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Contract Analysis is one of the QMS processes related to the Customers. ISO 9001:2015 defines the requirements to the Contract analysis in sub clauses of 8.2 Requirements for products and Services (cl.8.2.2, cl.8.2.3, cl.8.2.1.b, cl.8.2.1.e) Product requirements that have to be included into the contract (cl.8.2.2.a) :            - Customer requirements (cl.8.2.3.1.a)            - Safety Requirements (cl.8.2.3.1.b)            - Legal requirements (cl.8.2.3.1.d)            - Additional requirements have to be agreed upon (cl.8.2.3.1.c)            - Force Majeure Ability of the organization to meet the requirements (confirmed by the ‘Approval sheet’) (cl.8.2.3.1). Contract Analysis Quality System Procedure regulates ‘Con...

Q: ISO 9001:2015, does it require a documented risk register ?  Will it become a requirement, indirectly?  I plan to identify and review all risks and opportunities in the MRM but still unsure about maintaining a separate register (document).  A: 1. ISO 9001:2015 does not require neither development, nor maintenance of a Risk register . Risk register is a part of risk management methodology. Risk register development is a good practice, but not the Standard requirement. Risk- based thinking initiates the consideration of multi-variant approach in decision-making. It may be represented as a possibility of the expected result offset into a negative or positive part of a certain ‘scale’ depending on disturbances in the result achieving process. Usually, the ‘ risk register ’ development includes three stages : 1) risk formulating (naming the possible disturbances); 2) risk identification (digitization), as a rule, the negative consequences are considered; 3) ris...

Our ISO 9001:2015 Quality System Procedures collection was updated with the Control of Personnel Procedure . The key personnel competence requirements of ISO 9001:2015 are implemented in this documented procedure based on the best field experience: definition of the required competence;  provision of competence;  evaluation of the effectiveness of measures to ensure competence;  preservation of evidence of competence;  analysis of the adequacy of human resources, improvement actions.  Download the Control of Personnel Procedure Preview. Looking for a set of required procedures?  Take advantage of our May 2016 offer - 30% off the bundle of 9 Quality System Procedures

The revised version of ISO 9001:2015 requirements sometimes are confusing, especially regarding the ' documented information' . What is documented information ? What documented information is mandatory to keep - and what is optional ? New article by JP Russell and Denis J. Devos ' An ISO 9001:2015 Catch 22: Documenting Pans ' explores this topic focusing on clause 6.1.2 requirements - plans to address risks and opportunities. On one hand a plan is not classified as documented information and moreover the organization determines what documented information they need to maintain. On the other, when an organization documents their plans, an auditor expects the plans to be controlled and maintained as documented information and be available in some form or media. So the organization could be subject to plans being audited against documented information controls. More on Control of Documented information ISO 9001:2015 Quality System Procedure - Control of Docu...