It's seem like companies only care about the quality of product but just don't pay much attention to the safety of working environment. Can this issue be covered under ISO 9001:2000 clause 6.4?

It's seem like companies only care about the quality of product but just don't pay much attention to the safety of working environment. Can this issue be covered under ISO 9001:2000 clause 6.4?

Working environment is covered under 6.4. Safety manifests itself in many places - 6.3 for equipment safety, 6.4 for overall safety, 7.2 for product safety, 7.5.1 for operating safety, 7.5.5 for packing safety.

Not really, see clause 0.4 Compatibility with other management systems which states "this international standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management," etc.

Potdar is correct in saying that it could come up in a number of places and 6.3/6.4 are most the likely suspects.

What safety issues are you concerned with? Very often people don’t understand and they blame anything with its back facing the sun. While ISO 9001 is not a standard for safety, it does not stop you from incorporating industry good practices into your manufacturing activities. Take for example, the aluminum extrusion industry for which I guess you are in. You should have work instructions or SOP incorporating safety precautions and good practices while handling the oven, the extruded metal and other high temperature/risk areas because it is something needed or compulsory for this industry. The ISO 9001 third party auditor will not be bothered whether your safety precautions meet OHSAS requirements because it is outside his scope but if your workers are found not complying with your WI/SOP, he will penalized you.

Do what you do or supposed to do in your industry. Build the ISO system around your business and not the other way round.

It's seem like companies only care about the quality of product but just don't pay much attention to the safety of working environment. Can this issue be covered under ISO 9001:2000 clause 6.4?

I'm going to go into Sidney mode.

ISO 9001 says Nothing about safety. ISO 9001 Auditors are not entitled to assess against safety requirements. The bit about work environment includes "needed to achieve conformity to product
requirements." So that is the only obligation on an organisation going for certification to 9k2k.

However, having got the requirements out of the way, as has already been mentioned it is good practice to integrate your systems for safety, health, environment, quality, etc., etc. So by all means include safe systems of work in your QMS work instructions / procedures.

If you want a model for a H & S management system you could do far worse than look at OHSAS 18001.

ISO 9K does not require you to meet 'other standards' but the management responsibility does cover meeting statutory requrements. These requirements are met because they are for your own good.

I already covered the clauses. Just some examples.

You have a boiler in your factory, the auditor is not going to check whether it can stand the pressure. He will certainly ask whether the boiler inspector has checked and certified it. You can bet your maintenance QMS shall specify it because you want it there.

Same with welding glasses, gloves, masks, .. wherever required. Your QMS will specify it and the auditor will look into it becase the QMS specifies it.

If you make dynamite, you are going to handle it and pack it with utmost care. you will do it for your own good, because you have agreed to do so with your customer. It will be specified again in your QMS. The auditor will look into it.

You make foodstuff, want to continue in the business, your QMS will specify disinfected workplaces.

These things are done for your requirements. To combine your business requirements under a common simple system. The standard only provides a scope for it.

No again! Apologies to Sidney for adopting his style .... if not quite as gracefully! ;) This has been covered about 400 times in earlier threads.

ISO 9K does not require you to meet 'other standards' ... Agreed. But if you want to address other requirements (like health & safety) you need to use other models / standards.

...but the management responsibility does cover meeting statutory requrements. These requirements are met because they are for your own good. That does not mean they are documented in your QMS - and even if they are documented they are not subject to "Quality" audit.

Looking at the scope of the standard:
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for
continual improvement of the system and the assurance of conformity to customer and applicable regulatory
requirements.

So all regulatory requirements are those that apply to the product - not to occupational health & safety.

You have a boiler in your factory, the auditor is not going to check whether it can stand the pressure. He will certainly ask whether the boiler inspector has checked and certified it. You can bet your maintenance QMS shall specify it because you want it there. The auditor should evaluate the maintenance programme and assess to see if it is appropriate for ensuring the boiler can continue to do its work to produce product - nothing more.

As a quality auditor if I found they weren't carrying out statutory inspections then I might make a verbal observation - but it doesn't appear in the ISO 9001 audit report.

Same with welding glasses, gloves, masks, .. wherever required. Your QMS will specify it and the auditor will look into it becase the QMS specifies it. Same as for the example above. It has no impact on product quality - it doesn't appear in the report!

If you make dynamite, you are going to handle it and pack it with utmost care. you will do it for your own good, because you have agreed to do so with your customer. It will be specified again in your QMS. The auditor will look into it. I would expect proper control over the handling and storage processes .... to ensure the product conforms.

As a separate issue if I was assessing a company with poor dynamite handling processes I would stop the audit and tell the company that my company would not be certifying them. Not because of ISO 9001 but because I have to look after my own safety and those I direct.

I also wouldn't want my CB to be drawn into the bad publicity when they had an accident.

You make foodstuff, want to continue in the business, your QMS will specify disinfected workplaces. Now there is a clear requirement for product to conform with: c) statutory and regulatory requirements related to the product,
If you are a producer of foodstuffs your auditor should be a specialist in relevant controls that ensure product meets these statutory requirements and they would audit to see that these controls are operated throughout your plant.

