Is this only for quality related docs or for all docs in the company (ex: HR forms)?
@QualitySystemsExplained
2 жыл бұрын
Hi Jackie, The document control requirements cover all documents that are required by the Quality Management System (QMS). Some HR documents are required to show that you meet the requirements of ISO 13485 6.2 Human Resources. Any documents needed to show employees have the necessary background, training, education, skills, and experience are quality records. Those quality records would need a procedure outlining how they are managed and maintained. Check out executive video #8 Personnel and Training (kzitem.info/news/bejne/k21ny4KIh5qAd3o). There are also HR documents that would not be part of the QMS. Pay payroll, benefits, disciplinary, employee awards, etc. The other non-QMS documents may still be controlled within the QMS. It is up to the company to decide. I hope that helps. Send more questions. 😊 Sincerely, Aaron
@jackieokeefe1898
2 жыл бұрын
@@QualitySystemsExplained great information, thanks
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