ISO 13485 FAQ's

The below mentioned are the major reasons:

  • European Union Regulatory requirement
  • Global markets recognized ISO 13485 and CE Mark
  • ISO 13485 ensures consistent quality
  • ISO 13485 to ensure patient safety and timely access to medical device technologies across globe.
  • ISO 13485 conformity assessment and Certification are recognized and accepted worldwide.
  • Harmonized Quality Management Systems (ISO 13485:2003) is critical to global medical trade.
  • Most country specific Medical Device Regulations are harmonized with ISO 13485
  • The QMS of choice is ISO 13485:2003 and most Medical Device Regulations need it.
  • European Council accepts ISO 13485 for Annex II CE marking as per  93/42/EEC +2007/47/EC
  • US FDA 21 CFR Part 820 is in line with ISO 13485
  • ISO 13485 is a powerful Quality Management System standard
  • Finally, Regulatory authorities in more countries insist ISO 13485 based QMS for regulatory purposes.

Read More about ISO 13485

ISO 13485:2016 - Medical Devices - QMS Requirements for Regulatory Purposes
ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
ISO/TR 14969:2004 - Medical Devices - Guidance on the Application of ISO 13485:2003
ISO 9000:2005 - QMS - Fundamentals and Vocabulary
ISO 62304:2009 - Medical Device software life cycle requirements

The standards are aligned clause-for-clause for the convenience of building on the knowledge of ISO 9001 and to build on the process-based model

  • It is a standalone standard and no certification needed
  • ISO 13485:2003 is exclusive for Medical Device
  • ISO 13485:2003 has additional requirements in particular for medical devices, depending on class of Medical Device
  • Requirements related to continuous improvement and customer satisfaction have been removed from ISO 13485:2016
  • There is a distinction between exclusions and ‘areas of non application’ relevant to the medical device business
  • Infection and contamination control are addressed in ISO 13485:2016
  • Identification and traceability more extensive in ISO 13485:2016

Upon first sight review, the major differences between ISO 9001 and ISO 13485:2016 seems small, but in other ways, they are very large and distinct. In particular the following

  • Good manufacturing practices (GMP)
  • Terms and Definitions of ISO 13485:2016
  • Documentation Requirements of ISO 13485:2016
  • Traceability Documentation
  • Risk Analysis
  • Manufacturing Facility
  • Quality Assurance
  • Quality Control

More about ISO 13485:2003


(EN) ISO 13485:2016 Clause 4.2.1

The organization shall maintain a file containing documents defining the product specifications


(EN)ISO 13485:2016 Clause 4.2.4

Records must be maintained at least equivalent to the lifetime of the medical device, not less than 2 years.


(EN)ISO 13485:2016 Clause 6.4

Would cover all those requirements within you QMS for manufacture of a sterile device. OBL manufactures also need to validate the sterilization process


(EN)ISO 13485:2016 Clauses 7.1 & 7.3

Risk Management and Design Control to be documented


(EN)ISO 13485:2016 Clause 7.4.1

Supplier control, especially if you are outsourcing any critical process


(EN)ISO 13485:2016 Clauses 7.5.1 & 7.6

Sterile devices requirements related to sterilization need to be added into QMS, also installation, service, validation of processes, label and traceability requirements, etc.


(EN)ISO 13485:2016 Clause 8.2.1

Feedback /complaint handling analyzed with Post Market Surveillance


(EN)ISO 13485:2016 Clause 8.2.2

Internal Audits should have of auditing the MDD requirements


(EN)ISO 13485:2016 Clause 8.5.1

National or regional requirements for adverse events, documented procedures must be written

More about ISO 13485:2003