Discussion on TC 176 and ISO 9001:2015 8.7.1

[Big Jim]

The order in which the requirements are presented has little or nothing to do with how they are applied.

API Q1 prior to the 9th edition was in the same order as ISO 9001. With the 9th edition, API started marching more strongly to their own drum.

8.1 of ISO 9001:2015 is pretty much the same as 7.1 of ISO 9001:2008, and there planning (7.1) came before determining requirements (7.2 or even 7.3.2 about gathering requirements for design).

When writing a quality manual, I would sometimes put 7.2 in front of 7.1 because it better matched the flow of the organization.

Maybe API is more insightful than TC-176?

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

<snip>8.1 of ISO 9001:2015 is pretty much the same as 7.1 of ISO 9001:2008, and there planning (7.1) came before determining requirements (7.2 or even 7.3.2 about gathering requirements for design).

The object of 8.1 (and 7.1 from the previous edition) is to make the transition from designing and planning the QMS - including, for example, reference to process design requirements in 4.4, assigning roles and responsibilities (5.3), planning (6), providing necessary resources (7) to implementing the QMS and hence 8.1 rightly goes before 8.2.

In 8.1 the organisation has to look at the big picture of the processes it has designed and ensure they all work together with the necessary feedback mechanisms.

When writing a quality manual, I would sometimes put 7.2 in front of 7.1 because it better matched the flow of the organization.

Sounds like your quality manuals regurgitate the standard - sigh.

Maybe API is more insightful than TC-176?</snip>

I've lost touch with the work of API but hopefully the explanation above helps show that TC 176 understands what it is doing.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

The object of 8.1 (and 7.1 from the previous edition) is to make the transition from designing and planning the QMS - including, for example, reference to process design requirements in 4.4, assigning roles and responsibilities (5.3), planning (6), providing necessary resources (7) to implementing the QMS and hence 8.1 rightly goes before 8.2.

In 8.1 the organisation has to look at the big picture of the processes it has designed and ensure they all work together with the necessary feedback mechanisms.

Sounds like your quality manuals regurgitate the standard - sigh.

I've lost touch with the work of API but hopefully the explanation above helps show that TC 176 understands what it is doing.

I like your explanation about 8.1 transitioning between design and planning. It is interesting that the early drafts for the 2015 standard included such a transition with design, but it didn't make it to the final. It is also interesting that if that is what TC-176 had in mind, why didn't they say so in 8.1?

I write a manual that is tailored to the organization. While it is true that it is structured in the same format, it is by no means a regurgitation of the standard. It provides an outline or structure for the manual. Users find it very useful and I'm in high demand to write them.

As far as TC-176 fully knowing what they are doing, I have to weigh that carefully as I find numerous problems with the current version. A glaring example is 8.7.1c.

The organization shall deal with nonconforming outputs in ONE OR MORE OF THE FOLLOWING WAYS:

c) informing the customer

Do you really think that simply informing the customer could ever be enough? That it would be OK to tell the customer I'm shipping some nonconforming product and it's OK because the standard says that I need only to inform you?

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

<snip>As far as TC-176 fully knowing what they are doing, I have to weigh that carefully as I find numerous problems with the current version. A glaring example is 8.7.1c.

The organization shall deal with nonconforming outputs in ONE OR MORE OF THE FOLLOWING WAYS:

c) informing the customer

Do you really think that simply informing the customer could ever be enough? That it would be OK to tell the customer I'm shipping some nonconforming product and it's OK because the standard says that I need only to inform you?</snip>

How is your example a problem, not to mention a glaring example of TC 176 not fully knowing what they are doing?

It is impossible to write a standard that addresses each requirement of ISO 9001 in such a way that all the requirements are in one place and, at the same time, for the standard to be readable (or even to be picked up off the table! ).

Taking your example (but ignoring your EMPHASIS) for this clause to come into play the organization will have:

• Made a strategic decision to implement a QMS - Clause 0.1
• Had their leaders demonstrate commitment to satisfying customer requirements (among other things) - Clause 5.1.2 a and on enhancing customer satisfaction - Clause 5.1.2 c
• Published a quality policy that includes a commitment to satisfying customer requirements - Clause 5.2 c
• Established quality objectives to include satisfying customer requirements - Clause 6.2 d
• They will have captured customer requirements - Clause 8.2.2
• Unfortunately manufactured product or delivered a service that did not meet requirements.

