Medical device manufacturing is one of the most regulated sectors in which significant-quality systems and product requirements must be satisfied.

The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.

The BS EN ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). Adopting BS EN ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrate a commitment to the safety and quality of medical devices.

What is ISO 13485?

BS EN ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted BS EN ISO 9000 Quality management standard series.

BS EN ISO 13485 adapts the previous version of BS EN ISO 9001, BS EN ISO 9000:2015 process-based model for a regulated medical device manufacturing environment. While BS EN ISO 13485 is based on the BS EN ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore, it is more prescriptive in nature and requires a more thoroughly documented QMS.

BS EN ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures consistent design, development, production, installation. and delivery through to disposal of medical devices that are safe for their intended purpose.

The importance of ISO 13485

BS EN ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring the effectiveness, control, and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The value of BS EN ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.

High-performing organizations expect BS EN ISO 13485 auditing to be thorough, competent, relevant, and challenging of the manufacturers' QMS. Effective auditing provides significant benefits for the manufacturer. The beneficial outputs of an effective audit include:

• Meaningful feedback on the effectiveness of the quality management system

• Confidence in compliance with regulations

• Identification of areas requiring attention

• Detection of areas of non-compliance and risk

• Reporting and certification that is valuable and recognized

The relationship between medical device quality management and risk management

BS EN ISO 14971 is a risk management system standard, which was designed to be compatible with BS EN ISO 13485. It helps manufacturers meet the increasing global requirements and expectations to implement not only quality but full risk management systems throughout the entire life cycle of the medical devices they manufacture.

BS EN ISO 14971 satisfies the risk management requirement for BS EN 60601-1 for medical electrical equipment and systems. It is a helpful tool for manufacturers in identifying and controlling the risks associated with their medical devices, but also evaluating interactions with other devices. Increasingly, BS EN ISO 14971, in the footsteps of BS EN ISO 13485, is becoming an international requirement for medical device manufacturers to meet regulatory expectations globally.

To read more on the topic of risk management for medical devices, click here.

How to successfully implement ISO 13485?

When an organization adopts BS EN ISO 13485, it commits to establishing, documenting, implementing, and maintaining a QMS, which includes a commitment to an effective internal audit program. There are four steps to conducting a complete and effective internal audit.

Plan

Planning is an important component of the BS EN ISO 13485 standard. Organizations must consider product realization, BS EN ISO 13485 in its entirety, and QMS requirements established by the organization. This is in addition to all of the activities related to the product, such as planning of the product, customer requirements, design, purchasing, production, storage, measuring, and any additional requirements.

Do

Conducting internal audits is one of the biggest areas of nonconformity seen in support of the ongoing process over time. As costs rise and enthusiasm for an effective system fades, organizations begin to falter. However, in order to maintain an effective quality management system, an organization must press on and conduct its internal audit plan.

Check

Once an internal audit is conducted, the results are reported, and actions to correct deficiencies must be processed immediately. Any causes for non-conformities must be eliminated.

Act

The final step in conducting an effective internal audit focuses on understanding and measuring the effectiveness of the actions taken and understanding and measuring the effectiveness of the internal audit process.

Demonstrate your organization’s commitment to the safety and quality of medical devices by adding standard BS EN ISO 13485 to your collection today.

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