ISO 13485 COMPETENCE, TRAINING AND AWARENESS PROCESS & DOCUMENTS PACKAGE

Complete strategy and process for establishing training and competence requirements, and maintaining records of training and ‘deeming competence’.  This ISO 13485-compliant boilerplate procedure and these recordkeeping templates in Microsoft Word meet all ISO 13485 requirements for this ISO section.  To complete these boilerplates, you the customer will simply need to insert the information specific to your organization, such as your logo, the specific quality system training requirements of your organization, the competence requirements for jobs affecting product quality, and your document number.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the document and implementation of the process.
 

ISO 13485 section 6.2.2 + all Notes

1. DIY Do It Yourself Boilerplate documented procedure for competence, training, and awareness, 
2. DIY Do It Yourself Boilerplate (ISO required record) template for recording training,
3. DIY Do It Yourself Boilerplate (ISO required record) template for recording competence,
4. Completed Competence Record Template for an Internal Auditor (Can be used as example for all competence templates.
5. DIY Do It Yourself Boilerplate Index of Controlled QMS Documents.