Don’t be discouraged by the number of ISO 9001 procedures, because not all of them apply to your business or are mandatory. The 2008 edition included 6 mandatory policies necessary to get the certification. That’s not happening anymore. The 2015 version – ISO 9001:2015 has brought about some changes, so it is important to be aware of the things that are mandatory in this revision.
The 2015 edition offers much more flexibility in terms of documentation requirements. We review the reports stated in the standard that are mandatory for your organization to achieve ISO certification.
We, therefore, present the ISO 9001:2015 mandatory documentation list. Besides the required documents, you will find the most commonly used paper for the application of the Quality Management System.
List of Documentation required to become ISO 9001 Certification ⮯
Here are the documents you must submit if you want to comply with ISO 9001 Certification Quality Management System.
Please note: Certain papers will not be mandatory if the company does not carry out the relevant processes.
MASTER LIST
1 | Quality Manual |
2 | List of Internal & External Issues |
3 | List of interested parties and their requirements |
4 | Documented Scope |
5 | Sequence & Interaction Chart and Process Flow Diagram |
6 | Quality Policy |
7 | Organization Roles, Responsibility & Authority and KPIs |
8 | Risk & Opportunities |
9 | Legal Register |
10 | Quality Objectives |
11 | List of Resource & People |
12 | Competence, Training and Awareness records |
13 | List of Monitoring & Measuring Resources |
14 | Calibration Document |
15 | Maintenance & Breakdown Records |
16 | Document for Organization Knowledge |
17 | Control of papers and Records |
18 | Procurement & their Record |
19 | Competence, training and awareness |
20 | Design and Development & their Records |
21 | Steps for control of externally provided processes, products and services (outsourced processes) |
22 | Procedure for production and service provision |
23 | Product & Service Specification |
24 | Procedure for Review of the requirements for products and services |
25 | Changes to requirements for products and services |
26 | Procedure for property belonging to customers or external providers |
27 | Control of changes |
28 | Procedure for internal audit |
29 | Management review |
30 | Operation Planning & Control for each department |
31 | Procedure for Compliance Obligation |
32 | Customer enquiries, contracts, orders, feedback & complaints |
33 | Criteria for evaluation and selection of suppliers |
34 | Identification & Traceability Record |
35 | Non-conformance & Corrective Action Record |
36 | Internal Audit Record |
37 | Management Review Record |
38 | Sales Order & Purchase Order |
These are the mandatory clauses that require you to provide documentation and reports in order to become ISO 9001 certified. Your reports will come in a variety of forms, such as spreadsheets, charts, videos and written content. The ISO 9001:2015 mandatory documentation list asks you to have a system that controls your records. We note that retention policies will be needed to establish the retention period for records.