Senin, 14 Mei 2018

How to implementing ISO 9001: 2015 Standards?

Quality Management System Requirements

Mandatory Documents For Implementation of  ISO 9001:2015


  • The scope of the QMS (clause 4.3) 
  • Quality policy (clause 5.2) 
  • Quality objectives (clause 6.2) 
  • Criteria for evaluation and selection of suppliers (clause 8.4.1) 

For the requirements with the sign (*) are mandatory only in cases when the relevant clause is not excluded or is part of the Organization's/company's business practices.

Record Mandatory For Implementation of  ISO 9001:2015


  1. Recording monitoring and measurement equipment calibration * (clause 7.1.5.1) 
  2. The recording of the training, skills, experience and qualifications (clause 7.2) 
  3. Record review product/service requirements (clause 8.2.3.2) 
  4. The recording of the results of the review of the design and development * (clause 8.3.2) 
  5. Recording of input to the design and development * (clause 8.3.3) 
  6. Recording control design and development * (clause 8.3.4) 
  7. Recording the results of design and development * (clause 8.3.5) 
  8. Recording of changes in the design and development * (clause 8.3.6) 
  9. The characteristics of the product to be manufactured and the services to be provided (clause 8.5.1) 
  10. The recording of the customer's property (clause 8.5.3) 
  11. The recording of a change in production/service provision (clause 8.5.6) 
  12. Recording compliance with product/service acceptance criteria (clause 8.6) 
  13. Record output/outcome that is not appropriate (clause 8.7.2) 
  14. Monitoring and measurement results (clause 9.1.1) 
  15. Internal audit programs (clause 9.2) 
  16. The results of the internal audit (clause 9.2) 
  17. The result of the management review (clause 9.3) 
  18. The results of the corrective action (clause 10.1) 

Non-Mandatory Documents For Implementation of  ISO 9001:2015

There are non-mandatory document that can be used for the implementation of  ISO 9001:2015. Here are the documents of non-compulsory to be the most commonly used:
  1. The procedure for determining the organizational context and the parties concerned (article 4.1 and 4.2) 
  2. Procedures to deal with risks and opportunities (clause 6.1) 
  3. Procedure for competence, training and awareness of QMS (clause 7.1.2, 7.2 and 7.3) 
  4. The procedure for maintenance of the equipment and measuring instruments (clause 7.1.5) 
  5. Procedures for the control of documents (clause 7.5) 
  6. Sales procedure (clause 8.2) 
  7. Procedures for design and development (clause 8.3) 
  8. Procedures for the production and provision of services (clause 8.5) 
  9. Warehousing procedures (clause 8.5.4) 
  10. Procedures for the management of discrepancies and corrective action (clause 8.7 and 10.2) 
  11. Procedures for monitoring customer satisfaction (clause 9.1.2) 
  12. Procedures for internal audit (clause 9.2) 
  13. The procedure for review of management (clause 9.3) 
This requirement is not absolute as above but the management determines according to the policy direction of each organization.

Thank you & may be useful




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