QA Standards for ISO 13485

by itsbusiness AG

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO); it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.


The ISO 13485 standard is organized into the following sections:

Quality Management System (QMS)
Outlines the general and documentation requirements of a medical device manufacturer’s QMS. Makes explicit that a quality manual must be written and adhered to. Specifies the requirements for controlling documents and records.

Management Responsibility
Requires management involvement at the level of the person who makes policy and financial decisions. Establishes that the quality policy and objectives, support, and oversight of the QMS and provision of resources are the direct responsibility of upper management.

Resource Management
Requires management to provide the assurance of adequate facilities such as space, tools and equipment, including computer systems. The QMS must include processes that ensure all required maintenance activities are performed.

Product Realization
Covers everything that is required to realize a product, from planning to creating (designing and manufacturing) to implementing and supporting a medical device. This section of the standard includes information that has the greatest impact on the day-to-day activities of company personnel.

Measurement, Analysis and Improvement
Provides instruction on incorporating feedback and other related information that will enable management to sustain the effectiveness of the QMS, including:

  • Customer complaints and adverse events handling.
  • Internal audits.
  • Monitoring and measurement of processes.
  • Monitoring and measurement of products, including non-conformances
  • Corrective Action / Preventive Action (CAPA).

For more information on QMS and ISO 13485, see the Johner Institute articles at qm-system-iso-13485

With our experienced consultants, including staff who have developed and tested safety critical software, itsbusiness supports you in the development of robust software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.


If you have questions or need more information, please contact:

Andrew Connell
QA Consultant, itsbusiness AG
+41 31 370 32 05​

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