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All about ISO 9000

1. An overview

ISO9000 (more formally ISO9001:2000) is an international quality standard that defines minimum requirements for a company's Quality Management System (QMS). A company's QMS comprises the organization's policies, procedures and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction. Some of the areas of the company within the scope of ISO 9000 include:

  • Customer contracts

  • Hiring and employee training

  • Design and development of products and services

  • Production and delivery of products and services

  • Selection and managing of suppliers

  • Management responsibility

  • Internal quality audits

  • Monitoring and measuring

  • Continual improvement

  • Corrective and preventive action

To receive an ISO 9000 certification a company must put the required QMS processes and controls in place, monitor performance of its processes and demonstrate continual improvement. Most companies hire an experienced consulting firm to assist with these preparations. Once the QMS is in place, a registrar (or certification body) is hired to audit the company's compliance with ISO 9000 requirements. If discrepancies are found during the audit, they must be corrected before the ISO 9000 certificate is issued. The ISO 9000 certification must be maintained through regular audits (bi-annual or annual) conducted by the selected registrar.

2. Benefits of ISO 9000

Organizations that implement an ISO 9000 compliant QMS usually realize important benefits, including a more organized operating environment, a greater number of customers and a higher level of satisfaction among those customers. Whether you are planning a QMS in response to direct market requirements or want to increase the productivity of your organization, you will experience the following benefits:

Process Improvements
As you implement your QMS, you have the opportunity to improve your processes. You will outline the current process, add the requirements of the standard and then optimize the process with input from the process users. After achieving certification, you will likely see continual process improvements. A recent survey of 100 registered firms reported the average improvement in operating margin at 5% of sales. These firms also reported faster turnaround times, and a reduction in scrap and overtime.

Increased Quality Awareness
During implementation, quality awareness will increase, since all staff must be trained on ISO 9000. Staff will be required to take "ownership" of processes that they are involved in developing and improving. The QMS will also have built-in systems to report on key quality indicators, which will significantly reduce the reoccurrence of problems. This helps develop a strong quality culture, where the staff recognizes problems such as systems or process issues and works on fixing them, rather than placing blame with an individual. The result is increased confidence in workmanship and a more confident staff.

Consistency in Operations
With ISO 9000 certification, your operation will run more smoothly, as the QMS promotes consistency in how work is performed and recorded. This helps new employees learn processes more quickly and reduces misunderstandings with customers. If a problem does occur, it is traced to its root cause and fixed, saving the organization from "re-correcting" it every time it happens.

Market Advantages
ISO 9000 certification is becoming a requirement to do business in many markets. A recent survey of ISO 9000 certified companies shows that 41% were asked to achieve certification by a client. Considering that it can take 6 months or longer for some organizations to achieve certification, already having a compliant QMS in place can be a distinct advantage.

3. The Process Approach

"The process approach means that you improve your business by managing and improving certain key business processes that directly impact your ability to serve your customer."Since the release of ISO 9001:2000, all ISO certified companies have wrestled with the practical application of the "Process Approach" that was introduced in the current version of the standard. In fact, other than the reduction of the number of "required" (i.e. prescribed) documents, the shift to the Process Approach was the most significant change from older editions of ISO 9000. This struggle has been expressed by a number of common questions:

1. What exactly is a "process" as required by ISO?
2. How do we document our processes?
3. How does the rest of the Quality Management System (QMS) support our processes?
4. How do we audit using the Process Approach?
5. What are the Registrar's auditors really looking for?

If you've found yourself asking these or similar questions, or you've had other people in your organization ask them and you've struggled with a response, then understand that you're not alone. The continued confusion about this aspect of ISO 9000 stems from the generic language of the standard and the various ways companies have attempted to comply. It hasn't helped that Registrars seem to have different approaches to interpreting and auditing these requirements. Let's see if we can take some of the mystery out of this for those of us trying to make ISO add value to our businesses on a day-to-day basis.

4. Implementing - Process Approach

"Having an effective process management process may be a "missing link" in your current QMS and this gap may be a key reason ISO has lost some of its luster in recent years"

Ensuring that ISO 9001:2000 remains a vital, relevant tool for your top management to improve business performance is often of concern by those responsible to oversee the "ISO program" within your organization. It is too common for ISO to become "yesterday's news" if you've been certified for several years and today's "big event" is the annual return of the Registrar's auditors. If your organization has struggled to show measurable and sustainable improvements in performance for your customers or toward top-priority management goals, then ISO may be thought to be in "maintenance mode" within your organization, rather than a vital tool to address today's critical business needs.

The observable symptoms of this situation might include:
1. The same corrective actions come up again and again.
2. Audit reports identifying seemingly "petty" issues.
3. Management review meetings "going through the motions" and often poorly attended.
4. Improvements made in the past don't show sustained results today.
5. There is a "burn out" factor within your internal auditor team.

These indications point to a quality management system (QMS) that has generally lost its focus. But, why does this occur?

5. The Upcoming Release of ISO 9001:2008

As many of you who have worked with the ISO 9000 standards know, the standards are periodically updated. The last revision of the ISO 9001 standard was in the year 2000 (hence the title "ISO 9001:2000"). The next revision (technically an "amendment") is scheduled to be released by the end of 2008, probably around October.

"If you are currently preparing for your initial ISO 9001:2000 certification, there is no reason to delay or to change your approach."Any ISO standard goes through several formal steps on its way to final release. ISO 9001:2008 is currently at the DIS ("Draft International Standard") stage, meaning it is nearly complete. The draft of ISO 9001:2008 is now available for public review. The only step left is to finalize the language and then a formal committee vote.

Regardless of the schedule, most users of the ISO 9001:2000 standard (whether certified, conforming or preparing) want to know what is going to change in 2008. Those who went through the previous transition from ISO 9001:1994 to ISO 9001:2000 know first-hand the disruption that was caused by the significant changes introduced by the last revision. It was very costly for all certified companies to change over to the new version. The good news is that the 2008 release should not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is purposely planning the next release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only or for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely not intending to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified.

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