Bogdan Bătrânu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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.

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