What is ISO 13485? Explained in Detail

 

Precise medical equipment handling and manufacturing is vital to the healthcare industry. These processes must be strictly regulated, as non-compliant equipment can have serious consequences. This is where ISO 13485 comes in. But do you know What is ISO 13485?

It is a standard for Medical Devices and establishes a framework for its implementation, maintenance and manufacturing. According to the Hospital Harm Improvement Resource: Device Failure Report by the Patient Safety Institute, of all Medical Device-related incidents, 1.5% are caused by poor maintenance, 43.8% by device failure, and 29.3% by inappropriate use.

This quality standard helps in mitigating device failures by providing a proper framework. If you, too, are engaged in this industry, it is crucial to learn about this standard. In this blog, you will learn What is ISO 13485, its significance and requirements and discover how it can help improve processes and ensure quality standards.

Table of Contents

1) What is ISO 13485?

2) Latest standards of ISO 13485 

3) ISO 13485 documentation requirements

4) Responsibilities of management in maintaining the standard

5) ISO 13485 resource management

6) ISO 13485 product realisation planning

7) ISO 13845 measurement, analysis and improvement

8) Importance of ISO 13485

9) Conclusion

What is ISO 13485?

ISO 13485 is an international standard that specifies the Quality Management System (QMS) requirements for the Medical Device industry. It is a set of policies, procedures, and processes that ensure the quality and safety of Medical products and services.

ISO 13485 assists Medical Device companies in meeting regulatory and customer expectations throughout a device's life cycle. Compliance with this standard can also facilitate market access for Medical Devices in many countries worldwide.

It is based on the general Quality Management principles of ISO 9001. However, it has additional requirements and adaptations specific to the Medical Device industry. ISO 13485 is a voluntary standard that can be adopted by any organisation involved in the Medical Device industry, regardless of its size, type, or location.

However, ISO 13485 Certification by an accredited third-party body can provide a competitive advantage and demonstrate the organisation’s commitment to quality and safety.
 

 

Latest standards of ISO 13485

After learning What is ISO 13485, it is time to learn about the current developments in the standard. The latest ISO 13485 standard is ISO 13485:2016, last reviewed in 2020. This revision brings several significant changes and improvements to the standard. The major changes made in the latest version are as follows:  

a) The latest version emphasises effective document control. It requires organisations to establish and maintain documented procedures for document management, including revision control, distribution, and access.   

b) ISO 13485:2016 places greater emphasis on risk management throughout the product lifecycle. It requires organisations to identify, assess, and mitigate risks associated with their devices, ensuring patient safety.   

c) The revised standard adopts a process-based approach, emphasising the importance of clearly defined procedures, documentation, and traceability. This enables organisations to streamline their operations and improve overall efficiency.

d) ISO 13485:2016 considers the entire lifecycle of a Medical Device, including its design, development, production, installation, and post-market activities. This comprehensive approach helps organisations address quality requirements at each stage, ensuring consistent product performance.

e) It places greater emphasis on Supply Chain Management. It requires organisations to establish processes to ensure that quality components and materials are used in their devices.

f) The revised standard also promotes risk-based decision-making, encouraging organisations to use risk assessments to inform their Quality Management processes and decision-making activities.

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ISO 13485 documentation requirements

ISO 13485 requires the organisation to document various aspects of its QMS and its Medical Devices. Let's explore the documentation Requirements of ISO 13485:

Quality manual

The quality manual is an important document that defines the scope, structure, and main elements of the QMS. It includes the quality policy, the quality objectives, and the references to the relevant procedures and records. The quality manual also defines the roles undertaken by the organisation under applicable regulatory requirements.

Medical Device file

The Medical Device file is a document that contains the description, specifications, and records of the Medical Devices. It includes the following:

1) Intended use

2) The indications for use

3) The labelling

4) The instructions for use

5) The manufacturing instructions

6) Inspection instructions

7) Packaging instructions

8) Storage instructions

9) Handling instructions

10) Distribution specifications and procedures

11) Monitoring specifications and procedures

The Medical Device file also provides evidence of the conformity and traceability of the Medical Devices.

Document control

Document control is a procedure that ensures that the documents required by the QMS and the Medical Device are approved, updated, identified, available, legible, and retrievable. Document control also prevents the unintended use of obsolete documents and applies to both internal and external documents.

Control of records

Control of records is a procedure that ensures that the records of the QMS and Medical Devices are identified, collected, indexed, stored, protected, accessed, retained, and disposed of in an organised manner. Records provide evidence of the implementation and effectiveness of the QMS and the Medical Device, as well as the compliance with the regulatory requirements

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Responsibilities of management in maintaining the standard

A responsible management of Medical Devices and QMS is one of the key requirements of ISO 13485. It means that the top management of the organisation has to demonstrate leadership and commitment to the QMS and the quality of the Medical Devices. Let's explore the management responsibilities as per ISO 13485:

1) Establish quality policies: Establish quality policies and ideas that are consistent with the organisation’s vision and regulatory requirements.

2) Allocate necessary resources: Ensuring the availability of the resources needed to apply and maintain the QMS and the Medical Device.

3) Appoint a management representative: Appoint a representative who has the authority and responsibility to oversee the QMS.

4) Conduct reviews: Conduct reviews to evaluate the performance and effectiveness of the QMS and the Medical Device.

5) Cultivate quality culture: Promoting a culture of quality and customer focus throughout the organisation.

6) Drive continuous improvement: Support and encourage the continual improvement of the QMS and the Medical Device.

