ISO 9000
The ISO 9000 family of quality management systems (QMS) is a set of standards that helps organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfil.
Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.
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 UK’s Def Stan 05-21 and 05–24. Large organizations that supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded, which led the defense industry to adopt mutual recognition of NATO AQAP, MIL-Q, and Def Stan standards. Eventually, industries adopted ISO 9000 instead of forcing contractors to adopt multiple and often similar requirements.
The ISO 9000 series are based on seven quality management principles (QMP)
The seven quality management principles are:
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement
QMP 6 – Evidence-based decision making
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.
- Understand the needs of existing and future customers
- Align organizational objectives with customer needs and expectations
- Meet customer requirements
- Measure customer satisfaction
- Manage customer relationships
- Aim 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.
- Establish a vision and direction for the organization
- Set challenging goals
- Model organizational values
- Establish trust
- Equip and empower employees
- Recognize employee contributions
Principle 3: Engagement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
- Ensure that people’s abilities are used and valued
- Make people accountable
- Enable participation in continual improvement
- Evaluate individual performance
- Enable learning and knowledge sharing
- Enable open discussion of problems and constraints
Principle 4: Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
- Manage activities as processes
- Measure the capability of activities
- Identify linkages between activities
- Prioritize improvement opportunities
- Deploy resources effectively
Principle 5: Improvement
Improvement of the organization’s overall performance should be a permanent objective of the organization.
- Improve organizational performance and capabilities
- Align improvement activities
- Empower people to make improvements
- Measure improvement consistently
- Celebrate improvements
Principle 6: Evidence-based decision making
Effective decisions are based on the analysis of data and information.
- Ensure the accessibility of accurate and reliable data
- Use appropriate methods to analyze data
- Make decisions based on analysis
- Balance data analysis with practical experience
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.
- Identify and select suppliers to manage costs, optimize resources, and create value
- Establish relationships considering both the short and long term
- Share expertise, resources, information, and plans with partners
- Collaborate on improvement and development activities
- Recognize supplier successes
QS 9000
QS9000 was a quality standard developed by a joint effort of the “Big Three” American automakers, General Motors, Chrysler and Ford. It was introduced to the industry in 1994. It has been adopted by several heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the US automakers needed to implement a standard QS9000 system, before its termination.
The standard is divided into three sections with the first section being ISO 9001 plus some automotive requirements.
The second section is titled “Additional Requirements” and contains system requirements that have been adopted by all three automakers; General Motors, Chrysler and Ford.
The third section is titled the “Customer Specific Section” which contains system requirements that are unique to each automotive or truck manufacturer.
On December 14, 2006, all QS9000 certifications were terminated. With QS9000, the middle certification between ISO 9001 and ISO/TS 16949, no longer valid, businesses had a choice between either ISO9001 or TS16949. QS9000 is considered superseded by ISO/TS 16949, now a standard published by IATF, thus renamed IATF 16949:2016 (current version).
QS-9000 resources
Every QS-9000-registered company needs to have and follow six supplementary manuals in addition to the basic Quality System Requirement QS-9000:
- Failure Mode & Effect Analysis (FMEA)
- Statistical Process Control (SPC)
- Measurement System Analysis (MSA)
- Advance Product Quality Planning (APQP)
- The Production Part Approval Process (PPAP)
- Quality System Assessment (QSA); a checklist for evaluating supplier sites.
2 thoughts on “ISO 9000, QS 9000”