So as 8.7 is now applicable the organization now needs to decide what to do and ensure it is in line with all its commitments.

There is a whole set of requirements about what the organisation should do to manage nonconformity to meet the following all-encompassing requirement:

The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

The a - d list is examples of what can be done and c that you have selected specifically (IMHO) is there to cover the situation where a non-conforming product (or service(?)) has been delivered to the customer and the organization wants to warn them not to use it or send it on into the distribution chain. It can be step 1 in the recall process.

ISO 9001 is not intended to be picked up and used as a checklist. As with any other complex set of requirements, it has to be read and understood and, only when it is understood in totality should a quality professional look to design the new requirements into a new or existing QMS.

 

[Sidney Vianna]

Re: Who is registered to ISO 9001:2015?

Do you really think that simply informing the customer could ever be enough? That it would be OK to tell the customer I'm shipping some nonconforming product and it's OK because the standard says that I need only to inform you?

Certainly not OK and, as Paul mentioned, the a-d list is not a "pick and choose" options list.

The only "acceptable" way of shipping a knowingly nonconforming product would be to exercise option d of that list which reads

obtaining authorization for acceptance under concession.

As Paul indicated, the c bullet would apply to those situations where an organization found out, after shipment, that the product might be/is non conforming.

What, by the way, is an improvement, as the TC 176 had an official interpretation (RFI 117) which contravened that.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

How is your example a problem, not to mention a glaring example of TC 176 not fully knowing what they are doing?

It is impossible to write a standard that addresses each requirement of ISO 9001 in such a way that all the requirements are in one place and, at the same time, for the standard to be readable (or even to be picked up off the table! ).

Taking your example (but ignoring your EMPHASIS) for this clause to come into play the organization will have:

• Made a strategic decision to implement a QMS - Clause 0.1
• Had their leaders demonstrate commitment to satisfying customer requirements (among other things) - Clause 5.1.2 a and on enhancing customer satisfaction - Clause 5.1.2 c
• Published a quality policy that includes a commitment to satisfying customer requirements - Clause 5.2 c
• Established quality objectives to include satisfying customer requirements - Clause 6.2 d
• They will have captured customer requirements - Clause 8.2.2
• Unfortunately manufactured product or delivered a service that did not meet requirements.

So as 8.7 is now applicable the organization now needs to decide what to do and ensure it is in line with all its commitments.

There is a whole set of requirements about what the organisation should do to manage nonconformity to meet the following all-encompassing requirement:


The a - d list is examples of what can be done and c that you have selected specifically (IMHO) is there to cover the situation where a non-conforming product (or service(?)) has been delivered to the customer and the organization wants to warn them not to use it or send it on into the distribution chain. It can be step 1 in the recall process.

ISO 9001 is not intended to be picked up and used as a checklist. As with any other complex set of requirements, it has to be read and understood and, only when it is understood in totality should a quality professional look to design the new requirements into a new or existing QMS.

Paul,

You have never seen one of my manuals and your assumptions are way off base. I never said the manual should be read as a checklist. I'm not sure if it would matter if it did though and I don't think you can find a "shall" that says differently.

I think you are having trouble reading about what I posted as a glaring problem with 8.7.1c. How could it possible be OK that informing the customer is all that was needed if the product had already shipped? I don't believe for a moment that the committee ever intended that sort of response. "I'm sorry that we shipped trash. It has already shipped and that's all I'm going to do about it".

There simply is no rational way to justify that as anything but a mistake.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

Certainly not OK and, as Paul mentioned, the a-d list is not a "pick and choose" options list.

The only "acceptable" way of shipping a knowingly nonconforming product would be to exercise option d of that list which reads

As Paul indicated, the c bullet would apply to those situations where an organization found out, after shipment, that the product might be/is non conforming.

What, by the way, is an improvement, as the TC 176 had an official interpretation (RFI 117) which contravened that.

Thanks for pointing out that TC-176 has had errors in the past, and the one you pointed out is even related to the topic at hand.

I don't not agree, however, that the proper way of reading this "one or more of the following ways" would include "informing the customer" to ever be the only way needed to handle nonconforming product, especially after it has shipped.

