Friday, August 18, 2017

Clause 6.1 Actions to address risks and opportunities QnA

Question:
Is it possible to have two phase of Risk Based Thinking implementation in ISO 9001:2015?

I noticed that in clause 6.1, they mention the relation between this clause and clause 4.1 and 4.2, which is a new requirement, where organization shall identify the interested parties (either internal and external) and address the risk and opportunity. However, in the same clause of 6.1, they mention that the risk/opportunity addressed must be proportionate to product conformity, which still need us to do risk assessment to manufacturing process of product.

As to summarize, the two phase will be like:
Phase 1: Address Risk/Opportunity for Interested Parties
Phase 2: Risk Assessment towards process.

Answer:
The first paragraph of ISO 9001 Clause 6.1 is talking about a mandatory set of requirements that must be taken into account in any QMS planning, namely:
  • internal and external context of the organization (cl.4.1);
  • needs and expectations (balance of interests) of interested parties (cl.4.2);
  • identification of risks and opportunities, which are discussed further in clause 6.1.
This does NOT mean that the requirements of cl.6.1 should be applied to 4.1 and 4.2.

This should be interpreted in a way that the requirements of clause 6.1 are applied Together with clauses 4.1 and 4.2 in achieving planning objectives.

As for addressing of risks and opportunities, these requirements are applicable to all QMS processes (cl 4.4).

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