ISO 9000
Francis Castelino
1
Quality Management Principles (QMPs)
The seven quality management principles are:
O QMP 1 – Customer focus
O QMP 2 – Leadership
O QMP 3 – Engagement of people
O QMP 4 – Process approach
O QMP 5 – Improvement
O QMP 6 – Evidence-based decision making
O QMP 7 – Relationship management
These principles are not listed in priority order. The relative importance of each principle will vary from
organization to organization and can be expected to change over time. 3
ISO 9000
The ISO 9000 series of standards is a set of documents dealing with quality
systems that can be used for external quality assurance purposes.
ISO 9000, "Quality management and quality assurance standards –
Guidelines for selection and use" clarifies the distinctions and
interrelationships between quality concepts and provides guidelines for
the selection and use of a series of international standards on quality
systems that can be used for internal quality management purposes (ISO
9004) and for external quality assurance purposes (ISO 9001, 9002 and
9003).
2
ISO 9000 (Contd.)
The quality concepts addressed by these standards are:
o An organization should achieve and sustain the quality of the product
or service produced so as to meet continually the purchaser's stated or
implied needs.
o An organization should provide confidence to its own management that
the intended quality is being achieved and sustained.
o An organization should provide confidence to the purchaser that the
intended quality is being, or will be, achieved in the delivered product
or service provided.
Evolution of ISO 9000
o 1979 Introduction of the British standard for Quality Systems BS 5750
o 1987 Amalgamation of BS 5750 with European Norm
o 1994 Issue of BS EN ISO 9000 series which has discarded the title BS 5750
o 2000 Issue of ISO 9000:2000
o 2008 Issue of ISO 9000:2008
o 2015 Issue of ISO 9000:2015
3
The ISO 9000 Series
The ISO 9000:2000 series is composed of:
o ISO 9000:2000 (fundamentals and vocabulary) – replaces ISO 8402:1994
o Conformance standard: ISO 9001:2000 (requirements) – cancels and replaces ISO 9001:1994 together with
ISO 9002:1994 and ISO 9003:1994.
o Guidance standard: ISO 9004:2000 (guidelines for performance improvement) – replaces ISO 9004-1:1994.
o ISO 19011: Guideline for Auditing Quality and Environmental Management Systems
ISO 9001:2000 and ISO 9004:2000 are harmonized in structure and terminology to assist organizations in
moving smoothly from one to the other. Both standards apply a process approach. In addition, the following
Quality Management Principles (Customer focus, Leadership, Involvement of people, Process approach,
System approach to management, continual improvement, Factual approach to decision making and Mutually
beneficial supplier relationships) provide the basis for the performance improvement outlined in ISO
9004:2000.
For software organizations involved in developing and maintaining software
products, the appropriate conformance and guidance standards are:
o ISO [Link] Quality management systems - Requirements
o ISO 9000-[Link] Quality Management and Quality Assurance standards. Guidelines for the application of
ISO 9001 to the development, supply, and maintenance of software.
ISO 9001:2000 IS BASED ON:
• Preventive actions Business and
• Improving Actions management Models
• Re-Engineering Business Plan
• Communicating Approaches &
Methodology
Act Plan
Check Do
• Assessing the • Deploying the
performance approach
• Reviewing the • Controlling
performance Performance
• Corrective Actions
8
4
ISO 9001:2000 Clauses
Clause 1 – SCOPE
o The standard specifies the requirements of a QMS where an organization needs to
demonstrate its ability to provide products that meet customer requirements and also aims to
enhance customer satisfaction.
o Mentions that the standard can be tailored to suit the need of the organization
Clause 2 – Normative Reference
o Refers to ISO 9000:2000, Quality Management systems – Fundamentals and Vocabulary
Clause 3 – Terms and Definitions
o The terms and definitions given in ISO 9000:2000 apply.
Clause 4 – Quality Management System
o This clause talks about the framework of the QMS and also emphasizes on document and
records control.
ISO 9001:2000 Clauses (contd.)
Clause 5 – Management Responsibility
o This clause talks about senior management commitment and responsibilities. Also highlights
the Management Representative (MR) responsibilities. Defines the Mapping of Quality
Policy to Measurable Q-Objectives.
Clause 6 – Resource Management
o This clause talks about the various resource requirements in terms of manpower,
infrastructure and environment that go on to affect product quality.
Clause 7 – Product Realization
o This clause addresses the various processes involved in the making of a product viz.
planning, contract and review, design and development, purchasing, process control,
configuration management, etc.
o This is the ONLY clause can be tailored to suit an organization’s needs.
Clause 8 – Measurement, Analysis & Improvement
o This clause covers the various means of achieving continual process improvement. 10
5
ISO CYCLE
11
