The Modern Quality Manual

It is hard to believe that so many years after the release of ISO 9001:2000 there are still a lot of “old school” perspectives and misconceptions about the role, form, and function of the “quality manual” (ISO 9001:2008 sub-clause 4.2.2).  I developed the Lean QMS® Map (a 2-page graphical version of a quality manual) in […]

ISO 9001 Myth #3 – Failing ISO 9001 Certification

Sometimes the office chatter gets around to the outcome of a pending ISO 9001 certification.  With a healthy combination of fear of the unknown coupled with serious concern for getting the job done right, I often hear key players speculating whether the auditor “is going to pass us.”  Perceptions of over-zealous or inexperienced ISO 9001 […]

ISO 9001 Myth #4 – Lead Auditor Training

In my ongoing effort to counteract misinformation and misconceptions associated with ISO 9001 certification, I now turn to the misunderstood subject of Lead Auditor Training.  In the spirit of full disclosure, I must first admit that my firm owns an internationally accredited ISO 9001 Lead Auditor Training course.  In fact, Pinnacle holds the distinction of […]

ISO 9001 Myth #5 – Process vs. Procedure

In my article ISO 9001 Myth #2 – “Say What You Do & Do What You Say” I touch on the subject of considering business processes versus procedures.  As I expected, this has generated some criticism from ISO 9001 traditionalists.  While my main purpose was to debunk the “say what you do, do what you […]

Case Study – ISO 9001 Certification – Scripps Laboratories

“There was great resistance before to the documentation. But now everyone is actually happy to use it. It makes their lives easier.” Greg Stanton, Laboratory Manager Outcome: Scripps Laboratories uses Pinnacle’s Lean QMS® methodology to achieve ISO 9001 certification, simplify processes, reduce documentation, and increase collaboration. Industry: Biomedical, Biochemical Manufac Objective: Develop modern and practical […]

Case Study – ISO 14001 Certification – Johnson Matthey

“We wanted a system that not only worked for us, but one that added value to our business. With the Lean EMS® approach as a framework we developed a robust EMS that is at once a strong foundation and a useful system” Corbin Kearns, Plant Manager Outcome: Johnson Matthey, Smithfield, PA uses Pinnacle’s Lean EMS® […]

Case Study – ISO 14001 & OHSAS 18001 Certification – Hologic

“We understand all of our systems better because we did this. This process broadened our scope of understanding the entire business.” Jeffrey Joaquim Senior Manager, Corporate EHS “Although it appeared that ISO 14001 and OHSAS 18001 were going to burden the factory with some unnecessary tasks; during the training and after the certification we realized […]

Case Study – ISO 9001, ISO 14001 & Lean – RoMan Manufacturing

Outcome:    RoMan Manufacturing uses Pinnacle’s Lean QMS® and Lean EMS® to develop an integrated quality and environmental management system, achieve ISO 9001 and ISO 14001 certification, and support Lean Manufacturing transformation. Industry:     Automotive, Telecommunication, Electronics, Manufacturing Objectives: Improve and simplify the existing ISO 9001 quality management systems. Make the quality management system value-added for running […]

Case Study – ISO 9001 & TL 9000 Certification – RAD Data Communication

“Using the Pinnacle Lean QMS® provided checks and measures to help us do what we were already doing well, and offered us ways of doing things we hadn’t previously considered.” Don Swanerbury, Operations Quality Coordinator Outcome:     RAD Data Communications, Inc. uses Pinnacle’s Lean QMS® methodology to achieve TL 9000 and ISO 9001 certification, build a […]

Integrated Management System

On the “Integrated Management System – Lean BOS” page of our website I discuss the emerging trend in and demand for integrating quality, environmental, health & safety, regulatory, and business improvement objectives into a single business operating system (BOS).  On this page I state that “today’s integration objectives are generally clear: companies want a management […]