Please enjoy free use of these working documents that we hope you will find useful in your pursuit of a better QMS.
All that we ask in return is that if you make improvements that you feel would benefit others, then please so that we can continually improve these tools for everyone. New items or revisions are highlighted.
NEW! – - Please download this for the corrective action exercise. – added 3/31/11.
NEW! – – Please download and complete this for the NCR exercise and closing meeting role play. – added 3/31/11.
NEW! – - A recently created worksheet to guide you through a process definition exercise using the six sigma concept of Y=f(X) – added 4/15/10.
NEW! – - A PP Presentation for top management to help them understand their responsibilities related to the “Management System” requirements of ISO 9001. - added 10/28/09
NEW - - A complete measurement system package of stuff to determine if leadership / communication initiatives are effective. - added 3/31/11
- Let's face it, the process turtle is overrated and underused (for audits only) without adequate input and use by top management. It's time for it to evolve. The Six Sigma SIPOC model is better than the turtle but still has its limitations. Why not merge and improve these two tools and while we're at it start using Six Sigma and ISO 9001 together? If it's not measurable, then why define it at a high level / management level view of a process? Here is a MS Excel template for defining processes that I feel is an improvement over the turtle. The goal is to define a process in a way that can be used by top management to effectively manage processes through measurements. This is still in development and any input / help is appreciated. My Excel skills are limited so any formatting improvements are appreciated also. You may want to check often for updates. Eventually, this will be released within a full Quality Manual template. Current improvements include a focus on more meaningful information for top management such as process risk analysis. Why a spider you ask? It's got 8 boxes / legs and just plain sounds cooler than a turtle. All I want is credit for the name... - added 3/9/07
NEW! - by Mike Bupp - Please thank Mike for his efforts to improve this tool. - added 2/28/09
NEW! - - A MS Power Point based Business Manual for a Pizza Shop in one file. This is used for my QMS Auditor Training Course case study. I give it all away! – added 2/28/09
- A MS Power Point based Quality Manual that seems to be the "best" approach for ISO 9001 / TS 16949 based Quality Manuals. The most important part of the ISO 9001 requirements for any Quality Manual is to "define the interaction between the processes". This clearly achieves this goal and can be actually used within the organization as a tool for employee orientation training. NOTE: You need to start the QM using the Power Point Presentation file called "Quality Manual" in the QMS Manual sub-folder. - revised 1/9/07
- I have now given away ALL of my consulting materials! Here is a complete set of procedures required by ISO 9001 and TS 16949. They are much simpler than you would expect since most of the "fluff" has been removed. Each of these cover the most important topics that need to be addressed and explain how to make use of many of the tools provided on this site. You should find them very helpful as a starting point for your ISO journey or as a benchmark to improve your current procedures. - added 3/15/07
- Kindly provided by Allan Aanonson. Based on a quote from Taiichi Ohno - "Let flow manage the processes, and not let management manage the flow." Slide 1 shows today's typical management method. Slide 2 shows how we might ideally manage our business. Do your business objectives start with profit targets and attempt to cascade these down throughout the organization? This might make you rethink this concept as a backwards approach to managing a business. - added 2/25/07
- Kindly provided by Ted Schmitt. A MS Word based process diagram that expands on the basic "turtle" and "SIPOC" models by showing how PDCA works within the process and also includes environmental aspects for your ISO 14001 needs. A great tool to "define the interaction between the processes". - added 2/25/07
- A MS Excel based process definition tool to help define the QMS processes and form the basis for your Quality Manual.
- A MS Excel based balanced scorecard that can streamline and improve your management review process. NOTE: This example was done for a commercial printer. Your scorecard will be based on your processes and metrics as defined in your SIPOC Quality Manual. Please contact me directly for help customizing this for your business. - added 2/15/05
- A MS Word based worksheet that can streamline and improve your management review process. - added 11/29/06
- A simple tool to help define the basic information necessary to effectively manage a process. - added 3/28/04
- A PowerPoint slide that can be used to explain the concepts of an effective QMS based on PDCA. - added 1/21/04
- A MS Power Point presentation for educating top management on their critical leadership role on this journey. – REVISED 1/28/08
NEW! – - A detailed step by step procedure for this. – added 6/24/10.
