ISO 13485:2016 Standard Section 6 – Resource management »
Review of sction 6 Resource management of the ISO 13485:2016 Standard for Quality management systems — Requirements for regulatory purposes
ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
Human resources is considered a resource for the realization of an Medical device product, its components, or related services and has objectives that are derived from the type of the Medical device, the strategy
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ISO 13485:2016 Standard – 6.4.2 Contamination control
Contaminated or potentially contaminated products may risk the work environment and thus may have an adverse effect on product quality, performance, and safety of other products. The ISO 13485 Standard requires establishing, documenting, and
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ISO 13485:2016 Standard – 6.3 Infrastructure
Infrastructures are the stock of the basic facilities and equipment needed for realizing the medical device or providing a related service. Infrastructures should provide the suitable conditions and accessories to perform the appropriate business
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