ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.
What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
Who is ISO 13485 for?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
Read more about certification to ISO’s management system standards.
Why was ISO 13485 revised?
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.
What are the key improvements?
The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
How can I purchase ISO 13485:2016?
ISO 13485:2016 is available from your national ISO member or the ISO Store.
ISO 13485Certification Benefits & Oxford Cert Universal Services
• Evidence of adherence to legal and regulatory or contractual requirements
• Minimize and manage risks
• Emphasize competence
• Error prevention instead of error correction
• Improved performance quality
• Customer and employee satisfaction
• Transparency and clarity of internal processes
• Time and cost savings
• Realization of quality policy and company goals
• International harmonisation - ISO 13485 promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale. A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
• ISO 9001 quality - It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.
ISO 13485 certification from Oxford Cert Universal enables you to:
• Provide evidence that you have met all statutory requirements relating to medical devices
• Increase the safety of your products and production processes
• Work in accordance with an internationally recognized standard
• Improve your competitive position
• Use our certification mark in your advertising to highlight product safety and quality
Oxford Cert Universal Services
• Certification - Oxford Cert Universaloffer assessment and certification against ISO/TS 16949.
• Internal AuditAssessments - Oxford Cert Universaloffer gap analysis, preliminary assessments to prepare you for certification.
• Training -Oxford Cert Universaloffer training which will prepare you and your staff before and after the certification process.
Quality Management System for Medical Devices & ISO 13485
ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices.
The primary objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical device sector. It is based on ISO 9001.
In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.
An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs.
Medical devices and is an increasingly important health care area in relation to their impact on health and health care expenditure.
ISO 13485:2003 – “Medical devices – Quality management systems – Requirements for regulatory purposes” is the internationally recognized standard for quality management system in the medical device industry. It specifies requirements for a quality management system where an organization need to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation and servicing of medical devices.
As this is a highly regulated sector across the world, the primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile production and traceability and excludes some of the requirements of ISO 9001 that are not necessary as regulatory requirements. Because of these exclusions, organizations being certified to ISO 13485 can not claim conformity to ISO 9001 unless they also conform to all requirements of ISO 9001.
ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices (e.g. USA, Japan, Canada, EU). This standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition important terms have been defined, such as medical device, active medical device, active implanted medical device, sterile medical device, and many more.
ISO 13485 supports the reduction of unexpected risks with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical devices, but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.
ISO/TR 14969:2004 is a standard that provides guidance for the application of the requirements for quality management systems contained in ISO 13485:2003. This guidance can be used to better understand the requirements of ISO 13485 as it helps illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485:2003.
ISO 14971:2007 is a standard that specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control.
The requirements of ISO 14971:2007 are applicable to all stages of the lifecycle of a medical device, but do not apply to clinical judgments relating to the use of a medical device and it does not specify acceptable risk levels.
If you are a producer, distributor, or supplier of medical devices, in-vitro diagnostic devices, or active implants, we will certify your quality management system in line with ISO 13485. This standard combines all regulatory requirements relating to medical devices.
ISO 13485 is more than just a pure quality management system. In order to meet the high requirements in the field of medical devices, it also integrates a risk management system. This enables you to identify hazards relating to the medical device or the associated procedures at an early stage. You can then take swift, targeted action.