Insights into the ISO 13485 certification process for Quality Management System.

ISO 13485 certification is the process to certify that a quality management system is able to ensure quality, safety and efficacy of a medical device.

For instance, The current version of ISO 13485 has been published in 2016. It is a ISO standard of fundamental importance for the medical device sector. This is very more important considering that FDA will revise US QSR to make it aligned with ISO 13485. For an overview of the future versions of ISO 13485, refer to this link!

Structure of ISO 13485

Currently, there are 5 sections that contain all the requirements of ISO 13485, specifically between section 4 and section 8 of the standard.

Section 4: Quality Management System

Firstly, this section specifies the requirements for implementation of QMS processes and document management system. A QMS is a series of processes which transform inputs in outputs. This is performed according to specific instructions documented in quality procedures.

For instance, Section 4 describes as well the requirements for the Medical Device File (the equivalent of the Design Master Record for US QSR).

Section 5 ISO 13485 – Management Responsibilities

Secondly, this section specifies the role of top management in the QMS. Specifically, the company needs to document a quality policy shall that reflects the vision of the company for quality management system.

Furthermore, the organization shall also define measurable objectives to keep quality management system processes under control.

For instance, the management review process has the goal to perform an overall review of the quality management system. The goal is to ensure the correct implementation of all the processes. The ISO standard specifies in details the input and output of the management review.

Section 6 ISO 13485 – Resources Management for Quality

This section provides requirements for resources needed for the quality management system. Resources include:

  • Competent Personnel
  • Infrastructure including equipment, IT, buildings, etc.
  • Clean working environment
  • Control of contamination.

Section 7 ISO 13485– Product Realization

It is the largest part of the ISO 13485 standards and it covers different processes of quality management system: sale (7.2), Design & Development (7.3), Purchase (7.4), Manufacturing (7.5) and Management of Equipment (7.6).

For the sale process, the organization needs to review the requirements related to the product before the product itself reaches the customer.

For design & development, the requirements are related to the full development cycle of a medical device.

Specifically, this goes from design plan and identification of design inputs, until to arrive at the design transfer and implementation of the manufacturing process.

Section 8 ISO 13485– Measurement, Analysis and Improvements

In conclusions, how the organization ensures that requirements related to the product and to quality management system are met? This is the content of section 8 of the ISO 13485. This includes methods to get feedback from the field, regulatory reporting, data analysis, internal audit, corrective and preventive actions and implementation of monitoring system to keep QMS under control. Moreover, this section contains as well requirements for the Management of non-conformities and rework activities

Furthermore, for a general overview of the most important updates for medical device regulations, you can see the posts related to ISO 14971 (risk management), ISO 14155 (Clinical Evaluation).

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