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 quality management systems.
Create […]

Job Descriptions Done Right

Job descriptions, or whatever you may call them, are frequently an afterthought for most organizations.  They are often created on an as needed basis.  Typically, job descriptions are developed to assist in recruiting and employee reviews.  I have even seen employees write their own job descriptions in an effort to clarify their role in the […]

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 […]

Case Study - ISO 9001, ISO 14001 & Lean

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 the business.
Integrate with […]

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 #2 - “Say What You Do & Do What You Say”

A second myth that plagues ISO 9001 implementation efforts is the cliché “say what you do and do what you say”.  While the first myth is responsible for misconception regarding the amount, structure, and format of documentation needed for ISO 9001 certification, Myth #2 misleads organizations as to the purpose and true intent of ISO […]

ISO 9001 Myth #1 - Documentation Glut

Welcome to the first part of the ISO 9001 Myth series of articles that will attempt to dispel some common misconceptions about ISO 9001.  In this first installment, I will address the misperception of ISO 9001 as a documentation glut.
ISO 9001 certification has become almost synonymous with a bureaucratic documentation glut.  Most companies seeking ISO […]

ISO 9001 & the Law

A colleague who is an attorney and an ISO 9001 advocate requested my comment to his recent blog post.  In his post he asserts that several recent defense contractors settled law suites with the Department of Justice because “their ISO 9001 Quality Management Systems were broken.”  He also goes on to state that “it also […]

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 […]

Predicting and Preventing

My firm, Integral Concepts, Inc., and I provide consulting and training in quantitative statistical methods for optimizing product designs and manufacturing processes.  It is sad that almost all of our projects involve REACTING to major problems that have surfaced which are jeopardizing production, customer satisfaction, and profitability.
We much prefer to work with our clients PROACTIVELY […]