Hello
In my view this interpretation of points 4.1 and 4.2 are
4.1
Context: see the markets (American vs European) they are different and their regulations are different too. Or other markets where your company trade or work.
Internal and / or external competition
Single or Several customers
Suppliers forced or imposed or own that you or they can control
Defective Product Liability
Client ( and end/final customers, eg children)
Internal customers - employees with little experience can lead to problems Human resources
Young population vs older and more experienced population
Legislation appropriate to each activity
Cultural, political, environmental Ex PESTLE analysis
Internal (Organizational culture, values, knowledge) and external (Socioeconomic Conditions, legal, technology,Market, etc) factors
And this should Review in the management review!
4.2
4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF Interested Parts (IP)
Depending on the potential impact on the ability to provide Product and service that meets customer requirements and legal requirements,
The organization shall determine
Which stakeholders/ clients / suppliers/ internal clients/ the Banks/ Organizations/ State departments are relevant to the
quality management system
What are the relevant requirements of these parts Interested in the QMS
Monitor and review information on these IPs and their requirements