ISO 13485:2016 Medical Device -QMS|Clause 7.4 Purchasing |L-10|Purchase or Procurement Department

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ISO 13485:2016 Medical Device -QMS|Clause 7.4 Purchasing |L-10|Purchase or Procurement Department@ivdmanufacturing7208

Purchasing process needs to be controlled and meet the needs of ISO 13485. When purchasing products, organizations need to verify that the supplier are able to provide products to meet the needs of the organization and comply with all ISO regulations, along with any other requirements.

Organizations need to keep detailed information on the products they purchase, and verification of anything they purchased, and when they received the material

According to ISO 13485, your company should establish purchasing processes to make sure that the materials, components, and other products and services that you purchase meet defined specifications. This includes defining criteria for supplier evaluation, selection, and monitoring.

Supplier criteria should be risk-based and include:

Supplier’s ability to meet requirements.
Ongoing supplier performance.
Impact the purchased goods have on your overall product quality.
Risk purchased goods have on product risks.
Criticality purchased goods are to the overall medical device.

or items being purchased, you should define specifications and requirements for acceptance. You should have documented agreements in place with your suppliers. The supplier agreement should address roles and responsibilities, identify supplier’s need to notify you of any changes to purchased goods, and applicable responsibilities

Your supplier evaluation, selection, and monitoring activities should be commensurate with the risk a supplier poses to your products and business. The more critical the supplier to your overall product quality, the more importance should be placed on monitoring.
Planning of Product Realization
Customer-Related Processes
Design and Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring Equipment
Design and development processes include:
Design and Development Planning
Design and Development Inputs
Design and Development Outputs
Design and Development Reviews
Design and Development Verification
Design and Development Validation
Design and Development Transfer
Control of Design and Development Changes
Design and Development Files

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