Clause 8.3, documented information and risks

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.

Response:

1) It is applicable when the company conducts any design or development process within the scope of the organization.

For more information about clause 8.3, you can see this article:
- What clauses can be excluded in ISO 9001:2015: https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

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.

To learn more about document and record control, see this article:
- New approach to document and record control in ISO 9001:2015 : https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/

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.

For more information about risks and opportunities in ISO 9001:2015, see these articles:
- How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
- How to identify risk significance in ISO 9001:2015: https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/

These materials can also help you with IS 9001 requirements:
- Book – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line training – ISO 9001:2015 Foundations: https://advisera.com/training/iso-9001-foundations-course/