ISO9

To determine that your Quality Management System (QMS) is improving, you will have to develop some monitoring and measurement techniques to measure its effectiveness. Once you develop these techniques, you will need to demonstrate that the QMS is in fact increasing in effectiveness.

Since one of the goals of your QMS is to meet customer requirements, you will need to determine how you will measure your customers’ satisfaction with your product or service.

Internal audits, in the most basic sense, are double checks performed by your own personnel to determine that required procedures are being followed. The ISO 9000 Standard requires you to perform such internal audits on each area covered by your QMS. All audits must be documented and address the following:

Scope (what areas are to be tested and to what degree they will be tested)

Methods to be used (such as interview or review of documentation)

Who is responsible to perform the audit

The Standard requires you to measure that your processes produce desired results. If planned results are not achieved, corrective action must be taken and the effectiveness of the processes must be examined.

During the production process, you will need to monitor and measure the product in order to determine that requirements are met. You will need to document the following:

The product meets acceptance criteria

The product is reviewed prior to release

The person who authorized the product to be released to the customer

Nonconforming product is any product or service that does not measure up to requirements. Nonconforming product can be identified at any point in the production process: upon receipt of raw materials, finished goods inspection or anywhere in between. You will need to define, and document procedures to control, identify, and prevent use of nonconforming products. To the extent possible, you will need to control nonconforming product by taking action to eliminate or correct it. You are also allowed to release it with customer consent. You will need to maintain records documenting processes and actions taken.

The standard requires your organization to collect information on the functioning of the QMS and to analyze the information collected to evaluate the effectiveness and efficiency of your system. Information collected and analyzed should include information related to specific quality objectives. As stated in the Standard, these objectives are that customer requirements are met and that the QMS is continuously improving. The other area to be specifically evaluated relates to the performance of your suppliers. Statistics should be used when appropriate to control processes and product characteristics.

As added emphasis, the goal of achieving a continuously improving QMS is restated.

Corrective Action Requests, commonly referred to by the acronym CAR, are controlled documents that reflect the actions taken to fix problems related to an organization's QMS. These problems can be "nonconformances" where the QMS does not measure up to the requirements of the Standard, or, more commonly, problems that have occurred as the organization goes about producing its finished goods or services. Effective corrective action must be documented and call for the following:

Identifying the problem

Examining the root cause of the problem

Putting a plan in place to prevent recurrence

Evaluating the effectiveness of the plan

The same actions taken in the immediately preceding step relating to corrective actions should also be taken with respect to problems that have yet to occur, preventive actions. Effective preventive action calls for identifying the potential problem, examining the root cause, putting a plan in place to prevent recurrence and evaluating the effectiveness of the plan. Naturally, all of the above must be documented.