Historical Evolution of Quality and ISO 9000 Standards

Posted on Sep 7, 2024 in Other subjects

Historical Evolution of Quality

Origins:

  • The International Federation of National Associations of Standardization (1926-1939).
  • From 1943 to 1946, the Coordinating Committee of United Nations Organization for Standardization (UNSCC).

International Organization for Standardization (ISO):

  • Established in October 1946 in London by representatives of 25 countries.
  • First meeting in June 1947 in Zurich, Switzerland.
  • Headquarters in Geneva, Switzerland.
  • Promotes the development of international standards to facilitate the exchange of goods and services.

Milestones:

  • 1959: US Department of Defense established MIL-Q-9858, later revised to MIL-Q-9858A.
  • 1963: NATO adapted MIL-Q-9858A to create AQAP-1.
  • 1970: British Ministry of Defense adopted AQAP-1 in DEF/STAN 05-8.
  • 1979: BSI developed BS 5750.
  • 1987: ISO created the ISO 9000 series based on BS 5750. The same year, it was adopted in the US as ANSI/ASQC-Q90.
  • All ISO standards are reviewed at least every five years.
  • 1992/1993: Revision of ISO 9000 standards, including the creation of the Vocabulary of Quality (ISO 8402) and the ISO 10000 series.
  • 1990: ISO 9000 implemented in the US as the Passport to Europe.
  • Today: ISO 9000 is integrated into various courses and programs.

ISO Membership:

  • One organization per country.
  • 1) Members of the Executive Committee: Inform stakeholders, represent national interests, provide membership fees, and have voting rights.
  • 2) Corresponding Members: For countries with less developed standardization activities. They have a voice but no vote.
  • 3) Subscribed Members: Countries with small economies. Pay reduced fees to stay informed.

International Standards

All products and services should be safe and adequate. International institutions define parameters for different sectors.

Definition of a Standard: A document established by consensus and approved by a recognized body that provides rules, guidelines, or characteristics for activities to achieve optimal order.

  • Initially created to document technological processes, later used for administrative procedures.
  • ISO 9000 standards are reviewed every five years.
  • The 1994 ISO 9000 standards were replaced by the ISO 9000:2000 standards, which include guidelines for information management.
  • UNE-EN ISO 9001:2000 (current) replaces UNE-EN ISO 9001:1994, UNE-EN ISO 9002:1994, and UNE-EN ISO 9003:1994. A review is planned for 2009.
  • In Chile, the representative organization to ISO is the National Standardization Institute (INN).

Quality Gurus

Development of Quality Management (To 1900):

  • Linked to economic development.
  • Artisans controlled all phases of product development.

Industrialization and Division of Labor (From 1900):

  • Increased industrial production.
  • Separation of raw material purchasing, production, and distribution.
  • Breakdown of the producer-client relationship.
  • Around 1920, division between production and inspection.
  • Specialization of tasks increased productivity (Frederick Winslow Taylor).

Statistical Process Control (Since 1940):

  • Increased production during World War II led to increased inspection needs.
  • Statistical techniques were introduced to reduce inspection costs.
  • 1941: American universities offered courses on statistical methods for production.
  • 1946: American Society of Quality Control founded.

W. Edwards Deming (1950):

  • Focused on statistics for quality monitoring and improvement.
  • The 14 Points for Management and the Deming or PDCA cycle.
  • Lower process variability leads to higher quality.
  • Two types of variations: common variations (predictable and controllable) and special variations (sporadic and due to specific causes).
  • The goal of statistical process control is to detect assignable causes of variability.

Deming’s 14 Points:

  1. Create constancy of purpose: Establish long-term objectives.
  2. Adopt the new philosophy: Embrace change to eliminate waste and defects.
  3. Cease dependence on inspection: Build quality into the product.
  4. End the practice of awarding business on price: Build long-term relationships with suppliers based on loyalty and trust.
  5. Improve constantly: Incorporate quality during the design phase based on customer needs.
  6. Institute training: Train all members of the organization.
  7. Adopt and implement leadership: Train supervisors to be leaders who collaborate with employees to prevent errors.
  8. Dispose of fear: Encourage questions and problem-solving.
  9. Break down barriers between departments: Foster cooperation and teamwork.
  10. Eliminate slogans and targets: Focus on continuous improvement instead of unrealistic goals.
  11. Eliminate numerical quotas: Replace quotas with leadership and continuous improvement.
  12. Remove barriers to pride of workmanship: Eliminate evaluation systems that hinder motivation and collaboration.
  13. Encourage education and self-improvement: Support continuous learning and personal development.
  14. Act to achieve the transformation: Involve all employees in the improvement process and create a supportive organizational structure.

Joseph M. Juran:

  • Juran’s trilogy: Planning, Control, and Quality Improvement.

Integration of Quality Assurance (Since 1960):

  • Introduced the idea of overall quality, involving all departments.
  • Questioned the traditional approach to inspection.

Other Quality Gurus:

  • Philip B. Crosby: Promoted the culture of zero defects.
  • Genichi Taguchi: Taguchi loss function and design of experiments.
  • Armand V. Feigenbaum: Quality as an organization-wide concern.
  • Kaoru Ishikawa: Q7 quality tools and the fishbone diagram. Extended quality circles.

Total Quality Management (TQM) (Since 1980):

  • Quality as the responsibility of all members of the organization.
  • Focus on quality of processes and systems in addition to product quality.
  • TQM implementation involves quality at all levels of the organization.

Quality in the News

Implementing ISO 9000 requires more than just the standard. It necessitates a sensitization process involving all stakeholders to create an environment conducive to change.

  • Not all companies adopt the standard as a quality system. Some seek ISO certification for competitive advantage rather than actual improvement.
  • Some companies start the implementation process without proper preparation.

ISO 9000 Standards:

ISO 9001, 9002, and 9003 require:

  • An effective Quality System.
  • Valid measurements and calibrated instruments.
  • Appropriate statistical techniques.
  • Product identification and tracking system.
  • Record system for processes.
  • Adequate handling, packaging, storage, and delivery system.
  • Inspection and audit system.
  • Process for handling non-conforming units.
  • Training and staff development.

Specific Standards:

  1. ISO 9000: Explains quality concepts, defines key terms, and provides guidance for using ISO 9001, 9002, and 9003.
  2. ISO 9001: Model for quality assurance in design, development, production, installation, and service. The most comprehensive standard in the series.