This article aims to explain how medical device manufacturers or service providers can meet the requirements of the ISO 13485 standard, which is an internationally recognised standard for medical device quality management.
For the medical device industry, it is not only the quality that manufacturers and service providers need to take care of, but it is about assuring safety in quality. Therefore, regulations and best practices provided by the industry, high-level medical authorities, and legislative bodies are so important for the manufacturers or businesses. Meeting the ISO 13485 requirements helps them to abide by all regulations as it is the international standard for medical device quality management. It gives a framework for medical device businesses to realise the stringent regulations through the entire lifecycle of devices including designing, production, assembling, packaging, distribution, fitting in, using, and servicing. Thus, reaching compliance with the ISO 13485 standard would help a business to provide quality devices that ensure the safety of patients and simultaneously, enable them to gain better access to the market.
The following section points out the steps that you need to precisely follow if you own a medical device company to reach compliance with ISO 13485.
6 Elementary Steps to Meet Compliance with ISO 13485 Requirements
Acknowledge the QMS Requirements
ISO 13485 is based on the generic requirements of the world’s most used quality standard, i.e., ISO 9001. It is developed with some extra set of requirements that specifically applies to medical devices for validating their quality and safety. The general requirements focus on the implementation of a Quality Management System (QMS), development of documents of processes, risk-based thinking, effective resource management and periodic performance analysis for improvement. The medical-device specific requirements include clinical evaluation, software or technology uses, packaging instructions, post-market surveillance, sterilisation, medical device files, labelling, and a few more. Thus, to prepare for the ISO 13485 standard, you need to first fulfill each of these requirements necessary for making your devices compatible with the highly regulated industry.
Make the Management Responsible
The top management team of your organisation should take the prime responsibility for implementing the QMS and making it ISO compliant. They sit at the centre of an organisation and are main decision-makers. They would sit together to determine the quality objectives and policies that are the cornerstone of the QMS. They should also decide on the methods to conduct reviews at regular intervals to ensure their products are meeting the medical device regulations.
Get the Right Resources
To make your QMS system compliant, you also need to deploy the right resources including personnel, infrastructure, training or learning materials, and a positive work environment. Having the right resources ensure that your business is well prepared and would succeed at implementing a QMS and meeting the ISO compliance.
Implementation
This stage starts with a formal gap assessment where you must evaluate the existing quality program and discover which 13485 requirements are not met or partially met. Then, it goes with discussing the requirements to be met, total timeframe as well as costs required in meeting them. When everything is decided, it is time to train the employees and make sure they understand the requirements. Upon successful completion of training, the process of implementing the QMS shall take place.
Internal Audit
A review or internal audit is the most essential step to validate the ISO compliance of your QMS. The audit must be performed by experienced assessors or by auditors of a third party. The audit is a systematic procedure of investigating the QMS, policies and related processes thoroughly. It thus helps in identifying major errors or setbacks and nonconformity issues in your organisation so that you can quickly set them right.
Monitor and Improve the Performance
ISO compliance is not a one-time achievement, but it is an ongoing process. You need to keep monitoring the QMS and your product performance at frequent intervals to ensure they are meeting the ISO requirements, regulatory obligations as well as customer expectations. Thus, it helps you get varied outlooks of your QMS and find opportunities to make it better.
The specific use of medical devices makes the ISO 13485 requirements so crucial for manufacturers or businesses. With the implementation of structured QMS that meets the stringent medical device industry regulations, the companies can supply quality products, assure higher patient safety, achieve process efficiency, reduce costs, and gain access to more markets. Therefore, whether you are totally new to the standard or have known it, these steps are a must to achieve ISO compliance of your QMS and ensure greater consistency and reliability with your products.
