Important Customer News: ISO 9000:2000 Process Approach to Auditing IRS Tax Benefits of ISO 9000

ISO 9000:2000

The new quality system requirements for ISO 9001 have been organized into five main sections: Section 4-General Requirements/Document and Record Control; Section 5-Management Responsibility; Section 6-Resource Management; Section 7-Product and/or Service Realization; and Section 8-Measurement, Analysis and Improvement. The new structure makes ISO 9001 more compatible with the ISO 14001 standard and helps de-emphasize the role of manufacturing industries that was so prominent in previous editions. Most revisions in ISO 9001 are in customer-related processes and continual improvement. Other sections with major revisions are those involving training, awareness and communication as well as process control.

There are also several new miscellaneous requirements spread throughout the standard. These are often restated and expanded under several sections. For example, requirements on process control are introduced in Section 5, developed in two clauses of Section 7, and then restated in Section 8. While there are sound reasons for this approach, it can make it somewhat difficult to identify and understand the requirements. Therefore, the intent of the standard can be interpreted only after related requirements are culled from different sections and analyzed together.

CUSTOMER RELATED PROCESSES

The new requirements in customer-related processes call for determining customer satisfaction, identifying customer requirements and making employees aware of the importance of meeting customer requirements. The following are the new clauses as they pertain to customer-related processes:

• Clause 5.1–requires top management to demonstrate its commitment to creating awareness of the importance of fulfilling customer requirements.
• Clause 5.2–requires top management to ensure that customer needs and expectations are determined and met.
• Clause 7.2.1–requires the organization to implement a process for identifying customer requirements.
• Clause 7.2.3–requires the organization to define and implement arrangements for communication with customers.
• Clause 8.2.1–requires the organization to establish a system for obtaining and using information on customer satisfaction and dissatisfaction.

Together, the clauses demonstrate that the standard now requires that all departments and functions dealing with customers are included within the quality system. This can be a major change to some businesses but once the intent of the system is understood and accepted, interpretation and implementation of all underlying requirements will follow easily and naturally.

CONTINUAL IMPROVEMENT

In addition to having a specific section titled "Continual Improvement", the standard references it in numerous locations. The new requirements involve quality concerns and objectives, quality performance data and management reviews. The following requirements are new and clarify how the cycle of continual improvement is intended to work:

• Clause 5.3–requires the quality policy to include commitments to meeting requirements and to continual improvement. These must be periodically reviewed.
• Clause 5.4.1–requires the organization to establish quality objectives supporting the quality policy and the commitment to meet requirements and continuously improve.
• Clause 5.6.3–requires the management review to evaluate the need for changes to the quality system, policy and objectives. It also requires that review outputs include actions related to the improvement of the quality system, audits and resources.
• Clause 6.1–requires the organization to identify and plan activities and resources needed to maintain and continually improve the QMS.
• Clause 8.4–requires the organization to collect and analyze data to determine the effectiveness of the quality system and where improvements can be made to it.
• Clause 8.5.1–requires the organization to continually improve their QMS by use of the quality policy, objectives and quality-related data and information.

TRAINING, AWARENESS AND COMMUNICATION

ISO 9001:2000 training requirements are now considerably broader and are mostly gathered together in Section 6-Resource Management. While keeping some of the old requirements for providing training and identifying training needs, the standard now also requires organizations to evaluate the effectiveness of their program and to establish employee awareness programs.

• Clause 5.2–requires top managers to demonstrate their commitment to creating employee awareness of the importance of fulfilling customer requirements.
• Clause 5.5.2–requires management to ensure awareness of customer requirements throughout the organization.
• Clause 5.5.3–requires the organization to establish a process for internal communication regarding the quality management system.
• Clause 6.2.2–requires the organization to evaluate training and establish procedures to make employees aware of the importance of their own roles within the quality system. The new requirements for internal communications come in Section 5-Management Responsibility. Although these requirements are not specifically linked to training, it may be easier to integrate all elements together at one time.

PROCESS CONTROL

Section 7–Product and/or Service Realization contains most of ISO 9000:2000's requirements for process control. Clause 7.1 contains a lengthy and detailed list of formal process control measures and activities, but lacks clarity as to the extent of the mandatory implementation. That is to say, process control is no longer an optional activity and auditors will expect every organization to have knowledge of process control techniques, but the requirements within the standard itself allow each organization to decide how they want to control their own processes. The following two clauses contain new requirements for process control:

• Clause 7.1–requires organizations to determine and implement the criteria and methods to control processes to achieve consistent operation and product conformity.
• Clause 8.2.3–requires application of suitable methods for measurement and monitoring of processes.

The effort required for implementation will, once again, depend upon the current state of process control programs already in effect within the organization.

There are more than 30 new actionable and auditable requirements in ISO 9001:2000. Around 75% of them fall within the four major categories discussed above, but several minor diverse requirements are spread throughout the standard. These include a clause requiring implementation of a suitable work environment for product/service conformity, another requiring companies using software to validate the software prior to use, and yet another for organizations to identify and gain access to legal requirements regarding quality aspects of products.

While ISO 9001:2000 does have some negative aspects (mainly due to requiring new concepts of quality management without specifically stated requirements), it is a better overall standard than its predecessors. It represents a more modern approach to quality management and is closer to current management system thinking.