If you don't agree, then we will need to agree to disagree.

However, I'm chalking this up as a TC-176 screw-up. At best, something missed in proof-reading.

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

Forgive me for picking up on your reply to Sidney but there are a couple of factual errors I need to correct.

Thanks for pointing out that TC-176 has had errors in the past, and the one you pointed out is even related to the topic at hand.

Just because Sidney has posted information about an ISO process for providing sanctioned interpretations does not mean they are holding their hands up to a mistake.

Any ISO 9001 user can request, through their National Standards Body (NSB), an interpretation of a requirement in ISO 9001. There is a standing working group in TC 176 that considers these requests and replies.

Did you not know this?

I don't not agree, however, that the proper way of reading this "one or more of the following ways" would include "informing the customer" to ever be the only way needed to handle nonconforming product, especially after it has shipped.

I'm ignoring the double negative at the start of this section and I agree with you :mg: that an organisation always has to do more than inform the customer. The list I posted previously is the organisation's commitments. Their response has to be in line with their commitments.

Even if the organisations first action is simply to contact the customer, the customer's response will decide which of the other actions on the a - d list they have to do.

If you don't agree, then we will need to agree to disagree.

I can't speak for Sidney but I'm always happy to agree to disagree with your POV, Jim.

However, I'm chalking this up as a TC-176 screw-up. At best, something missed in proof-reading.

Every time you call foul it seems to come back to your misunderstanding.

You're an auditor and consultant, right?

Paul,

You have never seen one of my manuals and your assumptions are way off base. I never said the manual should be read as a checklist.

Nobody says the manual should be used as a checklist - this just plays into the 'regurgitate the standard' school of thought. My point was that all the requirements of ISO 9001 are interrelated and you can't go through the standard like a checklist and expect to come up with an effective QMS. Unless you can see the big picture you are likely to end up with this piecemeal approach.

I'm not sure if it would matter if it did though and I don't think you can find a "shall" that says differently.

You are right, there is no ISO requirement about what a manual should look like and nothing that prevents you regurgitating the standard for your clients. We are discussing here what value there is in this approach.

I think you are having trouble reading about what I posted as a glaring problem with 8.7.1c. How could it possible be OK that informing the customer is all that was needed if the product had already shipped? I don't believe for a moment that the committee ever intended that sort of response. "I'm sorry that we shipped trash. It has already shipped and that's all I'm going to do about it".

There simply is no rational way to justify that as anything but a mistake.

I presume you read my earlier reply? Your latest response says otherwise. I have no problem reading your posts.

If my pointing out the interrelationships between requirements all through the standard hasn't helped you then we have reached that point of agreeing to disagree.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

Forgive me for picking up on your reply to Sidney but there are a couple of factual errors I need to correct. Just because Sidney has posted information about an ISO process for providing sanctioned interpretations does not mean they are holding their hands up to a mistake.

Any ISO 9001 user can request, through their National Standards Body (NSB), an interpretation of a requirement in ISO 9001. There is a standing working group in TC 176 that considers these requests and replies.

Did you not know this?

I'm ignoring the double negative at the start of this section and I agree with you :mg: that an organisation always has to do more than inform the customer. The list I posted previously is the organisation's commitments. Their response has to be in line with their commitments.

Even if the organisations first action is simply to contact the customer, the customer's response will decide which of the other actions on the a - d list they have to do.

I can't speak for Sidney but I'm always happy to agree to disagree with your POV, Jim.

Every time you call foul it seems to come back to your misunderstanding.

You're an auditor and consultant, right?


Nobody says the manual should be used as a checklist - this just plays into the 'regurgitate the standard' school of thought. My point was that all the requirements of ISO 9001 are interrelated and you can't go through the standard like a checklist and expect to come up with an effective QMS. Unless you can see the big picture you are likely to end up with this piecemeal approach.

You are right, there is no ISO requirement about what a manual should look like and nothing that prevents you regurgitating the standard for your clients. We are discussing here what value there is in this approach.

I presume you read my earlier reply? Your latest response says otherwise. I have no problem reading your posts.

If my pointing out the interrelationships between requirements all through the standard hasn't helped you then we have reached that point of agreeing to disagree.