- A corrective action form that can be used for all types of problems as well as to track OFI's, preventive actions, and continual improvement projects. Includes the use of form fields for analysis purposes. Also includes the failure mode risk priority numbers (RPNs) before and after action is taken so the quality/effectiveness of individual corrective and preventive actions and ultimately the effectiveness of these systems can be measured. - Help text was recently added for most fields (use F1 key or look in MS Word status bar) . revised 7/20/04
- To be used with the Problem Solver Improvement Form. - revised 2/15/05
NEW! – - This is a powerful set of tools to identify the 6M specific causes of a failure mode using the fishbone and prioritize what needs attention using the FMEA - added 8/17/10
- This is a powerful tool to identify and prioritize problems in any company. FMEAs are a great source for preventive actions! Used in the automotive and aerospace industries for years. Also can and should be used with the Problem Solver Improvement Form. To order a great FMEA instruction manual / workbook go to and look under "products/training" then "quality" then "core tools" then "FMEA-3". - revised 11/1/07
- A good example of criteria for ranking FMEA severity, occurrence and detection values - added 6/1/07
- This includes a form used by Delphi to get to the root cause of a problem along with instructions and a critique guidance document. - updated 12/19/07
- This is a tool used by GM to get to the root cause of a problem. - added 2/15/05
NEW! – - A generic checklist that drives better auditor behavior without blinding them to what matters... - added 12/7/2010
NEW! – - (Performance, Risk, Variation, Waste) – A nice PP presentation for developing audit trails. From my auditor courses... - added 8/5/09
NEW! – – Additional questions for developing audit trails. From my auditor courses... - added 10/28/09
NEW! – – A “turtle” based audit report form that drives the auditor to focus on the process metrics -> process data -> process outputs (Y’s) -> and investigate only the key X’s causing variation - added 8/5/09
NEW! – - (Performance, Risk, Variation, Waste, Sell it!) - Can be used for 9001 and other management system standards. - revised 10/28/09
NEW! – – Please thank Mike Bupp for his efforts to combine and improve some forms from my site - added 2/28/09
NEW! – - Some helpful tips on how to correctly use a process turtle, SIPOC or other process based audit report. - added 2/28/09
- This procedure simply explains how to use the various tools that follow and is required for ISO 9001, TS 16949 and other management system standards. - added 3/15/07
- An audit program is only as effective as the competence of its auditors. Hint: Is the audit manager using ISO 19011 for guidance? Auditors need to know more than ever in order to be effective! An auditor training course is only the beginning of this journey and most audit programs do not assess their auditors' knowledge beyond this. This MS Excel matrix can be used to record and analyze auditor competency levels and raise flags when there are shortages using conditional formatting. This example was created for TS 16949 auditors - added 2/15/05
- A nice tool to evaluate, quantify and analyze the effectiveness of internal auditors and the internal audit program as reported by the auditees (the customers of the audit process) - revised 2/22/05
- Are you focusing your audits where they are needed most and getting a good return on investment for your audits? This is a simple and easy to use tool that clearly and logically demonstrates scheduling of internal audits by status and importance of the QMS processes. Based on FMEA concepts. - revised 3/14/07
- Some basic questions that should be covered during any process audit. Works well with ISO 9001 and TS 16949 Audit Summary Reports. - added 9/7/06
- Some helpful tips and audit trails for auditing top management. - added 10/25/06
- A nice tool to prepare top management for their involvement with the QMS and give auditors some specific questions to ask. This is a work in progress. - added 3/15/07
- A powerful form to focus auditors on the task at hand... To sample and record evidence of compliance & effectiveness. - revised 12/06
- First you need to know which ISO 9001 clauses and CSRs (Customer Specific Requirements) apply to each process so you know what to audit. Process owners can and should use this matrix to prepare for the audits as well.- revised 10/23/06
