Aligning the requirements of ISO 13485:2003 to ISO 9001:2008 (Part 3 of 5: Resources)

By: Mona Elkhatib

 

The focus of the ISO 13485:2003 in relation to resources is to determine and provide adequate resources to ensure that the effectiveness of the system is maintained, customer and regulatory requirements are met.

 

There are no additional personnel training, awareness and competency requirements (6.2) than those stated in the ISO 9001 standard, with the exception of a note. The note indicates that regulatory bodies, such as FDA, may require a documented procedure to address these requirements.

 

Most of the additional requirements are in the infrastructure (6.3) and work environment (6.4) clauses, as briefly described below:

 

Infrastructure

  • Documented requirements for maintenance activities
  • Maintenance activities records maintained

 

Work Environment

Documented requirements:

  • Health and cleanliness
  • Work environment conditions, monitoring and control
  • Temporary personnel
  • Product contamination


Leave a Reply

Time limit is exhausted. Please reload CAPTCHA.