ISO 9001:2015 Questions from a recent Webinar Part 1 of 3, Answers by George Hummel, member US TAG to ISO/TC 176

Question:

What is the deadline for being audited to ISO 9001:2015?

 

Answer:

Organizations have until September 2018, to complete the transition and be certified.  Certification Bodies should be informing clients of their exact process soon.  However, to avoid being caught in a “log jam” at the end of this period, it would be advisable to start the transition now.

 

Question:

How can we use our existing quality manual/procedures while incorporating in ISO 9001:2015 revision?

 

Answer:

You are free to incorporate any or all of your existing documentation.  However, it would be wise to check for required documented information you may not have. An effective technique for this is a Gap Analysis.

 

Question:

The new standard is causing a stir in the quality discussions, with some pointing to these clauses as an indication that ISO 9001 is becoming a Business Management Standard.

 

Answer:

ISO 9001 is a Quality Management Standard because of its Scope, which gives the requirements of when an organization “needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements…”

 

Further, ISO provides TC 176, Quality management and assurance, with a design specification for a quality standard.  The committee cannot exceed these inputs.  That is also why ISO 9001:2015 does not address “risk mitigation,” as that is the province of TC 262.

 

Question:

Can you explain Clause 6.1 and its application, as we see the subject of Clause 6 and the risks & opportunities applied to 8.1, 9.1.3, 9.3, and 10.2?

 

Answer:

One of the core concepts of ISO 9001:2015 is the methodology of Plan-Do-Check-Act.  Clause 6 addresses planning with regard to risks and opportunities. Clause 8.1 is “Do.”  Clauses 9.1.3 and 9.3 are “Check.”  Clause 10.2 is “Act.”