International standard organizations set a few standards as a requirement to implement QMS in the organization. There are more than thousands of ISO standards applicable in the medical device industry.
ISO 13485 certification for medical devices is an excellent quality management system required for regulatory functions which is an ISO standard, it represents the necessity for a complete best control machine for the design and production of medical devices. Regulatory necessities are more and more stringent during every step of a product’s lifecycle, along with services and delivery. Increasingly, more agencies within the industry are expected to illustrate their QMS procedures.
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If we specifically speak about ISO 13485, it is implemented by organizations that are involved in the designing, production, installation, and servicing of medical devices. It helps manufacturers in their auditing processes, but there is some ambiguity among the industry and stakeholders about who can certify for ISO 13485 which is a requirement for the registration of the devices under the MDR, 2017 by CDSCO.
MDR, 2017 uses the concept of Notified body (NBs) as practice in the EU for the audits under MDR of class A and Class B medical devices. As an ISO 13485 medical device consultant we know the difference between the NB, CB, and other regulatory bodies, and we assist our clients accordingly.
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ISO 13485 Accreditation:
Medical device manufacturers who wish to sell their devices in the EU market need to have a relationship with the Notified bodies as these are the bodies whose role is to perform conformity assessment of new medical devices. Often these are private firms with experts from the field of risk management & medical device safety and standards. NBs are registered under rule 13 as a body that carries out an audit of manufacturing sites, assessment, and verification of specified categories to establish conformity assessment with standards. It does not mention ISO 13485 or the certification words.
ISO 13485 was introduced as a certificate of compliance accredited by NABCB (National Accreditation Board for Certification Bodies) or IAF in respect of medical devices.
This clearly indicates that ISO 13485 is obtained by a Certified body i.e. CB not from NB (Notified Body).
CB should be accredited by NABCB, the Indian National Accredited Body (AB).
Countries like the US and Japan have multiple Accreditation bodies (AB) whereas some countries have single national AB. ISO 13485 operates under the oversight of IAF through Abs in each country. IAF defines 7 technical areas in a document IAFMD which is free to download from their website. So, the bottom line is industry makes sure that the Certified body (CB) is accredited by an AB. The ISO 13485 should carry the logo of AB which will ensure that it is accredited for the scope under which your industry falls.
The point to remember is that there are a number of non-IAF CBs in the market that offer ISO 13485 certificates-beware of them. To get this certificate from the correct CB you should hire the right consultant, who has experience in the regulatory domain.
To summarize, a few points to remember
- ISO 13485 certificate is to be obtained from CB not from NB.
The certificate should be from a CB accredited by NABCB or any IAF member AB that seems to be present in India.
- The certificate should carry the logo of the AB.
