What is ISO 13485?

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management Systemin the medical device industry.

What is the purpose of ISO 13485?

Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Together, these 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.

What are the requirements of ISO 13485?

ISO 13485:2016 specifies requirements for a Quality Management System to produce ISO medical devices and related services that consistently meet customer and applicable regulatory requirements. 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 supplied by the organization.

The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory 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 13485 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.

Why was ISO 13485 revised?

All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards, including the new edition of ISO 9001.

FDA and ISO Standards for Medical Devices

The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications. The quality system regulations (QSR) for FDA regulated products are known as current good manufacturing practices (CGMP). These requirements were first implemented in 1978 under the Federal Food, Drug and Cosmetic Act and defined in section 21 part 820 of the Code of Federal Regulations (21 CFR part 820).

For over a decade, these regulations primarily focused on manufacturing of medical devices. This changed with the Safe Medical Devices Act of 1990, which included product design controls. At the same time, the FDA sought to harmonize the CGMP regulations with applicable international standards. The primary standards included International Organization for Standards (ISO) 9001:1994* and 13485:1996.

The ISO 9001 standard was entitled ‘Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicing’. The ISO 13485 standard was entitled ‘Quality Systems – Medical Devices – Supplementary Requirements to ISO 9001’. Whereas ISO 9001 emphasizes continual improvement and customer satisfaction, 13485 encompasses the requirements that medical device manufacturers must incorporate into their management systems. These include maintaining effective processes while meeting regulatory requirements, customer requirements and managing risks.

A manufacturer that is certified to ISO 13485 does not inherently fulfill the FDA regulatory requirements. However, this certification aligns the company management systems with requirements of the FDA’s QSR and international regulatory requirements. As such, 13485 provides a management system that serves as a framework for compliance to various regulatory and customer requirements.

ISO 13485 certification also does not fulfill the requirements of ISO 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers. Benefits can be reaped from being both 9001 and 13485 certified, because 9001 focuses on business aspects not found in 13485 that are good for all businesses. Also, ISO 13485 is no longer thought of as pertaining solely to finished medical device manufacturers. Many manufacturers are requiring their sub-tier suppliers to attain ISO 13485 certification as well.

* ISO standard nomenclature includes the standard identification number, followed by the year of implementation. The current standards are ISO 9001:2015 and 13459:2016.

Sources:

www.fda.gov