These things are done for your requirements. To combine your business requirements under a common simple system. The standard only provides a scope for it. As a responsible member of your own organisation you have a responsibility for safety. You can use integration of H & S matters into a QMS to help but don't expect your auditor to use ISO 9001 to police compliance. They may not be competent to do so.

This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for
continual improvement of the system and the assurance of conformity to customer and applicable regulatory
requirements.

That does not mean they are documented in your QMS - and even if they are documented they are not subject to "Quality" audit.

Looking at the scope of the standard:


So all regulatory requirements are those that apply to the product - not to occupational health & safety.

I understand in point a) ISO talks about the product and in point b), not about the product.

The auditor should evaluate the maintenance programme and assess to see if it is appropriate for ensuring the boiler can continue to do its work to produce product - nothing more.

Pray how? You expect the auditor to be an expert on boilers? I have always been more comfortable when the auditor belives more in the boiler inspector rather than claiming to be an expert himself. (Just as you wouldnt touch the dynamite:tg: )

I also wouldn't want my CB to be drawn into the bad publicity when they had an accident.

See what I mean?

The management responsibility is ignored here. Who do you think ends up behind the bars if there is an accident and loss of life? The CB or the management?

As a responsible member of your own organisation you have a responsibility for safety. You can use integration of H & S matters into a QMS to help but don't expect your auditor to use ISO 9001 to police compliance. They may not be competent to do so.

Anything defined as the organisation as their QMS is subject to compliance audit once it is declard as adequate. How deep the auditor wants to dwell into it is to be decided by the auditor.

Secondly, all of us have agreed upteen (four hundred?) times so far that the QMS is meant for the organisation to improve their performance. It is not a baton handed over to the auditor so that the auditor can periodically give them a nice beating and keep them in line.

An expert in foodstuff (as required) would know zilch about working of the boiler that generates the steam to process the foodstuff. So what does he do?

My last attempt to have a sensible debate with you on this one, potdar.
I understand in point a) ISO talks about the product and in point b), not about the product.You can read point b as well as I can - it is about customer satisfaction - nothing about health and safety.

You expect the auditor to be an expert on boilers? I have always been more comfortable when the auditor belives more in the boiler inspector rather than claiming to be an expert himself.Look, you used the example of the boiler and I responded. I don't expect an auditor to be an expert on boilers.:bonk:

It just so happens that I have some experience of the statutory obligations for pressure vessel inspection (including boilers) so, from my fortunate position, I would be able to give the company some (value added) advice (off the record) if they weren't complying.

Read anything else into it if you will.

See what I mean? No.

The management responsibility is ignored here. Who do you think ends up behind the bars if there is an accident and loss of life? The CB or the management?I have never said the top management is not responsible for health and safety. They are.

All I have said is you don't use ISO 9001 to give you a safe and healthy working environment - that is not what it is there for. As I have posted (umpteen times) you can integrate other things into your management system (you can even set objectives other than quality objectives if you wish ;) ).
You cannot expect an ISO 9001 auditor to understand enough about all these other things and they should not be reporting on them.

Anything defined as the organisation as their QMS is subject to compliance audit once it is declard as adequate. How deep the auditor wants to dwell into it is to be decided by the auditor. Rubbish.

Anything the organisation puts in their system relating to quality is subject to audit under ISO 9001, anything they put in under environment is auditable under ISO 14001 etc., etc.

There is little enough time these days with the competitive market place for ISO 9001 certification to do all that is required to demonstrate the client has a compliant system without delving into areas that are nothing to do with ISO 9001.

Secondly, all of us have agreed upteen (four hundred?) times so far that the QMS is meant for the organisation to improve their performance. For quality, yes. Although some people want to make ISO 9001 a completley elastic management system to cover finance, health and safety etc. IMHO not appropriate.

It is not a baton handed over to the auditor so that the auditor can periodically give them a nice beating and keep them in line. Not sure of your point here. By "extending" ISO 9001 you want to give them a bigger stick?:confused:

An expert in foodstuff (as required) would know zilch about working of the boiler that generates the steam to process the foodstuff. So what does he do? You have assumed s / he has to be an expert (see above). All I would expect is that the auditor is aware of what conditions the boiler has to generate to assure product quality and checks to see that it is being monitored and maintained to do so.

Calm down, Paul, it's nearly the weekend.

I agree with most of your comments but:

As an external auditor I did, on occasions, include safety comments in an ISO 9001 report as observations. This was when I found a clearly dangerous working practice and I wanted to ensure that no-one would interpret my lack of action with tacit approval. Covering my back in other words.

I do remember once raising a non-conformity in a vehicle workshop when a mechanic was working on a car engine with the carburettor in pieces and a lighted cigarette in his mouth. The vehicle next to it was having the petrol tank removed and both mechanics on that one were also indulging in the addiction. I recorded it against protection of customers' property as I didn't think the vehicle owners would be too impressed with returning to collect a burnt out wreck.

As an internal auditor, I raise safety issues as non-conformities. I don't care what clause of the standard does or doesn't apply, I want the situation recorded and actioned.

