8.0 Operation

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8.4 Control of externally provided products and services

8.4.2 Type and extent of control

This requirement is comparable to the requirements from ISO 9001:2008 Clauses 7.4.1 – Purchasing Process and Clause 7.4.3 - Verification of Purchased Product. You should seek and record evidence you’re your organization has ensured that the supplied product or service meets the specified requirements. Confirm that your organization has established and implement a process of inspection to ensure that purchased products conform to:

  1. Purchase orders;
  2. Delivery notes;
  3. Product specifications;
  4. National or international standards.

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, e.g. level I/II/III/etc. Based on those categories, you can define the criteria for supplier evaluation and approval. You are free to define your supplier levels and approval parameters accordingly, but, whatever rationale is opted for, it should be properly documented.

Externally provided processes remain within the organizations QMS control e.g. documented information is aligned to ensure common inputs, outputs, controls, ownership, governance etc., between the organization requirements and those that are used to interface with the external provider.

Control mechanisms may include a check of products at delivery, site acceptance tests, supplier audits, etc. If supplier audits are required, this should be in the contracts with the suppliers. There is a section within the external providers register that focuses on controls.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:


  1. Ability to understand product requirements;
  2. Capability to meet product specifications, e.g. men, machines, materials, method;
  3. Logistical capacity;
  4. Operates a compliant QMS or other management system.


  1. Credit worthy;
  2. Legally registered;

Your specific requirements:

  1. Having passed a second party audit of their QMS;
  2. Capacity to work on continuous improvement;
  3. Commitment to cost reduction.

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