Tag: ISO 13485

ISO 13485 released an updated version of the standard in 2016 but it broke ranks with ISO 9001. In the past the two standards were aligned with the ISO 13485 capturing the additional requirements for the medical device industry. An ISO 13485 overview would reveal that it has retained a lot of the documentation requirements and not left the standard as subjective as the revised ISO 9001:2015.
ISO 13485 provides the requirements for quality management systems for use by the medical device industry. While it still remains broadly based on the framework set by ISO 9001 compliance with the standard will not inherently mean compliance with ISO 9001. The standard is published by ISO, an international organization. It is assessed by certification bodies across the globe accredited by IAF.
ISO 13485 overview of the standard will show much more in-depth requirements for rick management. This essentially aligns with the US CGMP regulations as also regulations by international bodies. The standard for further assessing risk is ISO 14971 which specifically deals with risk within the medical device industry. In dues course the US CFRs will get aligned with ISO 13485 and plans are underway for the update.
As a part of risk management of the systems companies will now have to assess add address the risks from outsourced processes, Lack of competent personnel, lack of adequate number of personnel, loss of traceability, failure in testing of the products at relevant stages, Failure to timely address non-conformities, and the documentation of risk itself. Management need to keep an ISO 13485 overview of their system through the planned management reviews and periodic internal audits. To ensure audits add value these must be conducted by trained and competent personnel.
QMII’s ISO 13485 lead auditor training prepares your personnel to not only effectively audit the system but also implement it as needed. An ISO 13485 overview version of the course is also available for senior management, so they understand their roles and responsibilities with respect to the standard. Having discussed this the question often arises if ISO 13485 is mandatory. As with all other ISO standards it is not mandatory to implement ISO 13485 though it is mandatory to meet regulatory requirement such as CFRs and EU MDR. However, implement ISO 13485 provides confidence to customers that the organizations uses a process based approach to continual improvement.
ISO 13485 overview of the standard demonstrates that product quality cannot be guaranteed just from implementing the standard but that it must be vigorously used. The standard can also be applied to all sizes of organizations.