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ISO 13485:2016 - Medical devices — Quality management systems

Home ISO 13485:2016 – Medical devices – Quality Management Systems (MDD)
ISO 13485:2016 Medical devices – Quality Management Systems (MDD)

Stellar is one among the Top ISO 13485: 2016 – Medical devicesQuality Management Systems and is regarded as one of the best by all of our clients.

Stellar has worked with most of the major PharmaCompanies like CIPLA Global Pharma etc..

As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of  MDD ISO 13485 Certification for their organization.

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ISO 13485 was first published in 1996 as a quality management standard for medical device companies based on the 1994 version of the ISO 9001. It was published in two versions: ISO 13485 for manufacturers (original equipment manufacturers (OEM), and ISO 13488 for contract manufacturers (suppliers). In the year 2003, the two versions were combined into one Quality Management System Standard that could be universally applied to medical device manufacturers.

ISO 13485 standard replaces earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published standard was ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

A final revision to ISO 13485 was released in 2016, just in advance of the new European Union Medical Devices Regulations (EU MDR)

In 2016, ISO 13485 was published based upon ISO 9001:2015. The ISO 13485:2016 was last reviewed and confirmed in the year 2020. Therefore, this version remains current.

ISO 13485:2016 is a quality management system required for regulatory purposes. It represents the requirements for a comprehensive quality management system.

The ISO 13485:2016 specifies requirements for a comprehensive quality management system for the design & development, production, storage, distribution, installation, servicing of a medical devicewhere an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system. For manufacturers and service providers both comply and demonstrate their compliance with regulatory requirements. The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers.

ISO 13485 Benefits

  • Increase access to more markets worldwide with certification.
  • Outline how to review and improve processes across your organization.
  • Increase efficiency, cut costs and monitor supply chain performance.
  • Demonstrate that you produce safer and more effective medical devices.
  • Meet regulatory requirements and customer expectations.

Requirements of ISO 13485:2016

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.

ISO 13485 2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. It is necessary to know the local applicable regulatory requirements and also any additional regulatory requirements, which you may have to comply due to an export of the product. When designing the QMS are per ISO 13485, it is also necessary to understand the size of the company, the risk classification of the product and applicable exclusions and non-applicability.

Certification

The Certification Procedure is a multiple-step process which is described as follows;

  • Executive and Management Overview / Planning
  • Gap Assessment and Planning
  • Documentation
  • Implementation and Training
  • Internal Assessment and Management Review
  • Certification audit – (Stage 1 + Stage 2)
  • Sustain and Continual Improvement
  • Surveillance audits at defined period
  • Recertification audit after 3 years

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Stellar’s ISO 13485:2016consulting consultants are designed to optimize benefits, provide cost effective and customer-focused solutions. Contact us now to discuss your needs.

Preview ISO 13485:2016

You can preview the freely available sections of ISO 13485:2016on ISO’s Online Browsing Platform .
To purchase this standard please visit the ISO Store .