Key Requirements of a Medical Device QMS Underlined by the ISO 13485 Standard

The ISO 13485 standard is the specifically devised standard for medical device manufacturing businesses, regardless of the size or type of devices they deal in. The standard enforces strong quality management practices in medical device companies to ensure that their products are completely safe for use by the patients. Just like any other ISO standards, ISO 13485 is based on the continuous Plan-Do-Check-Act or PDCA methodology. It is a continual cycle that medical device businesses should follow to plan the implementation of a QMS, deploy various activities underlined by the standard, improve the effectiveness and ensure consistent improvement of the quality aspects.

Clearly, the ISO 13485 standard defines the requirements for establishing a QMS and making it effective in your medical device organization. In the latest version, the requirements are compactly outlined in eight sections. The first three sections include the general requirements that must be followed for establishing a QMS in any sector. The last five sections explain the requirements that are specific to medical devices. Here are they explained in brief.


5 Requirements of a QMS Specific to the ISO 13485 Medical Device Standard


QMS Framework

The fifth section outlines the structure of a QMS and its specifications. It includes the procedures and practices to be deployed for quality control, including the documentation that has to be maintained. The QMS practices are specified depending on the expectations of users of devices and their quality and safety requirements. The documentation requirements include the maintenance of a quality manual, keeping records of medical device issues and their resolutions, controlling documents by a responsible team, and revision/updating of the documents.


Management Leadership

A special emphasis is placed on management responsibility and leadership in the ISO 13485 standard. The leadership of the management team is inherently required to ensure the implementation of the QMS is successful while aligning with the quality policy and focusing on the expectations of the customers/end users of devices. The section also highlights the importance of complying with regulatory requirements that apply to the medical device industry. Other key aspects that this section underlines are importance of regular management reviews, responsibilities of different management representatives, and proper internal communication.


Resource Management

The sixth section of the QMS requirements is all about the resources allocation and their management to ensure successful implementation of the QMS. The section hence covers the collection and administration of resources required for the QMS implementation activities. Resources include everything from personnel, tools or equipment, infrastructure, and specific work processes.


Product Realization

A crucial requirement of the ISO 13485 standard is product realization. It concerns the different aspects of the supply chain. By encompassing aspects of the supply chain, the QMS helps to ensure the delivery of fine-tuned and safe devices. This section of requirements is no doubt extensive. It includes the criteria for product realization and planning, designing and development, inputs/raw materials purchase, production methods, service provisions, measures for monitoring, and controlling of the processes.


Performance Analysis and Improvement

The last and eighth section of the medical device standard is about measuring, analyzing, and improving the QMS from time to time to ensure that medical devices of consistent quality are delivered to the customers.  This section hence includes complaint handling, responding to feedback, reporting to medical regulatory authorities, internal auditing, examining of devices and their production processes, handling of nonconforming products, collecting and analyzing of data, and implementing CAPA (Corrective and Preventive Actions).

 

Bottom Line

The latest version of the ISO 13485 standard underpins these vital requirements which are specific to the QMS of medical devices organizations. These requirements apply to any medical device organization, regardless of their size, type of products/services produced, or geographic location. Also, the standard is applicable to organizations in almost all countries, among which some countries have even made it a mandatory certification for medical device businesses to demonstrate their conformity to quality practices. If you own a medical device business, understanding these requirements is vital to build your QMS, implement it, and sustain it.


Contact Details:

Business Name: Compliancehelp Consulting, LLC

Email Id: info@quality-assurance.com

Phone No: 877 238 5855


Also Read: Know the Purpose of a QMS Before Implementing It

Location: 5686 S Redwood Rd, Salt Lake City, UT 84118, USA

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