spiffy rave: ISO9001 Implementation for Business Process Outsourcing

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Let say, a company is just a regional office in a country, with staff size of less than 20. All manufacturing processes are outsourced to subcontractors around the country.

In term of ISO9001 implementation for this regional office, can they exclude the product realization part, as they do not produce (their subcontractors produce for them) ?

Quote:

Let say, a company is just a regional office in a country, with staff size of less than 20. All manufacturing processes are outsourced to subcontractors around the country.

In term of ISO9001 implementation for this regional office, can they exclude the product realization part, as they do not produce (their subcontractors produce for them) ?

Can you be more specific about which clause/s you want to exclude?

When you talk about excluding the 'product realization part' are you saying you want to exclude ALL of section 7? Because you absolutely cannot. It matters not whether you yourself produce the stuff, or have others do it for you, you still have to make sure that requirements are met for your customer. Read Notes 2 and 3 under section 4.1 again. You are choosing to outsource manufacturing - fine. But it doesn't release you from responsibility.

You have to do planning (7.1).
You need processes relating to customers (7.2) etc etc

Yes, you may be able to exclude a clause or two in there (eg, 7.6 perhaps) but not the whole section.

And you had better pay very serious attention to clause 7.4!

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Quote:

Let say, a company is just a regional office in a country, with staff size of less than 20. All manufacturing processes are outsourced to subcontractors around the country.

In term of ISO9001 implementation for this regional office, can they exclude the product realization part, as they do not produce (their subcontractors produce for them) ?

One very basic tenet that you must pay attention to is that you cannot exclude something that you outsource.

Thanks to Big Jim for your informative Post and/or Attachment!

Section 7 encompasses such a wide variety of activities that by default, could not possibly be excluded in its entirety, mainly due to the outsourcing requirement in paragraph 4.1. I have never heard of a organization claiming exemption from "section 7" as a singular premise, because even if you don't perform any manufacturing, the fact that you "outsource" automatically invokes some part of product realization by virtue of your involvement and responsibility in ensuring that product is produced according to your stakeholders' best interests.

The extent as to which parts of section 7 are summoned are due to your specific situation. What JaneB posted sounds about right, plus I would consider what Big Jim said about the futility of excluding any activities that are outsourced. Fundamentally, anywhere in the standard where the words "establish", implement" and "ensure" exist can be tied to the outsourcing requirement in 4.1. Pay close attention to the first sentence in note 3 - I have always thought that this should have been placed in the requirements section, on account of the way it is worded, because it can be easily construed as a declarative statement.

Brian

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Quote:

Let say, a company is just a regional office in a country, with staff size of less than 20. All manufacturing processes are outsourced to subcontractors around the country.

In term of ISO9001 implementation for this regional office, can they exclude the product realization part, as they do not produce (their subcontractors produce for them) ?

Could you better explain the processes that you have identified or if you have a map to show interactions?

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Quote:

Let say, a company is just a regional office in a country, with staff size of less than 20. All manufacturing processes are outsourced to subcontractors around the country.

In term of ISO9001 implementation for this regional office, can they exclude the product realization part, as they do not produce (their subcontractors produce for them) ?

certification of ISO9001, the standard focus on what have you done about the doucments and process of effectiveness and compliance rather than require how many people you have and what product is produced or the nature of you company,