What should be changed in the ISO 9001:2015 Standard?

[ISO 9001 Guy]

Re: What should be changed in the ISO 9001:2014 Standard?

I couldn't agree more about the preventive action thing. Maybe just "action"--which can meet the same basic criteria for preventive and corrective action. But as long as organizations are taking actions to eliminate the causes of problems and improve, who cares if they are reactive or proactive? Although the promotion of a proactive actions is a good thing for an international standard for quality assurance, the assessment of it is awkward and should be eliminated. Moreover, proactive actions naturally occur during several normal processes: sales, design, production planning, management review, etc. But to subject each of these actions to the verification criteria of the preventive action requirement in many cases would cost more than the value gained from the action. And it doesn't make much sense, either, to (fully) verify the effectiveness of a preventive action--how does one measure the impact of an event that never occurred? I like the "oust the preventive action requirement" if it can be replaced with a simple "action" requirement. The action requirement, once relieved of the distinction between preventive or corrective, is good in promoting a permanent solution to problems instead of being satisfied with mere correction.

 

[Paul Simpson]

Re: What should be changed in the ISO 9001:2014 Standard?

Sorry if someone hasn't already said this but why isn't preventive action (8.5.3) a subset of quality planning (5.4.2)?

 

[John Broomfield]

Re: What should be changed in the ISO 9001:2014 Standard?

Sorry if someone hasn't already said this but why isn't preventive action (8.5.3) a subset of quality planning (5.4.2)?

Paul,

Of course the majority of the requirements in ISO 9001 are designed to prevent nonconformity.

The additional process for preventing nonconformity should therefore be data-driven and a subset of 8.4 as opposed to event-driven corrective action.

BTW, quality planning as necessary to fulfill customer requirements is 7.1 and quality system planning as necessary to fulfill objectives is 5.4.2.

John

 

[AndyN]

Re: What should be changed in the ISO 9001:2014 Standard?

I didn't spend time to go back through so many posts! so, at the risk of saying what's already been said:-

It seems to me that the words 'status and importance' need to be spelled out for some folks! When I read here - and in other places - that an internal audit, once a year is a satisfactory way to meet this requirement, then it clearly isn't being 'interpreted' adequately! There are some others but, to me, that's one of the most misunderstood and abused requirements that gives an indication of 'management commitment' to the maintenance of an effective system!! (Usually, they don't want to spend money on audits = no commitment!)

 

[Sidney Vianna]

Re: What should be changed in the ISO 9001:2014 Standard?

Sorry if someone hasn't already said this but why isn't preventive action (8.5.3) a subset of quality planning (5.4.2)?

Yes, Paul. The issue of preventive action definitely deserves to be addressed. Actually, when I started this thread, I wrote

The first one is preventive action. The TC 176 should re-phrase the requirements associated with preventive actions, so it can be meaningfully implemented in the real world. At present, the requirement is unclear and difficult to assess compliance against.

As I mentioned in the discussion of the ISO 9001:2008 draft documents, the TC176 membership should be ashamed for not addressing this issue, during the last review cycle of ISO 9001. One of the goals of the amendment was to CLARIFY the (dubious?/unclear) requirements of ISO 9001:2000. If the TC 176 does not know that the application of preventive action is a BIG problem in the real world, someone should call them back to Earth.

 

[John Broomfield]

Re: What should be changed in the ISO 9001:2014 Standard?

I didn't spend time to go back through so many posts! so, at the risk of saying what's already been said:-

It seems to me that the words 'status and importance' need to be spelled out for some folks! When I read here - and in other places - that an internal audit, once a year is a satisfactory way to meet this requirement, then it clearly isn't being 'interpreted' adequately! There are some others but, to me, that's one of the most misunderstood and abused requirements that gives an indication of 'management commitment' to the maintenance of an effective system!! (Usually, they don't want to spend money on audits = no commitment!)

Andy,

Surely auditing processes once or twice a year whether they need to be audited or not is a nonconformity: "failure to schedule audits according to the results of previous audits" or similar nature statement?

I see no need for TC176 to make this requirement even more obvious although I've yet to see an accredited registrar reporting this nonconformity!

John

 

[AndyN]

Re: What should be changed in the ISO 9001:2014 Standard?

Andy,

Surely auditing processes once or twice a year whether they need to be audited or not is a nonconformity: "failure to schedule audits according to the results of previous audits" or similar nature statement?

I see no need for TC176 to make this requirement even more obvious although I've yet to see an accredited registrar reporting this nonconformity!

John

I'd agree with you John, however, there's a lively debate, currently going on, on another website, where a number of folks seem to think that once a year is fine...Some of these folks are even CB auditors! The best they could offer was 'show me the shall' kind of response!

Plus, we've seen here and in other places that people have difficulty in doing anything other than replicate their CB audits.

 

[John Broomfield]

Re: What should be changed in the ISO 9001:2014 Standard?

I couldn't agree more about the preventive action thing. Maybe just "action"--which can meet the same basic criteria for preventive and corrective action. But as long as organizations are taking actions to eliminate the causes of problems and improve, who cares if they are reactive or proactive? Although the promotion of a proactive actions is a good thing for an international standard for quality assurance, the assessment of it is awkward and should be eliminated. Moreover, proactive actions naturally occur during several normal processes: sales, design, production planning, management review, etc. But to subject each of these actions to the verification criteria of the preventive action requirement in many cases would cost more than the value gained from the action. And it doesn't make much sense, either, to (fully) verify the effectiveness of a preventive action--how does one measure the impact of an event that never occurred? I like the "oust the preventive action requirement" if it can be replaced with a simple "action" requirement. The action requirement, once relieved of the distinction between preventive or corrective, is good in promoting a permanent solution to problems instead of being satisfied with mere correction.

Taking action to stop recurrence of nonconformity can be very effective up to a point. Further improvements in mature systems will also need data-driven preventive action. I think the airlines discovered this after years of digging black boxes out of the ground.

Leaders in systems that are content with corrective action rarely initiate additional actions to prevent the occurrence of nonconformity.

Surely a process-based management system would be weaker without its data-driven preventive action process?

 

[John Broomfield]

Re: What should be changed in the ISO 9001:2014 Standard?

Plus, we've seen here and in other places that people have difficulty in doing anything other than replicate their CB audits.

Some creative work with clause 4.1c could show that for internal audits to replicate certification audits is a nonconformity too!

For example. "failure to determine the criteria and methods necessary for obtaining value from internal auditing".

 

[AndyN]

Re: What should be changed in the ISO 9001:2014 Standard?

Some creative work with clause 4.1c could show that for internal audits to replicate certification audits is a nonconformity too!

For example. "failure to determine the criteria and methods necessary for obtaining value from internal auditing".

Maybe, so you'd agree that some work is needed on 8.2.2?