Safety Is Non-Negotiable for Medical Devices: Having an ISO 13485:2016 Registered Partner Is Essential to Your Business Success

As a medical device manufacturer, you know that safety and quality are non-negotiable. You also know that it is imperative to meet regulatory compliance and ensure quality management.

Delivering on these imperative requirements and staying ahead of the competition requires utilizing service partners with an ISO 13485:2016 registration

In this blog, we discuss what this means, its benefits to you and why Quest is your best choice for a service support partner.

What is ISO 13485:2016?

ISO 13485:2016 is an international standard that specifies requirements for a Quality Management System (QMS) designed explicitly for Medical Device Manufacturers. This standard applies to organizations involved in one or more life-cycle stages of a medical device, such as Design and Development, Production, Storage, Installation and Servicing.

Why is ISO 13485:2016 Registration Important?

ISO 13485:2016 registration is essential to medical device manufacturers for several reasons:

Regulatory Compliance: Compliance with ISO 13485:2016 is often required by regulatory bodies that approve medical devices, for example elements of 21 CFR 820 are imbedded in ISO 13485 as part of the FDA’s oversight of medical devices. Many countries, including the European Union, require medical device manufacturers to be ISO 13485:2016 registered to sell their products.
Quality Management: The ISO 13485:2016 registration helps ensure that medical devices are manufactured and serviced within the highest quality standards, reducing the risk of defects, recalls, and adverse events.
Competitive Advantage: Being ISO 13485:2016 registered can give medical device servicers a competitive advantage by demonstrating their commitment to quality and safety.

How stringent is ISO 13485:2016?

ISO 13485:2016 audits are thorough, competent, relevant and challenging. An effective audit can include the following:

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
Improved processes, consistency, and customer satisfaction
Reduction of risk (Risk management), non-conformities, and waste
Increased efficiency and cost reduction

How does Quest’s ISO 13485:2016 registration benefit my company?

Your company benefits from Quest’s ISO 13485:2016 registration in several important ways:

Compliance: First and foremost, Quest uses this registration to ensure that its Quality Management System (QMS) complies with the standard's requirements. This means that Quest is committed to implementing and maintaining an effective QMS that meets the needs of its customers and regulatory requirements.
Competitive Advantage: Quest uses this registration as a competitive advantage in the marketplace. Many customers, particularly in the medical device industry, require their suppliers to be registered to ISO 13485:2016. By achieving and maintaining this registration, Quest can demonstrate its commitment to quality and compliance, which gives prospective clients peace of mind that their devices will be in good hands.
Continual Improvement: ISO 13485:2016 is a process-based standard requiring organizations to continually monitor and improve their processes. Quest utilizes this registration as a tool for constant improvement, regularly reviewing and enhancing its QMS processes to ensure they are efficient, effective, and meet customer needs. Quest does this by periodically soliciting customer feedback through business reviews and surveys. Working with various clients gives Quest the constant input needed to improve its processes.
Risk Management: The ISO 13485:2016 standard places a strong emphasis on risk management, particularly as it relates to product safety and regulatory compliance. Quest utilizes this standard to ensure that it has effective processes in place to identify and mitigate risks throughout the product service cycle.

Overall, the ISO 13485:2016 registration is an essential tool for Quest to ensure that it provides the highest level of customer experience, safety, and satisfaction, complying with applicable regulatory requirements while continually improving its processes to ensure the highest level of quality is always achieved.

In Summary

Quest’s ISO 13485:2016 registration demonstrates its commitment to quality and safety when servicing medical devices. Contact us today to learn more about how we can provide superior support services to your company.

Quest International has a well-established process for implementing any changes related to revisions of the standard. Here are the steps Quest typically takes to meet the most current revision of any registered standard:

How Quest Maintains Its QMS to Ensure Compliance

When a new revision of a standard is released, Quest consults with its notified body and works diligently to revise its Quality Management System (QMS) to meet the requirements of the revision, then seeks registration to meet the revised standard in a timely manner.

Quest International has a well-established process for implementing any changes related to revisions of the standard. Here are the steps Quest typically takes to meet the most current revision of any registered standard:

Review the Changes: When a new version of the standard is released, or changes are made to the existing version, Quest's team of experts reviews the changes to identify how they will affect the company’s QMS and how it may affect their dealings with clients.
Communication: Quest communicates with its notified body to understand the nature of the revisions and how they will need to be implemented.
Gap Analysis: Quest conducts a gap analysis to identify any gaps in its quality management system compared to the standard’s new requirements.
Quality Management System Development: Based on the gap analysis, Quest develops and implements any necessary changes to the QMS to match the new revision of the standard.
Internal Auditing: Quest conducts internal audits ensuring QMS system changes are effective and compliant with the standard’s requirements.
External Auditing: Once the changes have been implemented, Quest schedules a registration audit with its notified body to obtain registration to this new revision of the standard.
Maintenance: Quest works to maintain its registrations by conducting periodic internal audits and making any necessary changes to its QMS.

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