Quality - SOP - Supplier Qualification

Quality - SOP - Supplier Qualification

$350.00 AUD

The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (7.4.1), 21 CFR (820.50), and EU MDR/IVDR.

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Purpose of Document

  • To define the criteria and methods for selecting, evaluating, and ongoing qualification of critical suppliers.
  • Potential suppliers are evaluated and their ability to supply requested products to the required specifications have been assessed before being added to the Approved Supplier Register
  • Purchased orders for products and other services affecting services impacting product quality, and conformity to product and service requirements are placed with approved suppliers.
  • Supplier performance is monitored.
    These processes will ensure that your company maintains control over its critical suppliers and only purchases product or services from approved suppliers.

Therefore, your company will ensure that it consistently delivers high quality products/services and complies with the requirements of 21 CFR 820.50, ISO 13485 (7.4.1) and EU MDR/IVDR.

Scope of Document/s

This procedure applies to the:

  • Selection, evaluation and ongoing qualification of both critical product and critical service suppliers to your company.
  • All suppliers of products, materials, goods, and services impacting product quality, and conformity to product and service requirements.
  • Contract manufacturers and test vendors who are going to be used in the Verification and Validation and Design Transfer phase.
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