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ISO 13485 / MDR document template:

Procedure for Control of Nonconforming Products

The purpose of this procedure is to describe all activities related to the identification of nonconformities, initiation, implementation, and keeping of records of nonconformities.

The document is optimized for small and medium-sized organizations - we believe that overly complex and lengthy documents are just overkill for you.

There are 3 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Nonconforming Product RecordRegistry of Nonconformities and Registry of Recalled / Withdrawn Products.

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 79.90
  • Compliant with
    ISO 13485 clause 8.3; 8.3.4
  • Format
    MS Word 2013, MS Word 2016, MS Word 2019
  • Number of pages
    7
  • Document language
    English

USABILITY

  • Can I edit the document?
    Yes. The document is fully editable – just enter information specific to your company.
  • Can I use this to become certified?
    Yes. The documentation template may be used for ISO 13485 certification audit purposes.
  • Well-defined instructions
    Document templates contain an average of twenty comments each, and offer clear guidance for filling them out.
  • Designed with your company in mind
    The template was created for small and medium-sized businesses.
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Preview Procedure for Control of Nonconforming Products template

  • The document is fully editable so that you can adapt it to your company design.
  • Documents include placeholder marks for all information you need to complete.
  • Each document includes comments and information, which guides you through completion.

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