Training Procedure (SYS-004)

This digital product includes three documents: SYS-004, the Training Procedure; FRM-002, the Training Record; and FRM-026, the Training Matrix.

The video below shows you exactly what you will receive when you purchase Medical Device Academy’s Training Procedure (SYS-004). The purpose of this procedure is to ensure that you understand what is included in the purchase of the procedure, how to complete the training matrix, and how to complete the training record. We also suggest how you might customize the various documents included in the package. The procedure is written for compliance with ISO 13485:2016.

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What is the purpose of the Training Procedure?

The purpose of this 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. 

This procedure covers staff who undertake activities that 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. 

Training Procedure (SYS-004) Contents

The following documents are included with this purchase. These documents are updated for ISO 13485:2016 and the new European Regulations Reg. (EU) 2017/745. The following is a list of documents included:

  • SYS-004 A, Training and Competence Procedure
  • FRM-002 A, Training Record
  • FRM-026 A, Training Matrix

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.

Training and Competency Training Procedure (SYS 004)
SYS-004, Training and Competency Procedure/Form
Price: $299.00

Training and Competency Training Procedure (SYS 004)

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