ISO 9001:2015 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
5 00.3 Appendix 3 – List of Types of Records
6 00.4
Appendix 4 – Registry of Records for Detention/ Central
01
7 Archive
02 Project Plan
8
02.1
9 Quality Policy 5.2
10
11 Appendix 1 – Quality Objectives 6.2
12 03 Quality Manual
13 Procedure for Determining Context of the Organization
04 4.1; 4.2
14 and Interested Parties
04.1 4.2
15 Appendix 1 – List of Interested Parties
04.2 Appendix 2 – Conformance Evaluation Record 4.2
16
04.3 Appendix 3 – Scope of Quality Management System 4.3
17
7.1.2; 7.2; 7.3
18 05 Procedure for Competence, Training and Awareness
7.2
19 05.1 Appendix 1 – Training Program
7.2
20 05.2 Appendix 2 – Training Record
7.3
21 05.3 Appendix 3 – Record of Attendance 6.1
22 06 Procedure for Addressing Risks and Opportunities 6.1
23 06.1 Appendix 1 – Registry of Key Risks and Opportunities 8.2
24 07 Sales Procedure
8.2.2; 8.2.3
25 07.1 Appendix 1 – Customer Requirement Review Checklist 8.2
26 07.2 Appendix 2 – Registry of Customer Complaints 8.3
27 08 Procedure for Design and Development
8.3.2; 8.3.3
28 08.1 Appendix 1 – Project Task *
8.3.2; 8.3.4;
29 08.2 Appendix 2 – Project Plan and Review
8.3.6
30 08.3 Appendix 3 – Change Review Record
8.3.5
31 08.4 Appendix 4 – Design Review Minutes
8.4
32 09 Procedure for Purchasing and Evaluation of Suppliers
8.4.1
09.1 Appendix 1 – Checklist for Evaluation of Suppliers 8.4.1 *
09.2 Appendix 2 – List of Approved Suppliers 8.4
09.3 Appendix 3 – Registry of Complaints about Suppliers 8.4.1
09.4 Appendix 4 – Request and Order for Purchasing

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33 10 Procedure for Production and Service Provision 8.5
34 10.1 Appendix 1 – Product Specification 8.5.1
35 10.2 Appendix 2 – Record of Product/Service Conformance 8.5.1
36 10.3 Appendix 3 – Quality Plan 8.5.1
37 10.4 8.5.3
Appendix 4 – Notification to a Customer about Changes
38 10.5 8.5.2; 8.6 *
on his Property
39 10.6 Appendix 5 – Record of Traceability 8.5.6
*
40 Appendix 6 – Production/Service Change Review 8.5.4
Record
41 8.5.4
11 Warehousing Procedure
Appendix 1 – Record of Warehousing Temperature
11.1 Control
Procedure for Management of Nonconformities and
42 12 Corrective actions 8.7; 10.2
43 8.7; 10.2.2
12.1 Appendix 1 – Non-Conformity Record
44 10.2.2
45 12.2 Appendix 2 – Corrective Action Record 10.2.2
12.3
Appendix 3 – Registry and Status of Nonconformities
and Corrective Actions
Procedure for Equipment Maintenance and Measuring
46 13 7.1.5
Equipment
47 7.1.5
13.1 Appendix 1 – List of Equipment
48 7.1.5
Appendix 2 – Plan for Preventive Maintenance of
13.2 Equipment
49 7.1.5.2
50 13.3 Appendix 3 – Maintenance and Calibration Record 9.1.2
51 14 Procedure for Measuring Customer Satisfaction 9.1.2
52 14.1 Appendix 1 – Customer Satisfaction Questionnaire 9.1.2
53 14.2 Appendix 2 – Report of Customer Satisfaction 9.1.2
54 14.3 Appendix 3 – Monitoring of Customer Satisfaction 9.2
55 15 Procedure for Internal Audit
56 15.1 Appendix 1 – Internal Audit Checklist
57 15.2 Appendix 2 – Internal Audit Program 9.2.2
58 15.3 Appendix 3 – Internal Audit Report 9.2.2
59 9.3
16 Procedure for Management Review
60 16.1 Appendix 1 – Matrix of Key Performance Indicators 9.1.3
61 9.1.3
16.2 Appendix 2 – Data Analysis Report
16.3 Appendix 3 – Management Review Minutes 9.3.3

*The listed documents are not mandatory if the corresponding processes don’t exist in the
organization.

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