Calm down, Paul, it's nearly the weekend. Thirsty Thursday indeed!

I agree with most of your comments but:

As an external auditor I did, on occasions, include safety comments in an ISO 9001 report as observations. This was when I found a clearly dangerous working practice and I wanted to ensure that no-one would interpret my lack of action with tacit approval. Covering my back in other words. I remember some detailed discussion at a CB we both know (and love?). The conclusion (that I personally agree with) was that the auditor should record in their notes that they had seen unsafe practices and had notified the guides to that effect.

The reason it never was to be reported in the report was
It was outside the remit we had been asked to cover
Auditors have a wide range of skills, experience and competence and recording NCs related to quality could lead to problems


I do remember once raising a non-conformity in a vehicle workshop when a mechanic was working on a car engine with the carburettor in pieces and a lighted cigarette in his mouth. The vehicle next to it was having the petrol tank removed and both mechanics on that one were also indulging in the addiction. I recorded it against protection of customers' property as I didn't think the vehicle owners would be too impressed with returning to collect a burnt out wreck. Spot on use of a relevant clause I would say. :applause:

As an internal auditor, I raise safety issues as non-conformities. I don't care what clause of the standard does or doesn't apply, I want the situation recorded and actioned. Again internally it is a completely different scope / duty - under UK legislation we have duty to look after our own h & s and that of others.

Can I go to the pub now? :agree1:

My last attempt to have a sensible debate with you on this one, potdar.
You can read point b as well as I can - it is about customer satisfaction - nothing about health and safety.

Lets talk about rest of the thing if you feel upto it after the weekend.

Just for my knowledge, please enlighten me about what 'applicable regulatory requirements' relating to 'customer satisfaction' do you include in your QMS (and audit) in your part of the world. Here arounds we seem to have none.:confused:

Lets talk about rest of the thing if you feel upto it after the weekend. I am always up to intelligent debate. Even after a really good weekend. :D

Just for my knowledge, please enlighten me about what 'applicable regulatory requirements' relating to 'customer satisfaction' do you include in your QMS (and audit) in your part of the world. Here arounds we seem to have none.:confused:
None. i I don't understand where you got this requirement from. You have to dissect the scope requirement to break it down into three elements

This International Standard specifies requirements for a quality management system where an organization aims to enhance customer satisfaction through the effective application of the system


This International Standard specifies requirements for a quality management system where an organization aims to enhance customer satisfaction through processes for continual improvement of the system and


This International Standard specifies requirements for a quality management system where an organization aims to enhance customer satisfaction through processes for the assurance of conformity to customer and applicable regulatory requirements.

So the point we are debating IMHO is the last one:

In my words the organisation has to make sure it manages those processes that make sure the product complies with any legal requirements.

Semantics? Maybe. But worth a debate.

ISO 9001 says: This international standard specifies requirements for a quality management system where an organisation

a) satisfies clause relating to demonstration of ability of product meeting customer and applicable regulatory requirements.

b) aims to enhance customer satisfaction through the effective appliction of a system including

- processes for continual improvement of the system and

- the assurance of conformity to customer requirements and

- the assurance of conformity to applicable regulatory requirements*.


What are the applicable regulatory requirements in clause b? What regulatory requirements enhance customer satisfaction? I see that requirements related to the product are alredy covered in clause a. Clause b IMO covers requirements beyond clause a.


* clause split to try enhance self understanding.

Semantics? Maybe. But worth a debate.

ISO 9001 says: This international standard specifies requirements for a quality management system where an organisation

a) satisfies clause relating to demonstration of ability of product meeting customer and applicable regulatory requirements.

b) aims to enhance customer satisfaction through the effective appliction of a system including

- processes for continual improvement of the system and

- the assurance of conformity to customer requirements and

- the assurance of conformity to applicable regulatory requirements*.


What are the applicable regulatory requirements in clause b? What regulatory requirements enhance customer satisfaction? I see that requirements related to the product are alredy covered in clause a. Clause b IMO covers requirements beyond clause a.


* clause split to try enhance self understanding.


Two requirements - same basis but different scopes:
a) is "product conforms"
b) is "system for producing product that conforms"

For both a) and b) the customer and legal requirements relate to product.

In one of the 400 earlier posts Sidney posted a link to the ISO Auditing Practices Group.

http://isotc.iso.org/livelink/livelink/3554429/APG-StatutoryRegulatory.doc?func=doc.Fetch&nodeid=3554429

I'm outa here!

I'm outa here!You are a patient man. The frustrating thing is that I (and others) have had discussions similar to this since 1994. And you know we are bound to repeat these discussions in the future, numerous times.
And, even worse. Although you put out very convincing arguments, you know that there are some people out there that think you are wrong and they are right...:mg:. So let them use ISO 9001 to address occupational safety, environmental management, corporate governance, labor relations, the cafeteria menu and solve World hunger, while they are at it.

Applicable regulatory requirments relate to product conformity, not the infrastructure.
example - we make parts CE marked in accordance with EU PED requirements. So that directvie is an applicable regulatory requirement.

