Documents and records required by ISO 9001:2015

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  • Documents and records required by ISO 9001:2015

Documents

1 - Scope of the Quality Management System (QMS)

2 - Quality policy   

3 - Quality objective   

4 - Quality manual (not compulsory)  

5 - Quality planning

6 - Organization chart

7 - Responsibility & authorities in QMS

 

Procedures

1 - Documents & data control procedure   

2 - Records control procedure  

3 - Provision of human resources procedure   

4 - Training & development procedure   

5 - Contract review procedure

6 - Purchasing procedure   

7 - Production control procedure   

8 - Control of service provision procedure  

9 - Monitoring and measuring control   procedure

10 - Customer feedback and complaints procedure   

11 - Internal audit procedure   

12 - Inprocees and final inspection procedure   

13 - Control of nonconforming product/service procedure   

14 - Analysis of data procedure   

15 - Corrective action and preventive action procedure

16 - Risks assessment and opportunity procedure   

17 - Management of changes procedure   

18 - Management of knowledge procedure  

19 - Control of after sales service procedures (maintenance, warranty, repair …)

20 - Product traceability procedure   

21 - Management review procedure

22 - Improvement procedure   

 

Work instructions

1 - Instructions for equipment operation

2 - Instructions for equipment maintenance   

3 - Instructions for inspection input material

4 - Instruction for warehouse output / input

 

Forms/Checklists

1 - Control of documents and records   

2 - Management responsibility  

3 - Resource management   

4 - Determination of requirements related to products and services

5 - Purchasing  

6 - Production and service provision   

7 - Customer satisfaction   

8 - Recruitment request

9 - Training plan

10 - Internal audit  

11 - Control of measurement  

12 - Analysis of data  

13 - Nonconforming products and services  

14 - Corrective and preventive action