Choosing The Right Agency For ISO 13485 Certification

ISO 13485 certification for medical devices is an excellent quality management system required for regulatory functions which is an ISO standard, it represents the necessities 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.

International standard organizations set 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.

If we specifically speak about ISO 13485, it is implementedby organizations who are involved in designing, production, installation and servicing of medical devices. It helps manufacturer in their auditing processes,but there is some ambiguity among the industry and stakeholder about who can certify for ISO 13485which 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 EU for the audits under MDR of class A and Class B medical devices. As aISO 13485 medical device consultantwe know the difference between the NB, CB and other regulatory bodies, and we assist our clients accordingly.

• ISO 13485 Accreditation:

Medical device manufacturers who wish to sell their device in 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 device .Offenly these are private firms with the experts from the field of risk management & medical device safety and standards. NBs are the registered under rule 13 as a body who carry out audit of manufacturing site, assessment and verification of specified category to establish conformity assessment with standards.It does not mention anywhere ISO 13485 or certification word.

ISO 13485 was introduced as a certificate of complianceaccredited by NABCB(National Accreditation Board for Certification Bodies) or IAF in respect of medical devices.

This clearly indicates the ISO 13485 is obtained byCertified bodyi.e CB not from NB (Notified Body).

CB should be accredited by NABCB, the Indian National Accredited body (AB). The list of CBs is available on NABCB link:

https://nabcb.qci.org.in/about.php

Countries like US and Japan have multiple Accreditation body (AB) whereas some countries have single national AB. ISO 13485 certification operates under the oversight of IAF through Abs in each country .IAF define 7 technical areas in a document IAFMD which is free to download from their website. So, the bottom line is industry make 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.

点记得是有号码的non IAF CBs in the market who offers ISO 13485 certificates-beware of them. To get this certificate from the correct CB you should hire a right consultant, who has experience in regulatory domain.

To summarize, few point to remember

• ISO 13485 certificate is to be obtained from CB not from NB.

• The certificate should be from CB accredited by NABCB or any IAF member AB which seems to be present in INDIA.
• The certificate should carry logo of the AB.