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
- Recording monitoring and measurement equipment calibration * (clause 7.1.5.1)
- The recording of the training, skills, experience and qualifications (clause 7.2)
- Record review product/service requirements (clause 8.2.3.2)
- The recording of the results of the review of the design and development * (clause 8.3.2)
- Recording of input to the design and development * (clause 8.3.3)
- Recording control design and development * (clause 8.3.4)
- Recording the results of design and development * (clause 8.3.5)
- Recording of changes in the design and development * (clause 8.3.6)
- The characteristics of the product to be manufactured and the services to be provided (clause 8.5.1)
- The recording of the customer's property (clause 8.5.3)
- The recording of a change in production/service provision (clause 8.5.6)
- Recording compliance with product/service acceptance criteria (clause 8.6)
- Record output/outcome that is not appropriate (clause 8.7.2)
- Monitoring and measurement results (clause 9.1.1)
- Internal audit programs (clause 9.2)
- The results of the internal audit (clause 9.2)
- The result of the management review (clause 9.3)
- 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:
- The procedure for determining the organizational context and the parties concerned (article 4.1 and 4.2)
- Procedures to deal with risks and opportunities (clause 6.1)
- Procedure for competence, training and awareness of QMS (clause 7.1.2, 7.2 and 7.3)
- The procedure for maintenance of the equipment and measuring instruments (clause 7.1.5)
- Procedures for the control of documents (clause 7.5)
- Sales procedure (clause 8.2)
- Procedures for design and development (clause 8.3)
- Procedures for the production and provision of services (clause 8.5)
- Warehousing procedures (clause 8.5.4)
- Procedures for the management of discrepancies and corrective action (clause 8.7 and 10.2)
- Procedures for monitoring customer satisfaction (clause 9.1.2)
- Procedures for internal audit (clause 9.2)
- 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.
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