ISO 13485:2016



ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25: 1993 + A1: 1999 safety of Electrocardiograms.

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

Who is ISO 13485 for?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.

Read more about certification to ISO’s management system standards.

Why was ISO 13485 revised?
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.

What are the key improvements?
The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

(SOURCE - https://www.iso.org/iso-13485-medical-devices.html
https://en.wikipedia.org/wiki/ISO_13485)


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Certification Process


The certification process includes following major steps. For further details kindly see procedure for certification system in the download section.


  1. Application/Enquiry
    Client submits the application form to KBS (Application for Certification).
  2. Review of Application by KBS
    KBS reviews the application to check if the requisite services can be provided and accordingly prepares the quotation/ estimate and the contract (Certification audit contract).
  3. Audit planning
    Once the contract is signed, KBS makes the audit programme and inform the client.
  4. Assessment
    Initial certification includes two stages assessment. Recertification includes only one stage. The assessment is carried out by the team at the sites against the applicable criteria. The report is provided to client identifying the compliancelevel includingany nonconformities.
  5. Verification of Non-conformities
    Client submits the implemented or proposed action based on the classification of non-conformity. KBS reviews the actions.
  6. Certification Decision
    KBS takes certification decision based on the report submitted by the audit team. If decision is in favour of grant of certification, a Certificate is Issued to the client.
  7. Surveillance assessment
    Surveillance assessment are held as per the periodicity defined and agreed. First surveillance within 12 months from the date of the stage 2 audit. Certificate is maintained based on the outcome of the surveillance audit and compliance with the requirements. First Surveillance within 12 months from the date of certification decision date.
  8. Recertification
    Before expiry of the certificate, recertification is planned and conducted.