Workplace safety is an infrastructure issue.
6.3 of ISO9001 (Infrastructure) specifies "in order to acheive conformity to product requirements".
a missing machine guard will generally not affect conformity of the product.
Neither will lack of a lockout/tagout program, confined space entry, or bloodborne pathogens procedure.

I agree that an auditor should point out safety issues that are seen during the course of an audit, but they cannot count against the audit unless product conformity in compromised.

Many years back when the 9001:2000 standard was first issued I had written Charles Cianfrani co-author of Iso 9001: 2000 Explained (http://www.amazon.com/Iso-9001-Explained-Charles-Cianfrani/dp/0873895088) regarding the clause "conformity to customer and applicable regulatory requirements" and had asked him if auditors where supposed to be proficient with regulatory requirements (which I think is rediculous) and of course he stated the opposite that auditors are considered professionals and are responsible for knowing and auditing to, if necessary, those regulatory requirements.
I do check for entries, exits, fire extinguishers, eyewash stations and safety showers during my 9001 walkthroughs however, I don't write up an area for it, I forward the results to the safety guy (oshas 18001).
I do believe that Ciafrani's interpretation falls in-line with Potdar's. So I think if you do include Safety like OSHA requirements, well thats fine, if you don't you won't get called on the carpet for any specific safety regs being violated in a 9001 external audit.

Many years back when the 9001:2000 standard was first issued I had written Charles Cianfrani co-author of Iso 9001: 2000 Explained (http://www.amazon.com/Iso-9001-Explained-Charles-Cianfrani/dp/0873895088) regarding the clause "conformity to customer and applicable regulatory requirements" .Regulatory and statutory requirements RELATED TO PRODUCT. That is one of the amendments proposed in the ISO 9001:2009 document. So, people understand that we are talking about PRODUCT SAFETY. Not occupational safety.
Examples of regulatory and statutory PRODUCT REQUIREMENTS? FDA, FAA, ASME, API, FCC, CE-Mark Directives, ROHS, WEEE, etc....

Regulatory and statutory requirements RELATED TO PRODUCT. That is one of the amendments proposed in the ISO 9001:2009 document. So, people understand that we are talking about PRODUCT SAFETY. Not occupational safety.
Examples of regulatory and statutory PRODUCT REQUIREMENTS? FDA, FAA, ASME, API, FCC, CE-Mark Directives, ROHS, WEEE, etc....

Thanks Sidney. If an AMENDMENT is proposed, there must be some reason for it. The committee members are supposedly quite busy people to waste their time discussing needless rewording of the standard.:tg:

I think we will keep our views to ourselves and let them settle it and keep our patience.:cool:

If an AMENDMENT is proposed, there must be some reason for it.The ISO 9001:2009 amendment is an attempt to clarify issues that some people still don't understand, after all these years. Sort of a poke-yoke, mistake-proofing effort... The committee members are supposedly quite busy people to waste their time discussing needless rewording of the standard. The jury is still out on that one...:lol:I think we will keep our views to ourselvesIs there any other way?

OK. Product safety and product requirements it is. I was told by my tutors and I believe that it should include process requirements.

I repeat here a case I had presented long time ago when I qualified as a Lead Auditor with IRCA.

We had a disaster here many years ago. A poisonous intermediate gas called Methyl isocyanate leaked from the then Union Carbide plant in the middle of the bustling city of Bhopal. It killed thousands of unsuspecting people and left many more maimed for life. It also crippled Union Carbide and continues to haunt Dow even today. There are many theories about the how and why but that is not the issue.

If an auditor goes to such a plant to audit their QMS and sees the possibility of such a leakage taking place due to whatever reasons, should he recommend certification if everything else is OK?

The gas leaking is not going to affect product quality. It does not feature in the product statutory requirements. It might just kill the operator and maybe a few thousand people along with him.

The answer I got from my tutor was NO. It should be an NC against the then 4.9g - suitable maintanance of equipment to ensure continuing process capability.

This is really on the lines of so many examples discussed here. Just for argument - and argue I did, a small leak in an automatically controlled process industry would at most kill somebody moving around. It wont affect 'continuing process capability'. Just like a missing safety guard on a machine wont. It would at most take somebody's finger away. Nor would a leak in the compressed air pipeline. It would do no harm so long as the required pressure is available at the delivery point.

We as auditors were taught to use our judgement to grade these findings and then stamp them. But all were supposed to be findings of the audit which an auditor must look for with open eyes.

Though the committee have extensively reworded and refocussed the standard in 2000, I dont think these essentials have been taken away.

Talking of boilers, I did find myself in an awkward situation few years ago. I had finished my audit of a paper mill and was preparing my notes for the closing meeting. In between a team from the local pollution control board landed for a check. They found the SPM levels in the boiler emission way too high and sealed the plant.:mg: Luckily for me, I didnt have to make any decisions as the management requested for a postponement of the closing meeting. I just postponed it till they got their plant reopened.

In this situation, I would like to know from all the votaries of PRODUCT ONLY - how many would go ahead and recommend certification there and then?

