07 Nov 2018

Root Cause Analysis
ISO standards such as ISO 9001, ISO 14001 and ISO 45001 provide the framework for management systems to function using a process-based approach, to achieve customer and other stakeholder’s requirements. Organizations, certified to ISO standards, strive to be compliant, efficient and remain certified. Successful systems have Top Management (TM) / Leadership that are committed to and engag...

05 Jun 2018

The only bad nonconformity it the one we do not know about. Understanding this fact is the key for leaders and their managers being careful not to create a culture that hides nonconformity. Even so it is common for managers to demand no mistakes and to react badly to errors. Leading organizations provide employees with management systems that help them to understand and fulfill the...

17 Nov 2017

Ensuring that the system positively contributes to the organization’s bottom line is important. With the cutoff date of Sept. 15, 2018, looming for transitioning to ISO 9001:2015 and ISO 14001:2015, there will be organizations chasing certificates. However, certificates can’t improve the system, guarantee better products, or render better service. The fundamental changes to the ISO st...

08 May 2017

Certifications often drive the implementation of a system approach, based on ISO standards. The primary implementation demand is for ISO 9001. Certifications do have initial costs and then recurring costs for surveillance and re-certification visits. This is a responsive approach to business requirements, invariably driven by a forthcoming contract that mandates the system approach. P...

27 Mar 2017

Not really, but it does require a new way of planning. Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check, act (PDCA) cycle, risk now appears in the “plan” phase and at each stage thereafter. This change formalizes an idea that has been around since...

15 Mar 2016

Objective auditing has always been a challenge, and this is especially true now for ISO 9001:2015 audits. To better meet customer expectations, fundamental changes have been introduced to the standard to address current business realities and advancements in technology. Much of the responsibility of meeting the new requirements falls on leaders, and a careful, objective audit to the ...

23 Dec 2014

  Some processes may be proactively designed and updated, but many just evolve.  In either case, when leaders allow the systems (in which the processes operate) not to deliver the necessary direction, information, resources and controls, these “starved” processes fail to add value. This article examines how process failure impacts quality management systems. Process Failure = Le...