Clauses in ISO 9001

Clauses in ISO 9001

. ISO 9001 defines 20 elements necessary for a quality management system, as listed below:

Management Responsibility (Element 1)

The company has to define its commitment to a quality policy, which is understood, implemented and maintained at all levels of the organization, and to define its quality goals. Responsibilities and authorities have to be defined and documented. The company must provide adequate resources and appoint a member of the management as a representative for quality management. At least once a year, a management review must be held and recorded to evaluate the quality system.

Quality System (Element 2)

A quality manual, covering all elements of the ISO standard, has to be prepared to document the quality system. Procedures must be documented and controlled. The company has to prepare a quality plan to ensure that quality requirements are understood and fulfilled.

Contract Review (Element 3)

The company has to establish and maintain documented procedures for contract review, to document the customers' requirements and ensure the capability to fulfill the contract or order requirements. Records of contract review shall be maintained.

Design Control (Element 4)

The company has to establish and maintain documented procedures to control and verify the design of a new product or service to fulfill customers' requirements. The requirements must be identified and there must be design reviews, design verification and design validation.

Design changes shall be documented, reviewed and authorized.

Document Control (Element 5)

All documents relevant for quality have to be controlled to ensure that the pertinent issues of appropriate documents are available at all locations. When necessary, they are to be replaced by updated versions. Changes shall be reviewed and approved by the same organization/person that performed the original review or approval.

Purchasing (Element 6)

The company must monitor the flow of purchasing and evaluate the subcontractor's ability to

fulfill specified requirements.

Purchaser Supplied Product (Element 7)

Goods supplied by the customer have to be recorded. It must be ensured that they are separately controlled and stored to prevent loss or damage.

Product Identification And Traceability (Element 8)

Where appropriate, purchased and delivered products or services must be made traceable through documentation or batches.

Process Control (Element 9)

All processes of production or service that directly affect quality must be documented and planned and carried out under controlled conditions to add consistency to the process. Control of process parameters and product characteristics must ensure that the specified requirements are met.

Inspection And Testing (Element 10)

The company must ensure receiving inspection and testing, in-process inspection and testing, and final inspection and testing. These inspections and tests must be recorded.

Control of inspection, measuring and

Test Equipment (Element 11)

The items of equipment used for inspection, measuring and testing must be identified and recorded. They must be controlled, calibrated and checked at prescribed intervals.

Inspection And Test Status (Element 12)

The status of the product or service must be identified at all stages as conforming or nonconforming. This is to ensure that only conforming products or services are dispatched or used

Control Of Nonconforming Product (Element 13)

The company must establish procedures to ensure that nonconforming products or services are prevented from unintended use. The disposal of nonconforming products must be determined and recorded.

Correctional Prevention (Element 14)

Procedures must be established to ensure effective handling of customer complaints and corrective actions after identifying nonconformities. The cause of nonconformities is to be investigated in order to prevent recurrence. The corrective action shall be monitored to ensure its long-term effectiveness. Preventive actions are to be initiated to eliminate potential causes of nonconformance.

Handling, storage, packaging and

Delivery (Element 15)

Documented procedures must be established to ensure that products are not damaged and reach the customer in the required condition.

Control Of Quality Records (Element 16)

All records related to the quality system must be identified, collected and stored together. The quality records demonstrate conformity with specified requirements and verify effective operation of the quality system.

Internal Quality Audits (Element 17)

The company must establish and maintain documented procedures for planning and implementing internal quality audits to determine the effectiveness of the quality system. The comments made by internal auditors must be recorded and brought to the attention of the personnel having responsibility in the area audited. Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken.

Training (Element 18)

The company shall establish and maintain documented procedures for identifying training needs and must have a training record for each employee.

Servicing (Element 19)

Where servicing is a specific requirement, the company must establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

Statistical Techniques (Element 20)

The company must establish and maintain documented procedures to implement and control the application of statistical techniques which have been identified as necessary for performance information.

This structure looks very theoretical at first glance, but this is because ISO 9000 stipulates the elements of a quality management system for any enterprise, irrespective of its branch of activity. "ISO 9000 is not a prescriptive standard, it does not detail the how but rather the what. This allows each individual company to define how it intends to comply with the standard in a way that best suits that company's method of operation".It is possible that some of the elements are of no relevance or almost no relevance in specific sectors. For example, elements 11 and 12 are not relevant for AMS Salzburg, and element 15 is only marginally relevant

The 20 elements (or the relevant ones) of ISO 9001 must be addressed in a quality manual and in operational procedures (possibly set out in a procedure manual) which comply with the standards set in the quality manual. The quality manual defines and documents the quality policy of the company. It is a statement of the company's intention to pursue a quality policy. The operational procedures set out the specific way in which ISO 9000 is implemented throughout the company's business process. Both types of document are required by ISO 9000: 1994. Almost every element of the standard requires records. Besides these, there may be other documents in the company, for example work instructions, specifications, check-lists, charts, data sheets, lists, forms and so on. Some of them are used to record events, but they are not directly required by the ISO norm, which allows the company a great deal of flexibility regarding whether or not to use such documents. AMS Salzburg, for example, decided to add work instructions (which define how an activity is performed) to documented procedures, as work instructions are liable to alteration. In the management of change, it is relatively easy to replace the work instructions addressed in the operating procedures, without touching the basic processes.