A Guide to ISO 13485

The ISO 9001 Group’s ISO 13485 quality management system consultants are experts that understand the steps to achieve ISO 13485 certification or compliance for medical devices. We can help your organisation design, develop and implement an ISO 13485:2016.

Benefits of ISO 13485

• Win more bids where certification is a requirement or a competitive advantage

• Provides the foundation for obtaining CE marking, which is required to gain access to the European market

• Meet customers’ requirements for certification

• Improved structure, processes and procedures internally

• Better internal controls, which will improve operations and reduce risks

• Achieve ISO 13485 certification

What is ISO 13485?

ISO 13485 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organisations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.

Why is ISO 13485 important?

ISO 13485 is crucial for manufacturers and suppliers of medical devices as it establishes a framework to ensure consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. It aids in meeting rigorous regulatory requirements and managing risk, while ensuring best practices in the manufacture of medical devices. This standard not only facilitates market access across different countries but also enhances trust among stakeholders through demonstrated commitment to safety and quality.

Benefits

•  Risk management enhancement: Provides systematic methods to identify and mitigate risks throughout the product lifecycle, ensuring patient and user safety
•  Regulatory compliance: Helps organisations meet strict regulatory requirements specific to medical device manufacturing, crucial for market access and global trade.
•  Operational efficiency: Streamlines processes to improve overall efficiency and effectiveness, reducing waste and increasing productivity
•  Market access: Facilitates entry into global markets with standardised compliance, enhancing competitive advantage
•  Enhanced reputation: Builds credibility and trust with stakeholders, including regulators, customers, and end-users, through proven adherence to a globally recogniaed quality standard

The most recent update to the standard was published in February of 2016, overriding previously published versions from 2003 and 1996. ISO 13485 derived from ISO 9001, a quality management system certification that’s available to businesses in a wide variety of industries. However, medical device and pharmaceutical companies have specialised requirements that made some of the requirements of ISO 9001 difficult to apply. ISO 13485 was developed to address these needs.

ISO 13485 provides a great advantage for organizations producing medical devices and related services. It assures a commitment to quality and increases efficiencies within the organization. Becoming ISO 13485 certified can increase your client base and reduce barriers to entry of foreign markets, product liabilities and production down-time.

Many businesses prefer to work with medical device organisations that have ISO 13485 certification, and some require all the companies they partner with have it. This is due in part to the fact that, under the latest version of ISO 13485, companies are responsible for ensuring any subcontractors they work with conform to ISO 13485 requirements. Because of these preferences and requirements, ISO 13485 certification enables you to win more business.

Applications of ISO 13485

ISO 13485 specifies quality management for medical device manufacturers and related organisations. This means a variety of companies in the medical device industry and pharmaceutical supply chain use ISO 13485 standards. Organisations that use this standard include:

• Manufacturers of medical devices.
• Organisations that supply products or raw materials to medical device manufacturers.
• Quality management organisations that contract to medical device manufacturers.
• Organisations that provide services to medical device manufacturers.
• Makers of sterile medical devices.
• Manufacturers of surgical medical devices.

A significant change in the 2016 update addresses outsourcing. This update requires an organisation to ensure that companies it contracts with meet ISO 13485 standards when outsourcing the development, design or servicing of a medical device.

ISO standards are voluntary, so being certified to ISO 13485 isn’t always necessary. Europe and Japan offer alternative national standards.

Although certification isn’t required, it can provide an advantage. Many countries base their regulatory standards for medical devices on this standard. Achieving either ISO 13485 or ISO 9001 certification is seen as the first step to approval for a medical device in Europe. Beyond earning regulatory approvals, following the ISO 13485 standard can produce higher quality medical devices. They’ll be more trusted in the marketplace, and your manufacturing processes will produce fewer errors, scraps and reworks.

About the 2016 Update

The deadline to transition to the 2016 version was March 31, 2019. ISO 13485:2016 is now the sole version of the standard that any organisation can hold an active certification for.

All ISO standards undergo review every five to ten years to determine if the standards need revisions to remain relevant in the current market.

Before 2016, the most recent version of the standard had been released in 2003. Over the next 13 years, multiple jurisdictions revised or introduced regulations for medical devices, leading to dramatic changes in the medical device industry. In 2016, ISO staff reviewed the 2003 standard with various regulatory bodies and came to the consensus that revisions were necessary to reflect current quality management needs.

Since the 2016 revision arrived, the requirements within ISO 13485 have been adopted into a number of different countries’ regulatory programs. Regulators in Australia, Canada, the European Union, Japan and the United States use it. It is used with modifications in the United Kingdom and by the Medical Device Single Audit Program.

Many of the revisions made to ISO 13485 reflect its importance to regulatory bodies. Among these revisions are:

• Increased alignment with regulatory requirements.
• Adjustment of software standards for measurement and reporting.
• Additional requirements for verification and validation planning.
• Increased emphasis on addressing consumer complaints.
• Additional requirements for reporting to regulatory authorities.
• Greater emphasis on risk-based decision-making and risk management.

These revisions ensured that ISO 13485 aligned more fully with regulatory requirements for medical devices while still incorporating the quality management requirements from the ISO 9001 standard.

Key Differences between ISO 13485 and ISO 9001

ISO 9001 outlines a quality management system for general industry, so it shares similarities with ISO 13485. Companies that manufacture both medical devices and other products, such as some contract manufacturers, may want to maintain both certifications.

Since the two certifications speak to different types of manufacturing and align with different regulatory standards, each has some key elements that the other lacks. For example, ISO 9001 is mostly geared toward customer satisfaction through high standards for quality management systems. Meanwhile, ISO 13485 focuses more heavily on the safety and efficacy of medical devices and is closely linked to many regulatory requirements. As such, its documentation requirements are more extensive.

Components and requirements unique to ISO 13485 include:

• Additional requirements for preventing contamination
• Monitoring focused on meeting customer requirements rather than on subjective customer satisfaction measures
• Multiple documentation requirements at all stages of product development
• Focus on maintaining the quality management system’s effectiveness instead of continuous improvement, as required for ISO 9001
• Risk management during design and production
• Additional requirements for regulatory reporting, advisory notices and recalls