Planning has always been required and buried in other areas, but is now a stand-alone requirement. The basic function of Planning is simply to meet customer requirements through the processes you have put in place to manufacture your product. This is where the standard really makes a major change by focusing on Risk Based Thinking. […]
How can you meet the requirements? As discussed last week, the good news is that the new requirements are very similar to the current version, so major changes are not required in the way top management must be involved in the QMS. The below list are ways to demonstrate that top management has a commitment […]
Requirement A major change in ISO 2015 is more focus on the company supporting the quality system. “Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction” (7.2.1 and 8.2.1). Management Commitment has always been a major part of ISO, but the 2015 version places more […]
Published on Feb 23, 2016 Watch Course Video Here: https://youtu.be/GnWf1vHL_LU Steve Williams, President of The Right Approach Consulting, will be teaching the Professional Development course PD23: Lean: 10 Things Every Manager Should Know – for Improved Organizational Performance and Competitive Advantage at IPC APEX EXPO® 2016 the week of March 13th in Las Vegas. Attendees will […]
The revised 2015 version continues to be consistent with the plan-do-check-act (PDCA) improvement cycle, and continues to use the process management structure widely used in business today. It introduces several new clauses intended to drive Risk Based Thinking. What the heck is a process-based system, or the process approach? ISO, and frankly good business practices, […]
Internal & External Factors Clause 4 of the new standard requires that an organization must determine what issues and requirements will impact planning and quality. To establish the context means to define the external and internal factors and must consider when and how they affect quality. The internal context may include: Your products and services […]
Where to Start? First, you need to determine which of the new requirements are already being satisfied in your existing quality system documentation (whether a formal certified QMS or homegrown), because some of the requirements scattered throughout ISO 9001:2008 are now consolidated into this new clause. If you have already implemented ISO 9001:2008, then you […]
Making the Simple Complex With each iteration of ISO 9001, the powers that be seem bent on developing one requirement using verbiage that makes a simple concept complicated to understand. For the 2015 version of ISO 9001, Context of the Organization is it. They can certainly take a cue from my friend Tom Peters when, […]
The new ISO 9001:2015 standard is now released and is quite a departure from the 2008 version. While the official drop-dead date to be fully compliant and certified is not until September 2018, this will come much faster than you think. Now is the time to begin the transition from your 2008 QMS to the 2015 version. These changes can […]
The goal of root cause analysis (RCA) is to find out what really happened, why it happened, and how to prevent it from happening again. Chasing symptoms instead of digging deep to find root cause will almost certainly guarantee that the problem will repeat. Peeling back the onion, layer-by-layer, can be a long and tedious […]
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