The impacts of roles in quality system management that many managers overlook but can significantly slow down your organization.
1️⃣ Reorganizations affect roles in quality system management.
2️⃣ The quality system must clearly define roles and responsibilities.
3️⃣ After a reorganization, organizational roles must align with roles in quality system management.
Key takeaway
When you reorganize, ensure that your organizational roles are consistent with roles in quality system management to avoid mismatches.
Benefits:
1️⃣ Less uncertainty during reorganizations.
2️⃣ Increased credibility.
3️⃣ Faster implementation—or no implementation issues—when roles in quality system management are clearly separated from organizational roles.
We have built this into our tool because we have seen how much time, energy, and money is wasted during reorganizations. This is one of the key reasons why we developed ColabON AG.
ColabON helps you reduce the time and effort of reorganizations by 90%
Why are clear roles in quality management required?
ISO 13485 Claus 4.1.1 und 5.1.1
CFR Title21 Part 820 subpart B 820.20
and many more
What is a Role in the Quality Management System?
A role refers to a function or responsibility of a person within the Quality Management System (QMS).
Each individual can take on multiple roles within the QMS.
Do not use organizational roles such as CEO, CTO, or organizational leader functions. The organization may change—don’t let this affect your Quality Management System!
What Are the Most Common Mistakes?
Using organizational roles such as CEO, CTO, or department heads as quality roles.
Organizations evolve. Teams and structures can shift, but your QMS must remain stable to ensure compliance and effectiveness. When organizational changes affect your quality roles, it can lead to:
Gaps in responsibilities.
Miscommunication across teams.
Reduced compliance and loss of trust during audits or inspections.
How to Avoid These Issues
1️⃣ Separate quality roles from organizational roles: Assign quality roles independently of the organizational hierarchy to maintain stability during changes.
2️⃣ Simplify reorganizations: Clearly defining quality roles reduces uncertainty, strengthens credibility, and allows faster implementation of changes.
3️⃣ Use tools for consistency: At ColabON, we’ve integrated these principles into our solutions. We understand how much time, energy, and money is wasted during reorganizations when quality roles are not managed efficiently.
This is how ColabON's Software has efficiently implemented the Roles in Quality System Management (QMS)
They are compliant with ISO/TR 24971:2020 - Technical Report on Medical Devices Risk Management. Clause 4.3 includes examples with attributes, which we have incorporated into ColabON.
By aligning quality roles with regulatory standards, ColabON ensures your processes remain compliant, effective, and ready to adapt to organizational changes.
Name | Responsibility | Authority | Competence Requirements |
90% More Efficient Role changes with ColabON
Don't let reorganizations derail your QMS.
With clear and consistent quality roles, you ensure the integrity of your quality processes and keep your organization on track.
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