Why Implement an ISO 9001 Quality Management System?

Bizmanualz Solutions

Why should your organization use the ISO 9001 Standard? An honest reply can say a lot about how effectively the standard can improve your business. If you are using the standard as a marketing gimmick (a plaque on the wall; a logo on a website), or just because a customer requires it, then the standard will be a burden, not a benefit. If the honest reason for implementing the standard is improvement, then it can truly help your organization become better.

What is the Goal – Improvement or Certification?

Did you notice in the above paragraph that I didn’t mention becoming ISO 9001 Certified? Of course, certification is a lofty goal and it will be necessary to get the plaque and the logo or to meet a specific customer requirement. But, again, if certification is the only goal then you may gain certification but miss the benefit of the standard. An organization can employ the standard, and benefit from it, without ever seeking certification.

In fact, a compelling argument could be made that the best approach is to put a functioning ISO 9001 QMS in place for a period of time before even attempting to gain certification. Perhaps even employing external auditors to review the QMS with an outside perspective - mainly to identify system weaknesses and opportunities for improvement - not to gain a pass/fail grade for certification.

In the next series of articles we will discuss how implementing the ISO 9001 Quality Management System (QMS) can serve as a business improvement tool. We feel that frequently the ISO standard is perceived as a checklist item….get ISO 9001 Certified…..done. The real goal of ISO 9001, however, is continual improvement of the organization. Embracing the concepts of ISO 9001 can enhance an organization in several ways, which we will cover in upcoming articles.

Is ISO 9001 Really a Documentation Nightmare?

In this article, however, we would like to address what we feel is a real misconception about ISO 9001; the documentation requirements. The common belief seems to be that implementing ISO 9001 can create a bureaucratic documentation nightmare with volumes of complicated procedures that require heavy oversight and manpower to create and maintain. That is not really the case. In fact, implementing ISO 9001 can actually streamline and simplify your documentation/record creation and management.

That’s right…ISO 9001 can help you simplify and improve your documentation and records. First…the ISO 9001 does not have complex or complicated documentation requirements. In fact, they are quite simple…there are only six required procedures for the ISO 9001 QMS. They are:

Document Control (per ISO 9001 clause 4.2.3)

Record Control (per ISO 9001 clause 4.2.4)
Internal Audit (per ISO 9001 clause 8.2.2)
Control of Non-Conformities (per ISO 9001 clause 8.3)
Corrective Action (per ISO 9001 clause 8.5.2)
Preventive Action (per ISO 9001 clause 8.5.3)

While it may difficult for most organizations to get by with these six procedures alone, the fact that these are the only required procedures should send a message that, despite the perception of the opposite, ISO 9001 is not about tons of procedures. As we described in a recent article, besides the required procedures above, your organization must decide what procedures are needed based on issues related to compliance, importance, and performance.

An important concept to understand is that procedures are only one way to document processes, and the ISO standard recognizes that. Processes can be documented by Work Instructions, Visuals Aids, or training materials. The real requirement by ISO is that key processes are understood and consistently carried out.

The Importance of Records

What receives more attention in the ISO 9001 standard are records. While there are only six required procedures, there are 21 required records. It is very likely that your organization is already keeping many of these records; but what do you do with them? The ultimate goal of ISO 9001 is improvement (as we will discuss in later articles), and one key to improvement is record keeping that captures important data related to performance metrics.

Frequently, whether it relates to the production floor or finance operations, the key factor for auditors and regulators are concerns with process control or internal controls. Does the existence of procedures really prove control? Not actually. Control is truly demonstrated by defined goals and objectives along with clear and complete records that demonstrate how well processes are meeting these objectives. Records should also demonstrate what analysis and actions are taken to improve the process when objectives are not being reached.

Using the ISO 9001 Standard can help organizations gain some perspective and reflection on how records are used, how they are controlled, and their role in gaining insight to your organization. In the proper perspective, ISO 9001 can help gain control of and assist with properly utilizing documents and records - not add additional record bureaucracy.

In the coming two weeks will continue to further explore the benefits of implementing the ISO 9001 Standard, such as gaining competitive advantage and improving organizational culture.

If you are interested in implementing the ISO 9001 Standard, or making more effective use of your ISO 9001 QMS, Bizmanualz can help. We offer off-the-shelf ISO 9001 Policy & Procedure Manual products, ISO 9001 Internal Audit training, as well as consulting services that help put your system in place or make it more compliant and beneficial. We are a firm believer in the improvement principles behind ISO 9001, and we will be happy to help make you a believer as well.

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