Regulatory Compliant Quality Management System - Bare Minimum

[fialor]

With the New EU MDR likely to come into effect May 2017 and implemented May 2020, businesses will continously be under more and more strain to streamline the compliance route, with regulatory professionals being challenged to become more pragramatic, and to think more along business lines.

With this in mind, what would you be your approach/strategy to setting up a regulatory compliant quality management system:

• What are your basics?
• How would you keep it pragmatic?
• How do you approach the road to bringing your current regulatory structure to compliance?

 

[Kronos147]

...what would you be your approach/strategy to setting up a regulatory compliant quality management system...

When you discuss your QMS, try saying "Management System" only. The 'Bare Minimum' approach is not effective. Do you want an ineffective Management System?

Make sure you look at what you do (Processes). Identify the requirements for that process. Review the process against the requirements. Find the gaps, fill in the gaps with easy things, like controlled checklists or work orders.

Don't re-invent the wheel! An effective internal audit should find the gaps, and once identified, these can be logged as Non Conformances and managed.


I suggest reading section 0.1 of the standard. The adoption of a Management System is a strategic decision. Failure to embrace the system cheats the organization of the benefits, and the culture turns to poo as everyone loathes to do the BS it takes to fool the auditor into letting you hang a piece of paper on the wall.


FWIW, not all auditors are like I was, but I was loath to write an NC if the company had already identified the issue and there was evidence of management.

 

[Sidney Vianna]

How do you approach the road to bringing your current regulatory structure to compliance?

While inefficiencies must always be corrected, an organization which's management wants to gamble with product regulatory compliance, within a context of diminishing goodwill by regulators and zero tolerance for failures, by society at large, is obviously uneducated in the science of assessing risks.

Failure to adequately address product regulatory compliance by denying proper resources is symptons of a very dysfunctional top management and it is just a matter of time until one of their risky bets come back to haunt them and everyone involved.