Changes In the New ISO 13485 Standard (DIS)

Thursday, 18 June 2015
ASR Editor
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The draft standard to ISO 13485 (ISO TC 210 WG1) has added new requirements and clarifications in a number of areas.

This article covers a few areas

  • QMS
  • Management Responsibility
  • Human Resources

Section 4 – Quality Management System

  • The draft standard requires a risk-based approach during process development. Preventative maintenance is not enough - you will need to consider the risks that it will affect quality. Also the controls of any outsource processes must also consider the risk to the quality system.
  • Records must be kept to show compliance with regulator requirements.
  • Any computer software used within the quality system must be validated.  This may require further discussion and clarification during the draft phase of the update.  If you validate the software it must be documented.
  • The revision requires that you keep a technical file about the device being manufactured.  There are over 20 elements to be documented: usage instructions, clinical data, specifications, etc...

Section 5 — Management Responsibility

  • There is a clarification about planning within the revision.  It states that the quality objectives are in alignment with action items, revisions and monitoring.
  • The revision requires the explanation of how those with responsibility and authority of the quality system are selected.  What are their qualifications, skills and what process was used to determine their involvement.
  • After a management review, the new standard will require documented improvements be stated to sustain the the quality management system.

Section 6 — Human Resources

  • Skill acquisition must be shown in terms of personnel evaluation.  The revision also requires a company detail what happens if an employee is not competent; this goes back to the risk based emphasis.  What happens if an employee is incompetent?  What are the risks to quality?
  • The revision draft requires that the type and qualification of personnel involved with processes affecting quality are more fully described.  This includes documenting training required, specific skills needed, and education achieved.
  • The new standard also requires documentation on monitoring the work environment in terms of sterility and cleanliness.  And further requires what risks are associated with specific work environmental aspects.

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