The plant being sealed by statutory authorities may not really 'enhance customer satisfaction' but then, his warehouse will take care of the deliveries and its not connected to his QMS anyway!

Sorry Sidney. I tried hard but after a good night's sleep, couldnt keep my views to myself.

If an auditor goes to such a plant to audit their QMS and sees the possibility of such a leakage taking place due to whatever reasons, should he recommend certification if everything else is OK?

The gas leaking is not going to affect product quality. It does not feature in the product statutory requirements. It might just kill the operator and maybe a few thousand people along with him.

The answer I got from my tutor was NO. It should be an NC against the then 4.9g - suitable maintanance of equipment to ensure continuing process capability.Just because your instructor told you something, it does not mean that it is correct. You are entitled to your opinions. But one could think that people who deliberate on the standards would know a little bit more about this than you.
As Paul Simpson already said yesterday, PLEASE read the document Auditing Statutory and Regulatory requirements (http://isotc.iso.org/livelink/livelink/3554429/APG-StatutoryRegulatory.doc?func=doc.Fetch&nodeid=3554429), developed by an ad-hoc group under the same TC 176 that writes the standard. In that document (if you read it), you will see the following text:

ISO 9001:2000 requires an organization to identify and control the statutory and regulatory requirements applicable to its products (including services). It is up to the organization how to do this within its QMS.

However, if nonconformance with other kinds of statutory requirements (e.g. health and safety, environment, etc.) is co-incidentally, detected during the audit, this fact cannot be ignored by the audits. It should be reported without delay to the auditee and, if required, to the audit client.
There is a difference between REPORTING the unsafe situation and writing an NC against a NON-APPLICABLE Standard. If you deny quality system certification to an organization due to a non-related discrepancy, such as an environmental or occupational health violation, you are violating ISO/IEC Guide 62. Your CB can be taken to court for that.

If I were auditing a site where I detected unsafe practices, I would report this to the organization, and if the situation was serious enough, I would simply leave the premises.

At our facility during the initial audit, auditor ask warehouse associated to find some stock. Associate used forklift to get that material from 3rd rack and he didn't wear safety harness belt. Auditor ask second time to get same material, he didn't wear safety harness belt second time as well.

Auditor went to HR, ask for training report and fortunately that fellow has forklift licence but still we got minor non conformity stating that all associates are not properly trained of health and safety procedure.

So i think ISO has to do with all regulatory standard

At our facility during the initial audit, auditor ask warehouse associated to find some stock. Associate used forklift to get that material from 3rd rack and he didn't wear safety harness belt. Auditor ask second time to get same material, he didn't wear safety harness belt second time as well.

Auditor went to HR, ask for training report and fortunately that fellow has forklift licence but still we got minor non conformity stating that all associates are not properly trained of health and safety procedure.

So i think ISO has to do with all regulatory standardWhat ISO? Your post reflects the prototypical auditee experience. Just because an auditor states something related to Standard s/he is auditing to, you take it as "the truth". If your post is related to an ISO 9001 audit, the auditor is w-r-o-n-g. Forklift operation is a common source of damaged products (quality related) and accidents (safety related). Your auditor write up is not supported by ANY requirement of the ISO 9001 standard. You chose(?) not to challenge.

Does it make sense for the forklift operator to wear the harness? You bet. Does ISO 9001 deal with OCCUPATIONAL HEALTH?

NO!

PLEASE read the document Auditing Statutory and Regulatory requirements (http://isotc.iso.org/livelink/livelink/3554429/APG-StatutoryRegulatory.doc?func=doc.Fetch&nodeid=3554429), developed by an ad-hoc group under the same TC 176 that writes the standard. In that document (if you read it), you will see the following text:
There is a difference between REPORTING the unsafe situation and writing an NC against a NON-APPLICABLE Standard. If you deny quality system certification to an organization due to a non-related discrepancy, such as an environmental or occupational health violation, you are violating ISO/IEC Guide 62. Your CB can be taken to court for that.
If I were auditing a site where I detected unsafe practices, I would report this to the organization, and if the situation was serious enough, I would simply leave the premises.

I agree with you and Paul. However, I see that you are speaking in the context of a CB. Not an internal auditor. From the link you graciously supplied.
"However, if nonconformance with other kinds of statutory requirements (e.g. health and safety, environment, etc.) is co-incidentally, detected during the audit, this fact cannot be ignored by the audits. It should be reported without delay to the auditee and, if required, to the audit client."
How does one report this, verballly or in the report itself? :) You stated that you would leave the premises for because of an unsafe condition, at some point, whether it is in an audit report or some other type of communication the reason why you left will have to be documented.
As you can tell by my history of posting it takes a lot for me to write up anything. I am just playing devils advocate here because also alot of what Potdar states was in the past, was supported by Cianfrani (considered an expert?).

What ISO? Your post reflects the prototypical auditee experience. Just because an auditor states something related to Standard s/he is auditing to, you take it as "the truth". If your post is related to an ISO 9001 audit, the auditor is w-r-o-n-g. Forklift operation is a common source of damaged products (quality related) and accidents (safety related). Your auditor write up is not supported by ANY requirement of the ISO 9001 standard. You chose(?) not to challenge.

