The importance of ISO 13485 compliance and how we can help you comply with the standard
What is ISO 13485?
If you have ever worked in a regulatory authority responsible for medical device regulatory oversight or medical device companies who are engaged in any of the medical device manufacturing stages or post-production services, you might have come across this standard. ISO 13485 is an internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. It outlines the requirements for a robust QMS to ensure the consistent and safe delivery of medical devices that meet customer and regulatory expectations.
- Importance of ISO 13485 compliance for medical device industries
- Patient Safety and quality assurance
It should be understood that National Regulatory Authorities (NRAs) and international standards set requirements for medical devices operations from its design and manufacturing until its use and disposal primarily to protect the safety and health of the patients. These requirements also emphasize a robust risk management approach throughout the entire product lifecycle. This helps identify and mitigate potential hazards, ensuring the safety and effectiveness of medical devices. They also require manufacturers to establish and implement an effective Quality Management System (QMS) that ensures consistent production of high-quality devices that meet relevant regulatory requirements, customers’ needs and applicable international/national standards.
2. Regulatory Compliance
ISO 13485 aligns with many national and regional regulations, such as the Medical Device and In vitro diagnostic medical device (IVDs) Regulations (MDR and IVDR) in EU, the US Food and Drug Administration (FDA) Quality system regulations (21 CFR Part 820/QMSR), Ethiopian Food and Drug Authority’s medical device Good manufacturing practice requirements, and Indian CDSCO’s medical device rules (MDR-2017) requirements. The Medical device single audit program (MDSAP) being conducted by recognized and reputable conformity assessment bodies whose reports and certifications are used by the five founding countries (US, Japan, Canada, Brazil and Australia) of the program- also depend on this standard. Nowadays, almost all NRAs around the world have harmonized their regulatory requirements for medical device manufacturers’ quality management system with the ISO 13485 requirements. Compliance with this standard demonstrates a commitment to quality and regulatory requirements, facilitating market access in almost all countries.
3. Business Advantages
Compliance Certification with this internationally recognized standard builds trust and credibility with customers, healthcare providers, and regulatory bodies. When a company works towards achieving compliance with the standard and maintaining its operations effectiveness in accordance with this standard, this will streamline its QMS processes and reduce errors leading to increased efficiency and cost savings. Demonstrating a commitment to quality and patient safety also provides a significant competitive advantage in the market.
4. Continuous Improvement
This ISO 13485 standard encourages a culture of continuous improvement, driving ongoing enhancements to product quality and organizational processes. In essence, ISO 13485 compliance is not just about meeting regulatory requirements; it’s about prioritizing patient safety, enhancing quality, and building a strong foundation for long-term success in the medical device industry.
B. Our support to assist you in your ISO 13485 compliance efforts
Ethiobiomedical provides a comprehensive support to medical device manufacturers and suppliers to help them comply with the international standard- ISO 13485 that includes a range of different activities including- Assessment of existing QMS and Gap Analysis, Development of actions plan to establish and fully implement and monitor the effectiveness of the QMS in a company, Providing Training to staff members who get involved in any QMS subsystems within the company, Assist in conducting internal audits and management reviews, and supports in regulatory compliance audit or certification process.
- Gap Analysis and Assessment
We conduct a thorough assessment of your existing Quality Management System (QMS) against the requirements of ISO 13485:2016. Following the assessment findings, we specifically locate the areas of non-compliance, weaknesses, and opportunities for improvement. We also evaluate potential risks associated with non-compliance and develop mitigation strategies.
2. Development and Implementation of action plan to establish the QMS
We assist in the development of plan of actions that contains the detail activities, execution timeframe, responsibilities, associated costs and others to establish full QMS as per the standard. Some of the key activities that we will support a company in its journey of attaining the ISO 13485 compliance is to identify the key processes that make up the QMS and define their interactions, identify mandatory documentation and support in their development and implementation process, the company’s quality objectives achievement.
3. Training and Awareness
Ethiobiomedical provides comprehensive training to companies on different medical device regulatory compliance requirements including the QMS (ISO 13485), Risk management system, Essential Principles of Safety and Performance, etc. We have a number of training packages where companies may select their areas of interest that they want to get training on. Please click here to access the training packages and request for any of them.
4. Internal Audits and Management Reviews
We also assist medical device manufacturers in conducting internal audits to assess the effectiveness of the QMS. We facilitate management review meetings to evaluate QMS performance, identify improvement opportunities, and make necessary adjustments.
5. NRAs or Certification Bodies Pre-audit Support
If your company is planned to be audited by a certification body or national regulatory authority, we prepare you for the audit by conducting a readiness assessment. We also help the company develop the necessary Corrective and Preventive Actions (CAPA) and assist in implementing the CAPA.
6. Ongoing Support and Maintenance
Even after the company has achieved the ISO 13485 requirements, we conduct periodic reviews to ensure the continued effectiveness and compliance of the QMS. We always make sure that the companies we support stay updated on changes to ISO 13485 and other relevant regulations, and assist in implementing necessary revisions. We also provide guidance and support for continuous improvement initiatives.
Our recommendations on establishing and implementing the QMS based on ISO 13485
In essence, the ISO 13485 is a process-based QMS standard where every activity performed makeup the process and the processes makeup the required QMS. The overall QMS is described by the company’s quality manual, processes are described with documented procedures, and activities are described through work instructions. The presence and appropriateness of these documents are the core of QMS requirements. The evidence of their implementation is demonstrated through records (filled forms or tables). All these documentations (Quality manual, quality policy and quality objectives statements, documented procedures, work instructions, records) are reviewed during the manufacturing site audit.
It should be noted that systematic development and effective implementation of these QMS documents are critical to have a robust quality management system and ultimately comply with regulatory and certification requirements. Systematic identification and timely preparation of these documents consume huge resources (needs- involvement of highly experienced experts, high financial resources) and consumes huge amount of time delaying the readiness for audit and QMS implementation and leading to regulatory or certification incompliance. Therefore, to avoid the risk of incompliance due to inappropriate documentation, Ethiobiomedical has developed the ISO 13485 mandatory documents templates and made it available for medical device manufacturers to purchase and use it with very affordable prices. You can find these ISO 13485 mandatory documents templates here.