Paul,

It is interesting that you finally quit defending an indefensible issue. My point is that TC-176 is not perfect. Sydney's post where he pointed out that TC-176 erred on the same general topic in the past. I never said that TC-176 admitted to the gaff, only that Sydney pointed it out.


As to how to ask for an interpretation, I'm aware of it. I'm amazed that no one has raised this with TC-176, or if they have why there has not been a response.

Your the one that raised the question about how to write a manual, not me. That was an attack, to which I provided the lightest possible defense, and as I pointed out, you have never seen one of the manuals I have written so you are not in a position to criticize it. Assumptions can be dangerous, especially when it is done with a very broad brush, and you made some very bad and broad assumptions.

So I really wonder where the misunderstanding is here.

You just admitted that the standard's way of handling how to handle nonconforming product is inadequate, for which you early attacked me.

And then you made up something about the way I write a manual and used your assumptions to attack me.

I'm having trouble following your circular logic.

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

Paul,

It is interesting that you finally quit defending an indefensible issue. My point is that TC-176 is not perfect. Sydney's post where he pointed out that TC-176 erred on the same general topic in the past. I never said that TC-176 admitted to the gaff, only that Sydney pointed it out.

So where, exactly did I quit? In Sidney's post he directed you to an interpretation on ISO 9001:2008 where someone asked the very specific question (linked in Sidney's post):

When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 a)), does the standard require that the organization inform the customer of the nonconforming product?

The TC 176 answer, correctly, is that the standard doesn't require it and nothing in the 2015 edition changes that.

As to how to ask for an interpretation, I'm aware of it. I'm amazed that no one has raised this with TC-176, or if they have why there has not been a response.

I'm not aware of a request for interpretation on this matter. Perhaps most users don't see it the same way as you?

As far as TC-176 fully knowing what they are doing, I have to weigh that carefully as I find numerous problems with the current version. A glaring example is 8.7.1c.

Perhaps you could contact ANSI and see if you can get the question raised.

Your the one that raised the question about how to write a manual, not me.

The first mention of a manual was in your post - here - where you spoke about changing the order of clauses from those in ISO 9001.

You shouldn't be surprised to see that I am not impressed that someone recommends following ISO clause numbering in the structure of their manual - I've been saying this for years, through multiple clause number structures.

That was an attack, to which I provided the lightest possible defense, and as I pointed out, you have never seen one of the manuals I have written so you are not in a position to criticize it.

You've taken it personally, your prerogative. I don't need to see a manual if you've already told me you follow ISO clause numbering.

Assumptions can be dangerous, especially when it is done with a very broad brush, and you made some very bad and broad assumptions.

So where are these bad and broad assumptions?

I have been very specific in my responses and try to link my responses to sections of your post to keep the discussion together.

• 8.1 is a valid clause to have before 8.2 as it covers 'big picture'
• I don't like manuals that follow ISO Clause structure or regurgitate standard requirements - by your posts it seems you do at least like ISO clause numbering in manuals - we don't have any information on whether you regurgitate standard requirements
• I don't believe there is any glaring error in clause 8.7, you do
• I understand clause 8.7.1 requires more than just informing the customer but you think that option 8.7.1 c would be allowable on its own (even if not desirable)
• We agree the manual shouldn't be used as a checklist. My criticism here was of you looking at 8.7.1 c in isolation of all the other standard clauses I listed.

So I really wonder where the misunderstanding is here.

I don't believe there is a misunderstanding. I have responded to every point you have made and you choose to change the argument and cry foul.

You just admitted that the standard's way of handling how to handle nonconforming product is inadequate, for which you early attacked me.

Untrue. I never said any such thing. ISO 9001 provides a flexible framework for responding to nonconformance, I don't see any inadequacy.

And then you made up something about the way I write a manual and used your assumptions to attack me.

As ever, Jim, all I did was repeat your words back to you and comment on them.

I write a manual that is tailored to the organization. While it is true that it is structured in the same format, it is by no means a regurgitation of the standard. It provides an outline or structure for the manual. Users find it very useful and I'm in high demand to write them.

I don't like manuals that follow standard clause structure - happy to agree to disagree.. again, if you want a review, please feel free to post an example - take out anything personal to your client of course.

I'm having trouble following your circular logic.

I'd be interested in where you find the circular logic. I go out of my way to break your responses down and reply to each point individually, not the case for your replies.