Responsible management is essential for the success and compliance of the QMS and the Medical Device. It ensures that the organisation meets the expectations and needs of its customers, especially the patients who use Medical Devices. It also helps the organisation to achieve its strategic goals and to fulfil its regulatory obligations.

ISO 13485 resource management

ISO 13485 requires the organisation to provide adequate resources to apply and maintain the QMS and the Medical Device. Let's explore the processes involved in resource management:

Provision of resources

The organisation has to determine and provide the resources needed to establish, implement, maintain, and improve the QMS and Medical Devices. These resources include human resources, infrastructure, work environment, and contamination control.

Human resources

The organisation has to ensure that the personnel performing work affecting the QMS and Medical Devices are competent, trained, and aware of their roles and responsibilities. The organisation has to document the necessary competence, education, training, skills, and experience of the personnel and evaluate the effectiveness of the training.

Infrastructure

The organisation has to provide and maintain the infrastructure required to achieve conformity to product requirements. The infrastructure includes buildings, workspaces, utilities, equipment, and supporting services, such as transportation, communication, or information systems.

Work environment and contamination control

The organisation has to manage the work environment needed to achieve conformity to product requirements. The work environment includes physical, social, and psychological factors that affect the QMS and the Medical Device. The organisation also has to control the contamination of the product, the personnel, and the work environment, especially for sterile Medical Devices.

ISO 13485 product realisation planning

Product realisation is the process of designing, developing, producing, installing, and servicing a Medical Device. Product realisation planning is the activity of defining and documenting the objectives, resources, methods, and controls for product realisation. Let's explore the processes involved in product realisation planning:

1) Establishing the quality objectives and requirements for the product based on the customer and regulatory needs and expectations.

2) Identifying and providing the resources needed to carry out the product realisation processes, such as human resources, infrastructure, work environment, and contamination control.

3) Determining and documenting the product realisation processes. It includes design and development, purchasing, production and service provision. It also includes control of monitoring and measuring equipment.

4) Defining and documenting the verification, validation, monitoring, measurement, inspection, and test activities and criteria for the product

5) Establishing and documenting the traceability, identification, preservation, handling, storage, distribution, and delivery requirements for the product

6) Planning and documenting the records that demonstrate the conformity and effectiveness of the product realisation processes and the product

Product realisation planning helps the organisation to confirm that the product meets the particular requirements and performs as intended. It also helps the organisation to manage the risks and opportunities associated with the product.

ISO 13845 measurement, analysis and improvement

Measurement, analysis and improvement are the activities that the organisation performs to monitor, evaluate, and enhance the QMS and the Medical Device. Let's explore the processes involved in it:

1) Data collection and analysis: Collecting and analysing data and information related to the QMS and Medical Devices is essential. This includes customer feedback, complaints, regulatory reports, internal audits, process and product performance, and improvement actions.

2) Cause identification: Identifying and investigating the existing and potential causes of nonconformities and problems in the QMS and Medical Devices is a crucial step. This process involves using risk management and statistical techniques.

3) Corrective and preventive actions: Taking appropriate and effective corrective or preventive actions to prevent the recurrence or occurrence of nonconformities and problems is a key responsibility. Furthermore, verifying or validating the effectiveness of these actions is equally important.

4) Continuous improvement: Continually improving the QMS and the Medical Device is an ongoing endeavour. This involves identifying and implementing opportunities for enhancement and measuring and monitoring their results.

Measurement, analysis, and improvement help the organisation comply with regulatory requirements and satisfy the customers' and patients' needs and expectations.

Importance of ISO 13485

ISO 13485 holds significant importance in the Medical Device industry. Let’s explore the Importance of ISO 13485 certification for organisations:

Regulatory compliance

ISO 13485 aligns with regulatory requirements in various regions, such as the European Union's Medical Device Regulation (MDR) and the U.S. Food and Drug Administration's Quality System Regulation (QSR). Compliance with this standard demonstrates compliance with these regulations, facilitating market access for Medical Devices.

Enhanced product quality

ISO 13485 promotes implementing robust Quality Management Systems, focusing on risk management, design and development processes, production controls, and post-market surveillance. By adhering to the standard, organisations can identify and mitigate potential risks, resulting in safer and more reliable Medical Devices.

Customer confidence

Adherence to this ISO standard shows a manufacturer's commitment to delivering high-quality products that meet customer expectations. It enhances customer confidence by demonstrating compliance with internationally recognised standards and a dedication to continuous improvement. This, in turn,his can lead to improved customer trust and satisfaction.

Streamlined processes

ISO 13485 emphasises process-based approaches, documentation, and traceability. By implementing efficient processes, organisations can enhance productivity, reduce errors, and minimise costs. A well-structured Quality Management System helps streamline operations and ensures consistent adherence to regulatory and customer requirements.

International recognition

It is globally recognised and accepted, providing a common language for organisations operating in the Medical Device industry. This recognition allows manufacturers to expand their market reach, attract international customers, and collaborate with partners worldwide. ISO 13485 Certification shows an organisation's commitment to meeting international quality standards.

Risk management

ISO 13485 places significant emphasis on risk management throughout the product lifecycle. Organisations can ensure patient safety and minimise adverse events by implementing a systematic risk assessment and mitigation approach. This proactive approach to risk management enables informed decision-making and the implementation of appropriate measures to mitigate potential hazards.

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Conclusion

Now that you know What is ISO 13485, you can adhere to this standard to demonstrate a commitment to quality, improve market access, and gain a competitive edge. It is a crucial standard for the Medical Device industry, ensuring regulatory compliance, enhancing product quality, and instilling customer confidence. By embracing this standard, organisations can establish themselves as trusted players in the market and contribute to advancing patient safety and healthcare worldwide.  

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