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Introduction of ISO 9001 QMS

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

A set of procedures that cover all key processes in the business:

  • Monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness;
  • facilitating continual improvement

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered."ISO 9000 includes the following standards:

Introduction of ISO 9001 QMS

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-
A set of procedures that cover all key processes in the business;

Contents of ISO 9001

ISO 9001:2000 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:

Page iv: Foreword Pages v to vii: Section 0 Introduction
Pages 1 to 14: Requirements Section 1: Scope
Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
Pages 2 to 14 Section 4: Quality Management System
Section 5: Management Responsibility Section 6: Resource Management
Section 7: Product Realization Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.
Page 23: Bibliography
The standard specifies six compulsory documents:
Control of Documents (4.2.3) Control of Records (4.2.4)
Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2) Preventive Action (8.5.3)

In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents).

Summary of ISO 9001:2000 in informal language

The quality policy is a formal statement from management, closely linked to the vision, mission, business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.

Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness

Records should show how and where raw materials and products were processed, to allow

Products and problems to be traced to the source

You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.

To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.

You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.

For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required (note: a “product” is hardware, software, services, processed materials, or a combination of these).

You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.

You need to have clear requirements for purchased product

You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.

When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.

You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.

You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.

Advantages of ISO 9001 certification

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade, and Barnes, who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:

  1. Create a more efficient, effective operation
  2. Increase customer satisfaction and retention
  3. Reduce audits
  4. Enhance marketing
  5. Improve employee motivation, awareness, and morale
  6. Promote international trade
  7. Increases profit
  8. Reduce waste and increases productivity

In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.

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