A Brief Intro to the 20 Elements of ISO-9000:1994

While this is not a copy of the standard, it is a brief synopsis of the elements and offers an idea of the  requirements.  

4.1: Management Responsibility
Top Management is required to:

1. develop a Quality Policy reflecting the organization's attitude to quality and ensure it is communicated throughout the organization.

2. allocate appropriate resources and trained personnel to perform the work.

3. appoint a management representative to monitor the Quality System.

4. conduct regular management reviews to ensure the health of the quality system .

4.2: Quality System
The system must:

1. be fully documented within the framework of ISO 9000.

2. satisfy customer's requirements and specifications.

3. be adapted to your organization.

4. define how quality requirements will be met.

5. demonstrate thorough planning to meet customer requirements.

4.3: Contract Review

1. Sales must review the orders and contracts with the customer.

2. Any change must be reviewed and agreed to with the customer.

4.4: Design Control
All phases of product or service design (engineering) must be controlled and conducted by qualified personnel. (This pertains to ISO-9001 only.)

4.5: Document and Data Control

1. All documents and data used must be controlled and authorized.

2. Obsolete documents must be removed form circulation; latest issues must be located at appropriate areas throughout the facility and available at the workplace.

3. Changes must be recorded and released in a controlled manner.

4.6: Purchasing

1. Purchasing information must be complete and accurate.

2. Suppliers must be qualified and selected based on demonstrated quality.

3. Suppliers must be monitored continuously.

4.7: Control of Customer Supplied Product
If and when customers supply the materials for their products, you must ensure that:

1. you report to the customers any discrepancy or damage to their products.

2. their products can be identified easily.

3. their products are handled and stored accordingly.

4.8: Identification and Traceability
Products must be identified at all times and through all phases of production.

4.9: Process Control
You are required to have a complete process, with appropriate written procedures, to perform and monitor all production activities, which affect quality.

4.10: Inspection
You are required to have documented verifications at all critical stages of your process:

1. Receiving of raw material.

2. Work in process.

3. Final inspection.

4.11: Calibration
All inspection and measuring equipment (Gauges, thermometers, scales , test software...) must be controlled and maintained in calibration. You are required to:

1. provide unique identification and list of all inspection and measuring equipment.

2. determine the required accuracy.

3. protect and maintain the equipment to ensure continuing accuracy.

4. calibrate each instrument on a pre-determined cycle to established procedures.

4.12: Inspection and Test Status
The test status of all product must be identified through all phases of production.
The test status indicates whether the product has passed or failed inspection.

4.13: Control of Nonconforming Product
Any nonconforming product must be properly identified and segregated (if practical)  with a documented disposition.

4.14: Corrective and Preventive Action
You are required to have a formal process to correct and prevent problems form occurring. The process will insure that:

1. root cause is investigated

2. corrective and/or preventive action is taken

3. the effectiveness of corrective and/or preventive is verified

4.15: Handling, Storage, Packaging, Preservation and Delivery
You are required to have documented procedures for:

1. Handling

2. Storage

3. Packaging

4. Preservation

5. Delivery

4.16: Control of Quality Records
Records which demonstrate compliance to procedures and ISO-9000 must be:

1. identified

2. legible

3. accurate

4. filed and indexed properly

5. easily retrievable

6. retained for a specified period of time

4.17: Internal Quality Audits
You are required to conduct formal internal audits to examine all activities affecting quality, and evaluate their compliance to:

1. documented procedures.

2. ISO 9000 requirements.

4.18: Training
You are required to:

1. identify training needs.

2. provide appropriate training.

3. document training activities.

4. ensure only trained people carry activities affecting product quality.

4.19: Servicing
If you provide "servicing" as part of the contract, you are required to control:

1. the design and use of the service equipment.

2. use trained and qualified personnel.

3. ensure product and parts availability.

4. document working procedures and methods.

4.20: Statistical Techniques
Any data analysis, sampling methods, and SPC used must be based on established procedures and sound statistical techniques.

For a complete copy of the Standard, please visit the American Society of Quality web site ( www.asq.org ) or call 1-800-248-1946 .