Guidelines for Achieving ISO 13485 Medical Devices Quality Management System

Summary:

This article explains the basic steps for medical device businesses to implement a strong quality management system (QMS) following the requirements of the ISO 13485 standard.

ISO 13485 is a specifically designed and harmonized quality management standard for medical device companies or manufacturers. It defines the requirements for laying a comprehensive QMS that help in regulating the development, processing, supplier management, storage, delivery and installation of medical devices to ensure that they are reliable for use, but why is a QMS validated with the internationally acclaimed certification, i.e., ISO 13485 certification so necessary for medical device manufacturing? It is necessary because the quality and accuracy of medical devices directly impact the health and treatment of ailing ones. Many devices are used for diagnosis and analysis of diseases so that appropriate treatment can be undertaken. It is henceforth essential for businesses or manufacturers to take care of the quality of products and assure their accuracy and consistency in diagnosis or treatment.

Deploying a QMS adhering to all the specified requirements is not always plain sailing. A manufacturer needs conscious planning and a systematic approach to make sure their QMS complies with every requirement. Here are some easy-to-follow guidelines for medical device companies to implement a QMS and achieve compliance with ISO 13485.

Basic Guidelines for Implementing QMS and Getting ISO 13485 Certification

Defining the Scope

Depending on the type of medical devices produced and activities required to maintain their quality, the manufacturer should determine the scope of the QMS. The more comprehensive the scope is, the better it is. Often, the scope of the QMS includes the development process of products, production processes, storage and sterilization, delivery and installation, requirements of the customers/health service providers, and maintenance of the products.

Getting a Compliance Assistance Agency

The manufacturer should get some expert advice on ISO 13485 certification compliance. The requirements of the standard aren’t as simple as the ISO 9001 quality management standard. There are huge additional requirements beyond those general requirements which are specific to the quality of medical devices. Therefore, a professional team with knowledge of ISO compliance can guide the manufacturing organization better in formulating their QMS.

Establishing the QMS

To establish the QMS, a manufacturer first needs to define its processes or standard operating procedures which are used every day in production of devices. Apart from that, the QMS should also incorporate the various work instructions, checklists, procedural templates etc., which the organization uses to classify inputs and outputs of their processes. They should make sure that all these are covered by the QMS while meeting the regulatory requirements of ISO 13485.

Operate the Quality Management System

The manufacturing organization now should operate the QMS, integrating it with every process/department. They should work according to the specifications of the QMS i.e., standard operating procedures, work instructions, and checklists. The management team should review whether the QMS is operated well and should keep records of certain performance metrics to prove its effectiveness as well as compliance.

Preparation for ISO Certification Audit

To get the QMS certified with ISO 13485, the organization needs to pass the certification audit which is to be conducted by a notified certification body/registrar. To prepare for the audit, they need to appoint assessment officials internally or from a consultancy, who will meticulously review the QMS and identify any nonconformity issues, if present. The manufacturer should incorporate the changes needed in the QMS to address the compliance issues.

Getting Certified

The notified certification body will conduct a two-stage audit. In one stage, they will review the documentation of the processes of the organization and in the second, they will see if all ISO 13485 requirements are met by the QMS in practice. On being convinced of its ISO compliance, the organization is awarded the certification.

These are the prerequisite steps that every medical device manufacturer should pass through if it seeks ISO 13485 certification. These are quite straightforward guidelines which a reliable ISO consultancy can help them through. However, there are many factors that assure the successful implementation of the QMS and its subsequent ISO certification. They include invariable management commitment and leadership, a proper understanding of processes, understanding of quality requirements, and a process-based approach (i.e., Plan, do, check and act) for implementation.
Author Bio:

Damon Anderson is the owner of a distinguished ISO consultancy that assists organizations in obtaining crucial ISO certifications for quality management systems, environmental management systems, and so on. He is an ISO 13485 certification consultant and dedicates his free time to writing blogs on medical device quality management, prevalent risks and challenges in medical device industry, and compliance guidelines for ISO 55001.

Contact Details:
Business Name: Compliancehelp Consulting, LLC
Email Id: info@quality-assurance.com
Phone No: 877 238 5855

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Created on Jul 14th 2021 07:46. Viewed 342 times.

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