ISO 13485 Certification: A Guide for IVD Startups

ISO 13485 is an internationally recognized quality management system (QMS) standard specifically designed for medical devices and related services.¹ But what are the benefits of obtaining ISO 13485 certification and how do you go about it?

Understanding ISO 13485

What is ISO 13485?

The ISO is the International Organization for Standardization.² It’s an independent, non-governmental international organization with 170 national standards bodies as its members.² These members work to develop official international standards that are:^2,3

• Voluntary
• Consensus based
• Market relevant

ISO 13485 is an internationally recognized quality management system (QMS) standard specifically designed for the medical device industry.¹ It includes standardization requirements for any organization involved in designing, producing, installing, servicing and/or manufacturing medical devices.¹ The system provides a framework for these organizations to ensure that their products and services consistently meet customer and regulatory requirements.¹

ISO 13485 was first published in 1996; the latest version, ISO 13485:2016, came into effect in 2016.¹

Key principles of ISO 13485

The main principles of ISO 13485 are as follows:

• Product quality and patient safety: These are the top priorities for ISO 13485. This means that the medical/IVD device is safe for the patient and gives accurate results so the patient receives the right treatment. The device must be safe for all users, should that be professionals in hospitals or patients buying a test for home use.⁴
• Customer focus: Medical device companies must understand and meet the requirements of all their stakeholders. This includes patients, healthcare professionals and regulatory bodies. Placing the customer at the center of the QMS means improved customer trust and satisfaction.⁵
• Employee participation: ISO 13485 recognizes the value of employees and encourages them to actively contribute to the QMS. Involving employees creates a culture of responsibility and allows everyone in the organization to feel a sense of ownership in the quality management process.⁵
• Adopting a process approach to quality management: A process approach involves managing activities and resources as interrelated processes rather than as separate steps, to effectively achieve the desired outcomes.⁵ 
• Risk-based decision making: Identifying and mitigating risks is an essential part of ensuring the safety, efficacy and regulatory compliance of a medical device. A risk-based approach to decision-making means an organization will identify, analyze, evaluate and control risks throughout the entire product life cycle.⁵ 
• Striving for improvement: Organizations must continuously seek opportunities to improve their processes, products and overall performance to meet customer expectations and regulatory requirements.⁵
• Documentation: It’s essential to maintain a system of documenting and recording all relevant information to ensure effective operations and demonstrate compliance.⁵
  

Applicability in the medical device industry

Medical device organizations face stringent regulatory requirements at every step of their products’ life cycles. ISO 13485 certification allows these organizations to demonstrate their commitment to quality management and ensure best practice in all their operations.⁶

ISO 13485:2016 is designed to address the latest QMS practices, including changes in technology and regulatory requirements.⁶

Is ISO 13485 mandatory for medical devices?

ISO 13485 is mandatory for IVD producers in many countries and it is typically considered mandatory elsewhere. It’s not mandatory for raw material providers like Medix Biochemica; however, we have gone the extra mile to ensure that we are certified, following the same QMS as our customers.⁴

Which countries require Quality Management Systems like ISO 13485 certification for medical/IVD device manufacturers?⁷

• Europe
• UK
• USA
• Canada
• Australia
• Japan
• Singapore
• Malaysia

While ISO 13485 certification isn’t mandatory for Medix Biochemica, it does give us the edge over competitors who are not certified.⁴ There are many benefits to getting ISO 13485 certification.¹

ISO 13485 certification benefits

The key advantages of ISO 13485 certification include the following:¹ 

• Meeting internally agreed and recognized regulatory requirements
• Improved credibility as an organization that takes quality control seriously
• Greater efficiency and more streamlined quality control processes
• A robust risk management system
• A solid foundation for expansion into new markets
• Improved customer satisfaction

So how can a new startup IVD company go about becoming ISO 13485 certified?

