Context of the organisation and design and development

Answer:

In order to meet requirements regarding context of the organization you need to identify all internal and external issues that can affect ability of your company to deliver quality product and achieve customer satisfaction.

Internal issues, or internal context includes organizational culture, organizational structure, communication channels in the company, competence of employees, condition of the equipment and facilities, etc. Basically anything that can have effect on your business performance and comes from within the organization.

External context includes relevant legislation, conditions on the market, competition, suppliers, customer requirements, etc.

In order to meet requirements regarding the context you do not need to document every single detail but it is better if you have some procedure or record about it in order to facilitate demonstration of compliance to the requirements to certification body. For more information, see How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

Design and development is one of the clauses that can be excluded form the scope of QMS if it is not applicable to the type of business that company performs. You only need to document justification for the exclusion. If you do perform a design and development process you need to address all the requirements from this clause. For more information, see: The ISO 9001 Design Process Explained https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/