About ISO9001 Scope and Applicable Statutory and Regulatory Requirements

[somashekar]

The scope in ISO9001 at clause 1.1 addresses two things in 1.1 a) and b) ... viz
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The statutory and regulatory requirements is also mentioned in clause 1.2 Application.
This applicable statutory and regulatory requirements is seldom mapped as I have noticed in various QMS applications, which I guess is a very important requirement when we see the clause 4.1 also in line with the scope and application that is ...
The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization

Does this mean that the legal requirements mapping as stated and required in ISO14001 and OHSAS18001 is to be considered (planned, implemented, maintained) within the QMS operations in line with the ISO9001:2008 ?
How seriously is this viewed by the CB and how many organizations view it in this way ?
If an organization is ordered to be shut down due to non compliance of any of such requirements then how can that organization meet the scope as in 1.1 a) and b) even with a good QMS in place minus the legal stuff mapping ~~~

 

[harry]

You've to realize that the Applicable Statutory and Regulatory Requirements here refers to the product.

With regards to statutory and regulatory requirements not related to the product, a section to take note of is: 0.4 Compatibility with other management systems

 

[samsung]

The scope in ISO9001 at clause 1.1 addresses two things in 1.1 a) and b) ... viz
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The statutory and regulatory requirements is also mentioned in clause 1.2 Application.
This applicable statutory and regulatory requirements is seldom mapped as I have noticed in various QMS applications, which I guess is a very important requirement when we see the clause 4.1 also in line with the scope and application that is ...
The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization

Does this mean that the legal requirements mapping as stated and required in ISO14001 and OHSAS18001 is to be considered (planned, implemented, maintained) within the QMS operations in line with the ISO9001:2008 ?
How seriously is this viewed by the CB and how many organizations view it in this way ?
If an organization is ordered to be shut down due to non compliance of any of such requirements then how can that organization meet the scope as in 1.1 a) and b) even with a good QMS in place minus the legal stuff mapping ~~~

The requirement with respect to legal compliance in all the standards is that the legal obligations be determined and complied with. However, there's a slight difference when it comes to 14001 which states that the organization should also determine how it's legal obligations relate to it's significant aspects. Although ISO 9001 talks of those requirements pertaining to product or services only but the customers do desire a sustaining relationship with the organization so that they can rely on consistent quality, supplies and cost; therefore it is not only the product-related regulations that can affect customer satisfaction.

If the operations are suspended/ stopped due to noncompliance with other legislation (EHS or finance), this will affect both the existing as well as potential customers.

 

[harry]

.................................... How seriously is this viewed by the CB and how many organizations view it in this way ? ......... ............

Another place to get a good 'handle' is this: Auditing Statutory and Regulatory requirements

 

[somashekar]

Agree with harry when we see 1.1 a)
Agree with samsung when we see 1.1 b)
Thanks to harry for the attachment which is very useful.
A good work done as in clause 7.2.1 and 7.2.2 will perhaps meet most of the statutory and regulatory requirements.

 

[John Broomfield]

The scope in ISO9001 at clause 1.1 addresses two things in 1.1 a) and b) ... viz
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The statutory and regulatory requirements is also mentioned in clause 1.2 Application.
This applicable statutory and regulatory requirements is seldom mapped as I have noticed in various QMS applications, which I guess is a very important requirement when we see the clause 4.1 also in line with the scope and application that is ...
The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization

Does this mean that the legal requirements mapping as stated and required in ISO14001 and OHSAS18001 is to be considered (planned, implemented, maintained) within the QMS operations in line with the ISO9001:2008 ?
How seriously is this viewed by the CB and how many organizations view it in this way ?
If an organization is ordered to be shut down due to non compliance of any of such requirements then how can that organization meet the scope as in 1.1 a) and b) even with a good QMS in place minus the legal stuff mapping ~~~

somashekar,

I look for a process that deploys the legal requirements to the relevant processes in the management system.

I expect to see subject matter experts (from within the organization or from a competent service) alerting process owners of upcoming changes to legal requirements so they can update the relevant parts of the management system and provide any necessary training.

I expect to see evidence of compliance audits to verify effective deployment of legal requirements to the management system and corrective action when this is less than fully effective.

By using and improving the management system in this way compliance with applicable statutes and regulations is reasonably assured.

John

 

[Paul Simpson]

Here, here and here are a couple of threads related to health and safety in an ISO 9001 system.

So, just to be clear, there is no requirement to have any process related to occupational health and safety in your QMS and typically a CB will be looking for this in the areas of product design (7.3) and customer requirements (7.2) in order to assess that the organization understands the regulatory requirements in connection with the product.