ISO 9001 Lead Auditor Training

MODULE 1 - Fundamentals Of ISO 9000 Quality Management Systems 

1.4 Quality Management Systems – Rationale
The organization’s quality management system must be designed to consistently meet the current and future quality requirements of the marketplace. A good start is to implement one based on the ISO 9000 series of quality management standards. The ISO 9000 family of standards (See ISO 9001 FAQ) can help organizations of all types and sizes implement and operate effective quality management systems to achieve this objective. Registration to the ISO 9001:2000 quality management standard will provide customers with objective evidence of a supplier’s commitment to quality.

ISO 9000 Lead Auditor Training  - Customers express product requirements in product specifications. These requirements may be contractually specified by the customer or determined by the organization. Customers ultimately decide if the resulting product is acceptable. Organizations must continually improve their processes and products since customer needs and expectations change over time.

Quality management systems provide a framework for continual improvement and increase the odds of achieving customer satisfaction.

1.5  ISO 9001 QMS Versus Product Requirements
It is important to recognize the difference between product requirements and system requirements. Product requirements are defined by customers, by the organization, and possibly by regulation. These requirements can be specified in technical specifications, product standards, process standards, customer contracts, and government regulations.

ISO 9000 Training - Requirements for quality management systems are specified in the ISO 9001 standard. These requirements are generic and applicable to organizations in any industry, regardless of the type of product. ISO 9001 does not establish product requirements.

1.6  ISO 9001 Implementation
The key steps for implementing a quality management system are to:

• Determine the needs and expectations of customers (and other interested parties)
• Establish the quality policy and quality objectives of the organization
• Determine the processes and responsibilities necessary to attain the quality objectives
• Determine and provide the resources necessary to attain the quality objectives
• Establish and apply methods to measure effectiveness and efficiency of each process
• Determine means of preventing nonconformities and eliminating their causes
• Establish and apply process for continual improvement of quality management system

1.7  ISO 9000 Quality Management Principles
A successful organization is managed in a systematic way. Eight quality management principles for helping organizations to achieve their objectives are:

1. Customer Focus to Exceed Expectations
2. Leadership on Purpose and Direction
3. Involvement of People at All Levels
4. Process Approach to Resources and Activities
5. Systems Approach to Management
6. Continual Improvement as a Permanent Objective
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

Customers: organizations depend on their customers and should understand current and future customer needs, meet customer requirements, and strive to exceed customer expectations.

Leadership: leaders create an environment in which people get involved and can become fully involved in achieving the organization’s objectives.

Involvement: People at all levels of an organization must be fully involved for their activities to benefit the organization.

Process: desired results can be more efficiently achieved when resources and activities are managed as a process.

Systems: identifying, understanding, and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of an organization.

Improvement: an ongoing objective of an organization is continual improvement.

Decisions: effective decisions are based on the logical analysis of data and information.

Suppliers: the ability of organizations and suppliers to create value is enhanced by mutually beneficial relationships.
 
1.8 Management Role
Top management should create a work environment that fully involves everyone and enables the effective operation of the quality management system. The above principles can be used to assist top management in its role of:

• Establishing the quality policy and quality objectives
• Focusing on customer requirements throughout the organization
• Ensuring the processes meet requirements and objectives
• Ensuring an effective quality management system
• Ensuring the availability of resources
• Comparing results to quality objectives
• Deciding on actions regarding the policy and objectives
• Deciding on actions for improvement
   
ISO 9001 Auditor Training - One of the roles of top management is to carry out regular and systematic evaluations of the system with respect to the policy and objectives. This review determines if the policy and objectives need to be adapted in response to changing needs and expectations.  

1.9 Evaluations of Quality Management System
There are some basic questions to answer when evaluating a quality management system:

• Are processes identified and appropriately described?
• Are the responsibilities assigned?
• Are the procedures implemented and maintained?
• To what extent are processes effective in realizing planned activities and achieving planned results?

The evaluations of a quality management system can consist of reviews, self-assessments, and audits.

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.