ISO-13485 Medical Devices Quality Management Systems

Quality Management System for Medical Devices

Manufacturing medical devices is one of the most high-risk industries, with stringent quality systems and product requirements. The regulatory requirements ensure that medical device manufacturers consistently design, produce, and market safe and effective products.

ISO 13485 Standard

ISO 13485 is an independent QMS standard derived from the globally recognised and accepted ISO 9000 quality management standards. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008, to manufacturing medical devices in a regulated environment.

ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, and Act; however, it is more prescriptive and requires a more thoroughly documented QMS.

The ISO 13485 standard is efficient for fulfilling the extensive QMS requirements. Implementing ISO 13485 enables manufacturers to address regulations and responsibilities while demonstrating a commitment to the quality and safety of medical devices.

Unlike others, ISO 13485 doesn’t require Certification.


ISO 13485:2016 Standard

ISO 13485:2016 is the updated standard version designed to accommodate the most current quality management system practices, such as technological and regulatory expectations and guidelines. The new version places a stronger focus on risk management and risk-based decision-making, in addition to modifications relating to the increased regulatory requirements for supply chain organisations.

Why does Medical Industry require ISO 13485 Standard?

ISO 13485 was published to assist manufacturers of medical devices in developing a QMS that ensures the effectiveness of their processes. It guarantees the safe design, development, production, installation, delivery, and disposal of medical devices for their intended use. ISO 13485 is essential for medical device designers, manufacturers, and distributors. In addition, suppliers and service providers can increase a company’s marketability as many manufacturers require Certification to conduct business with a vendor.

Patient safety is highly dependent on the quality and consistency of medical products in medical device manufacturing. Ensuring the effectiveness, control, and maintenance of your QMS is crucial for customers, stakeholders, patients and users, and regulatory agencies.

ISO 13485’s value lies in its implementation and ability to facilitate a comprehensive audit of the system’s efficacy and certificate of enrolment.

It instils greater confidence in the manufacturer’s capacity to achieve and maintain regulatory compliance consistently. In addition, it can aid in minimising surprises and failures that could compromise patient safety and harm a manufacturer’s reputation.

Why Choose Anitech?

Anitech’s QMS Consultants have experienced professionals with hands-on industry experience designing and implementing robust Quality Management Systems like ISO 13485.

Our team is dedicated to offering value to our customers and will create a strategic plan to help you enhance and maintain the quality of medical devices.

We also offer Compliance and will work as an extended team to aid your organisation.

Our Services include

  • ISO 1485 design, implementation, and Compliance
  • Documentation of procedures and Reports on findings
  • Internal Audits
  • Professional and Committed ISO Consultants

If you want our ISO 9001 Consultants to help you implement a robust Quality Management System for your Medical Devices, perform internal audits, and provide Compliance Support, feel free to reach out to us at 1300 802 163 or e-mail – info@anitechgroup.com.


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