Does it make sense for the forklift operator to wear the harness? You bet. Does ISO 9001 deal with OCCUPATIONAL HEALTH?

NO!

No i didn't choose to challenge, as it was my first experience, first time i implemented ISO 9001:2000 and it was successful with above said minor one. They found that issue and they relate the issue with training. they stated health safety training requirement in their report with clause number and we also submitted our corrective action.

they stated health safety training requirement in their report with clause number and we also submitted our corrective action.

What claus did the auditor cite it under? 6.2.2?
6.2.2 a specifically says "work affecting product quality".
Not wearing a safety harness has nothing to do with product quality because product can be damaged whether or not the driver is wearning a harness.

ah well. live and learn.

Just because your instructor told you something, it does not mean that it is correct. You are entitled to your opinions. But one could think that people who deliberate on the standards would know a little bit more about this than you.
As Paul Simpson already said yesterday, PLEASE read the document Auditing Statutory and Regulatory requirements (http://isotc.iso.org/livelink/livelink/3554429/APG-StatutoryRegulatory.doc?func=doc.Fetch&nodeid=3554429), developed by an ad-hoc group under the same TC 176 that writes the standard. In that document (if you read it), you will see the following text:





The same document (I have read it) further states:

If auditors become aware of any deliberate legal non-compliance that could affect the image and credibility of the QMS before, during, or after the audit (including, for example, breach of antitrust law, labour law, health and safety or environmental regulations) then this should be taken into consideration and investigated further, as appropriate. Apart from the regulatory authority’s action, it is for the auditors to assess the effectiveness of the QMS in meeting customer requirements (stated or generally implied) and report this to the certification/registration body management to take appropriate actions.


Therein I find the relevance of my tutor's guidance about grading the finding and taking appropriate action. The QMS does not bother about anybody's safety. It does however bother if this lapse on safety countervenes or is deemed likely to countervene the organisations commitment to the customer (stated and unstated).

There is a difference between REPORTING the unsafe situation and writing an NC against a NON-APPLICABLE Standard. If you deny quality system certification to an organization due to a non-related discrepancy, such as an environmental or occupational health violation, you are violating ISO/IEC Guide 62. Your CB can be taken to court for that.

If I were auditing a site where I detected unsafe practices, I would report this to the organization, and if the situation was serious enough, I would simply leave the premises.

Leaving the premises. Wouldnt that amount to denial of QMS certification? And the attendant consequences thereof?

Just wondering. Why are all of us so hell bent on dividing QMS, EMS, OSHAS, ... and so many other standards / systems into watertight compartments. They are not. No organisation can be carved into such pieces. There are overlapping grey zones. There will always be these zones.

Just wondering. Why are all of us so hell bent on dividing QMS, EMS, OSHAS, ... and so many other standards / systems into watertight compartments. They are not. No organisation can be carved into such pieces. There are overlapping grey zones. There will always be these zones.What a change of direction...QMS, EMS, OHSMS, ISMS, etc... are subsets of the continuum known as enterprise management. Any organization has to be managed in a holistic manner, addressing multiple stakeholders expectations. However, the question at hand is: See the title of this thread.
Nice try, but no cigar.

I am not so sure that anyone is trying to divide anything. You have some experienced auditors telling you that your 9001 auditor shouldn't be writing nonconformances because the OSHA (or whatever occupational safety department rules your area) violations were found, but instead a simple "hey I saw this and you should do something about it".

At my company, we always tell our auditors to make sure to bring anything they see to our attention, as it can only make us better, and we stress to our employees that all of our systems are like a jigsaw puzzle, none complete without all the others. But, still, I would not want an ISO 9001 surveillance citing a nonconformance because a person walked through a roll up door instead of a man door. It does not affect the product, process, customer satisfaction but it is in direct violation of our safety system. I also wouldn't expect the 9001 auditor to ask questons about our environmental aspects or impacts (even though you could say that siimilarly, that would tie in to regualatory/statutory requirements). No one is insinuating that it is not important, it is just not the purpose of the ISO 9001 standard. UNLESS, you have included safety in your QMS.

The discussion seems to have quietly given a burial while I was away. I believe everyone seems to have agreed (at least not contested) that the various standards are not watertight compartments in an organisation and that it has to be looked at in a holistic manner by everybody - including an auditor of whatever standard.

I couldn't however digest the legal tangle.

There is a difference between REPORTING the unsafe situation and writing an NC against a NON-APPLICABLE Standard. If you deny quality system certification to an organization due to a non-related discrepancy, such as an environmental or occupational health violation, you are violating ISO/IEC Guide 62. Your CB can be taken to court for that.

If I were auditing a site where I detected unsafe practices, I would report this to the organization, and if the situation was serious enough, I would simply leave the premises.

Leaving the premises. Wouldnt that amount to denial of QMS certification? And the attendant consequences thereof?
What a customer can do in such a situation as per the guide is to appeal to the CB or at the most complain to the AB.

