Do we need to treat local law as external origin documents?

[John Broomfield]

Sidney,

Fair point, but it still depends on the stated scope of the quality management system.

Having understood how the organization stays on top of applicable laws and regs may expose a process that can be adopted to deploy the legal requirements specific to its services and products.

Adapting the organization's "natural system" is better than ignoring it.

John

 

[Sidney Vianna]

Fair point, but it still depends on the stated scope of the quality management system.

John, do you know ANY organization that includes regulatory compliance (non-product related) in the scope of the quality management system?

I've never seen it. Most of the typical organizations have a hard time keeping ahead of product regulatory compliance already. To unload responsibility for legal (environmental, labor relations, occupational health and safety, accounting etc...) compliance to the quality function would seem extremely risky, in my opinion. How to make these people competent for such business-critical processes?

 

[John Broomfield]

Sidney,

Yes, I’ve worked with companies who think Big-Q instead of little-q where QC/QA/QM strictly is limited to the product.

As we’ve agreed many times, organizations tended to limit the scope of their thinking wrt quality but I thought Big-Q thinking was continuing to grow in popularity.

Hence my emphasis on scope.

Thanks for bringing out this point.

John

Standard Issues: Big Q vs. Little q

 

[Sidney Vianna]

As you know I am also a proponent of big Q, but legal compliance is clearly outside the scope of the quality system for most typical organizations.

Big Q still has boundaries. At least, the way I see it.

 

[qualprod]

Thanks to all, some doubts still persist, please help
1-Does the standard allow to put such aspects outside of the system (out of the scope), even if such
issues are very important to comply to the customer requirements of products and services?
2-Wouldn´t be something similar when we declare any non-applicability into the system (e.g. 8.3 ) in the sense that
this exclusion has to be fully justified? and what the justification can be?
3-At what extent any auditor can refuse such exclusion?

4-Finally the scope you refer is the one in 4.3?

Final comment:
I have seen some companies to include such controls into an ISO 9001, because
they feel, that issues (local regulations) can have a good control.

Please share your comments


Thanks

 

[John Broomfield]

You may choose to restrict the scope of your certification by omitting processes, services, products and locations.

This scope may then be applied to limit the extent of the development of your organization’s management system.

Organizations may do this to quickly achieve certification on a limited budget/timescale.

But I’d recommend this be done only on a strictly temporary basis for reasons that should be obvious,

After all, the management system conforming to the standard is meant to be a benefit not a burden.