Why we need ISO 13485 certificate?

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 System in the medical device industry.

ISO 13485 Overview

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. For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016.

A survey of ISO 13485-certified companies shows that the number of companies that have implemented an ISO 13485 Quality Management System still shows a general positive trend worldwide (the drop in 2018 was mainly due to a different measurement methodology).

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.

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.