By the way, which court of which land recognises Guide 62?:confused:

The discussion seems to have quietly given a burial while I was away. I believe everyone seems to have agreed (at least not contested) that the various standards are not watertight compartments in an organisation and that it has to be looked at in a holistic manner by everybody - including an auditor of whatever standard.I think you assume too much. The fact that some people (like me) have decided to save our energy does not mean that we have accepted your argument - merely that we no longer see any benefit (for us and the readers of the thread) in continuing to bang our respective heads against a brick wall. :frust:

I couldn't however digest the legal tangle.Perhaps this is the problem. 15 years ago the CB I worked for spent many man hours in investigating the legal position of a CB and came up with the guidance for auditors that you do not accept. Ah well, perhaps everyone is marching out of time and it is you that is correct. :lol:




What a customer can do in such a situation as per the guide is to appeal to the CB or at the most complain to the AB.
Perhaps we could abide by the principles of quality assurance and eliminate the problem at source by making sure auditors don't raise incorrect non compliances? :D
By the way, which court of which land recognises Guide 62?:confused: Not sure of your argument here. Any court will consider accreditation of a CB in any legal case involving management systems certification.

Calm down, Paul, it's nearly the weekend.



Paul
How many times do I have to tell you?:)

Perhaps this is the problem. 15 years ago the CB I worked for spent many man hours in investigating the legal position of a CB and came up with the guidance for auditors that you do not accept. Ah well, perhaps everyone is marching out of time and it is you that is correct. :lol:

Maybe people who are presently involved with the legal positions can shed a better light.;)

Perhaps we could abide by the principles of quality assurance and eliminate the problem at source by making sure auditors don't raise incorrect non compliances? :D

Definitely yes. There is always an option of walking out.:rolleyes:

Not sure of your argument here. Any court will consider accreditation of a CB in any legal case involving management systems certification.

If I go to the court in your land with a petition stating "Auditor A of certification body Z came to audit our organisation against standard ISO 9001:2000 on date 9999999 and walked out on us refusing a certificate even though we met all requirements of the standard in full. This contravenes the requirements of Guide 62 issue 4. Hence we may be compensated by amount X and auditor A and MD B of CB Z should be put behind the bars...." would your court admit my petition?

I dont know what requirements are contravened, but I'm told they are.

Paul
How many times do I have to tell you?:)

:topic: I envy you guys. It seems to be a perpetual weekend for you.:)

Herearounds situation is not so cool:nope:

Anyways Cheers to you:beerdive: :drunk:

Maybe people who are presently involved with the legal positions can shed a better light.;) Good idea. I haven't heard of any CBs in court as part of a legal action regarding safety- perhaps other covers have some information.



Definitely yes. There is always an option of walking out.:rolleyes:
In UK law there is a duty of care on individuals to take care of their own safety (and that of others). So if I believe I am at risk I am legally bound to leave the premises.


If I go to the court in your land with a petition stating "Auditor A of certification body Z came to audit our organisation against standard ISO 9001:2000 on date 9999999 and walked out on us refusing a certificate even though we met all requirements of the standard in full. This contravenes the requirements of Guide 62 issue 4. Hence we may be compensated by amount X and auditor A and MD B of CB Z should be put behind the bars...." would your court admit my petition?

I dont know what requirements are contravened, but I'm told they are.This is a different argument. If, as a CB, I refuse to certify an organisation for no good reason then I am in breach of accreditation criteria (can't remember where) as I am obliged to offer my services to anyone who wants them.

If the company is breaking the law that would be my defence that my decision not to work with a company is not unreasonable.

I can't imagine many companies taking me to court when my defence is going to reflect badly on them and possibly lead to criminal action on them by the government for breaches of health & safety law.

If I go to the court in your land with a petition stating "Auditor A of certification body Z came to audit our organisation against standard ISO 9001:2000 on date 9999999 and walked out on us refusing a certificate even though we met all requirements of the standard in full. This contravenes the requirements of Guide 62 issue 4. Hence we may be compensated by amount X and auditor A and MD B of CB Z should be put behind the bars...." would your court admit my petition?

I dont know what requirements are contravened, but I'm told they are.

The legal jurisdiction is normally defined within the contract with the registration body. This would be a civil matter so, in the UK at least, prison wouldn't be an issue but compensation could be awarded if the registrar or auditor acted improperly. However, no employee can be required to work in an unsafe environment and, if the auditor judged his health and safety was being put at risk, he has both the right and responsibility to avoid the risk.

I have walked out of such situations where I believed the working environment was unsafe. One, a vehicle workshop, I listed in a previous post. The other two were in Austria and Italy. In both cases, I believed particular protective equipment (face masks to avoid particulate inhalation) were necessary. This would have been the norm in the UK but was considered unusual in those countries. In both cases, the organizations changed their working practices, after I rasied the issue, and made the PPE mandatory for their employees too.

What is considered a safe working practice varies around the world. The UK is highly regulated in this field and I've seen safety standards throughout Europe aand the USA which would not pass muster at home. That has to be handled with tact but also without compromise to my own well being.

