ISO 9001 Lead Auditor Training

MODULE 1 - Fundamentals Of ISO 9001 Quality Management Systems 

1.2   ISO 9000 Lead Auditor Training - Quality Management

The principal objective of any business is to make money and stay in business. It accomplishes this by providing a product or service that meets the demands and requirements of the marketplace. In order to ensure its share of marketplace demand, a company must ensure its ability to retain repeat business.

ISO 9000 Lead Auditor Training - Customers provide repeat business to those companies that can consistently meet its quality expectations: delivery of the right product and quantity; in the right packaging; at the right time and place; at the right price; that meets requirements and satisfies the customer. Customers demand assurance that its suppliers can measure up to this expectation for consistency and will take active measures to provide this assurance. ISO 9000 Lead Auditor Training

Senior management must ensure that its management of quality - organizational structure, responsibilities, processes, documentation of processes, controls, training and resources are determined and available to the organization in order to achieve quality assurance in the manner described above.
Having established what is meant by quality, some consideration must be given to the various quality management tools that are available for implementing an effective quality management system.

The definition of Quality Management is “coordinated activities to direct and control an organization with regard to quality”.   A management system developed and implemented based on the ISO 9001:2000 quality management system standard provides assurance through applying the following four tools:

• Planning activities (Quality Planning)
• Prevention activities (Quality Assurance)
• Conformity activities (Quality Control)
• Continual improvement activities (Quality Improvement)

See chart 1.3

In order to meet the broader definition of quality described in section 1.0, an organization must control the processes it uses to meet (customer and other stakeholder) requirements. ISO 9000 Lead Auditor Training

ISO 9000 Lead Auditor Training - To apply the four tools, an organization may use the controls (requirements) of the ISO 9001 standard and the eight quality management principles. Managing the organization’s processes in this way significantly improves customer confidence and assurance of the organization’s ability to consistently meet requirements. It also provides the objective evidence that customers seek for an effective quality management system.

1.3.1 Quality Planning – is defined as the part of quality management focused on setting quality objectives and specifying necessary operational processes and resources to fulfill quality objectives.

An organization must identify the processes, resources and controls needed to meet defined quality objectives (customer and organization).  Specific requirements from the ISO 9001 standard, coupled with the customers’ and organization’s requirements, are used to plan for meeting quality planning requirements.

Quality planning will also include planning for the quality assurance, quality control and quality improvement activities.

1.3.2 Quality Assurance - is defined as the part of quality management focused on providing confidence that quality requirements will be fulfilled.  It includes all the proactive controls to prevent problems, associated cost and customer dissatisfaction.

The intent of prevention is to look at requirements, design, processes, activities, etc, and define controls at the source (the design and planning stages). Controls should address structure, organization and resources to prevent or minimize the occurrence of problems in product, processes and activities.

Examples of preventive controls include employee training, supplier qualification, preventive maintenance on equipment, process capability studies, etc.

1.3.3 Quality Control – is defined as the part of quality management focused on fulfilling quality requirements.  Ideally, prevention based controls should prevent problems from occurring, but in reality, no system is foolproof and problems do occur. Accordingly, controls to detect quality problems must be established so that customers receive only products that meet their requirements. ISO 9000 Lead Auditor Training

ISO 9001 Auditor Training - Detection based controls are reactive – the problem and cost have already occurred and the company is resorting to damage control.  The intent of detection is to evaluate output from processes and activities by implementing controls to catch problems when they do occur. For example, final inspection to catch defective product before it gets shipped.

1.3.4 Quality Improvement – is defined as the part of quality management focused on increasing the ability to fulfill requirements. Continual improvement results from ongoing actions taken to enhance product characteristics or increase process effectiveness and efficiency. This is one of the key characteristics that differentiate a quality management system from a quality assurance system, i.e., being able to improve the effectiveness and efficiency and of a process or activity by setting measurable objectives and using performance data to manage the achievement of these objectives.

Effectiveness is defined as the extent to which planned activities are realized and planned results are achieved. In determining the effectiveness of quality assurance and quality improvement activities, the following questions should be asked:
– To what extent have problems in product or processes been prevented?
– To what extent have planned objectives for quality been met?

Efficiency is defined as the relationship between result achieved and resources used. The measure of efficiency is determined by asking the following:
– Can we get the same output using fewer resources?
– Can we get more output without adding resources?

These questions may be applied to the output of any activity within the quality management system of an organization.

ISO 9000 Training - It should be noted that ISO 9001 requires organizations to achieve QMS effectiveness through quality assurance and continual improvement activities. QMS efficiency is desirable, but not currently required by ISO 9001. ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the QMS.

Quality improvement actions may include:
• Measuring and analyzing situations
• Establishing improvement objectives
• Searching for possible solutions
• Evaluating these solutions
• Implementing the selected solution
• Measuring, verifying, and analyzing results
• Formalizing the changes 

Also see ISO 9000 Lead Auditor Training - Appendix for Key Definitions

Related ISO Lead Auditor Training Resources:

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.