The procedure manual, context and interested parties

Answer:

The standard has several requirements for documented procedures but, it does not require documented procedure for each clause. For those clauses that require documented procedures, they usually define the content of the procedure and the key requirements that the procedure must cover. For more information, see: 7 steps in writing QMS policies and procedures for ISO 9001 https://advisera.com/9001academy/blog/2015/03/10/7-steps-in-writing-qms-policies-and-procedures-for-iso-9001/

As far as context of the organization is concerned, you need to gather relevant people in the organization and determine internal and external issues that affect Quality Management System. For more information, see: How to define the context of the organization in IATF 16949:2016 https://advisera.com/16949academy/knowledgebase/how-to-define-the-context-of-the-organization-in-iatf-169492016/

Within requirements for determining context of the organization, the organization also needs to identify interested parties and their needs and expectations related to Quality Management System. For more information, see: Determining interested parties and their requirements according to IATF 16949:2016 https://advisera.com/16949academy/knowledgebase/determining-interested-parties-and-their-requirements-according-to-iatf-16949/