Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4

[Big Jim]

I wouldn't be completely convinced about that .
When the standard States, " comply with customer and local regulations"
Local laws to have safety in buildings for personnel, anti fire systems, are they local regulations to comply with or no?
Yes it doesn't affect directly the product but, you have to comply with local laws. What is your thinking?

Please read the standard again. 8.4.1a is the most pertinent element.

"The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization's own products and services . . ."

 

[Candi1024]

Please read the standard again. 8.4.1a is the most pertinent element.

"The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization's own products and services . . ."

However the maintenance team is not a product or service of the organization.

 

[Big Jim]

However the maintenance team is not a product or service of the organization.

And your point is?

 

[Candi1024]

And your point is?

"The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization's own products and services ."

Therefore since the external providers (in this case plant maintenance) are not incorporated into the organizations own products and services, then the organization does not need to determine the controls to be applied (for the purpose of ISO certification).

Is that what you were trying to say?

 

[Kronos147]

The Instrument and Electrical (I&E) Manager is a company employee. The electricians that work under him daily are from a maintenance contractor company.

Are they part of your Context (4.1) and\or considered an Interested Party (4.2)? What are their needs and expectations?

Are they part of the effective head count?

Are they required to know the quality policy? Do you expect the vendor to send the electricians over knowing the quality policy or any other QMS information? How is that flowed down? (There would be the 8.4, IMHO.)


There are many clauses to deal with most scenarios. I tend to start at the lowest number (4.1, 4.2 in this example) and see if I can't make it work from there.

 

[Kronos147]

Define it in your supplier evaluation process. Category 1 - High risk....

Oh yeah, 6.1....

 

[Big Jim]

"The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization's own products and services ."

Therefore since the external providers (in this case plant maintenance) are not incorporated into the organizations own products and services, then the organization does not need to determine the controls to be applied (for the purpose of ISO certification).

Is that what you were trying to say?

Yes, but I left the conclusion to the reader.

 

[Big Jim]

Are they part of your Context (4.1) and\or considered an Interested Party (4.2)? What are their needs and expectations?

Are they part of the effective head count?

Are they required to know the quality policy? Do you expect the vendor to send the electricians over knowing the quality policy or any other QMS information? How is that flowed down? (There would be the 8.4, IMHO.)


There are many clauses to deal with most scenarios. I tend to start at the lowest number (4.1, 4.2 in this example) and see if I can't make it work from there.

The original question is only about 8.4. Does a supplier that does not provide something that goes into the product need to be approved? All of the clauses you listed are red herrings to the original question.

 

[Kronos147]

The original question is only about 8.4. Does a supplier that does not provide something that goes into the product need to be approved? All of the clauses you listed are red herrings to the original question.

Ok, good point.

But, if the other clauses\questions are not answered how can you really determine that the supplier is providing (or impacting) something that is product or service?

 

[Sidney Vianna]

Are they part of your Context (4.1) and\or considered an Interested Party (4.2)? What are their needs and expectations?

Are they part of the effective head count?

Are they required to know the quality policy? Do you expect the vendor to send the electricians over knowing the quality policy or any other QMS information? How is that flowed down? (There would be the 8.4, IMHO.)


There are many clauses to deal with most scenarios. I tend to start at the lowest number (4.1, 4.2 in this example) and see if I can't make it work from there.

That's the kind of convoluted thinking that creates so much resentment on the implementation of the standard by so many people. In my assessment, these concerns are totally irrelevant to the question and doubt of the OP.

The litmus test to answer his question is, as already expressed, do their maintenance services DIRECTLY impacts product conformity and customer satisfaction? Most reasonable people would answer that as a resounding NO. Therefore, they are not REQUIRED to be managed as per 8.4.

Creating an unnecessary complex, artificially cumbersome mental checklist to answer that simple question detracts from down-to-earth ISO 9001 implementation efforts. We always have to remember one thing about The Cove. This is meant to be a place where people help people; not people confuse people.