What is ISO 9000?
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- Why do ISO 9000?
- How does a company register to the ISO 9000 Standard?
- Should I do ISO 9000?
- Why do ISO 9000?
ISO 9000 is a series of international quality standards, the guiding principle of which is the prevention of defects through the planning and application of best practices at every stage of business - from design through to installation and servicing. These standards focus on identifying the basic disciplines and specifying the general criteria by which any organization, regardless of whether it is manufacturing or service oriented, can ensure that product leaving its facility meets the requirements of its customers. These standards ask a company to first document and implement its systems for quality management, and then to verify, by means of an audit conducted by an independent accredited third party, the compliance of those systems to the requirements of the standards.
Currently, the ISO 9000 series is comprised of the following international standards:
- ISO 8402 - Quality management and quality assurance vocabulary
- ISO 9000 - Guidelines for selection and use
- ISO 9001 - Model for quality assurance: design, development, production, installation and servicing
- ISO 9002 - Model for quality assurance: production, installation and servicing
- ISO 9003 - Model for quality assurance: final inspection and test
- ISO 9004 - Quality management and quality system elements
- ISO 10011 - Guidelines for auditing quality systems
- ISO 10012 - Requirements for measuring equipment
- ISO 10013 - Guidelines for quality manuals.
Fundamentally these standards can be grouped into two categories:
- Requirements - These mandatory standards dictate what a company shall do. Companies become registered to or compliant with one of the requirements standards. There are four requirements standards:
- ISO 9001
- ISO 9002
- ISO 9003
- ISO 10012
- Guidelines - These assist a company to interpret the requirements standards, suggesting what a company should do. There are also four guidelines:
- ISO 8402
- ISO 9000
- ISO 9004
- ISO 10011
- ISO 10013
Regardless of whether an organization is involved in a total manufacturing operation, including design, or only inspection and testing process, it can develop a quality management system based on one of the ISO 9000 requirements standards. By design, these standards can accommodate variation from company to company and between economic sectors. It is simply up to each individual business to interpret the appropriate requirements standard in light of its own processes.
The principle standards within the group are ISO 9001, 9002 and 9003. These are the requirements standards, and all of the other standards within the series are related to these three. Of the three, ISO 9001 is the most comprehensive. Divided into 20 specific elements, deliberate and organized, it provides a foundation for basic quality management and continuous improvement practices. Each of its 20 elements covers a particular area of an organization's business processes:
- Management Responsibility
- Quality Planning
- Contract Review
- Design Control
- Document and Data Control
- Purchasing
- Control of Customer-Supplied Product
- Identification and Traceability
- Process Control
- Inspection and Testing
- Control of Inspection, Measuring and Test Equipment
- Inspection and Test Status
- Control of Nonconforming Product
- Corrective and Preventive Action
- Storage, Handling, Packaging, Preservation and Delivery
- Control of Quality Records
- Internal Quality Audits
- Training
- Servicing
- Statistical Techniques
ISO 9002 and ISO 9003 are derivatives of the 9001 requirements standard. ISO 9002 is comprised of 19 elements as it does not include section 4.4, Design Control and ISO 9003 consists of only ?? elements.
Main Page
ISO 9000 Index
