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

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#22
From 9001:2015

"This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on."

Risk based thinking and adequately resourced and managed. If you apply the same scrutiny to ALL OF YOUR SUPPLIERS you are not using Risk based thinking and you are not not managing them. Management is making decisions understanding that not all suppliers are created equally.
 

tony s

Information Seeker
Trusted
#23
I totally agree that maintenance of lawn is not something that we need to control as per 8.4 for a manufacturing company. But should be in the case of a golf course organization. However, maintenance services provider of production machines and equipment, I believe, fall in the statements under 8.4.1c where it specifies "The organization shall determine the controls to be applied to externally provided processes, products and services when: c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization".

ISO/TS 9002:2016 in its 8.4.1 guidelines has the statement below:

1566184549062.png
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#25
I totally agree that maintenance of lawn is not something that we need to control as per 8.4 for a manufacturing company. But should be in the case of a golf course organization. However, maintenance services provider of production machines and equipment, I believe, fall in the statements under 8.4.1c where it specifies "The organization shall determine the controls to be applied to externally provided processes, products and services when: c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization".

ISO/TS 9002:2016 in its 8.4.1 guidelines has the statement below:

View attachment 25964
Now Tony, you are assuming that the maintenance services you quoted above refer to production equipment used by an organization. My reading of that is that the maintenance services referred to relate to the maintenance services of the product delivered by the organization. For example, Caterpillar can outsource the maintenance of some mining equipment to an organization in The Phillipines.

If one thinks that the outside maintenance providers need to be controlled as per 8.4 (for a typical manufacturing organization), then, they should also control the utilities, providing them with electricity, water, etc...control the municipality that provides them with roads to deliver products, the Internet Service Provider, etc...As I said, the slippery slope can get ludicrous. FAST.
 
#26
I totally agree that maintenance of lawn is not something that we need to control as per 8.4 for a manufacturing company. But should be in the case of a golf course organization. However, maintenance services provider of production machines and equipment, I believe, fall in the statements under 8.4.1c where it specifies "The organization shall determine the controls to be applied to externally provided processes, products and services when: c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization".

ISO/TS 9002:2016 in its 8.4.1 guidelines has the statement below:

View attachment 25964
Pay attention to the wording of the guidance. "For example, the organization might require . . . "

Not a requirement of the standard, but something the organization may choose to do.

Don't go making requirements that the standard doesn't.
 
#28
Should is not a requirement. Should is a recommendation. In this case, evidently your recommendation.

Don't go making requirements that the standard doesn't.
FWIW, my goal is to have an effective system. Anyone has the right to ignore my 'recommendation'.

"4.1 Understanding the Organization and Its Context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."
 
#29
FWIW, my goal is to have an effective system. Anyone has the right to ignore my 'recommendation'.

"4.1 Understanding the Organization and Its Context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."
That's a worthy goal, but don't state them as requirements. State them as your recommendations or perhaps as a possible best practice. Keep the standard pure.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#30
FWIW, my goal is to have an effective system. Anyone has the right to ignore my 'recommendation'
The question that triggered this thread was very straight forward:
is the maintenance contractor company considered an external provider subject to clause 8.4?
The OP was not asking if it would add value if the maintenance contractors be controlled as per 8.4. He did not ask if it would be a good idea to formally approve them, either.

He was VERY CLEAR in his question. I think it is incumbent on people engaging on the thread to understand the question and provide feedback accordingly. That's how we help people who come here, asking questions.
 
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