Knowledge Axis
Background
ISO 9000 was first published in 1987 by ISO (International Organization for Standardization). It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the United States Department of Defense MIL-Q-9858 standard in 1959, and the U.K's Def Stan 05-21 and 05-24.
Reasons for use
The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, as the basis of contractual arrangements with their suppliers. This helped reduce the need for "supplier development" by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending the complexity of product, business type (design responsibility, manufacture only, distribution, servicing etc) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. The adoption of a single Quality Assurance requirement also lead to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.
ISO 9000 was first published in 1987 by ISO (International Organization for Standardization). It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the United States Department of Defense MIL-Q-9858 standard in 1959, and the U.K's Def Stan 05-21 and 05-24.
Reasons for use
The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, as the basis of contractual arrangements with their suppliers. This helped reduce the need for "supplier development" by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending the complexity of product, business type (design responsibility, manufacture only, distribution, servicing etc) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. The adoption of a single Quality Assurance requirement also lead to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.
What are the benefits of ISO 9001?
An ISO 9001 quality management system:
1. Shows that you provide products and services of consistent quality;
2. Shows that you provide products and services that meet the customer’s requirements, comply with the law and legislation, and meet the organisation’s own requirements;
3. San help you streamline your business processes and continuously improve them.
4. ISO 9001 helps you increase customer satisfaction;
5. ISO 9001 is positive for your image: you show that you comply with internationally recognised quality standards. This is often a requirement for customers and suppliers to do business with you.
The ISO 9000 series are based on seven quality management principles (QMP)
The seven quality management principles are:
1. QMP 1 - Customer focus
2. QMP 2 - Leadership
3. QMP 3 - Engagement of people
4. QMP 4 - Process approach
5. QMP 5 - Improvement
6. QMP 6 - Evidence-based decision making
7. QMP 7 - Relationship management
1. QMP 1 - Customer focus
2. QMP 2 - Leadership
3. QMP 3 - Engagement of people
4. QMP 4 - Process approach
5. QMP 5 - Improvement
6. QMP 6 - Evidence-based decision making
7. QMP 7 - Relationship management
Principle 1 - Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
Principle 2 - Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
Principle 3 - Engagement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be simpler. If, for used for the organization's benefit.
Principle 4 - Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Principle 5 - Improvement
Improvement of the organization's overall performance should be a permanent objective of the organization.
Principle 6 - Evidence-based decision making
Effective decisions are based on the analysis of data and information.
Principle 7 - Relationship management
An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
Principle 2 - Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
Principle 3 - Engagement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be simpler. If, for used for the organization's benefit.
Principle 4 - Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Principle 5 - Improvement
Improvement of the organization's overall performance should be a permanent objective of the organization.
Principle 6 - Evidence-based decision making
Effective decisions are based on the analysis of data and information.
Principle 7 - Relationship management
An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
What are the main differences between ISO 9001:2008 and ISO 9001:2015?
ISO 9001:2015 has ten clauses instead of eight. The following table shows the relationship of the ISO 9001:2008 clauses to those in the new ISO 9001:2015.
ISO 9001:2015 has ten clauses instead of eight. The following table shows the relationship of the ISO 9001:2008 clauses to those in the new ISO 9001:2015.
| ISO 9001:2008 | ISO 9001:2015 |
| 0. Introduction | 0. Introduction |
| 1. Scope | 1. Scope |
| 2. Normative reference | 2. Normative reference |
| 3. Terms and definitions | 3. Terms and definitions |
| 4. Quality management system | 4. Context of the organization |
| 5. Management responsibility | 5. Leadership |
| 6. Resource management | 6. Planning |
| 7. Product realisation | 7.Support |
| 8. Measurement, analysis and improvement | 8. Operation |
| 9. Analysis | 9. Performance evaluation |
| 10. Improvement | 10. Improvement |
The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act).
ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS) :
As a result of the new arrangement in ten clauses, ISO 9001:2015 now has the same unambiguous structure as all standardised management systems, known as a ‘High Level Structure’ (HLS).The core elements of ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, etc. are therefore all the same from now on. This has made the integration of various management systems much example, an organisation wishes to implement ISO 14001 in addition to ISO 9001, the parts that cover the same topic can easily be seen in the standards.
ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS) :
As a result of the new arrangement in ten clauses, ISO 9001:2015 now has the same unambiguous structure as all standardised management systems, known as a ‘High Level Structure’ (HLS).The core elements of ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, etc. are therefore all the same from now on. This has made the integration of various management systems much example, an organisation wishes to implement ISO 14001 in addition to ISO 9001, the parts that cover the same topic can easily be seen in the standards.
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