- Next you need to record the results of your audits and show that you covered the applicable ISO 9001 clauses and CSRs in each process. Then you might want to analyze the audit program results and present this analysis to top management. This MS Excel form records, tracks and analyzes audit results. Note the conditional formatting so management can easily see where they have issues that need attention. - revised 2/22/05
- A powerful form to focus auditors on the task at hand... To sample and record evidence of compliance & effectiveness. Also provides a measurement of management communication and employee awareness as required by TS 16949 clause 22.214.171.124. - revised 9/7/06
First you need to know which ISO/TS clauses and CSRs (Customer Specific Requirements) apply to each process so you know what to audit. Process owners can and should use this matrix to prepare for the audits as well. - revised 10/23/06
- Next you need to record the results of your audits and show that you covered the applicable TS clauses and CSRs in each process. Then you might want to analyze the audit program results and present this analysis to top management. This MS Excel form records, tracks and analyzes audit results. Note the conditional formatting so management can easily see where they have issues that need attention. - added 2/22/05
- TS 16949 additionally requires very focused manufacturing process audits. Some customers require a specific methodology for these audits called "Layered Process Audits". This MS Excel based process audit checklist and scoring / analysis tool can be used for this purpose. - added 3/31/06
- This MS Excel matrix can be used to record and analyze employee competency levels and raise flags when there are shortages using conditional formatting. - added 2/10/05
- This MS Word matrix can be used to define competency and training requirements and track employee competencies. - added 8/18/04
NEW! – – Do you believe that you are effectively evaluating training effectiveness per ISO 9001, 6.2.2-c? Please read this and then re-evaluate where your system is. Please thank Elaine Arnold for her contribution. - added 12/14/10
- A nice tool to evaluate, quantify and analyze training effectiveness as reported by the trainees - added 4/2/04
- An "on-line" version of this tool. MS Word Form Fields can be used to automate data collection and analysis. added 4/4/04
- This procedure was created for a small company using these tools but clearly addresses all of the key HR and training processes - hiring, orientation, OJT, and ongoing improvement. It can be included in your Quality Manual or can be controlled on its own but obviously will need to be modified to explain your company's own responsibilities and methods. - added 8/18/04
- The title of this article is a little harsh but it brings some important points to the forefront. HR should be accountable for employee and organizational competency and its impact on the bottom line should be MEASURED! - added 12/18/05
In my experience as a TS 16949 auditor I have found that clause 126.96.36.199 is almost never adequately understood by most companies or auditors. What I look for is some planned, executed, recorded, analyzed, and summarized laboratory testing / calibration process validation methods. This is sometimes called "lab proficiency testing". Each type of test or calibration listed on your lab scope should have been initially validated as capable. Examples would be round robins, R&Rs on test / calibration METHODS, repeated checks using XbarR charts on retained samples / gages, etc. The results of these studies should be reviewed and additional, ongoing studies should be considered where the variation in the test / calibration process is not fully understood and controlled.
- This report can be used to summarize your lab's proficiency testing results for management review. - added 1/12/05
- MS Excel based process / element analysis & audit scoring tool automatically provides scoring summary and conditional formatting. - added 2/22/05
- A MS Excel PPAP tool. This is how suppliers / parts / materials should be approved! - revised 2/23/05
- A MS Excel worksheet for completing full MSA studies, not just gage R&Rs! - added 12/18/05
- A nice tool to logically approve suppliers with. - Revised 8/12/07
- Everyone needs to lighten up sometimes... A nice collection of these classic inspirations. Just download and unzip the file then point your screen saver towards it when you choose "my pictures slideshow" in the display/ screensaver menu. This file is almost 6MB so allow for some download time. Of course, you can always go directly to for these and other fun stuff.
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