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EN ISO 9001 - Guidelines for use by the chemical industry - Appendix 3 & 4


EN ISO 9001 - Guidelines for use by

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the chemical industry

Appendix 3
Rules of certification under which certification of a supplier's complete business activity may occur.
1. EN ISO 9001 concerns all functions in the line of progress from raw material purchase by the supplier through to finished
product delivery to a customer. This is considered to be a complete business.
2. In the simplest case, certification of a business to EN ISO 9001 may be applied to a single unit or site producing one or
more related products with the normal support functions (e.g. purchasing, testing, distribution, sales R & D) located at the
same site.
3. The situation becomes more complex if a company has all or part of the support functions at a separate location. These
support functions may serve one or more production units or sites which may or may not have related products.
Certification in this case may be done by:
i. certification of single sites or production units together with the relevant local support functions;
ii. certification of the single separate off-site functions.

It is recommended that certification as in (i) should be done first since this is normally the basic quality system.

4. Where there is a common relationship between production units on several sites and their central support functions, e.g. by
product or group of products, then this may also be regarded as a complete business. Thus, if certification of all these
entities has been achieved, then a certification of the complete business may be considered. In this case, particular attention
should be given to the interfaces between each of the entities to ensure that the new quality system functions at least as well
as its constituent parts.
5. A limiting factor to the size of a complete business is the ability of management to maintain effective control of the quality
6. Certification bodies will normally define the scope covered by a certification. Since organizational changes may take place
in businesses, the scope of such a business should be carefully monitored by the certification body, and reassessments
should take place as appropriate.
7. Special considerations apply where any manufacture occurs outside the direct control of the supplier (e.g. PFR product, or
product supplied under exchange deals).
Where PFR material is manufactured and supplied from a certified EN ISO 9001/2 source, provided the material meets the
customer's specification, the product can be sold within the suppliers scope of certification.
However, it is incumbent upon the supplier in developing the contract with his customer to ensure that all relevant aspects of the
specification are agreed. This may in special cases include the notification of a change of source or manufacturing process. The
supplier should consider whether the source is:

i. 3rd Party Certified to EN ISO 9001/2

In this case, the supply is covered by the supplier's certification scope. However, the use of EN ISO 9001/2 approved
sources does not relieve the supplier of the duty to exercise appropriate control to ensure PFR material continues to meet
customer specifications.
ii. 2nd Party Assessed to EN ISO 9001/2
In this case, the supply could fall within the certification scope of the supplier if an assessment to EN ISO 9001/2 of the
subcontractor's quality System is performed by the supplier. Such assessment must be equivalent to that performed by a
3rd party certification body.
iii. Not Meeting EN ISO 9001/2 Assessment Criteria
In this case, the supplier shall ensure that such products are only supplied under a concession agreed with the customer.
The concession shall make it clear that such a product is being supplied under a quality system relating to a service of
distribution only.
Where distribution is defined as a service of sourcing, procurement, storage and delivery of chemicals, the services of testing,
repacking and similar operations may be included.
For such distributors, all the requirements detailed in appendix 2 are appropriate.

Appendix 4
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EN ISO 9001 - Guidelines for use by the chemical industry - Appendix 3 & 4

Check list for customers against a supplier's claim of certification against EN IS0 9001, 9002 or 9003:
1. Does the scope of the certification cover the products you intend to purchase ?
2. Does the scope of certification relate to the manufacture of the product, or to the provision of a service such as distribution
3. Does the scope of certification provide you with sufficient assurance of the effectiveness of this supplier's quality system
for your purposes?
4. Is the certification still current?
5. Has the certification been made by a certification body meeting the requirements of EN 45012 and having competence in
the chemical industry ?

Answers to questions 1, 2 and 3 should always be sought and may be obtained by requesting a photostat of your supplier's
registration certificate together with any appendices or endorsements forming part of it. Your supplier should always be willing to
co-operate in this, if his claim is genuine.

Answers to questions 4 and 5 need only be sought if suspicions warrant. In the case of question 4 such answers should be
sought from the appropriate certification body and for question 5 the answer from the appropriate accreditation body.

EN ISO 9001 - Guidelines for use by

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the chemical industry

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