ISO 9000 Standards: Quality Management & Certification
ISO 9000 Standards: Foundations of Quality Management
The ISO 9000 standards represent a comprehensive set of models applicable to organizational quality, proving invaluable for achieving effective quality management in diverse situations. A standard must fulfill its intended purpose, remaining clear and concise for correct interpretation, regardless of the individual, group, or company using it. Furthermore, standards must adapt and be updated based on user recommendations.
Addressing Technical Barriers to Trade
Products sold internationally often face varying national technical specifications, creating technical barriers to trade and resulting in additional costs for goods and services. To address these issues, Policy 83/189/CEE was established. This policy mandates informing the European Commission and other national agencies of any draft technical regulation or initiative to establish or modify a standard.
ISO 9000 Standards: The 2000 Revision
ISO 9000 standards are subject to revision at least every five years. Consequently, the technical committee ISO/TC 176 conducted the second review of these standards to update the 1994 version. Major changes proposed in this revision included:
- ISO 9000: Quality management systems – Fundamentals and vocabulary.
- ISO 9001: Quality management systems – Requirements.
- ISO 9004: Quality management systems – Guidelines for performance improvements.
- ISO 10011: Guidelines for auditing quality systems.
Proposed changes to the new structure focused on:
- Management responsibility
- Resource management
- Process management
- Measurement, analysis, and improvement
Standardization in Europe: The New Approach
Known as the “New Approach,” European standardization emphasizes the importance of rules related to product technical specifications, safety, and quality. Its objectives include:
- Simplifying and accelerating the EU legislative process.
- Preventing the proliferation of conflicting guidelines and standards.
- Reinforcing the work of national standards bodies and certification.
Characteristics of the ISO 9000 Series
The ISO 9000 series comprises international standards applicable to quality management and assurance, including: ISO 9000-1, ISO 9001, ISO 9002, ISO 9003, and ISO 9004-1. Most importantly, ISO 9000 standards are applicable to any type of business, from large multinationals to small and medium-sized enterprises (SMEs). Developed in 1987, these standards were initially designed for supplier-client relationships. Their implementation involves both internal and external audits. Compliance with ISO 9000 is demonstrated to customers through external audits. Companies that conform to ISO 9000 ensure their products or services are delivered consistently and reproducibly.
It is crucial to understand that ISO 9000 standards are not product standards; it is impossible to inspect a product by referencing them directly.
Structure of the ISO 9000 Family
The ISO 9000 family is broadly divided into three groups of standards:
- Group 1: Guidelines and Aids
Includes UNE-EN-ISO 9000-1, 9000-2, 9000-3, and 9000-4. These provide guidelines and assistance for selecting, using, and applying standards 9001, 9002, and 9003 in quality management and assurance.
- Group 2: Quality Assurance Standards
Aimed at quality assurance with a clear purpose of evaluating specifications: UNE-EN-ISO 9001, UNE-EN-ISO 9002, UNE-EN-ISO 9003.
- Group 3: Quality Management Standards
Primarily focused on quality management, represented by UNE-EN-ISO 9004. This standard is structured into seven parts:
- 9004-1
- 9004-2
- 9004-3
- 9004-4
- 9004-5
- 9004-6
- 9004-7
Its primary mission is to provide guidance for implementing a quality system.
Standardization in Spain: AENOR
In Spain, the organization responsible for standardization activities is AENOR (Asociación Española de Normalización y Certificación), designated by order of the Ministry of Industry and Energy on February 26, 1986.