After an Audit, What Next?

Internal Audit Management and Tracking SoftwareHave you ever felt anxious about something that was about to happen at your workplace.? Imagine if the “something” was called an audit, increasing your anxiety to a stratospheric level regardless of the preparations you have made for it.

Well, Product Audit, Process Audit, System Audit, Safety Audit, 5S Audit, Internal Audit, External Audit, certification audit, re-certification audit, surveillance audit, environmental audit, energy audit… the list goes on and when it’s an ISO certified site it gets worse.   People working ISO Certified facilities get familiar with all different audit types mentioned above and in some way all of the different types of audits types can be addressed by using an effective QMS system.
Continue reading

Requirement of Knowledge Management in ISO 9001:2015

Requirement of Knowledge Management in ISO 9001:2015This blog refers to ISO 9001:2015 Clause 7.1.6 “Organizational knowledge” and is specifically in relevance to organizations seeking to implement or update to the latest version of ISO 9001:2015 along with anyone thinking about implementing the international standard.

“You know more than you can tell”

Albert Einstein’s research assistant Michael Polanyi outlined a fine distinction between tacit and explicit knowledge through the above sentence. And so has the ISO organization through this revised version of ISO 9001:2015.
Continue reading

CAPA by filtering – It’s not everything that requires a CAPA!

EQMS Software for Medical Devices

Oftentimes in business it is felt that in the quest of excellence organizations tend to capture all adverse effects (events) to initiate Corrective Actions by overlooking the question of its criticality.

Surprisingly it happens in both type of organizations – one where QMS is comparatively immature and the other where organizations primarily work towards an improved excellence level. The former striving to attain stability and the latter to achieve consistency.

However, by indulging in attaining such perfection level they end up in slowing down the situation and loosing efficiency due to the absence of a filtering system that separates the critical from the non-critical events.
Continue reading