QMS Deployment & Training
A quality management system cannot be bought, only built. No matter how good a QMS is, without the appropriate deployment and training it will not work effectively.
Unlike a UKCA/CE Mark, a Quality Management System (QMS) is applied to a company as a whole rather than individual product(s). Therefore, nearly all members of staff will have some form of involvement in the different processes. It is important they are aware of their responsibilities and are appropriately trained to be competent in their respective roles.
A QMS is a living system and needs to be amended and improved over time to ensure it remains relevant and works efficiently. It is also important that top management allocate sufficient resources for all staff members to conduct their roles.
Best Practices
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Prior to a procedure being made effective, training needs to be conducted to ensure that all relevant staff members understand them. Prior to this, a basic understanding of Quality Management Systems including the relevant standards/regulations such as ISO 13485 & CFR 820 is understood. Best practices are to include a QMS induction as part of the onboarding process for all staff members including relevant external training such as Internal Auditors/Lead Auditor courses.
For AI-based SaMD, Hardian also works with clients to ensure compliance to the international standard ISO/IEC 42001:2023 which covers management systems for AI and machine learning.
Case Study
How Hardian solves the problem.
As well as working with clients to implement Quality Management Systems from scratch, Hardian also offers training sessions to wider staff and guides companies through the entire implementation process. We are highly experienced in training companies not only in establishing the QMS, but also in understanding the philosophy of quality assurance and why it matters when building cutting-edge technologies.
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