Medical devices. Quality management systems. Requirements for regulatory purposes

• Bs En Iso 13485:2016 Pdf
• Bs En Iso 13485 2016 Pdf

In Europe, ISO 13485 Standard designated as EN ISO is seen as the de facto standard for the medical device industry. ISO 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.

This is the internationally recognized quality management system (QMS) standard for the medical device industry. It has more than 27,000 accreditations worldwide. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose.

It can be used by any organization involved in one or more stages of the lifecycle of a medical device, including:

• Design and development
• Production
• Storage and distribution
• Installation or servicing
• Final decommissioning
• Design, development or provision of associated activities (such as technical support)

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

ISO 13485:2016 can be used to test an organization’s ability to meet both customer and regulatory requirements. Certification is not a requirement and organizations can reap the benefits of the standard without being certified.

Its use shows a commitment to quality, however, and users will be able to:

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of quality management system practices that consistently yield safe and effective medical device s
• Manage risk effectively
• Improve processes and efficiencies
• Gain a competitive advantage

What’s changed since the last update?

This revision ensures that the standard provides a quality management system that’s kept up with the evolving directives and other international regulatory changes that have occurred since 2003. Some of the key changes include:

Bs En Iso 13485:2016 Pdf

• Harmonization of regulatory requirements
• Inclusion of risk management throughout the quality management system
• Additional clarity with regard to validation, verification and design activities
• Strengthening of supplier control processes
• Increased focus regarding feedback mechanisms
• Harmonization of the requirements for software validation for different software applications

This standard BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes is classified in these ICS categories:

Bs En Iso 13485 2016 Pdf

• 03.120.10 Quality management and quality assurance
• 11.040.01 Medical equipment in general

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. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.