ISO 13485 – QMS for Medical Devices


ISO 13485 Medical devices — Quality management systems. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

ISO 13485 requirements include compliance to ISO 9001 and Other sector specific requirements. These include :

  • The promotion and awareness of regulatory requirements as a management responsibility.
  • Controls in the work environment to ensure product safety
  • Focus on risk management activities and design control activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Evolution of ISO 13485 and Revision History

  • Year 1996 – ISO 13485 standard was published
  • Year 2000 – EN ISO 13485 the European Committee for Standardization (CEN) unifies the European version with the International standard and withdrawing the previous EN 46001
  • Year 2003 – 2nd Revision of the standard (2nd Edition)
  • Year 2012 – EN ISO 13485 harmonized European version with three European directives associated with the medical sector 93/42/EEC, 98/79/EC, 90/385/EFC
  • Year 2016 – 3rd Revision of the standard (3rd Edition)

Eligibility / Applicability (Which organizations can avail ISO 13485 certification??)

The certification is availed primarily by the companies which are into design and manufacture of medical devices. This standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001:2015 system is needed.

NOTE : The eligible organizations shall be able to furnish data related to design and manufacture of the medical devices while certification audit.

Focus Points – ISO 13485:2016 Implementation

  • Integration of customer requirements specific to design and manufacture of medical devices
  • Standardization of the manufacturing processes and other business processes
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up system for documentation and records.
  • Management information system
  • Business performance and sustainability

Benefits of ISO 13485:2016 Implementation

  • Opportunity to supply medical devices and/or supply to medical devices OEM.
  • Recognition and opportunity to cater to the export market
  • Recognition of the certificate and the system by other industry sectors
  • Improved product safety and tracebility management
  • Manufacturing process controls enhancing Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Better business performance and Enhanced sustainability

ISO 13485:2016 Implementation Process by PQSmitra

ISO 13485 being a specific standard for design and manufacture of medical devices, the requirements are very stringent as it directly associated with the human health and safety. The manufacturing and administrative controls expected to be implemented are at shop floor and office processes as well. In such scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra team with an expertise more than 20 years has supported many clients implement ISO 13485 and get the successful certification.

The ISO 13485:2016 implementation process is described below:

  • Review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization.Product safety related requirements are assessed right from the designing and manufacturing operations.
  • 100% documentation support is offered by PQSmitra. This includes shop floor controls as well as control on documentation and records.
  • Training and hand holding for better understanding of the requirements and effective implementation.
  • Routine assistance and system verification to ensure compliance to the requirements.
  • Internal audit and Management review
  • Certification audit – Stage 1 and Stage 2
  • Submission of action plan on audit observations
  • Review of report by the certification authority and awarding the certificate to the organization

ISO 13485:2016 Reference Standards

  • ISO 9000:2015 – Quality management system
  • ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment