ISO 13485 Consultant
Companies throughout the world use ISO 13485 to implement effective management systems, and to meet regulatory requirements for medical device manufacturers.
Cavendish Scott - Your ISO 13485 Expert
Our turnkey consulting projects offer comprehensive support, including ISO 13485 implementation, project planning, gap analysis, document writing, training, implementation support, assistance with auditor selection, and a guarantee of success. We also provide tailored solutions to address specific project requirements.
Contact Cavendish Scott today to learn more about ISO 13485 and how our expertise can benefit your organization.
Rules and Regulatory Requirements
ISO 13485 is widely used in a regulatory environment, particularly by medical device manufacturers to meet the regulatory requirements of countries such as Canada, Europe, and others. In the United States, the FDA QSR (Quality System Requirements) outlined in the Federal Regulations CFR 21 Part 820 serves as the regulatory framework. While there are differences in terminology and specific requirements between ISO 13485 and FDA QSR, the overall effect of both sets of requirements remains the same.
Organizations aiming to comply with both ISO 13485 and FDA QSR must demonstrate conformance to each set of requirements. While one management system is implemented, it is essential to address and meet the requirements of each set individually.
ISO standards play a crucial role in a regulatory context, as organizations failing to implement them thoroughly risk losing their ability to conduct business. Regulatory authorities can halt production and sales if they are not convinced of an organization’s compliance. While ISO 9001 is a voluntary standard chosen by organizations, ISO 13485, along with certification bodies and regulators, carries significant weight and must be taken seriously.
It is worth noting that regulated industries find it relatively easier to implement ISO standards due to their familiarity with controls and the importance of documentation. However, this should not result in overly bureaucratic systems that are difficult and costly to maintain. Rather, it emphasizes the need to clearly demonstrate conformance and avoid controversies.
Non-regulatory Use of ISO 13485
Some organizations, even if they are not directly involved in medical device manufacturing, opt to implement ISO 13485 to demonstrate their understanding and commitment to quality within the medical device industry. ISO 13485 certification serves as evidence of their alignment with the industry’s quality expectations.
While ISO 9001 is technically the correct standard for such organizations, ISO 13485 implies a better understanding of the medical device industry. However, it should be acknowledged that certain additional requirements included in ISO 13485 may not be applicable to these organizations. These requirements focus on processes, issues, and situations that are specific to medical device manufacturers.
For subcontractors seeking ISO 13485 certification, many of the additional requirements can be simplified or adapted to their context. Although not directly applicable, all additional requirements must still be addressed, and a simplified documented system can suffice.
If you have questions about integrating ISO 13485 with FDA QSR, the process of a turnkey consulting project, or alternative options available, we are here to provide guidance. Our team can assess your readiness for ISO 13485 and offer the necessary support and insights.
