ISO 13485 Quality Management System certification
Evolving in the Medical Device field calls for a level of understanding of the regulatory environment and what it implies for duties and obligations.
Countries are increasingly developing their local regulations based on the GHTF (Global Harmonization Task Force, now the International Medical Device Regulator’s Forum - IMDRF) model.
Already-existing regulatory schemes tend to be assessed by Health Authorities controls and/or Certification Bodies.
The majority of these regulations have as common base the Quality Management System (QMS) and Risk management principles. ISO 13485, in its recent evolution confirms that the regulatory requirements are meant to be a key consideration in the future of Quality Management Systems.
What is the ISO 13485 standard?
ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry. Companies are using compliance to this standard to obtain the certification of their Quality Management System. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems. The latest survey conducted by the International Organization for Standardization (ISO) shows that in 2015, the number of ISO 13485 certificates issued worldwide was 26255.
Who can be ISO 13485 certified?
The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc…
Note that ISO 13485:2016 expands the profile of companies and organizations to which the standard can apply: Organizations involved in one or several stages of a Medical Device Lifecycle or a Supplier or other External Parties providing such organizations with products for example.
|Organizations involved in one or more stages of the medical device lifecyle||Suppliers or External Parties who provide products to such Organizations|
In addition, the ISO 13485 standard requires that the organization identifies its role(s) in connection with the regulatory requirements (e.g. Manufacturer, Representative, Importer and / or Distributor), and determines the applicable regulatory requirements depending on the role(s), then integrates the regulatory requirements in the QMS.
A Quality Management System is neither meant to be a frozen in time nor is the company. The QMS is defined to help streamline and reinforce internal processes and procedures while carrying on with the changes and evolutions affecting the market.
How is ISO 13485 recognized worldwide?
ISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. It is not surprising to see that many jurisdictions recognize or even require that Medical Device manufacturers obtain ISO 13485 certification in order to access their market. A number of regulatory authorities have adopted the ISO 13485 certification standard as part of their own requirements to enable the sale of Medical Devices on their territory. The Medical Device Single Audit Program commonly referred to as MDSAP went a step further: it is built on the ISO 13485 principles and includes those principles as part of the audit criteria.
ISO 13485 and Canada
For a medical device manufacturers looking to obtain market approval in Canada for Class II, III and IV, it is mandatory to obtain ISO 13485 certification within the CMDCAS scope. In addition, a medical device manufacturer can only select a recognized registrar according to the Canadian Medical Device Regulation to obtain this certification. Companies should therefore carefully select their registrar by taking a look at list of CMDCAS recognized registrars available on Health Canada’s website.
On August 4th, 2016, Health Canada published a notice entitled “Transition to the Revised Version of ISO 13485 and its impact on the Compliance to the Quality Management System Requirements of the Canadian Medical Devices Regulations”. This notice discussed the transition period to ISO 13485:2016 for CMDCAS certified companies, but also what their obligations and what conditions need to be met for them to maintain certification.
The notice explains that Health Canada has set “[March 1st 2019, as the transition date to ISO 13485:2016. All manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1st, 2019]. Health Canada reiterates to select a CMDCAS recognized registrars to obtain ISO 13485 certification.
Health Canada announced on December 4th, 2015, the ending date for the current Canadian Medical Devices Conformity Assessment System (CMDCAS) which will be replaced by MDSAP, providing more information on the transition modalities and schedule.
A manufacturer’s note: Selecting a Certification Body that is both a Notified Body and a CMDCAS Recognized Registrar will allow the Medical Device manufacturer access a larger market while minimizing time and cost by using a single Certification Body. In addition, CMDCAS recognized registrars are the first ones in line to be authorized MDSAP Auditing Organization.
ISO 13485 and the Medical Device Single Audit program (MDSAP)
In the framework of the Medical Device Single Audit Program (MDSAP), organizations’ Quality Management System can be audited for potentially five different Medical Device markets. For companies selling or looking to expand their sales to one or to all of the countries involved in the MDSAP program (Australia, Brazil, Canada, USA, Japan), it is important to know that at a minimum, the requirements of ISO 13485 will be included in the auditing criteria along with only the applicable regulations of the authorities the company is concerned with.
Medical Device Single Audit Program (MDSAP) has also seen Regulatory Authorities stepping forward in their involvement and the impact of the program on their own processes.
Note: On February 11th, 2016, the Food and Drug Administration (FDA) announced that effective March 31, 2016; it will no longer accept ISO 13485:2003 voluntary audit reports issued on or after April 1, 2016.
Why should I get ISO 13485 certified?
Voluntarily conforming to ISO 13485 is the best approach that companies have to prepare for an international market access. Being ISO 13485 certified provides stakeholders and business partners with the confidence that the organization has put all the efforts to conform to the standard.
Why select a LNE/G-MED for your ISO 13485 certification?
LNE is a well-established Notified Body (CE 0459) and a single source provider of regulatory and Quality Management System (QMS) certification services. LNE/G-MED’s combined audits make it easy for manufacturers to be audited at once for ISO 13485, CMDCAS, and CE Marking.
ISO 9001 and ISO 13485 QMS Certification Services
LNE is ISO 17021-1:2015 accredited by COFRAC (Accreditation N°4-0038) for its activities of Quality Management System Certification according to ISO 9001:2008, ISO 9001:2015 and ISO 13485:2003 standards in Medical Devices and health field.
LNE is also accredited for other non-medical Quality Management System ISO standards:
- ISO 14001:2005 and ISO 14001:2015 Environmental Quality System
- ISO 27001:2013 Information security Management System
Details on LNE’s accreditation with COFRAC can be found on this page
CMDCAS Registrar accredited by SCC
LNE is a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and is recognized by Health Canada (the Canadian Ministry of Health).
Authorized Auditing Organization for MDSAP
G-MED is one of 10 organizations authorized to conduct Medical Device Single Audit Program (MDSAP) Audits. As an Authorized Auditing Organization, LNE/G-MED performs MDSAP audits since April of 2015.