Revised medical device quality management system EN ISO 13485:2016 - when and for whom is it needed?

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ISO 13485:2016 is accomplished and intended for use in organizations that deal with the design, development, manufacture, installation, service and sale and distribution of medical devices. It is now gaining prominence relatively quickly and is becoming the standard for organizations operating in the medical device industry.

What does a medical device or equipment mean?

These are instruments, apparatus, tools, implants or similar devices intended for use in the diagnosis, treatment and prevention of diseases or other medical conditions. There are a large number of medical devices, from basic hand tools to computer-controlled devices. As an example, we can mention from the simplest to the most complex devices:

• wound and scalpel dressings
• durable equipment such as wheelchairs, adjustable beds and dental chairs
• implantable devices such as pacemakers, monitors and prosthetic joints
• life-saving devices such as respirators, fans
• sophisticated software-driven devices such as CT scanners and MRI machines

What are the benefits of EN ISO 13485 for organizations?

Safety and compliance with medical devices are paramount in this highly regulated industry. Organizations have to comply with strict legislative and normative requirements, and therefore requirements for a quality management system are becoming mandatory in several EU countries. Companies that have an established and certified medical device quality management system declare the following:

• demonstration of compliance with regulatory and legal requirements
• ensuring a quality management system and procedures that deliver safe and effective medical devices
• effective risk management and elimination
• gaining a competitive advantage

Updates in ISO 13485

The new version of ISO 13485:2016 places more emphasis on risk management and risk-based decision making. It focuses on the risks associated with the safety and parameters of medical devices and their compliance with standards and legislative requirements. The ISO 13485:2016 standard imposes stricter requirements in the case of the use of outsourcing of processes related to the main activity of the organization, implementation of control mechanisms, evaluation of external partners and compliance with the requirements set on the basis of written contracts. Specifically, these are more stringent supply chain requirements in the area of:

• increased compliance with regulatory requirements and related documentation
• emphasis on appropriate sterile medical infrastructure
• focus on post-market activities, including complaint handling and regulatory reporting
• requirements for the design and development of medical devices and their connection with usability, verification, validation and other development activities
• harmonization of software application requirements

ISO 13485:2016 encourages manufacturers to work with doctors and users who should be involved and stimulates:

• design, development and maintenance of medical devices
• use of materials, components or subassemblies
• performing and improving services such as contract manufacturing, sterilization, logistics or calibration
• import and distribution of medical devices

Compliance with EN ISO 13485:2016 with EN ISO 9001:2015

ISO 13485 is a separate standard based on ISO 9001, but contains some specific requirements for medical devices, such as: risk analysis, sterile production and traceability. ISO 13485 contains specific requirements for organizations involved in the life cycle of medical devices, while some requirements of ISO 9001, which are not relevant, have been omitted. Today, almost all ISO management system standards are designed to have the same structure and therefore be easier to integrate into an organization's existing management systems. The standard omits some ISO 9001 requirements that are not required as legal requirements. Due to these gaps, an ISO 13485 certified organization cannot comply with ISO 9001. Unless otherwise required by the organization, we recommend that the organization providing the manufacture or sale of medical devices primarily implement and certify only ISO 13485 separately according to the organization's needs and related legislation.
 

Source:
https://www.iso.org/caring-about-health-and-safety.html

You might be interested in:

EN ISO 13485:2016 and documentation

Certification of the medical device quality management system according to the ISO 13485 standard

Internal auditor of the quality management system in the field of medical devices