ISO 13485 Requirements: Everything You Need to Know

Quality in the medical device industry is all about saving lives and earning trust, and ISO 13485 sets the gold standard for medical device Quality Management. By outlining essential ISO 13485 Requirements, it provides a clear roadmap for regulatory compliance, product safety, and improved efficiency in this vital industry.

But what does it take to gain this certification? Look no further than this blog for the answer. It explores the key ISO 13485 Requirements, including the eight clauses that an organisation must fulfil. So read on and make sure your products meet the highest safety and regulatory standards in this competitive market!

Table of Contents  

1) What are ISO 13485 Requirements? 

2) Overview of ISO 13485 Requirements 

3) Who Audits the ISO 13485 Requirements?  

4) Does the FDA Recognise Compliance With ISO 13485 Requirements?

5) How do ISO 13485 Requirements Differ From ISO 9001?

6) 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 Quality Management System (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 their ability to deliver safe and effective medical devices.

Overview of ISO 13485 Requirements  

The ISO 13485 standard, last reviewed in 2020, is currently ISO 13485:2016. This version places greater emphasis on risk-based decisions, risk management, effective document control, and additional documentation procedures.

The eight clauses of ISO 13485 are:   

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 

Scope  

This scope outlines the intended application of the standard. Remember these points about this first clause:

a) ISO 13485 applies to organisations involved in designing, developing, producing, installing, and servicing medical devices.

b) It includes manufacturers, suppliers, distributors and other entities in the medical device industry.

c) It covers diverse aspects of the medical device lifecycle.

d) It prioritises the requirements for establishing, implementing and maintaining a good 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:

a) ISO 14971 for Risk Management.

b) ISO 15223-1 for symbols used in medical device labelling.

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Terms and Definitions  

This clause offers 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. Here are the key points pertaining to this clause:

a) It emphasises the importance of documenting policies, processes and procedures to ensure adherence to this standard.

b) The QMS serves as the foundation for managing quality within an organisation.

c) It outlines the requirements for creating a quality manual.

d) It specifies unique record requirements for medical device manufacturers, including specific product guidelines.

e) It requires documentation on implementing a control plan while maintaining document integrity.

f) It establishes a record control plan to ensure data authenticity and document security.

Management Responsibility  

This is Clause 5 in ISO 13485 Standard. It emphasises the role of top management in establishing and maintaining the QMS. Remember the following points pertaining to this clause:

a) Define and communicate a quality policy across the organisation.

b) Oversee implementation and provide necessary resources for an effective QMS.

c) Conduct regular management reviews of QMS performance.

d) Maintain the rules during the manufacturing process.

e) Ensure effective communication to help employees understand quality policies and procedures.

f) You must demonstrate management’s commitment to the quality system.

g) Make sure everyone adheres to the quality plan throughout the process.

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Resource Management  

Clause 6 of ISO 13485 focuses on allocating and managing resources within the organisation. It covers areas such as:

a) Personnel

b) Infrastructure

c) 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. Here are the key points about this clause:

a) You must apply a systematic approach to design and development, including Risk Management.

b) Ensure verification, validation and control of design and development changes.

c) Focus on efficient communication throughout the product life cycle.

d) A strong quality system helps identify capital ideas, plan and develop products, and monitor customer reception.

Measurement, Analysis, and Improvement  

Clause 8 in ISO 13485 highlights the importance of monitoring, measurement, analysis, and continuous improvement within the QMS. Here are some key points to remember:

a) Its requirement is to establish processes for measuring customer satisfaction, conducting internal audits and implementing preventive actions.

b) Utilising data for decision-making and continuous QMS improvement is integral to this clause.

c) It’s important to continuously analyse generated data to improve processes.

d) This clause needs organisations to identify and control products that don’t meet customer demands or original design specifications.

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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. Understanding the Benefits of ISO 13485 can help organisations see how compliance not only improves quality management but also enhances credibility during the audit process.

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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Does the FDA Recognise Compliance With ISO 13485 Requirements?

Yes, the Food and Drug Administration (FDA) recognises compliance with ISO 13485 Requirements. However, while ISO 13485 is a widely recognised standard for medical device Quality Management Systems, it's not a substitute for FDA regulations. Manufacturers must still comply with all applicable FDA regulations.

How do ISO 13485 Requirements Differ From ISO 9001?

The ISO 13485 Requirements were derived from ISO 9001, which offers a general framework aimed at customer satisfaction and continuous improvement. However, ISO 9001's criteria can be too subjective to measure for many MedTech companies. Conversely, ISO 13485 focuses on specific metrics that evaluate medical device Quality Management performance and ensure QMS effectiveness.

Conclusion  

The ISO 13485 Requirements as outlined in this blog provide a comprehensive framework for medical device manufacturers to establish and maintain an effective QMS. By understanding the clauses of ISO 13485 and the auditing process, manufacturers can work towards certification. Achieving certification not only gives them a competitive edge but also instils confidence in the safety and reliability of their medical devices. 

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