This digital product includes three documents: 1) SYS-004, Training Competency Procedure; 2) FRM-002, Training Record; and 3) FRM-026, Training Matrix.
1. Training Competency Procedure
Purpose – The purpose of this (4)-page procedure is to ensure that personnel performing work that may affect product quality or other functions essential to the business are competent on the basis of appropriate education, training, skills and experience.
Scope – This procedure covers staff who undertake activities which may have an impact on the quality or safety of products. It covers assessment of competency when staff are recruited, training of staff according to quality management system documentation and the planning and recording of more general training…
7 – Procedure
1 – Recruitment
The recruitment process includes identifying requirements for education, training, skills and experience. These competency requirements shall be documented in a job description. There shall also be a training matrix (FRM-026) created for the position if one does not already exist…
Description of FRM-002 – Training Record
Record of training for a group of people or an individual, often associated with the release of a version of a document or group of related QMS documents but also used for other purposes. Supporting material, e.g. the course outline for external training, may be attached to the form as part of the record, or competency assessment records specific to the training, e.g. quiz results…
This procedure has been updated to the requirements of ISO 13485:2016 and simplified for easier implementation by start-up companies. This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for a subscription confirmation email. If you do not confirm your subscription you will not receive the three documents or any future updates. Future updates to the procedure or forms are at no charge to subscribers.
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