What are the Clauses of the ISO 9001:2000 Standard?

ISO 9001:2000 clauses are documented rules and guidelines for implementing a Quality Management System (QMS) into your company's daily operations. Specific technical specifications and/or other specific criteria may also be included depending on the standard you select.

The ISO 9001 standard is a model of a QMS, describing the processes and resources required for registration of a company's quality system. This ISO System diagram shows the management system and processes that are part of the ISO quality management standard. A brief summary of the key requirements is detailed below.

  • QMS - Document processes necessary to ensure product or service is of high quality and conforms to customer requirements.
  • Management Responsibility - Provide a vision. Show commitment. Focus on the customer. Define policy. Keep everyone informed.
  • Resource Management - Assign the right person to the job. Create and maintain positive workspace.
  • Product Realization - Clearly understand customer, product, legal and design requirements. Ensure specifications are followed. Check your suppliers.
  • Measurement, Analysis & Improvement - Identify current and potential problems. Monitor and measure customer satisfaction. Perform internal audits. Fix problems.

Why Implement ISO?

Implementing ISO in your company is a management decision that requires consideration of your organizationís operations, strategy, staff and, most importantly, your customers.

ISO standards are now readily being applied by organizations in industries ranging from manufacturers and labs to auto suppliers and pharmaceuticals. In many instances, the choice to implement an ISO standard into a company is not only the result of a company seeking to improve quality, efficiency, and profitability, but also as a result of ISO implementation being:

  • Mandated by certain Industry Leaders, as the Big Three (DaimlerChrysler, Ford and GM) has required of automotive suppliers (See ISO/TS 16949 for more information on deadlines)
  • Required by your Customers, especially internationally-focused businesses
  • Required by overseas regulatory bodies for suppliers of quality-sensitive products, e.g. medical devices
  • Necessary to maintain market presence and a competitive advantage

For whatever reason your company decides to pursue or update its ISO certification, you need to consider the benefits and costs involved with this process.

ISO Benefits

ISO standards are a guide that can help transform your companyís quality system into an effective system that meets and exceeds customer expectations. Your company will start to realize these benefits as you implement and adhere to the quality standards, and you will see the internal and external benefits accrue over time.

Internally, processes will be aligned with customer expectations and company goals, therefore forming a more organized operating environment for your management and employees. Product and service quality will improve which decreases defects and waste. Process improvements will help to motivate employees and increase staff involvement. Products and services will be continually improved. All of these internal benefits will continually drive better financial results, hence creating more value for your business.

As for the external benefits, ISO certification shows your customers and suppliers worldwide that your company desires their confidence, satisfaction and continued business. Your company also has the opportunity to increase its competitive advantage, retain and build its customer list, and more easily respond to market opportunities around the world.

ISO Costs

Although the costs of implementation can be offset with increased sales, reduced defects and improved productivity throughout the organization, the investment of implementing and maintaining an ISO quality system needs to be considered.

Many factors should be considered when calculating your companyís ISO implementation costs. The time, effort and money your organization puts into ISO registration depends on the number of employees, locations, the ISO standard selected for registration and the current state of your quality system and processes. Typical costs include:

  • Management and employee time and effort
  • Upgrading and creating documentation
  • Training employees
  • Registration fees
  • Maintenance

As with implementation of any new tool, the key to minimizing costs is to arm yourself with knowledge about the process, and then to design a sensible plan that has realistic objectives, adequate resources and a practical time schedule. Having a leader or consultant to guide you through the process and manage deadlines can also help you to control costs and achieve your goals more quickly. In addition, if you have multiple locations or departments, costs can be minimized by leveraging the information you learn and the resources you use as you move through the implementation and maintenance process.

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