Hi sarializade¡¡ I have been reading the standard ISO 9001:2015 and in my opinion we must doing a matrix DOFA in which we can describe the requirements that the points 4.1 and 4.2 mention. Maybe some interviews with our workmates and our boss can help us in order to see clearly the target of this point of the standard.
The correct order here would be to do 4.2 then 4.1. In 4.2 the organization must first identify the interested parties before addressing the context of the organization (4.1). Review Annex A.3 also as there are some limits to whom should be an interested party.
Once you understand the interested parties you can then identify the company’s role in the market, regulatory responsibilities and the requirements of the industry served. This is done to assure that developed QMS reflects the organization. (Clause 4.1.)
The most basic way to document this information would be in a table within the develop document procedure or a spreadsheet. However document you are looking at documenting the following:
1) Interested Parties: Name of party (customer, end user, certification body, employees), are they internal or external to the organization and their reason for interest 2) Issues: Internal and External issues of concern related to the interested parties.
At he beginning of the year our corporate cascade the Business Plan and Quality Policy.
We conduct a SWOT analysis to determine if we could meet that journey (4.1)
After determining the requirements of the interested parties (4.2) we develop the strategy and scope of the QMS (4.3). That order of QMS makes sense for us.