Scope of Document/s
This procedure relates to the control of non-conforming product (suspected or confirmed) which was "manufactured" under the quality management system of your company. Non-conforming product can be identified by any means, e.g. quality control inspections by your company, review of batch records, the receipt of customer complaints (e.g. non-functioning components, incorrect versions, incorrect risk scores, incorrect IVD kit components), or through internal or external audits or inspections.
This procedure describes how to:
- prevent the use and release of non-conforming product, and
- manage product returned from the market. Where this relates to software, physical return of "product" will not be relevant.
