There are various regulations formulated by different agencies highlight as a whole or part the supplier qualification guidelines. few are below.
ISO 13485
Clause 4.6.2: Assessment of Sub-contractors–ISO 13485:2003
– Clause 7.4.1 mimics previous clause; standard adds explicit reference to “outsourced process” (4.1)
– Clause 7.4.1 – The type and extent of control applied to the supplier… shall be dependent upon the effect of the purchased product on… product realization or the final product.”
- The organization shall evaluate and select suppliers based on their ability to supply product in accordance with…requirements.
- Criteria for selection, evaluation, and re-evaluation shall be established.
- Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
FDA–GMPs :
No requirement, but sometimes “unofficially” reviewed during inspection
- 21 CFR 820.50 – Purchasing Controls: “all …product and services…”
- 21 CFR 820.50(a) – Evaluation of suppliers, contractors, and consultants
Requirements
- “…establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.” “including quality requirements” that must be met by the suppliers/contractors/consultants – indicates that there are requirements OTHER than those that deal solely with component acceptance
- Each manufacturer shall:
- Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
- Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
- Establish and maintain records of acceptable suppliers, contractors, and consultants.
Canada Device Regulations states that
For Application for a Medical Device License under Section 32 for Class II, III and IV License a copy of a quality system certificate certifying that QMS under which the device is manufactured satisfies the requirements of CAN/CSA-ISO 13485
ISO 9001
Clause 7.4.1 – Purchasing
- The type and extent of methods to control these [purchasing] processes shall be dependent on the effect of the purchased product and/or service upon the final product and/or service.
- The organization shall evaluate and select suppliers based on their ability to supply product in accordance with…requirements.
- Criteria for selection, evaluation, and re-evaluation shall be established.
- The organization shall evaluate and select suppliers based on their ability to supply product and/or service in accordance with…requirements.
- Evaluation and selection criteria for suppliers shall be established.
- Supplier evaluations, supplier audit records, and evidence of previously demonstrated ability shall be considered when selecting suppliers and when determining the type and extent of supervision applicable to the purchased product and/or service.