Managing ISO 13485 certification

Before you apply for ISO 13485 certification, there are a few steps you should take internally as an organization:⁴

• Set clear objectives: Define your quality management goals.
• Identify key stakeholders: Establish stakeholder roles and responsibilities.
• Optimize documentation of processes: Make sure you have standard operating procedures (SOPs) and a quality manual in place.

How to get it: 8 steps to achieving ISO 13485 certification

Are you a medical device organization looking to get ISO 13485 certified? Here is a breakdown of the certification process:^4,8

1. Preparation

• Obtain a copy of the ISO 13485 standard and other necessary documents.
• Determine and establish relevant processes.
• Assign internal auditors and teams to these processes.
• Set a schedule, create workflows and define guidelines for each process.
• Conduct a gap analysis for each task or process.
• Provide ISO 13485 certification training for process owners.
• Improve and finalize the processes.
• Standardize the processes and document the necessary records.
• Conduct a readiness assessment.

2. Internal audit

Conduct an audit to help verify the effectiveness of your QMS. This allows you to identify any non-conformities and take action to mitigate them.

3. CAPA

Use the internal audit report to identify issues or opportunities for improvement. Then initiate a Corrective and Preventive Action (CAPA) process.

4. Management review

Have the top management review the organization's quality objectives and finalize a list of action items found in the internal audit before applying for the certification.

5. Engaging certification bodies

• You will need to research and select a third-party organization among recognized ISO 13485 certification bodies to conduct the certification

• Fill out the ISO 13485 application form, review it and submit it to the certification body

6. Documentation survey

• A certification auditor from the third-party organization will assess how well your organization documents its systems.

7. Primary audit

• The auditor will conduct an onsite assessment to check if all regulatory requirements have been met, and evaluate the effectiveness of your overall QMS by sampling records from each process.

• The auditor will establish a schedule of surveillance audits and reassessments (typically done annually).

8. Post-audit activities

Any non-conformities found during the audit process must be resolved before certification can be issued. Certification will be awarded once your organization is fully ISO 13485 compliant. 

Medix Biochemica has the latest ISO certifications, making it easier for you to get yours

Partnering with a compliant raw materials manufacturer helps you to put a more compliant supply chain in place, making the process of getting ISO 13485 certified smoother and easier.

Medix Biochemica is committed to maintaining the highest quality standards in every aspect of our operations. All of our manufacturing sites stick to strict quality management systems and most of them are ISO 13485 or ISO 9001 certified. 

As of 6 February 2024, Medix Biochemica’s Espoo Headquarters has had an ISO 13485 certificate for 20 years.
See our ISO certification here.

This commitment to quality ensures that our in vitro diagnostics (IVD) customers can trust us to deliver effective, reliable IVD materials to meet their requirements - every time. 

References:
1. Everything you need to know about ISO 13485. Qualio. Accessed January 22, 2024. https://www.qualio.com/blog/iso-13485-standard. 
2. ISO - About us. ISO. Accessed January 22, 2024. https://www.iso.org/about-us.html.
3. What we do. ISO. Accessed January 22, 2024. https://www.iso.org/what-we-do.html.
4. Expert opinion. Hanna Kosita. Quality & ESG Director, Medix Biochemica. January 2024.
5. Learn the ISO 13485 principles in details: a comprehensive guide. TheKnowledgeAcademy. Accessed January 22, 2024. https://www.theknowledgeacademy.com/blog/iso-13485-principles/.
6. ISO 13485 — Medical devices. ISO. Accessed January 22, 2024. https://www.iso.org/iso-13485-medical-devices.html.
7. Which countries and which regulations require ISO 13485 certification? Advisera. Accessed January 30, 2024. https://advisera.com/13485academy/blog/2021/03/09/list-of-worldwide-regulations-that-require-implementation-of-iso-13485/.
8. A guide to ISO 13485 certification. SafetyCulture. Accessed January 22, 2024. https://safetyculture.com/topics/iso-13485/iso-13485-certification/.