PD ISO/TR 14969:2004

Courtesy: PD ISO/TR 14969:2004

The guidance given in this Technical Report is applicable to the design, development, production,
installation and servicing of medical devices of all kinds. It describes concepts and methods that can be
considered by organizations which are establishing and maintaining quality management systems.

Guidance contained in this Technical Report can be useful as background information for those
representing quality management system assessors, Conformity Assessment Bodies and regulatory
enforcement bodies.
The guidance contained in this Technical Report is not to be used for identifying specific deficiencies of quality
management systems, unless such guidance is voluntarily incorporated by the organization into the
documentation describing and supporting the organization’s quality management system, or unless such
guidance is specifically made part of the regulatory requirements relevant to the organization’s operation.

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

ISO 13485 provides for the organization to omit from its quality management system those product realization
requirements that are not applicable due to the nature of the medical device.
For example, an organization providing single-use, sterile medical devices does not need to include within its
quality management system elements related to installation and servicing. Similarly, an organization providing
non-sterile medical devices does not need to include the elements related to sterilization.
It is important for the organization to review carefully all the requirements of ISO 13485:2003, Clause 7, in
order to identify those requirements that do apply to functions performed by the organization. Once those
requirements are identified, the organization is obliged to comply with ISO 13485:2003, 7.1, and to perform
the planning associated with identified product realization requirements.
EXAMPLE An organization intends
 to place its own label on a medical device designed and developed, produced, and serviced by suppliers outside its
quality management system, and to market this medical device,
 to communicate with customers who have purchased the medical device, and
 to have systems in place for receiving customer complaints.
Even though the organization does not perform design and development activities itself, it cannot consider 7.3 to be
non-applicable. It still has obligations to meet the requirements of 7.3, unless relevant regulations permit an exclusion.
Once the organization identifies those requirements, it is obliged under 7.1 to plan for the quality management system
processes needed to meet those requirements.