(ISO) Quality Manual Chat

As part of your quality management system, your organization should identify training needs, provide training, and periodically evaluate the effectiveness of that training. Employees should be made aware of the relevance and importance of their activities and how they contribute to the overall achievement of quality objectives and company goals.

One or two people in your organization should be made responsible for ensuring that personnel are adequately trained and are competent in their role.

Training needs may be identified at any time, from initial hiring to a changing role, or perhaps due to a corrective/preventive action request.

Your ISO9001:2000 quality manual should include a section on provision of resources. It should state something to the effect that management is committed to providing adequate resources for the implementation and improvement of your quality management system.

One member of top management should be designated as responsible for providing adequate resources to ensure the effectivness of your quality system.

This section of your quality manual should also specify some types of resources that may be needed. Examples include personnel, office equipment, measuring equipment, a workspace environment, and financial resources.

One member of top management must also be designated as having responsibility for determining what resources are required for the implementation and improvement of your quality system. This person may or may not be the same person responsible for ensuring that adequate resources are provided, as stated above.

Your process for determining resource requirements should also be stated. I imagine that most organizations determine resource requirements during management review meetings. It is sufficient for your quality manual to state something to the effect of ” the principal forum for determining and communicating resource requirements is during the management review of the quality management system”.

One of the requirements of an ISO9001:2000 quality management system is Management Review. Management review is a meeting of key company personnel with the intent to review the quality system.

Your management review should follow a structured format, and should include inputs and outputs.

Some possible inputs include the following:

- Results of internal audits
- Review of customer feedback and complaints
- Process data and product performance data
- Status of corrective and preventive actions
- Changes that could affect the quality system
- Follow-up actions from previous management reviews
- Recommendations for improvement
- Review of the Quality Policy and Quality Objectives

The inputs to your management review should reflect your company and your situation. The above listed inputs might be a good place for you to start, but you should choose inputs that best fit your company.

When embarking on a new quality management system, one of the most important decisions you’ll want to make is regarding what it is exactly that you want to accomplish. What you decide now will have a great impact on the direction your quality system takes.

A requirement of an ISO9001:2000 quality management system is to formulate an organizational quality policy statement. This is an overall, high level statement that gives a general idea of where your goals are. It should not be too specific. Something like “Our goal is to achieve 100 percent customer satisfaction, strive for excellence and continual improvement in all our activities” is a good example of a quality policy statement.

Quality objectives are also a requirement of ISO9001:2000. Quality objectives are intended to be specific, measurable goals that you keep track of on a regular basis, and keep records of how you’re doing. Your performance in relation to your quality objectives is one of the records that will be looked at during a third party audit.

With a modern computer system, it is entirely possible to control your required documents and records electronically. It is vital that your quality system documentation and records be adequately controlled, and you might find that keeping these on your computer network is the best bet.

Some advantages of controlling documents electronically include:
1. If properly password protected, the people you want to have access, will have access, as long as they have a computer on your network. The people you don’t want to have access, won’t.
2. Computer records, if backed up and stored properly, are less likely to undergo deterioration from the environment.
3. Documents and records that are properly password protected can not be altered or deleted by unauthorized personnel.
4. It is much simpler to update or change electronic documents. All users will instantly have the latest and greatest version of the document. There are no paper copies to update, no obsolete paper copies floating around.

Of course it takes a little discipline to have a system of controlling documents and records electronically. For example, your people must be somewhat trustworthy and not divulge passwords to unauthorized people. Also, it is important that people do not print copies of documents and records and leave these uncontrolled copies laying around. You may wish to consider labeling all documents “Uncontrolled If Printed”.

It’s a great idea to control your company’s records. By controlling, I mean that your organization should store important records in a secure environment, with access available to those who truly need to see the records, and access prevented from others. Controlling records pertaining to your quality management system is a requirement of an ISO9001:2000 quality system.

One of the beautiful things of ISO9001:2000 is that it gives you great latitude in how you choose to meet the requirements. As long as your methods are effective and will pass the scrutiny of a third-party auditor, you can do things pretty much how you like.

Records can be controlled in several ways…at least a couple I can think of. Of course, there’s always the paper variety, locked in a cabinet in an office. There are a few pros and cons to this method. Pros include simplicity and…um…simplicity. You don’t have to be a computer scientist to file pieces of paper in a cabinet. This doesn’t require any backup, passwords, or the like. Some cons include the fragility of paper, it is easily damaged or lost. And if you only have one copy, it might be inconvenient for some members of your team to see records that they need.

These days many people keep their records electronically, on their computer network. More on this later.

A segregated area for nonconforming material can be a great way to get a handle on returns, keep track of defective items bought or produced by your company, and prevent defective products from shipping to your customers. A segregated area for nonconforming product is a requirement of some quality management standards, such as ISO9001:2000 and AS9100. And even if you don’t need ISO or AS9100, a segregated area can be a great management tool.

Nonconforming material, or product, is defined as material that does not conform to your requirements. Whether it be raw materials, product manufactured by your company, or materials purchased from vendors, any material or item that does not meet your requirements can be considered “nonconforming material”. Perhaps its the wrong color, wrong dimensions, maybe its scratched or dented or otherwise damaged. Whatever the item, and whatever the reason, if its something you don’t want to ship to your customer, you should segregate it from the rest of your stock.

A company that wants to be successful and profitable is nearly always focused on meeting customer requirements. Of course, in order to meet or exceed customer requirements, you must first determine what those requirements are.

Every industry and company is different, and methods of determining customer requirements can vary widely. Your ISO9001:2000 quality management system should include a method or methods to determine customer requirements.

It is easier to determine customer requirements for some kinds of products than for others. For example, if you are machining aircraft parts for a large aircraft manufacturer, chances are your customer has given you specifications and/or drawings, detailing exactly what they are looking for in the product. This is probably the easiest way to determine customer requirements, and it is perfectly reasonable to write in your quality manual that your customer requirements are determined by having your customer put those requirements into writing.

At the other end of the spectrum, when selling certain consumer items it may be very difficult to accurately know customer requirements. For example, let’s say you are making high performance exhaust systems for motorcycles. You know that, in general, your customers want to increase the horsepower and sound level of their bike, and want it to look good, at a reasonable price. But these are rather vague requirements. How much horsepower? A 10 percent improvement at a cost of $1000.00? Or a 5 percent improvement at a cost of $600.00? How loud do your customers want their exhaust systems to be? And “good looks” is a subjective evaluation.

In this example, some methods of determining customer requirements include doing market research, going to motorcycle events and talking to people, keeping up with current trends in magazines and other media, and keeping up with your competitor’s offerings. These are all good methods to include in your quality manual, assuming you sell high performace motorcycle exhaust systems.