Implementing quality management systems, ISO 9001, TS 16949, ISO 13485 (there are more) is a quite a task. Despite the amount of effort necessary, the number of QMS registrations continues to increase each year. Sure, in many instances these registrations occur because a customer is requiring a QMS certification as a condition of doing business with your company.
And some organizations stop right there… they do the work, spend the money, consume all those valuable resources, become registered… and then ignore what the QMS can do for their company.
Remember that many of the quality management system standards are based upon ISO 9001. The concepts and strategies detailed here are valid for those QMS standards as well. So, beginning with the basics, let’s get started.
What is ISO 9001? This standard was developed to provide guidelines for the manufacture of products by ensuring that production was accomplished under controlled conditions. Quality standards began to emerge after World War 2 as a method of control and standardization for military supplies. These controls evolved into BS 5750, which was later revised and issued as ISO 9000 (1987) and its associated documents ISO 9001, 9002, and 9003.
The standard was updated and issued in 1994, using the same structure as the 1987 model. A complete rewrite of the standard was released in 2000 as ISO 9001. This version eliminated the need for three separate standards.
ISO 9001:2008 was released on November 15, 2008. While no new requirements were written into this revision, several clarification notes were added. These notes, along with come text changes will impact your QMS in many ways. Internal auditors should become aware of the differences in ISO 9001:2008 because it will affect your auditing.
Hundreds of thousands of companies have implemented and maintained ISO 9001 in their organizations. What is it that separates the better companies from the merely good ones? It’s not magic, no smoke and mirrors. The better companies simply utilize the standard effectively!
These better companies are seeing an impact on the bottom line, the truest metric of effectiveness. They use the standard as it was intended, not as window dressing, not as a blurb on the company letterhead. These organizations use the standard as a means to improve their processes and their product or service.
It’s the successful use of the inherent feedback loops in the standard that helps these companies excel. These important communication vehicles are listed below:
The Policy and Objectives are a critical portion of your quality management system. The Policy describes the mission and vision of your organization, the “where we’re heading” concept. The Objectives are the measurable criteria of the Policy, the “how we’ll know when we get there” concept. Don’t be afraid to set aggressive goals for your organization, just be sure you have a plan in place to meet these goals.
Your entire workforce should be aware of the Policy, although they don’t have to memorize it (after all, recalling the policy word for word doesn’t make your product or process any better). They should be able to show an auditor where it is posted, or be able to produce an index card, magnet, etc. Some organizations are now printing the policy and objectives on employee ID cards.
The Policy and Objectives are best reviewed during Management Review.
ISO 9001 states that you will at the very least monitor the processes you’ve identified as part of your overall quality management system. However, measuring is always better than monitoring, and all processes can be measured. It then becomes a matter of which process measures are important to your organization right now.
Analysis of data directly corresponds to one of the underlying management principles of ISO 9001, the factual approach to decision making. The standard requires you to collect specific data about processes, suppliers, etc. Then it states that you must conduct analysis of the data and make decisions based upon this data.
In addition to having determined how your customers contact you regarding product information, contracts and changes, and complaints, there should be data collected from your customers that detail how well you meet their requirements.
Your internal audit program is the essential link between your processes and management review. A successful Internal Audit Program not only distinguishes issues and concerns in your processes; it complies with the standard, and identifies improvement opportunities.
The most critical, and easily the most misunderstood feedback loop is management review This review of your organization’s QMS assists in identifying improvement opportunities, resource requirements, and requires action items as an output of the meeting. Ironically, the standard defines the meeting agenda for you, and yet many companies still can’t review the quality management system effectively.