Permissible Exclusions - ISO 9001

[John Broomfield]

Hi all,

Hoping for a bit of guidance as I'm currently writing our quality manual.

We are a transport company. We pick package up at point A and deliver to point B. We also hold packages at out warehouses for a short-time prior to delivery to point B.

My initial thoughts are that we would exclude 7.3 as we are not involved in design in day-to-day processes, however we do have specialists vehicles, that we lease but are built especially for us. These are designed by a supplier to our specifications. Does this change whether we exclude or not? Edit: Also we do design our own training packages, so where does this fit?

Also thought that we should exclude 7.5.2 as once we have delivered the package onto a 3rd party our role is done and we therefore cannot do any subsequent validation once the package is delivered.

Finally I initially thought we should exclude 7.6 as we do not use any measuring equipment however I'm not sure where we stand after discussion with our fleet manager. Our vehicles are leased and are fully maintained as part of the contract and therefore they have equipment that would be used in measuring and monitoring. Also our fleet manager does do some inspections on vehicles occasionally but only uses a tyre pressure gauge and a tread-depth gauge. Where do we stand on this?

Thanks in advance for your help. Having been through a number of threads on this forum I know there are some very passionate and experienced individuals who may be able to help.

Cheers.

NewtoISO9001,

Your product is a transportation service. Therefore to conform to ISO 9001 your management system for design and delivery of this service will include processes and controls that conform to the following parts of clause 7:

7.1 planning selling and delivering to fulfill customer requirements.
7.2 understanding your customers' requirements, committing (or not) to meet their requirements and communicating with your customers.
7.3 translating your customers' needs into requirements (specifications) for your service (perhaps when you design a new route or feature of your delivery service).
7.4 purchasing goods and services to support delivery of your transportation service from suppliers selected because they can meet your requirements.
7.5 controlling the selling and delivery of your transportation service (7.5.2 may be excluded because you can verify the quality of your product - not having to waste money on verifying the quality of your product may mean that you decide to invest in making sure your deliver processes conform to 7.5.2) but all other parts of 7.5 apply in any case.
7.6 controlling equipment and software used to verify product quality (you could exclude but it makes sense to ensure that torque wrenches and air pressure guages [including those used by suppliers] are calibrated and controlled per this clause for the quality of safety if not for the quality of your service) - this also depends on your 7.5.2 decision (see above).

Continually improving your performance specifications for purchasing new equipment is important for the effectiveness and conformity of your purchasing process and your system may benefit from applying clause 7.3 to it.

Be sure so you do not have to ask your registrar if your system conforms. Know that it does before going for certification so you can properly defend your system during the registrar's audits.

Lastly, do not write your manual until you have analyzed your core process (end-to-end: from customer needs to cash in the bank), determined your key processes and analyzed, interlinked and documented each of them (per clause 4.1 and 4.2.1d).

Cheers,

John

 

[Sidney Vianna]

My initial thoughts are that we would exclude 7.3 as we are not involved in design in day-to-day processes, however we do have specialists vehicles, that we lease but are built especially for us. These are designed by a supplier to our specifications. Does this change whether we exclude or not? Edit: Also we do design our own training packages, so where does this fit?

Read this advice coming from the ISO TC 176:

3.1 Design and development of the service

When considering the applicability or not of clause 7.3 of ISO 9001 to a service organization, it is important to remember the definition of “Design and development”, which, according to ISO 9000 clause 3.4.4 is the “set of processes that transforms requirements into specified characteristics”. Again, according to ISO 9000 requirements are “needs and expectations that are stated, generally implied or obligatory”, and characteristics of the service are distinguishing features that can include:

• sensory (e.g. related to smell, touch, taste, sight, hearing)
• behavioral (e.g. courtesy, honesty, veracity)
• temporal (e.g. punctuality, reliability, availability)
• ergonomic (e.g. physiological characteristic, or related to human safety)
• tangible (e.g. measurable characteristics; these may be either the characteristics of the physical means used to deliver the service, e.g. the maximum speed of an aircraft, or of the environment in which the service is provided, e.g. the interior temperature or facilities of an aircraft).

It is quite common for organizations to consider only the tangible component of their product when addressing the requirements of clause 7.3, forgetting that the design and development of the intangible product (the service itself) should be the main focus. Additionally, the organization will need to design how the service will be delivered to its customers.

If the organization proposes to justify the exclusion of design and development from its QMS, the auditor should make a careful assessment of the justifications in light of the above. The auditor should also examine whether the organization has an effective design and development process that sufficiently defines the characteristics of its service, and of its service delivery processes, that are needed to meet customer needs and expectations.

