What is ISO 9001?

So you really want to know what is ISO 9001? Really? OK, here’s an overview …as it’s officially known in the United States, the standard ANSI/ISO/ASQ Q9001-2000 was formally approved on December 13, 2000. The 2000 version is the third and current revision, replacing the three ISO 9000 standards, 9001, 9002 and 9003. This revision can be used by all organizations, sometimes with certain exclusions (covered later).

The current version is a complete technical rewrite of the previous edition. The emphasis centers on Top Management Responsibility, and Customer Satisfaction. Ironically, both topics were included in the previous version, but now additional importance is placed in these areas. What an excellent change of direction! It follows the lead of quality professionals who have been saying for years that no quality initiative will succeed without top management’s commitment.

Management commitment is even detailed within the standard. Their commitment can no longer be words, instead they must be able to prove their responsibility for the QMS by (among other topics) conducting management review meetings and providing resources (money, labor, equipment) to make certain the QMS is developed and maintained. Top management is also ultimately responsible for assuring that the QMS improves.

Customer satisfaction is the other mainstay of the current version. In clause 8.2.1, appropriate called “Customer Satisfaction” we’re told to monitor the customer perception of an organization’s ability to meet their requirements. The key word is perception. We can no longer assume our customers are happy if we deliver mostly on time with acceptable quality levels. Now we must obtain information directly from the customer describing if they are indeed happy with us.

Planning is another key to your company’s performance. The standard describes six different types of plans, all important to the overall success of your company. Beginning with quality planning, the standards states that you determine how changes in your organization affect the overall system and that you plan the implementation of these changes. You must also decide upon the types of training necessary within your company and develop a plan to conduct that training.

The standard requires structured planning for design/ development of your product, internal auditing and production. There’s no substitute for a good plan, and upfront planning minimizes back-end firefighting. Beginning to understand what ISO 9001 is?

The Foundation of ISO 9001

The standard is based upon eight simple management principles. These are:

• Customer Focus- understand current customer needs and anticipate future needs, meet customer requirements and exceed customer expectations.

• Leadership- leaders set the vision for the organization and need to create a culture where people are involved in achieving the company’s objectives.

• Involvement of People- an organization is its people, and should strive for full involvement for the benefit of the organization.

• Process Approach- achievement of results is more efficient when managed as a process.

• System Approach to Management- understanding the interrelationships between processes and managing those relationships within a system provides a more efficient opportunity to achieve the organization’s objectives.

• Continual Improvement-always strive to improve processes, methods, etc.

• Factual Approach to Decision Making- rely upon data and information when making decision.

• Mutually Beneficial Supplier Relationships- create supplier relationships that benefit both the supplier and your organization.

Common Misconceptions of ISO 9001

We don’t manufacture anything. That may be true for your company, but all for-profit companies provide something of value to customers. Otherwise they wouldn’t be open for business very long. This item of value, the product, service, information, or combination of the three, is why your company exists. Regardless of what you sell, the standard provides a structure for business excellence.

Our product quality is already great. Wonderful, that’s great news! Now consider how much money your company spends to ensure that only the best product is shipped to the customers. Where do the average products end up? How much is rework currently costing you? How efficient are your processes (are you wasting time and efforts)? The standard should be considered a business model; it considers all the processes necessary to create your final product. This is what ISO 9001 is!

It’s a money pit. Not using the standard as it was intended will create a money pit (go back to the previous page). It’s very easy to throw some documents together, hold some meetings, and call that a quality system. You’d be wrong, but it is easy. The goal of the standard is to develop a system that continually improves. So if you’re spending money making your processes faster, with fewer mistakes, this expense is improving your company’s profitability. Where’s the downside?

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