ISO 13485 Requirements: A Comprehensive Guide

The International Quality Standard, ISO 13485, helps medical device manufacturers comply with the Quality Management System (QMS) standards. The ISO 13485 Requirements ensure that your organisation is compliant and meets customer and regulatory requirements, demonstrating your commitment to the safety and effectiveness of medical devices.    

According to the Hospital Harm Improvement Resource: Device Failure report by the Patient Safety Institute, of all medical device-related incidents, 43.8% are caused by device failure, which can have severe consequences for the patients. This is where standards like ISO 13485 come in. Explore our blog on ISO 13485 Requirements and learn how to elevate Quality Management and ensure Regulatory Compliance effortlessly. Read along to know more!

Table of Contents  

1) What are ISO 13485 Requirements? 

2) Overview of ISO 13485 Requirements 

    a) Scope   

    b) Normative references   

   c) Terms and definitions    

   d) Quality management System   

   e) Management responsibility    

   f) Resource management    

   g) Product realisation   

   h) Measurement, analysis and improvement 

3) Who audits the ISO 13485 Requirements?  

4) Conclusion  

What are ISO 13485 Requirements? 

The ISO 13485 Requirements refer to a set of criteria that medical device manufacturers must fulfil to establish and maintain an effective QMS. These requirements ensure the consistency, traceability, and control of processes throughout the device's life cycle, from manufacturing to maintenance. By earning the ISO 13485 Certification, companies can demonstrate their commitment to quality and the ability to deliver safe and effective medical devices.


 

Overview of ISO 13485 Requirements  

The ISO 13485 Standard was last reviewed in 2020, and the latest standard is the ISO 13485:2016. The changes made in the standard put a greater emphasis on risk-based decision and Risk Management, effective document control and additional documenting procedures.   

Clauses 4 to 8 of ISO 13485 outline the requirements an organisation must fulfil to obtain the certification. These clauses delve into the specific areas of the QMS that must be addressed and fulfilled.  

The eight clauses are:   

a) Scope  

b) Normative references  

c) Terms and definitions   

d) Quality Management System

f) Resource management   

g) Product realisation  

h) Measurement, analysis and improvement 

Scope  

This scope outlines the intended application of the standard. It specifies that ISO 13485 applies to organisations involved in designing, developing, producing, installing, and servicing medical devices. This includes manufacturers, suppliers, distributors, and other entities in the medical device industry. It also entails that this standard has several aspects of the medical device lifecycle and emphasises the requirements for establishing, implementing and maintaining a quality standard in the medical device industry.

Normative references  

ISO 13485 references other standards that provide additional guidance and requirements for specific processes or activities related to medical devices. These may include standards such as ISO 14971 for Risk Management or ISO 15223-1 for symbols used in medical device labelling.  

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Terms and definitions  

This clause provides definitions for key terms used throughout the standard. Clear and consistent definitions ensure a common understanding of terminology, facilitating effective communication and implementation of the requirements. It also outlines that there are certain definitions that should also focus on implantable medical devices and sterile devices. In these new additions, all the definitions are quite descriptive. Definitions on risk, Risk Management, performance evaluation and post-market surveillance are also required to be focused here.

Quality Management System  

Clause 4 outlines the general requirements for establishing and maintaining a QMS in accordance with ISO 13485. It emphasises the importance of documenting policies, processes, and procedures to ensure adherence to the standard. The QMS serves as the foundation for managing quality within an organisation.  It also outlines that this standard includes creating quality manual. It specifies that there should be unique record requirements for medical device manufacturers, which has specific product guidelines on how to use them or how should they be used. There should be documents on how to implement a control plan at the same time maintaining document integrity, and a record control plan. This help in ensuring that the data in the document is authentic and the security of that same document is maintained.

Management responsibility  

This is Clause 5 in ISO 13485 Standard. It emphasises the role of top management in establishing and maintaining the QMS. Top management must define and communicate a quality policy, ensure its implementation throughout the organisation, and provide the necessary resources to operate the QMS effectively. Management review of the QMS performance is also an essential requirement.   It also outlines that all rules must be maintained during the manufacturing process. Effective communication with the employees, will help them understand the importance of quality policies and procedures. They will also affirm Management’s commitment to the system. Managment should also make sure that the implementation of quality plan is adhered during the process. 

Resource management  

Clause 6 of ISO 13485 focuses on allocating and managing resources within the organisation. It covers areas such as personnel, infrastructure, and the work environment. This includes ensuring that personnel are competent, appropriately trained, and aware of their quality-related responsibilities. Adequate infrastructure and a suitable work environment are necessary to support the QMS processes. 

Product realisation  

Clause 7 in ISO 13485 addresses the processes involved in product design, development, and manufacturing. It emphasises the importance of applying a systematic approach to design and development, including Risk Management activities. Verification and validation of the design and control of the design and development changes are essential aspects of this Clause.  It also places an emphasis on the importance of communicating efficiently throughout the product life cycle. If an organisation has a strong quality system in place, then it will become easy for them to identify their initial capital ideas and requirements to plan and develop products and monitor how customers are receiving those products.

Measurement, analysis, and improvement  

Clause 8 in ISO 13485 highlights the importance of monitoring, measurement, analysis, and continuous improvement within the QMS. It requires organisations to establish processes for measuring customer satisfaction, conducting internal audits, and implementing corrective and preventive actions. The use of data for decision-making and the continual improvement of the QMS are integral to this Clause.  The data generated also need to be continually analysed  as  it helps in further improving the process. This Cause also outlines these organisations should also identify and control products which are not meeting the customer demands and the original design of the product. 

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Who audits the ISO 13485 Requirements?  

Independent certification bodies audit ISO 13485 Compliance. These organisations have qualified auditors who assess an organisation's adherence to the ISO 13485 Requirements. The auditors review the QMS documentation, processes, and practices to determine if they align with the Standard. The certification body issues an ISO 13485 certificate upon completing the audit, indicating compliance. Regulatory authorities and customers may also conduct audits to assess compliance with the requirements.  

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Conclusion  

ISO 13485 Requirements provide a comprehensive framework for medical device manufacturers to establish and maintain an effective Quality Management System. Manufacturers can get the certification by understanding the clauses of ISO 13485 and the auditing process. Getting certified gives them a competitive edge and instils confidence in their medical devices. 

Learn the benefits of ISO 13485 and the first steps for its compliance by signing up for our ISO 13485 Lead Implementer Course.