Committee Draft of ISO 9001 Is Out

Changes include genuine improvement; some will make implementation more difficult

Editor’s note: Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She will be reporting on the revision progress to ISO 9001, which will be completed in 2015. Read other articles in the series here.

The first committee draft of the next revision of ISO 9001 is out. Multiple changes are being proposed and the structure is markedly different. Terms have been added, and concepts and requirements have been shifted around.

This new structure is based on Annex SL, a new high-level structure developed by the Joint Technical Coordination Group (JTCG), which was subsequently approved and incorporated into the ISO directives. While the Technical Management Board (TMB) issued a resolution allowing for deviation from the high-level structure and common text, it has requested that any deviation be explained.

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ISO 9001:2015 References to Documents and Records

I was stunned by the fact that the latest revision no longer talks about documents and records. I did not see one place where it says a documented procedure is required. Does that mean we get to decide what gets documented and ISO no longer cares?

Also, I found the clause on corrective action to be disturbing. It says "When a nonconformity occurs, the organization shall: a) react to the nonconformity, and as applicable 1) take action to control and correct it; and 2) evaluate the need for eliminating the causes of the nonconformity, in order that it does not recur or occur elsewhere...". This entire statement says we need to react to everything and then decide in each case whether a corrective action (not just a correction) is warranted. In fact, the way it should be done is a correction should be done for all nonconformities. A corrective action should be done through the analysis of all or a sample of all nonconformities in order to determine if a systemic issue is in place. To require a response to each nonconformity which also evaluates the need for corrective action seems a bit like overkill to me. I know that the previous standard was not that clear on this either. But the point is, if we keep treating common cause issues as if they are special cause, we will quickly wear ourselves out with huge expenditures of resources and little to show for it.

- Mike Harkins

Excellent Observation

Your comments about distingushing between special and common causes is right on. The time wasted on searching for special causes that don't exist is uncalculable.

Rich

Outsource, corrective action

Based on my study of CD 9001, I think the idea of controlling for outsourcing has been beefed up. 9001:2008 had a paragraph under 4.1. In CD 9001, section 4.1 Understanding the organization and its context, 4.2 Understanding needs and expectations of interested parties, and 4.3 Determining the scope of the qms all apply to outsourcing. Now organizations will need to really think about the structure of the qms and the interrelations with interested parties which includes suppliers and others invovled in the supply chain. This must include outsourced services.

I hope organizations react to nonconformities with scraping, reworking, segregating, containing, identifying, removing, waiving, etc. All requirements after the intial reaction are "as applicable." "React" is not defined and control, correct and deal with consequences are "as applicable". I think an organzition could define react in a very geneal sense and try to defend that no control, correction or dealing with consequence was appicable. The next section states to evaluate the need for action. If the evalaution determines the issue is a common cause and you don't want to take action for fear of tamerping, you don't have to per CD 9001.

It's only words ?

Yes, I can't but think of the Bee Gees' Words song lyrics, when reading about the "new" ISO 9001. I'm especially concerned with the requirements 4.4.2 - 5.1.2 - 6.1 and 9.2: my comments on which so called novelties can probably be read somewhere else. In short: the elephant gave birth to a mouse, I expected a much more thorough job from ISO, to counter-act its addiction to the year 2000 edition approach. Thank you.