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This guidance has been superseded by ISO 9001:2015 Clause 8.4.1 General. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.
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ISO 9001:2008: Supplier evaluation 7.4.1 (superseded)
Evaluate and select suppliers based on their ability to meet your requirements by deciding what is important, e.g. criteria. Supplier evaluation and approval can be based on previous performance, the results of supplier audits or questionnaires, but these are not are not mandatory. This guidance has been updated for ISO 9001:2015, please click here to review the changes.
Maintain records of suppliers that you approve, using an approved supplier list. The onus is on the organization to prove that they control the quality of any input, service or supply which could impact product quality. You can download a free copy of the ISO 9001:2008 purchasing procedure in .docx format.
Try to limit the use of the term 'supplier' to those suppliers whose product or service has direct a impact or effect on the quality of your own product or service. This does not normally include products and services that the organization uses, e.g. proprietary office materials and equipment that do not directly impact on product or service performance.
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All potential new suppliers should complete a supplier quality questionnaire since the questionnaire will provide an initial overview of the supplier’s organization. After the completed questionnaire has been evaluated, a decision can be made regarding the level of approval to be granted. This should be based on the requirement for further, future action, such as an audit of the supplier's quality system.
Approval is often granted for a three-year period, thereafter, a further review should be conducted either by audit or by questionnaire. Also considered, as part of the three-year review, is previous performance data analysed to assess the applicability for continued business.
You could consider dividing your suppliers into groups based on the product or service they provide and what effect it has on the quality of your products or processes. There is no ‘right way’ for vetting suppliers. To meet the intent of the clause you simply need to establish a process with properly documented criteria which are based upon customer requirements. Such criteria might include:
- Ability to understand product requirements
- Capability to meet specifications, e.g. men, machines, materials, method
- Logistical capacity
- Operates a compliant QMS
- Credit worthy
- Having passed a second party audit of their QMS
- Capacity to work on continuous improvement
- Commitment to cost reduction
Approved suppliers list
You should implement a process to define and control the selection and use of external services and suppliers, and records both of the suppliers used and of their quality level. This means that you should compile a list of approved suppliers with, where appropriate, a list of the goods or services that each is approved to supply.
The quality manager should review the approved suppliers list at least annually and should review any particular supplier immediately if problems become apparent. There must be a general instruction that any staff member who has problems with the quality of materials, goods or services, should report them to the quality manager as this ensures that all of the information comes together at one point.
Supplier audit checklist
On site audits can be conducted as part of the initial introduction and vetting process. The decision to audit a newly identified supplier may depend on many aspects such as criticality of supply, approvals held, location and financial implications. Notification of the audit and a scope must be given to the supplier well in advance of the actual audit.
|Supplier Audit Checklist||21 page audit checklist covering 16 supplier aspects|
Using non-ISO 9001 registered suppliers
There is an urban myth that you can only deal with other ISO 9001 approved companies. This is NOT an ISO 9001 requirement. You may decide the selection criteria that suit your requirements and ensure that non-registered suppliers conform to your QMS requirements. Supplier performance must re-evaluated periodically using data analysis techniques.
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