In the fast-moving world of medical devices, ensuring the safety and effectiveness of your devices are of upmost importance. Regulatory bodies across the world have implemented rigorous quality management systems (QMS) requirements that guarantee consistency, safety, and reliability of devices of the regions they distribute in. These requirements can differ dependent on the regions in which you wish to sell your device and the regulations that govern QMS requirements.
ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Requirements is the globally recognised harmonised standard for quality management systems (QMS) within the medical device and IVD industry in regions such as the European Union, United Kingdom and Canada, etc.
In this article, we explore how ISO 13485 can be implemented to build a strong and effective QMS for your business.
Key Elements of ISO 13485
To better understand how ISO 13485 helps to build an effective quality system, let’s start with the core elements of any QMS:
- Quality Management System (QMS) Requirements: Organisations must establish, document, implement, and maintain procedures that ensure product quality throughout all stages of the device lifecycle — from design and development to production, distribution, and post-market surveillance.
- Documentation and Traceability: Comprehensive and controlled documentation is critical. This ensures that all procedures, records, and device information is properly documented, controlled, and traceable. Proper documentation not only ensures regulatory compliance but also enhances product accountability and problem-solving efficiency.
- Risk Management: Medical device manufacturers face significant risks due to the nature of their devices. ISO 13485 emphasises a systematic approach to risk management, requiring organisations to identify, assess, control, and monitor risks at every stage of product development and use. Organisations need to apply risk-based decision-making to ensure that higher risk processes receive more stringent controls.
- Design and Development Controls: The standard ensures that manufacturers follow stringent design and development processes. These include, but are not limited to, verifying that product designs meet requirements, validating them through real-world testing, and documenting the entire process to ensure traceability.
- Supplier Management: In an increasingly global supply chain, it is crucial to maintain control of your suppliers. ISO 13485 requires companies to evaluate, monitor, and manage suppliers to ensure the quality of purchased components and services that affect the product’s final quality.
- Internal Audits: Regular internal audits are essential in verifying the effectiveness of any QMS. ISO 13485 mandates periodic internal audits to ensure compliance with the standard’s requirements, assess operational performance, and identify areas of non-compliance and room for improvement.
- Corrective and Preventive Actions (CAPA): ISO 13485 requires companies to establish processes for identifying nonconformities, investigating their causes, and taking corrective actions to prevent recurrence. It also takes steps to prevent any potential non-conformance by implementing preventive actions early on. By focusing on continuous improvement and learning from failures, organisations can maintain high product quality over time.
Why is ISO 13485 Important?
For everyone involved in the medical device industry, ISO 13485 is not merely just a regulatory checkbox—it’s a strategic tool that enhances product quality and boosts credibility. Here’s why it is so important for your organisation:
Global Recognition and Market Access
ISO 13845 is required for regulatory approval in key markets such as the EU and the UK, etc.
Complying with ISO 13845 opens doors to global markets and can simplify the regulatory approval process.
Customer Trust
ISO 13485 certification shows customers that your medical device is safe and reliable. This in turn creates a relationship with customers built on trust, which is essential in an industry where patient health is at stake.
Regulatory Compliance
ISO 13485 is a globally harmonised standard, and many authorities, including the FDA (U.S.) reference ISO 13485 as part of their own regulatory framework. Implementing an ISO 13485 robust QMS ensures that you are aligned with regulatory requirements.
How to build a Robust ISO 13485 QMS
Now that we’ve talked about the significance of ISO 13485, the next, and more crucial, step is implementation and building a robust QMS. But before we discuss how to build a robust QMS, it is worth noting what the QMS documentation structure and hierarchy consists of:
Let’s document a basic roadmap for applying ISO 13485 in your organisation:
- Gap Analysis: If you have processes in place, it is worth starting with conducting a gap analysis to understand the status of your QMS. The gap analysis will highlight the areas in which you are compliant and areas which need some remediation. Once the gaps have been identified, this will aid in effectively allocating resources to create processes to build a seamless QMS. If you have no QMS documentation in place, there is no need to carry out a review. If you are unsure on how to conduct a gap analysis, it is always best to reach out to an expert such ourselves, or independent contractors.
- Develop a Quality Manual
A quality manual is a cornerstone of your QMS. It should outline your company’s policies, objectives, and processes for meeting the requirements of ISO 13485. For more information on what a quality manual should consist of, see our article – ISO 13485 Quality Management System Implementation: A Guide to Creating a Quality Manual - Establish Regulatory Specific Procedures
Depending on where you are looking to market your product will be dependent upon the regulatory requirements you need to comply with. You will need to consider establishing processes such as:- Risk Management – This will involve creating systematic procedures for identifying, assessing and controlling risks associated with your medical device. A useful standard to refer to is ISO 14971:2019 Medical device – Application of risk management to medical devices when creating risk procedures.
- Clinical/Performance Evaluation – The safety and performance of a device is based on sufficient clinical or performance evidence for the lifetime that the device is on the market. A clearly defined process should be written to cover these requirements taking into consideration the stipulations of the regions in which you will distribute your product.
- Post Market Surveillance (PMS) – It is a critical process for any organisation to monitor the safety and effectiveness of their product after it has been launched on the market. PMS requirements will be dependent on the risk classification of your device and your processes should clearly define PMS requirements.
- Post Market Follow Up – Post Market Clinical Follow Up (medical device) is a continuous process in which a manufacturer proactively collects and evaluates clinical data about how their device is used within its intended purpose. Post-market performance follow-up for IVDs is a continuing activity that ensures the performance evaluation of a medical device remains up to date throughout its entire lifetime. Making sure you have a robust process will ensure you meet these requirements.
- Vigilance – The purpose of vigilance is to enhance the protection of health and safety for patients, healthcare professionals, and other users. This system aims to reduce the likelihood of incidents related to the use of devices. Having a robust process will help in dealing efficiently with any potential adverse events and recalls.
- Implement Design Controls
Make sure you have robust design and development controls in place, which include stages like design inputs, outputs, verification, validation, and reviews. If this is not implemented early on it, it can cause issues for product certification, increasing timeframes to market and costs for the purposes of remediation.
See ‘What Are the Main Phases of Medical Device Development: Do you Understand the Requirements?’ for more information on design requirements. - Get Certified
Once your QMS is aligned with ISO 13485, you can seek certification through an accredited third-party certification body. They will conduct a thorough audit of your system to ensure compliance before granting you ISO 13485 certification. - Set Up Supplier Management Protocols
Develop a supplier management system that includes criteria for evaluating, selecting, and monitoring suppliers to ensure they meet quality standards. - Train Employees
Training your team on ISO 13485 requirements is crucial. Employees must understand their roles in maintaining the quality system and adhering to regulatory standards. To keep everyone engaged, we find interactive training works best, alongside encouraging open discussions to look at and improve the procedures. - Internal Audits and Continuous Improvement
Conduct regular internal audits to assess the effectiveness of your QMS and make adjustments as and when needed. Continuous ongoing improvement is a critical aspect of ISO 13485 compliance.
And finally…
ISO 13485 plays a vital role in the medical device and IVD industry, providing the structure and tools necessary to build a robust, compliant and effective quality management system. Implementing ISO 13485 isn’t just about regulatory compliance—it’s about ensuring product safety, managing risks, and continuously improving your processes to meet customer and market needs. By embedding the standard into your organisation, you’re setting the foundation for long-term success in a competitive and highly regulated industry.
Need further help?
If you have any questions or need help with your quality management system, or need help to create, implement or remediate your QMS, please get in touch with our expert consultants today, by phone on +441484662575 or via email at info@lfhregulatory.co.uk.
