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Module 3 of 5 · ISO 13485 · Clause 6

Resource management

The resources clause covers staff competence and the infrastructure and environment conditions needed to avoid contaminating the product.

Content reviewed on

Human resources

Staff whose work affects product quality must be competent through education, training, skills and experience, with documented evidence.

Infrastructure

Buildings, workspace, process equipment and supporting services maintained according to documented procedures.

Work environment and contamination control

Specific work environment requirements, including contamination control when the product or its manufacture requires it.

What an auditor usually asks for

  • Staff training and competence records
  • A maintenance plan for infrastructure and process equipment
  • Documented work environment requirements per product
  • Contamination control records where applicable

How to cover resource management in Kimobox

  1. 1Log each employee's training and competence on their record in the employee portal.
  2. 2Manage equipment and infrastructure maintenance with alerts before each review.
  3. 3Document work environment requirements per product on its own record.

Staff competence stays linked to every product they manufacture or inspect, not in a separate file.

See Kimobox's employee portal

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
  2. Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
  3. ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.
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