ISO 9000

History

The ISO 9000 series contains four standards:

1. ISO 9000:2015—Quality management systems—fundamentals and vocabulary.
   • This standard specifies the terms and definitions that apply to all quality management and quality management system (QMS) standards developed by ISO Technical Committee (TC) 176.
2. ISO 9001:2015—Quality management systems—requirements.
   • This is an international management system standard (MSS) that specifies requirements for a QMS.
   • This is the only standard in the series to which organizations can certify.
3. ISO/TS 9002:201—Quality management systems—guidelines for the application of ISO 9001:2015.
   • This Technical Specification (TS) is intended to be informative and provides guidance on ISO 9001 requirements. It is formatted with a clause-by-clause correlation to clauses in ISO 9001.
   • This TS does not add new requirements to ISO 9001; however, it offers examples of how an organization may apply the requirements.
4. ISO 9004:2018—Quality management—quality of an organization—guidance to achieve sustained success.
   • This standards provides guidelines for enhancing an organization’s ability to achieve sustained success.

ASQ administers the U.S. Technical Advisory Groups and subcommittees responsible for developing the ISO 9000 standards series. In its standards development work, ASQ is accredited by ANSI.

The popularity of the ISO 9000 series has paved the way for other MSSs, including:

• ISO 14001—Environmental management systems—requirements with guidance for use.
• ISO/IEC 27001—Information technology—security techniques—information security management for inter-sector and inter-organizational communications.
• ISO 29001—Petroleum, petrochemical and natural gas industries—sector-specific quality management systems—requirements for product and service supply organizations.
• ISO 45001—Occupational health and safety management systems—requirements with guidance for use.
• ISO 50001—Energy management systems—requirements with guidance for use.

ISO 9000

ISO 9000 is the normative reference for ISO 9001 and many other ISO MSSs. “Normative” means it is indispensable for applying the particular standard in which it is cited. It can help an organization satisfy its customers, meet regulatory requirements, and achieve continual improvement. It should be a first step or the base level of a quality system.

The standard contains terms, fundamentals and seven quality management principles (QMP).

Terms

There are almost 200 terms in the latest revision of ISO 9000. For consistency and effectiveness, the terms must be applied uniformly and as defined.

Fundamentals

The fundamentals describe the culture in which behavior, attitudes, and processes are inculcated into the organization’s fiber to fulfill customer expectations. They include considering factors that affect the organization and relevant interested parties.

QMPs

Originally, the QMPs were developed based on various criteria such as the Baldrige award, the Deming Prize, and the European Foundation for Quality Management Excellence Award. They also reflect the legacy of the great luminaries of quality: Joseph M. Juran, W. Edwards Deming, Walter Shewhart, and Kaoru Ishikawa.

The seven QMPs are:

1. Customer focus.
   • 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.
   Learn more about the customer experience and customer satisfaction.
2. Leadership.
   • Establish a vision and direction for the organization.
   • Set challenging goals.
   • Model organizational values.
   • Establish trust.
   • Equip and empower employees.
   • Recognize employee contributions.
   Learn more about leadership.
3. Engagement of people.
   • Ensure people’s abilities are used and valued.
   • Hold people accountable.
   • Enable participation in continual improvement.
   • Evaluate individual performance.
   • Enable learning and knowledge sharing.
   • Enable open discussion of problems and constraints.
   Learn more about employee involvement.
4. Process approach.
   • Manage activities as processes.
   • Measure the capability of activities.
   • Identify links between activities.
   • Prioritize improvement opportunities.
   • Deploy resources effectively.
   Learn more about a process view of work and process analysis tools.
5. Improvement.
   • Improve organizational performance and capabilities.
   • Align improvement activities.
   • Empower people to make improvements.
   • Measure improvement consistently.
   • Celebrate improvements.
   Learn more about approaches to continual improvement.
6. Evidence-based decision making.
   • Ensure accurate and reliable data are accessible.
   • Use appropriate methods to analyze data.
   • Make analysis-based decisions.
   • Balance data analysis with practical experience.
   Learn more about tools for decision making.
7. Relationship management.
   • Identify and select suppliers to manage costs, optimize resources, and create value.
   • Establish relationships considering the short and long term.
   • Share expertise, resources, information, and plans with partners.
   • Collaborate on improvement and development activities.
   • Recognize supplier successes.
   Learn more about supplier quality and see resources related to managing the supply chain.

Revisions

ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of more than 160 countries.

The standard has gone through two major revisions in 2000 and 2015.

ISO 9000:2000

The 2000 revision of ISO 9000 included the addition of eight QMPs. 

1. Customer focus.
2. Leadership.
3. Involvement of people.
4. Process approach.
5. System approach to management.
6. Continual improvement.
7. Factual approach to decision making.
8. Mutually beneficial supplier relationships.

ISO 9000:2015

A technical group was established to review and revise the QMPs for the 2015 update to ISO 9000. The group reduced the eight QMPs to seven.

1. Customer focus.
2. Leadership.
3. Engagement of people.
4. Process approach.
5. Improvement.
6. Evidence-based decision making.
7. Relationship management.

“Involvement of people” was changed to “Engagement of people,” giving more strength to this principle.

“Factual approach to decision making” was changed to “Evidence-based decision making” to clarify the meaning.

“Continual improvement” was changed to “Improvement” because many users understood “continual” to mean only small incremental improvements, but it also should include breakthrough changes.

“Mutually beneficial supplier relationship” was changed to “Relationship management” to clarify that relationships with all relevant interested parties should be managed.

Beyond the changes to the quantity and titles of the QMPs, the text explaining each principle was enhanced to include a statement, a rationale, key benefits, and possible actions.

ISO 19011

Although ISO 19011—Guidelines for auditing management systems is not an MSS, it has significant relevance for them. Without internal audits, no MSS can be complete. This standard is the pre-eminent authority on auditing. It provides guidance on:

• Managing an audit program.
• Conducting audits.
• Auditor competence.
• Multiple annexes with additional guidance on a variety of auditing topics.

ISO 19011 also is being revised and expected to be published in February 2026.