1) where clause 8.3 applicable?
2) how do you diifferentiate between documented info and documents
3) do you give eg. Of risk and opportunity register of QMS? There is confusion. People are mixing environmental aspects in qms risk register. So pls differentiate iso 9001 and 14001 by risk and opportunity.
1) It is applicable when the company conducts any design or development process within the scope of the organization.
2) Documented information is referred to all documents. According to ISO 9001:2015 documented information can be mantained, commonly known as procedures or documented information can be retained, commonly known as records.
3) Risks and opportunities in ISO 9001 are related to customer satisfaction while risks and opportunities in ISO 14001 are related to the protection of the environment, i.e. environmental aspects. For instance a risk in ISO 9001 can be a short assemblig capacity in a manufacturing company, while a risk in ISO 14001 in the same manufacturing company can be wrongdoing in waste classification.