ISO 9000 Lead Auditor Training

MODULE 1 - Fundamentals Of Quality Management Systems

1.1     Meaning Of the term - Quality

Quality has many meanings ---- many of them are subjective, such as the term “excellent” or “outstanding” quality. In the quality management field, quality has a more specific meaning.

ISO 9001 Lead Auditor Training - Definitions

According to ISO 9000:2000, quality is defined as “ the degree to which a set of inherent characteristics fulfills requirements”.

Requirements that need to be fulfilled in a contractual situation typically relate to the provision of a specific product, service or intangible item such as intellectual property. Requirements may be stated or implied. In a contractual situation, stated needs are specified in contract requirements and translated into specific product or service features, functions and characteristics with specified acceptance criteria.

Implied needs on the other hand are basic features and characteristics that are identified and defined by the manufacturer, based on knowledge of the marketplace expectations. For example, the implied characteristic of a watch is its basic ability to provide accurate time. Stated characteristics may be “options” stated by the marketplace, such as being waterproof, serving as a stopwatch, and having light, alarm, month and day features.

Lead Auditor Training - Definitions continued

The ISO definition goes further in that it may include related characteristics beyond product or service such as delivery, packaging, labeling, billing, as well as, processes and systems within the supplier’s organization. A customer may specify some or all these characteristics.

A problem or nonconformity in any of these areas may lead to customer dissatisfaction. An organization must ensure that it has systems and controls to assure that it can consistently fulfill all these requirements and enhance customer satisfaction.

The needs of customers vary and change over time. Therefore, companies should review quality requirements periodically. Requirements may also come from regulatory, statutory, industry and other sources. An organization must be aware of and ensure that all these diverse requirements are defined and met.

ISO 9000 Training - It could therefore be stated that ‘quality’ includes all of the characteristics of an organization’s products, services, processes, support and management system that contribute to meeting requirements and enhancing customer satisfaction.

An organization applying this broader definition would then have to consider the following four facets of quality due to:
• Defining marketplace requirements and opportunities
• Designing the product to meet marketplace requirements
• Consistently conforming to product design
• Providing product support throughout the product’s life cycle.
An effective ISO 9001 quality management system must address all four facets of quality.

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

"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.