ISO 13485 – Medical Devices Quality Management System

Introduction to Medical Devices Quality Management System 

Regulatory requirements in Medical Devices Manufacturing Industry, are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the Medical Devices manufacturing Industry, are expected to demonstrate their quality management processes and ensure best practice in everything they do. Medical Devices manufacturing sector, requires evidences of documented management system and effective monitoring of all construction activities.

SWISS APPROVAL is an accredited Body as:

– Certification of Medical Devices Quality Management Systems in accordance with EN ISO 13485:2016

– Certification Body of Quality Assurance Systems in accordance with E.C. Directives

Definition of Medical Device

A medical device is a just a product, which could be a machine, an instrument, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

SWISS APPROVAL EN ISO 13485 Certification Body for Medical Devices Management System

Swiss Approval is an accredited Certification Body for EN ISO 13485, regarding:

  • Non Active Medical Devices
  • General Non Active, Non Implantable Medical Devices
  • Devices for Wound Care

Accreditation according Normative Regulation:

  • EN ISO 13485:2016

Certification to ISO 13485

Certification to ISO 13485, is an added Value for any Medical Devices Manufacturer. Third-party accredited certification by SWISS APPROVAL, can demonstrate to regulators that the Company have met the requirements of the standard.

Market Demands

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.

ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance.

It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was launched to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes.It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Benefits of being certified to ISO 13485

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and demonstrate commitment to quality. Additionally, certifying by SWISS APPROVAL also affects:

  • Increase access to more significant markets worldwide
  • 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

SWISS APPROVAL Accreditation, in Accordance with E.C. Directives

Swiss Approval is an accredited Certification Body for FULL QUALITY ASSURANCE SYSTEM – [Annex II], regarding:

  • Non Active Medical Devices
  • General Non Active, Non Implantable Medical Devices
  • Devices for Wound Care

Accreditation according Normative Regulation:

  • Directive 93/24 EEC
  • EN ISO 13485:2016

Reccomendation for industry:

  • ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry.
  • ISO 13485 is the quality management system standard accepted as the basis for CE Marking Medical Devices under European Directives.
  • Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world.