The Good, the Bad And the Ugly

In the service industry, change is the only constant. ISO 9001 is a vehicle to educate your management team about systems thinking, the process approach and process improvement tools and techniques. These topics require basic knowledge for manufacturing managers but pretty much a foreign language in your service industry.

Here is the challenge. Take a nonmanufacturing service organization that has electronic transaction processing as its main product and get registered to ISO 9001. Piece of cake!

The Good
Implementing a quality management system (QMS) can clarify the way you do business. You establish formal methods for measuring your processes and taking corrective action when results don’t meet goals, which is something you didn’t do previously. Frequent management review facilitates improvement, and tying the QMS to your strategic plan makes both the strategic plan and the QMS stronger.

The quality policy supports your quality manual. It provides focus on improvement and makes you think about what the QMS is really all about. Every external auditor queries you on the policy, which is good reinforcement and emphasis of those tenets.

ISO 9001 requires measurement. Setting measurable objectives at all levels helps employees understand what is expected of them and also provides a benchmark for managerial improvement activity.
During your quarterly management review meetings senior management identifies global improvement opportunities and collaborates on best practices. Management also shares ideas for improvement when operational and strategic goals are not being met.

The implementation of ISO 9001 facilitates educating all levels of management in tools of TQM and process improvement. Root cause analysis, control charts and process variation are becoming a language service industry people actually understand.

Your employees have clearly defined documentation to perform their work. If they follow it, they know they are doing exactly what they are supposed to do. There are feyour errors, which makes for satisfied customers and happy management.

Members of management like the QMS for many reasons:
• They know everyone will produce a consistent product if he or she is following the work instructions.
• They have one central place to make process changes and corrections.
• They understand their processes much better because they are responsible for documenting, maintaining and improving them.
• That understanding of the process helps managers know what to measure, which is the basis for all improvement.

Your customers are impressed with the ease with which you can provide information and data for their numerous auditing requirements.

ISO 9001 also supports your internal compliance program. You are moving toward identifying the measures and work instructions related to your control objectives so they can be better monitored by management and through the ISO 9001 internal auditing process.

Measurement and continuous improvement are key successfully reaching strategic plan goals and objectives, and the ISO 9001 QMS supports your numerous strategic plan measurable drivers and initiatives.

The Bad

The first thing to do when you are to be the management representative for the ISO 9001 initiative is to take a five-day lead auditor training class. By looking at an implementation from the perspective of an auditor you can gain insight into how to implement ISO 9001.

You will learn about the fine art of auditing, about detailed ISO 9001 requirements and about manufacturing terminology. But you may be dazed and confused. Design control? Identification and traceability? Non-conforming product? Handling and packaging? How do you package a service? Preservation of product? Servicing? Calibration? Calibration! You pay claims. How do you calibrate a claim?

To add to the implementation confusion, your customer evaluates you by how well you perform your critical processes. For example, your main process is to pay Medicare claims. You do this at seven of your nine locations. Because CMS evaluates you by how well you do it, senior management decided to certify to ISO 9001 by process rather than by location or organization as most companies do.

You certified your medical review process across multiple locations first. This made sense because you had many process experts available to lead the implementation and certification of an entire process. Lessons learned at one location are incorporated at another location, and best practices still are shared across all locations. However, getting certified by process makes internal and external auditing a challenge (see “The Ugly”).

So, on with implementation. The main people responsible for implementing the QMS are the project (or process) leaders and the management representative. It is a big responsibility, and to do the job well requires support from every level of the organization.

Not So Bad After All
Each project leader has responsibility for ISO 9001 implementation and certification for one or more departments/processes at multiple locations. Each location has had a different schedule for implementation.

Most departments are able to implement ISO 9001 and become certified within about 12 months. You found it best to create corporate level work instructions for the elements of ISO 9001 that apply to the entire corporation. For you, these are document control, control of records, training, management review, internal audit, corrective and preventive action and planning of product realization. 

The Ugly

Your audit cycle runs for two years. Prepare for the audit, do the audit, write the audit reports, answer questions—that’s about eight to 10 hrs per audit. That adds up to 5,600 to 7,000 man-hours per audit cycle. Ouch! Any managers want to pony up some auditors to help?

A volunteer internal auditor can audit for 80 hours a cycle. Count auditor training and annual retraining for another 40 hours. This may turn out to be a nightmare.

So after wrestling with internal auditors, you end up hiring two experienced certified auditors to audit full-time. They continue to provide a fresh eye on improving your QMS.

You are slowly simplifying the jumble required in the minds of auditors and making your QMS more effective for you. Everything you do for the QMS must make sense and add value to your business. In the sequence and interaction example, you created a work group to define and document sensible value added requirements for flows that are useful to you.

Some of the other issues you have difficulty with concern corrective and preventive action. Root cause analysis is one of those strange foreign manufacturing phrases. What about plan-do-check-act?

You have had process improvement training, but you never really had to formally use it. You understood it conceptually, but when you received an audit finding and had to do corrective action, your root cause analysis was less than perfect. When you implement a correction based on a poor root cause, it’s difficult to verify, so your verification of implementation was weak as well.

You are correcting that by providing your management team with real hands-on process improvement and project management training. Senior management provided each management team a real-life process improvement project focused on improving customer requirement measures.

You hired a trained improvement specialist to facilitate the team through the improvement process, which included root cause analysis and verification of results. That worked swimmingly. Actual doing an improvement project made the tools that are used meaningful, and the managers now know them.

Not So Ugly After All

After all that, you have to admit the external auditing process actually does bring value to your QMS in many ways, and external auditors are pretty flexible when it comes to requirements that neither make sense nor add value to your organization. They are reasonable when it comes to elements such as control of measuring and monitoring devices, preservation of product, customer property, and identification and traceability because these requirements are more appropriate for a manufacturing environment than a service company.

Also, external auditors help you identify inconsistencies in your quality manual. They show you how to make management review more effective. And, they provided opportunities for improvement that really strengthened your QMS. Are they nitpicky? Sometimes. But generally they pointed to areas that really do need improvement. So, the ugly isn’t really so ugly.
Implementing ISO 9001 in a service environment is an ongoing adventure, as I am sure it is in manufacturing. It is something you never finish because you never quite reach TQM utopia. The bottom line is to continue to learn and continue to improve, and that is what the ISO 9001 certification process is all about.

Check our website for more information on the ISO 9001 Internal Auditor course or ISO 9001 Lead Auditor course.

Article Reference: QP