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 ...