Quality management systems

ISO 13485:2016 Medical devices

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 for Medical Device Manufacturers.

What is the ISO 13485:2016 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

What is the Approach of ISO 13485:2016?

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.

What are the benefits of getting ISO 13485:2016 certified?

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.

Who should be ISO 13485:2016 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 LifecyleSuppliers or External Parties who provide products to such Organizations
Design and DevelopmentRaw materials
DistributionMedical devices
InstallationSterilization services
ServicingCalibration services
Distribution services
Maintenance services

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.

Is getting ISO 13485:2016 certified mandatory?

The ISO 13485:2016 is a voluntary certification. However, voluntarily conforming to ISO 13485 is the best approach that companies have to prepare for an international market access. Being ISO 13485:2016 certified provides stakeholders and business partners with the confidence that the organization has put all the efforts to conform to the standard.

Why choose GMED as ISO 13485:2016 certification body?

GMED is a well-established Notified Body (CE 0459) and a single source provider of regulatory and Quality Management System (QMS) certification services. GMED’s combined audits make it easy for manufacturers to be audited at once for ISO 13485, MDSAP, and CE Marking.

What is the NF EN ISO 13485:2016?

It is the French standard of ISO 13485:2016, and it is required if you want to sell in France or you are based in France. It can only be issued by a French Certification Body in order to issue the NF ISO 13485:2016 certificate.

This International Standard specifies the requirements for the quality management system when an organization needs to demonstrate its ability to regularly provide medical devices and associated services in accordance with customer requirements and applicable regulatory requirements. These organizations may be involved in one or more stages of the life cycle including the design and development, production, storage and distribution, installation or associated services of a medical device, as well as the design, development or the provision of associated activities (eg technical support). This International Standard may also be used by suppliers or external parties that supply products.

GMED is an Organization Recognized by the MDSAP Regulatory Authority Council

Following the completion of the recognition procedure established by the five participating regulatory authorities (USA, Brazil, Japan, Australia and Canada), GMED joined the exclusive group of MDSAP Recognized Auditing Organization.

Authorized Auditing Organization for MDSAP

GMED is one of 10 organizations authorized to conduct Medical Device Single Audit Program (MDSAP) Audits. As an Authorized Auditing Organization, GMED performs MDSAP audits since April of 2015.

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