I agree with Sidney and Paul that such safety issues are not covered by the scope of ISO 9001. Unlike Paul, I would always reference safety issues in my report, but not as ISO 9001 nonconformities. I would want to ensure that the organization, my employer and any colleagues carrying out subsequent visits were aware of my concerns.

Paul
We seem to have replied at the same time.
Fortunately we seem to be taking a consistent stance.

Calm down, Paul, it's nearly the weekend. and

Paul
How many times do I have to tell you?:)

I know I should resist, where's that ignore button? :lol:

Paul
We seem to have replied at the same time.
Fortunately we seem to be taking a consistent stance.

Yes, Sorry. It looks like we're ganging up on Potdar - not the case.

Re the same stance - I'm not surprised - I had a great teacher!

This is a different argument. If, as a CB, I refuse to certify an organisation for no good reason then I am in breach of accreditation criteria (can't remember where) as I am obliged to offer my services to anyone who wants them.

Nor do I remember. I tried a cursory :read: of Guide 62. Couldnt locate any. If you find it please update me.

If the company is breaking the law that would be my defence that my decision not to work with a company is not unreasonable.

I can't imagine many companies taking me to court when my defence is going to reflect badly on them and possibly lead to criminal action on them by the government for breaches of health & safety law.

You need to defend if you are called upon by the court to defend. Unfortunately I have some legal background in the family. The legal system in India is also modelled on the British system. The court will simply throw out any claim against the CB for violating "accreditation criteria" as "not under jurisdiction". Just the same way you as a QMS auditor would not bother about a safety issue "not related to product".:notme:

The legal jurisdiction is normally defined within the contract with the registration body. This would be a civil matter so, in the UK at least, prison wouldn't be an issue but compensation could be awarded if the registrar or auditor acted improperly. However, no employee can be required to work in an unsafe environment and, if the auditor judged his health and safety was being put at risk, he has both the right and responsibility to avoid the risk.

The issue is not violation of the contract. The issue is relating to the violation of Guide 62 - which is neither a criminal nor a civil law. I wonder under what jurisdiction you might put it.:rolleyes:

Nor do I remember. I tried a cursory :read: of Guide 62. Couldnt locate any. If you find it please update me.



You need to defend if you are called upon by the court to defend. Unfortunately I have some legal background in the family. The legal system in India is also modelled on the British system. The court will simply throw out any claim against the CB for violating "accreditation criteria" as "not under jurisdiction". Just the same way you as a QMS auditor would not bother about a safety issue "not related to product".:notme:



The issue is not violation of the contract. The issue is relating to the violation of Guide 62 - which is neither a criminal nor a civil law. I wonder under what jurisdiction you might put it.:rolleyes:

I am sorely tempted to say "don't bother replying to my posts" and I, in turn, will ignore yours as it appears we cannot agree on anything.

Instead I will simply say do not misquote my posts as you have done above. For the 401st time please understand.
Any auditor has a duty to bring to the attention of a client any areas of safety that they feel needs attention
Safety "infringements" are not reportable under ISO 9001

If you want to reply to either of these points with any new information please feel free to do so. If you have nothing new to say then it is best just to say nothing.

I am sorely tempted to say "don't bother replying to my posts" and I, in turn, will ignore yours as it appears we cannot agree on anything.

Instead I will simply say do not misquote my posts as you have done above. For the 401st time please understand.
Any auditor has a duty to bring to the attention of a client any areas of safety that they feel needs attention
Safety "infringements" are not reportable under ISO 9001

If you want to reply to either of these points with any new information please feel free to do so. If you have nothing new to say then it is best just to say nothing.

No. Nothing new. Still the same old brew. But by now I know that we agree on certain issues and disagree on some. And we are not likely to change so easily. Frankly my views hold little practical value as I dont conduct any certification audits any more.

Thanks for the lively debate. One discovery is - both of us are extremely patient guys. In this case that started bordering on stubbornness. So when you write now for the 401st time, lets close the debate.

Thanks are also due to Sidney, tyker, chaosweary, discordian and all other participants. I dont know how many pressed their ignore button on me. Not everyone would be as patient as you. But they have contributed a range of views and viewpoints.

This thread has thrown up many loose ends. Lots of things to munch over and maybe brought back to the cove for discussion. But this thread is not the place to discuss them.

Enjoy the long weekend.

I believe everyone seems to have agreed (at least not contested) that the various standards are not watertight compartments in an organisation and that it has to be looked at in a holistic manner by everybody - Actually, the STANDARDS do have a narrow focus of application. By design, they propose management models to the management system subsets, such as QMS, EMS, OHSMS, etc. The organization, NOT THE STANDARD, NOT THE AUDITOR, has to manage the enterprise in a comprehensive, holistic manner.

Actually, the STANDARDS do have a narrow focus of application. By design, they propose management models to the management system subsets, such as QMS, EMS, OHSMS, etc. The organization, NOT THE STANDARD, NOT THE AUDITOR, has to manage the enterprise in a comprehensive, holistic manner.

Possibly. The fat lady has retired from singing.