Read more....

 

[John Broomfield]

All,

Read and understand the definition of product and make sure that someone is designing the whole product. Customers often do a lousy job of design especially the design of their suppliers' service.

In amazes me how many organizations that do not design their goods refuse to acknowledge that, if they fail to design the service part of their product, their products will be diminished in value so customers see it as a commodity.

Service quality often is the key to customer retention. And service adds value customers are willing to pay for; perhaps after trying a few other suppliers that ignore the design of their services.

Too many systems exclude 7.3 and fail to continually improve the quality of the service part of their products. Some organizations are even encouraged in this folly by their registrars!

John

 

[newtoiso9001]

Thank you for your response John and the advice Sidney. Makes things clearer.

I think it'll only be 7.5.2 that we will look to exclude.

With regards to 7.6, we will ensure suppliers are controlling measuring equipment etc. How would you recommend we audit this? Would we just visit their head office and check their procedures, documentation etc or would we need to go out to each location (and there are many across the UK) that services our vehicles to do an audit?

 

[John Broomfield]

Thank you for your response John and the advice Sidney. Makes things clearer.

I think it'll only be 7.5.2 that we will look to exclude.

With regards to 7.6, we will ensure suppliers are controlling measuring equipment etc. How would you recommend we audit this? Would we just visit their head office and check their procedures, documentation etc or would we need to go out to each location (and there are many across the UK) that services our vehicles to do an audit?

newtoISO9001,

Before asking for travel authorizations for trips all over the UK why not obtain evidence from the suppliers of how they verify conformity to clause 7.6 of their national quality management system standard.

Surely their insurers do not allow them to ignore this standard?

You could also specify this calibration requirement in your purchase orders.

John

 

[Brunetta]

I read through this thread today...and I have gotten myself confused.

Can someone explain to me the difference between ISO 9001 clauses 7.1 and 7.5.1?

Thanks!

 

[John Broomfield]

I read through this thread today...and I have gotten myself confused.

Can someone explain to me the difference between ISO 9001 clauses 7.1 and 7.5.1?

Thanks!

Brunetta,

As I read the standard itself:

7.1 focuses on planning the processes (includes resources and controls) required to fulfill the order or project.

7.5.1 focuses on planning controlled work environment/working conditions for production and service delivery so it is a lot easier for competent employees to meet requirements than it is for them to make mistakes.

John

 

[Deburr]

I am new to this list and have similar question. I am in the business of removing sharp edges from machined parts. My business does what is normally a very small part of the manufacturing process in the realization of aircraft engines, military weapons, and medical devices. We specialize in this service, which adds value to the customer's product, but do not actually produce parts, use raw materials, design parts or product. Generally speaking, a customer has designed a product, had it machined, and presents it to me to clean it or take the burrs off, and then continues the manufacturing process to further condition, assemble or deliver his product. I may be in possession of his product from a few hours to a couple of days. We generally work to the customer's instructions and return those instructions with the product when it is finished. Because what we do is aircraft parts related. we are being required to get AS9100 certified. With that in mind, I can not over complicate the simple task of removing a burr to the point that I can no longer provide efficient service to my customer. It would seem to me that 7.3 has to do with design of the product, and not with designing a process to instruct which end of the file to use in taking off the burr. I guess my question is at what point does 7.3 not apply and become a legitimate exclusion.

Thanks

 

[John Broomfield]

I am new to this list and have similar question. I am in the business of removing sharp edges from machined parts. My business does what is normally a very small part of the manufacturing process in the realization of aircraft engines, military weapons, and medical devices. We specialize in this service, which adds value to the customer's product, but do not actually produce parts, use raw materials, design parts or product. Generally speaking, a customer has designed a product, had it machined, and presents it to me to clean it or take the burrs off, and then continues the manufacturing process to further condition, assemble or deliver his product. I may be in possession of his product from a few hours to a couple of days. We generally work to the customer's instructions and return those instructions with the product when it is finished. Because what we do is aircraft parts related. we are being required to get AS9100 certified. With that in mind, I can not over complicate the simple task of removing a burr to the point that I can no longer provide efficient service to my customer. It would seem to me that 7.3 has to do with design of the product, and not with designing a process to instruct which end of the file to use in taking off the burr. I guess my question is at what point does 7.3 not apply and become a legitimate exclusion.

Thanks

Deburr,

Yes, from a certification point of view you are correct in excluding 7.3 from the system that governs your deburring service.

John

 

[Big Jim]

I agree. I don't see how a deburing company would have any design involvement.