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Midwest QualityTM

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ISO 9001:2002 Implementation

ISO 9001:1994 to ISO 9001:2000 Transition  ISO 9000:2000 Home
ISO 9000 Education  ISO 9000 Improvement Program   

Midwest Quality's trend-setting Focused ISO-9000 Registration program.  An extremely effective audit-proven 100 day program which guides your organization to registration.  The proof is in the hundreds of satisfied clients who now know it works, because they are now registered.  In fact, it has never failed.  The reason is not magic but good Midwest Quality professionals combined with the right approach, project management, training, and leadership.

The Midwest approach to developing a quality system is two phased:

  1. Describe what you do now in the ISO 9000 format, and add only what is essential to be registered. This is Minimal ISO 9000. Most locations which can routinely ship material which is not returned have good basic systems, but when people examine systems to document them, they often see opportunities to improve. It is the Midwest recommendation to keep the systems (which have been working for years) for a few more months, so that there are no additional changes to implement just before the registration audit. This approach significantly reduces the risk of over-compliance, i.e., when a procedure is implemented which is not required by ISO 9000 and does nothing to benefit the company.
  2. As soon as the quality system fully complies with the requirements of ISO 9000, the location aggressively begins to improve their "quality system" throughout the company, and to see improvement in the related results. Improvements are implemented only because they will clearly benefit the location: the issue of compliance was settled by registration. The implementation team members keep track of their improvement ideas while they prepare, and after registration begin an orderly process of improvement which continues forever. The implementation team becomes the improvement team.
Kickoff Workshop Day 1:

The first visit to each site provides an opportunity for the Midwest auditors to meet with the location implementation team and management. The average site requires100 days from kickoff to registration date, the initial visit is scheduled based on the desired completion. The average site can complete all the required tasks and register to ISO 9000 without additional personnel. Ask for help in determining who should attend the Kickoff.

Kickoff Workshop: This visit includes the six hour "ISO 9000 Kickoff Workshop" which establishes the implementation team, trains the team in the concepts of ISO 9000, and establishes a plan with target dates. And the participants have fun as well!

Status Assessment Audit, day 7-8:

The auditor will assess the quality system with a Status checklist, and can then confirm the status of the quality system. The auditor also spends time with each element champion and ensures that they are headed in the right direction in writing the procedures for the Rough Cut Audit. The auditor and team then establish if any other Midwest activities are appropriate, and confirm the timetable for the Rough Cut Audit. A full report is made available to management, and the audit counts as the first internal audit cycle.

Rough-cut Audit, Day 37-38:

The first full audit occurs as soon as a location has completed its procedures, typically 30 days after the status. The auditor determines if the system addresses the requirements of the standard prior to the training and implementation effort. It is hard enough to train people to comply with requirements, and an outright shame to train them to do something which is not in compliance with or required by ISO 9000.

The audit also serves as a complete internal audit cycle, and serves as the basis for the first management review. The location internal quality auditors participate to gain experience under professional guidance, which gets the internal quality audit program off to a good start. The auditor provides a complete audit report and copies of the completed checklist.

The auditor also helps the implementation team with the corrective actions to fix the system deficiencies discovered during the assessment. The location ends up with a complete to-do list, with timing and responsibility.

The audit is also training and practice for passing the registration audit. The auditor coaches the people who are interviewed, and helps train them in how to pass. By the end of the three audits (Rough Cut, Preliminary, Dress Rehearsal), people are ready! The guides who will escort the registration auditors practice that essential skill.

Fine-cut (Preliminary) Audit, day 69-70:

The fine-cut preliminary audit is scheduled once the corrective actions have been completed, and the location thinks they are ready (typically 30 days after the Rough Cut Audit). The fine-cut preliminary audit will be the second complete internal audit cycle, and determines readiness for the registration audit. Location internal quality auditors participate to improve their skills.

The audit is conducted the same as the registration audit to provide training to the auditees. The auditors continue to coach the people they interview as they determine that the system is in full compliance with the ISO 9000 requirements. The guides improve their skills, and the auditors work with the implementation team to ensure that the corrective actions are appropriate and planned.

When the audit finds no significant deficiencies in the location quality system (which is normal at this stage), the date for the registration audit is selected, and the registrar contacted.

Dress Rehearsal Audit, Day 90:

The Dress Rehearsal Audit is held about ten days before the registration audit. The auditor and guides review all the interview questions with the probable auditees to remind everyone what to expect. Any corrective actions from the Fine Cut Audit are reviewed for effectiveness. This audit usually finds details which are easy to clean up, and would have been findings in the registration audit.

Third Party ISO 9000 Registration Assessment, Day 100:

There is usually no need for Midwest personnel to attend the registration audit. The location team is in place, and the guides are prepared. The implementation team is ready to complete immediate corrective action for any nonconformances noted by the auditors. Their goal is to have no open findings at the closing meeting so that the auditor recommends immediate registration. Midwest is proud that our customers usually achieve that goal!

After registration Midwest Quality offers a formal Performance program to guide your team in making the difficult transition from implementation to operating a High Performance Quality System.  We call this the "Performance Engine."
Midwest also provides custom-tailored programs for unusual situations, such as corporate multi-site registrations, or companies who are experiencing real quality problems which they need to fix.  We call this just "consulting".
 

For More Information Contact: tony@midwestquality.com or 800 464-9008 

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