Quality - SOP - Purchasing

$250.00 AUD

The process outlined in this document will ensure that your company complies with the relavant clauses of ISO 13485 (7.4), 21 CFR (820.50), and MDR (2017/745)/IVDR (2017/746).

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Please view more information below. After purchase, you will be sent an email with a link to download the Word, Excel, PDF or Zip file.

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Purpose of Document

The purpose of this procedure is to provide instructions and assign responsibilities for the selection, evaluation, and ongoing qualification of critical suppliers. This process will ensure that your company maintains control over its purchasing procedures, and therefore consistently delivers high quality products and complies with ISO 13485 (7.4), 21 CFR (820.50) and MDR (2017/745) and IVDR (2017/746).

Specifically, it will:

  • manage the purchasing process including the establishment of procurement specifications,
  • apply purchasing controls according to risk,
  • manage spending within budgetary plans.

Scope of Document/s

This procedure applies to the preparation of purchase orders and associated documents for purchases of:

  • materials, components, parts, and sub-assemblies that are incorporated into final devices;
  • capital equipment such as manufacturing equipment that has a direct impact on the safety, performance, or quality of the finished product; and
  • design and printing of all labelling, user manuals or other product information including all advertising and promotional materials;
  • associated services that may affect product quality, such as design, delivery, maintenance of production equipment and environmental controls, calibration of measuring equipment or provision of sub- contract services, such as radiation and filling services; and
  • all other general materials and services used by your company (including contract Clinical Research Organisations), and
  • excludes incidental items which are purchased through the petty cash system.
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