ISO 9000 – 9001 Series Standards and Certificat

ISO 9000 – 9001 Series Standards and Certificat

The ISO 9000 – 9001 series and certification was created by the International Organization for Standardization (ISO) as international requirements and guidelines for quality management systems. It was originally introduced in 1987 and over the years has established itself in the global economy having been adopted in over 178 countries with over one million registrations.

The phrase “ISO 9000 family” or “ISO 9000 series” refers to a group of quality management standards which are process standards (not product standards).

  • ISO 9000 Quality management systems – Fundamentals and Vocabulary, referenced in all ISO 9000 Standards.
  • ISO 9001Quality management systems – Requirements, contains the requirementsan organization must comply with to become ISO 9001 certified.
  • ISO 9002 –Guidelines for the application of ISO 9001:2015
  • ISO 9004  Managing for the sustained success of an organization, provides guidelines for sustaining QMS success through evaluation and performance improvement.

ISO 9001:2015 is the current version of the ISO 9001 standard. ISO 9001 lists requirements, while the other standards in the 9000 families provide guidelines and information. People often say “ISO 9000 certified“, but what they mean is they have met the requirements of the ISO 9001 standard.

The ISO 9000 Series of Quality Standards is not industry-specific and is applicable to any manufacturing, distribution, or service organization. It is managed by Technical Committee (TC) 176, comprised of international members from many industries and backgrounds.

What are the older (obsolete) ISO 9000 quality standards?

ISO 9000 (1994) originally had three QMS models depending on the primary function:

  • ISO 9001:1994Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
  • ISO 9002:1994Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. Learn more about ISO 9002.
  • ISO 9003:1994 Model for quality assurance in final inspection and test covered only the final inspection of the finished product, with no concern for how the product was produced. Learn more about ISO 9003.

All of these were combined into ISO 9001:2000, which was updated to ISO 9001:2008 and is now ISO 9001:2015.

Quality Glossary Definition: ISO 9000 series standards

ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. It should be considered to be a first step or the base level of a quality system.

  • ISO 9000 vs. 9001
  • 25 years of ISO 9000
  • ISO 9000 resources

ISO 9000 VS. 9001

ISO 9000 is a series, or family, of quality management standards, while ISO 9001 is a standard within the family. The ISO 9000 family of standards also contains an individual standard named ISO 9000. This standard lays out the fundamentals and vocabulary for quality management systems (QMS).

ISO 9000 series of Standards

The ISO 9000 family contains these standards for series & certification:

  • ISO 9001:2015: Quality Management Systems – Requirements
  • ISO 9000:2015: Quality Management Systems – Fundamentals and Vocabulary (definitions)
  • ISO 9004:2018: Quality Management – Quality of an Organization – Guidance to Achieve Sustained Success (continuous improvement)
  • ISO 19011:2018: Guidelines for Auditing Management Systems

ASQ is the only place where organizations can obtain the American National Standard Institute (ANSI) versions of these standards in the ISO 9000 family.

ISO 9000 history and revisions: ISO 9000:2000, 2008, and 2015

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 standards underwent major revisions in 2000 and 2008. The most recent versions of the standard, ISO 9000:2015 and ISO 9001:2015, were published in September 2015.

ASQ administers the U.S. Technical Advisory Groups and subcommittees that are responsible for developing the ISO 9000 family of standards. In its standards development work, ASQ is accredited by the American National Standards Institute (ANSI).

ISO 9000:2000

ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.

The ISO 9000:2000 revision had five goals:

  1. Meet stakeholder needs
  2. Be usable by all sizes of organizations
  3. Be usable by all sectors
  4. Be simple and clearly understood
  5. Connect the quality management system to business processes

ISO 9000:2000 was again updated in 2008 and 2015. ISO 9000:2015 is the most current version.

ISO 9000:2015 principles of Quality Management

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles that senior management can apply to promote organizational improvement:

  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 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
  1. Engagement of people
  • 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
  • Learn more about employee involvement
  1. Process approach
  • Manage activities as processes
  • Measure the capability of activities
  • Identify linkages between activities
  • Prioritize improvement opportunities
  • Deploy resources effectively
  • Learn more about a process view of work and see process analysis tools
  1. 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
  1. Evidence-based decision making
  • 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
  • See tools for decision making
  1. Relationship management
  • 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
  • Learn more about supplier quality and see resources related to managing the supply chain

30 YEARS OF ISO 9000

The ISO 9000 series of standards celebrated its 30th anniversary in 2017

First published in March 1987, ISO 9001: Quality management systems – Requirements has become the most successful standard in the history of the International Organization for Standardization.

The popularity of the ISO 9000 series and certification paved the way for other management system standards, including:

  • ISO 14000: Environmental management systems
  • ISO 26000: Guidance on social responsibility
  • ISO 31000: Risk Management Principles and Guidelines

What is an ISO 9000 Certification for Series?

If you are researching the ISO 9000 requirements or how to become ISO 9000 certified, you should really be focused on ISO 9001. You see an organization cannot become ISO 9000 certified. First issued in 1987 and last updated in 2015, ISO 9001 is the standard that sets out the criteria for a quality management system and is also the only standard within ISO 9000 that an organization can certify to. Therefore, it is incorrect to say that an organization is ISO 9000 compliant. However, a business can be ISO 9001 certified or compliant. While an ISO 9001 certification is not a regulatory requirement, ISO reports that “over one million companies and organizations in over 170 countries have certified to ISO 9001.”

An organization must demonstrate the following in order to be ISO 9001 certified:

  • The company follows the guidelines within the ISO 9001 standard;
  • The company meets its own requirements;
  • The company meets its customer requirements and statutory and regulatory requirements; and
  • The company maintains documentation of its performance.

An ISO 9001 series and certification can enhance an organization’s credibility as it shows customers that the organization’s products and services meet quality expectations. Additionally, there are some instances where an ISO 9001 certification is required or legally mandated for businesses in some industries.

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