What is ISO 13485?

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.

There are many different stages of medical device development from design and development to distribution and servicing, and this standard was developed to be used in organizations no matter what their role in the life-cycle.

ISO 13845:2016 can also be used by suppliers and external parties that are involved with providing medical device products.

Who is ISO 13845:2016 for?

ISO 13845:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products.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.

Benefits of ISO 13485

Safety and performance of medical devices are paramount in this highly regulated industry; this is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle:

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
• Manage risk effectively
• Improve processes and efficiencies as necessary
• Gain a competitive advantage

What does ISO 13485 actually look like?

The ISO 13485 structure is split into eight sections, because it is aligned with ISO 9001:2008. The first three are introductory, with the last five containing the requirements for the Quality Management System. Here is what the five main sections are about:

• Section 4: Quality Management System – This section talks about general QMS requirements, as well as the documentation requirements of the standard. It includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS.
• Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be instrumental in the implementation and maintenance of the QMS. Along with planning for the QMS, there is a need for top management to be involved in the ongoing review of the system to ensure customer satisfaction and improvement.
• Section 6: Resource Management – The section on management of resources is short, but covers the necessity to control all resources, including human resources, buildings, and infrastructure and the working environment.
• Section 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. ISO 9001 allows for requirements in the section to be excluded if they are not applicable to the company (such as a company that does not design products or services).
• Section 8: Measurement, Analysis and Improvement – This last section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions.

These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.

What are the practical steps to becoming ISO 13485 certified?

What is ISO 13485 certification? There are two types of certification: certification of a company’s Quality Management System against the ISO 13485 requirements, and certification of individuals to be able to audit against the ISO 13485 requirements. This section discusses the necessary steps for a company to implement an ISO 13485 Quality Management System and have it certified.

ISO 13485 certification for your company involves implementing a QMS based on the ISO 13485 requirements, and then hiring a recognized certification body to audit and approve your QMS as meeting the requirements of the ISO 13485 standard.

Starting with management support and identifying the customer requirements for the QMS, you will need to start with defining your quality policy, quality objectives, and quality manual, which together define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.