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ISO 13485:2016 Certification

ISO 13485:2016 standard is for a Quality Management System for the design and manufacture of Medical Devices.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that launch and maintain the efficiency of their processes. It make sure the constant design, development, production, installation, and delivery of medical devices that are harmless for their intended purpose.

ISO 13485:2016, the Medical Device Quality Management System standard, has been consistent to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the earlier version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of 'cessation of assumption of conformity' of EN ISO 13485:2012 stated as 31 March 2019.

Note that ISO 13485:2016 increases the profile of companies and organizations to which the standard can apply: Organizations involved in one or few stages of a Medical Device Lifecycle or a Supplier or other External Parties provided that 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
  • Design and Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing
  • Raw materials
  • Components
  • Sub-assemblies
  • Medical devices
  • Sterilization services
  • Calibration services
  • Distribution services
  • Maintenance services
Why should You get ISO 13485 certified?

Voluntarily conforming to ISO 13485 is the greatest method that companies have to get ready for a global market access. Being ISO 13485 certified make available stakeholders and business partners with the confidence that the organization has put all the efforts to obey to the standard.

Why choose us for your ISO 13485 certification?

We are well-established and a single source provider of regulatory and Quality Management System (QMS) certification services. Our combined audits make it easy for manufacturers to be audited at once for ISO 13485, CMDCAS, and CE Marking.

ISO 13485 training and certification for individuals

Training on ISO 13485 is available, and there are a collection of course options for individuals to choose from. Each of these courses differ in their purpose, but upon the completion of the course, the participant will get the certificate:

ISO 13485 Lead Auditor Course – This is a four- to five-day training course focused on understanding the ISO 13485 QMS standard and being capable to use it for auditing management systems against these necessities. The course includes a test at the end to verify knowledge and competence, and it is only with an accredited course that an individual can developed approved to audit for a certification body.

ISO 13485 Internal Auditor Course – This is frequently a two- or three-day course that is based on the lead auditor course above, but does not include the test for competence, so this is most useful for someone start to do internal audits within a company.

ISO 13485 Responsiveness and Implementation Course – Numerous courses are offered that provide knowledge of ISO 13485 and how to appliance it. These can be one- or two-day courses, and they can even include online e-learning meetings as a method of teaching the material. These courses are good for those who requirement an overview of the ISO 13485 standard, or those who will be involved in the implementation within a company, and many are more economical than investing in the lead auditor course for those involved at this level.

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