The document defines key terms related to quality management systems including quality management system (QMS), quality, ISO 9000 standards, and documentation requirements. It explains that a QMS is a management system that directs and controls an organization regarding quality. It establishes quality policies, objectives, planning, control, assurance and improvement. ISO 9001 provides requirements for implementing a QMS to consistently meet customer needs and requirements. Effective documentation is important for training, communication, process control and continual improvement.

1. QUALITY MANAGEMENT
SYSTEMS,
CONCEPTS & DEFINITIONS

2. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Definition of Quality –
• Degree to which a set of inherent
characteristics of a product or service fulfill the
needs or expectations of our customer.
• Quality can be used with such adjectives as:
• Poor
• Good
• Excellent

3. Section 1 – Quality Management System (QMS)
Concepts and Definitions
QUALITY MANAGEMENT SYSTEM (QMS)
A Management system to direct and control an organization with regards to quality.
MANAGEMENT SYSTEM
A system to establish policy and objectives and to achieve these objectives.
DIRECTION AND CONTROL GENERAL INCLUDES ESTABLISHMENT OF:
• Quality Policy • Quality Control
• Quality Objectives • Quality Assurance
• Quality Planning • Quality Improvement

4. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Quality Management System Benefits
• Help organizations to enhance customer satisfaction
• Encourages organizations to:
• Analyze customer requirement
• Define processes that contribute to achieving
quality product or service
• Keep these processes under control
• Provides:
• A framework for continual improvement
• Confidence in ability to consistently fulfill
customer requirements

5. Section 1 – Quality Management System (QMS)
Concepts and Definitions
ISO 9000: 2000 SERIES
• ISO 9000 – Quality Management Systems:
Fundamentals and Vocabulary
• ISO 9001 – Quality Management Systems:
Requirements
• ISO 9004 – Quality Management Systems:
Guidance for Performance
Improvements
• ISO 19011 – Guidelines on Quality and
Environmental Auditing

6. Section 1 – Quality Management System (QMS)
Concepts and Definitions
8 Quality Management Principles –
• Customer focus
• Leadership
• Involvement of people
• Process approach
• Systems approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

7. Section 1 – Quality Management System (QMS)
Concepts and Definitions
HOW DOES ISO 9001 WORK?
• It is a strategic, stakeholder focused, performance
driven mechanism for delivering business quality
objectives.
• Requires business processes to be defined and
controlled to achieve quality policy and objectives.
• Requires continual improvement of the QMS to
ensure changing customer needs and expectations
are met.

8. Section 1 – Quality Management System (QMS)
Concepts and Definitions
ISO 9001 gives high level principles, e.g. to paraphrase the document Control clause:
“ You must have the right document, at the right issue level, in the right place, at the right time “.
This holds true for any business (whether service or manufacture), and for any media (e.g. paper, electronic or optical). In principle,
ISO 9001 requires nothing that a reputable organization should not want to do anyway.

9. Section 1 – Quality Management System (QMS)
Concepts and Definitions
DEVELOPING/IMPLEMENTING THE QMS
• Consists of several steps, structured around the PDCA cycle.
• The same approach is also applicable to maintaining and improving an established quality
management system.
PLAN
ACT DO
CHECK

10. Section 1 – Quality Management System (QMS)
Concepts and Definitions
QUALITY MANAGEMENT SYSTEM APPROACH involves the
following:
• Determining needs and expectations of customers and other interested
parties.
• Establishing the quality policy and objectives.
• Determining the processes and responsibilities necessary to attain the
quality objectives.
• Determining and providing the resources necessary to attain the quality
objectives.
• Establishing methods to measure the effectiveness and efficiency of each
process.
• Applying these measures to determine the effectiveness and efficiency of
each process.
• Determining means of preventing nonconformities and eliminating their
causes.
• Establishing and applying a process for continual improvement.

11. Section 1 – Quality Management System (QMS)
Concepts and Definitions
ISO 9001: 2000
4.2.1 Documentation Requirements
The QMS shall include:
 Documented statements of quality policy and
objectives
 A quality manual, documented procedures
required
 Documents needed by the organization to
ensure effective planning, operation and
control of its processes
 Quality records required

12. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Documenting The QMS
• Each organization determines:
 Extent of documentation required.
 Media to be used.
• Emphasis is on controlling processes and meeting
quality objectives, not on generating unnecessary
documentation.
• Documentation can be in any type or form of media.

13. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Objectives of Documenting the System
To communicate the company’s policy procedures and
requirements.
To train personnel in the quality system requirements &
methods of compliance.
To demonstrate, for external purposes, compliance with
required quality standards.
To provide continuity of the quality system.

14. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Value of Documentation
• Enables:
 Communication of intent.
 Consistency of action.
• Contributes to:
 Conformity to customer requirements.
 Continual improvement.
 Provision of appropriate training.
 Repeatability and traceability.
 Provision of objective evidence.
 Evaluation of effectiveness and suitability of QMS.
• Generation of documents should add value, if not, don’t
document it!

15. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Extent of Documentation
• Depends on factors such as:
 Type and size of organization.
 Complexity and interaction of processes.
 Complexity of products.
 Customer requirements.
 Regulatory requirements.
 Demonstrated ability of personnel.
 Extent to which it’s necessary to demonstrate
QMS requirements is met.

16. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Documentation of a System
 Quality Manual
 Company Procedures
 Work Instructions/Plans of work
 Forms, Records, Documents, etc.

17. Section 1 – Quality Management System (QMS)
Concepts and Definitions
Types of Documents Used in a QMS
• Documented statements of quality policy and
objectives.
• Quality manual.
• Procedures.
• Work instructions.
• Quality Plans.
• Specifications, drawings, standards.
• Guidelines.
• Records.