ISO 9001 systems were designed to help business gain from the cumulative experience of best-in-class companies. The best-in-class practices were supposed to be captured in ISO 9001 standards.
After overcoming initial resistance to the standards and deploying it at three companies, I learned that it was a great system to help companies in their journey to excellence. However, the first time I experienced a challenge during standardization was in 1994. I helped a company prepare its quality manual, and the registrar auditors did not like it. I was slapped on the wrist for not making it look like the 20 requirements of the standard.
To appease the auditors and the customer, I changed the quality manual with its 20 sections to look like everyone else’s manual. This eventually became a standard practice.
Why are companies unable to deploy ISO 9001 standards as intended? The list could be a long one, starting with the lack of understanding of the standards at the executive level. ISO 9001 must be considered a business tool by the executive team, rather than a tool for verifying some vague quality of the business.
With this understanding, ISO 9001 can be a great tool for strengthening corporate financials and achieving business objectives. Without such an understanding, actions taken to deploy ISO 9001 standards are geared toward merely passing the registration audit and receiving certification.
With such a shaky foundation, the management review, corrective action and internal audit are poorly designed to meet the needs of the registration audits. The poor implementation of these three processes is evidenced through sustained questionable value of the standards, recurring process problems, or customer complaints, and a little reduction in verification and testing activities.
Besides the above three critical management processes, the production and other supporting operations get bogged down by either too much or too little documentation. The 1994 version of the standard was enforced through documentation, and it trivialized documentation. The 2000 version is enforced for effectiveness, which is trivializing both the documentation and the results. The more we revise the standards, the more we dilute their value without focusing on effective implementation. It is the deployment, not a version of the standard, that is the real problem.
In our assessment of quality management systems at many corporations, we normally find that compliance for management, support and operations areas is about 20%, 50% and 80%, respectively. While deploying the quality management system, we focus more on operations than management and support processes. When developing new versions of standards, we either change requirements or add new requirements. Somehow, the field performance of various versions remains practically the same.
Following is a list of things that can help implementation of ISO 9001:
Management review frequency aligned with operations and financial reviews
Effective documentation of processes in all areas with clearly defined performance targets
Weekly internal process audits conducted to reinforce commitment to excellence
Actionable root cause analysis performed to prevent recurrence of problems
Clear expectations for reduction in cost of poor quality established
Performance measures relate deployment of quality management system to the corporate performance
The challenge of an effective quality management system is still in play at many companies. What can be done? ISO 9001 can help in a big way, but we must make ISO 9001 implementation-friendly. We must focus on sharing best practices in implementation of various requirements, where the best means creating real value at the process or the corporate level.
Third-party audits are to be used as a tool to independently verify implementation of a good quality management system, however, the fundamental intent to implement ISO 9001 systems must still be internal and for business results.