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Training Regulations & Standards

The following are excerpts taken verbatim from the FDA's Quality System Regulation and ISO 13485:2003 that relate to training requirements.


21 CFR Part 820, Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation

Sec. 820.25 Personnel.

(a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.


ISO 13485 Medical devices — Quality management systems —Requirements for regulatory purposes

See the following section and subsections: (copyright restrictions prevent reproducing the verbiagein its entirety)

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education,
training, skills, and experience.

6.2.2 Competence, awareness, and training

The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute
to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills, and experience (see 4.2.4).
NOTE—National or regional regulations might require the organization to establish documented procedures for identifying training

NOTE: The requirements specified in ISO 13485 are very similar to those identified in FDA 21 CFR Part 820.

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