Permissible ISO 9001 Exclusions/Omissions for the Service Industry

[ChrissieO]

I am currently conducting a 2nd Party audit on one of our key suppliers and they have stated 3 Exclusions/Omissions from 9001. Over the last 13 years I have been auditing 9001 I was always under the impression that the only clause that can be exlcuded is 7.3 Design and Development and even this is now questionable even within service industries i.e. the Design and Development of Processes and Services.

This supplier has stated:-

7.3 Design and Development - Comment as above

7.5.2 Validation of Processes for Production and Service Provision -

Now this I really can't get to grips with how their CB auditor can allow exclusion as they are a key service provider, providing a large number of temporary asscociates for our manufacturing plants within the UK and here at the distribution centre and also with in operational support.

I am also almost certain that a company cannot be exempt from part of a clause.

7.6 Control of Monitoring and Measuring Devices - I can sort of see why on this one but am sure exemption from this is not permitable.
Welcome your comments

Chrissie

 

[kedarg6500]

The whole clause 7 can be exlcuded according to standard

Clause 1.2 of ISO 9001:2008 calls for "Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Can you catch them up in red highlighted point?

 

[ChrissieO]

Thanks for that. I stand corrected.

However I think there exclusion to 7.5.2 is a little lame.

7.5.2
The organisation shall validate any processes for production or service provision where the resulting output cannot be verified by subsequent monitoring or measurement, (why do they put a comma after measurement there is no need and it is not gramitacally corect lol ) and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Surely this is very poignant to recruitment of employees. You cannot verify totally someone's true ability and suitability to a job or work situation until they are in that role.

We have had situations where temporary associates have been taken on who do not have sufficient ability to read and write english to a given standard. This not only hampers their ability to do their job but can also have health and safety implications i.e. signage, employee communications etc. We have a large number of different nationalities here and it would not be practical to have everything translated into all languages.

Chrissie

 

[somashekar]

Chrissie ...
Can you state the scope of the certified QMS of your key supplier for our better understanding please...

 

[ChrissieO]

SCOPE:-

This Quality Management System (‘QMS’) has been based on the requirements of BS EN ISO 9001: 2008 for implementation in all branch offices and the Head Office departments which are within scope.

****** ****** Staffing offers a wide range of services to our clients across 4 key industry sectors and caters for all role levels within those sectors.

The 4 key sectors are IT & Telecoms, Sales & Retail, Finance & Insurance. Office Admin Support and Secretarial.

*********** offers a bespoke outsourced recruitment solution to our clients.

The requirements of the QMS Manual extend to all personnel within ****** UK & Ireland. It establishes a quality standard for providing recruitment services for both associates and permanent candidates to clients.

The scope does not extend to Finance, Information Technology or Human Resource departments within ********.


Chrissie

 

[ChrissieO]

With reference to 7.3 surely a service that a company provides is it's "Product" ?

Chrissie

 

[ChrissieO]

I am currently conducting a 2nd Party audit on one of our key suppliers and they have stated 3 Exclusions/Omissions from 9001. Over the last 13 years I have been auditing 9001 I was always under the impression that the only clause that can be exlcuded is 7.3 Design and Development and even this is now questionable even within service industries i.e. the Design and Development of Processes and Services.

This supplier has stated:-

7.3 Design and Development - Comment as above

7.5.2 Validation of Processes for Production and Service Provision -

Now this I really can't get to grips with how their CB auditor can allow exclusion as they are a key service provider, providing a large number of temporary asscociates for our manufacturing plants within the UK and here at the distribution centre and also with in operational support.

I am also almost certain that a company cannot be exempt from part of a clause.

7.6 Control of Monitoring and Measuring Devices - I can sort of see why on this one but am sure exemption from this is not permitable.
Welcome your comments

Chrissie

Just realised where I got the idea that 7.3 is the only permitable exclusion. It's TS that only allows exclusion from 7.3 not 9001. As I audit to both I was confusing them.

Chrissie

 

[supermac]

Chrissie,
of course it is.
See 3 Terms and definitions
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

See also ISO 9000:2005
3.4.2
product
result of a process (3.4.1)
NOTE 1 There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).

There was a lobby in 2000 that wherever the term 'product' appeared in the standard it should be 'product and/or service'; this was vetoed in 2000 and 2008. It MAY change in 2015.

I have long argued that the standard is not very user friendly for software (for example design is a sub-process of development) and services (examples abound). Sadly the majority of the experts (and national standards bodies) have hardware backgrounds. Until there are more folks from the service sectors I don't see it changing.

 

[somashekar]

SCOPE:-

This Quality Management System (‘QMS’) has been based on the requirements of BS EN ISO 9001: 2008 for implementation in all branch offices and the Head Office departments which are within scope.

****** ****** Staffing offers a wide range of services to our clients across 4 key industry sectors and caters for all role levels within those sectors.

The 4 key sectors are IT & Telecoms, Sales & Retail, Finance & Insurance. Office Admin Support and Secretarial.

*********** offers a bespoke outsourced recruitment solution to our clients.

The requirements of the QMS Manual extend to all personnel within ****** UK & Ireland. It establishes a quality standard for providing recruitment services for both associates and permanent candidates to clients.

The scope does not extend to Finance, Information Technology or Human Resource departments within ********.


Chrissie

Hi Chrissie.
I feel that they must be validating the service providing continually as they are providing it.
They perhaps have not understood what validation means for their sector of service provision and claimed exclusion and likewise the CB have accepted.
On the monitoring and measuring devices, when no any devices, exclusion justified.

 

[dorisanddoug1]

I'm trying to figure out if there are things in clause 7 we can exclude.


I was thinking that we could exclude purchasing because in my mind purchasing doesn't really have anything to do with our delivered product - which is emailed electronic files.


The purchase of building, software, computers and network servcie to do our job is covered in Clause 6 Resource Requirements. Or is because purchasing has to pay for the infrastructure - does it have to be included in the Quality Manual?


I wish I had a sample Quality Manual of a company that does similar work as us.