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About installation and maintenance of quality systems and internal auditing. Services offered by Lewis Conquer Consultancy Services
Information about ISO 9001 Quality Standard; and related systems; ISO 13485; ISO 14001 and ISO/IEC 17025
How to get a quaotation for installation and maintenance of a quality system to ISO 9001; BS EN ISO 13485; ISO 14001, ISO/IEC 17025 and ISO 27001
Quality Systems training; ISO 9001; ISO 13485; TS 16949. Courses available on aCD

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The benefits of using an Institute of Quality Assurance, Mangement Consultants Register; registered consultant
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ISO 9001 The Process Model

ISO 9000 has achieved global recognition, particularly amongst organisations who have demonstrated their capability to meet stringent customer expectations through quality assurance. Over 350,000 companies worldwide are registered to one of the ISO 9000:1994 series of Standards

A major survey of these users was commissioned in 1997 by an ISO Technical Committee (TC 176) which revealed criticism of the 20 element model in terms of it being manufacturing biased, too cumbersome and having too many guidelines. In recent years, other business disciplines have become driven by processes, not procedures. Industries began to find the ISO 9000 series inflexible and less relevant to their needs. 

How is the Standard changed ?

The good news is that the  2000 version of the standard promises benefits that will apply equally to small firms as to large organisations. These include the following :

  • Written in clear language; simple to use and less bureaucratic
  • Applicable to all sizes of organisation and all product sectors - including service
  • More emphasis on 'the processes' of a business
  • Ability to reduce the scope, according to the type of organisation
  • Compatible with related standards, such as ISO 14001 (Environmental)
  • Provides a pathway to continual improvement

ISO 9002:1994 and ISO 9003:1994 have been withdrawn and incorporated into a single requirements standard; ISO 9001:2000.  The standard was further amended in 2008 although the changes were fairly minor.

Four core standards

There will be four core standards for Quality Management Systems :

  • ISO 9000 Fundamentals and vocabulary
  • ISO 9001 Requirements
  • ISO 9004 Guidance for performance improvement
  • ISO 19011 Guidelines for Auditing Quality Systems (used to be ISO 1001)

Of these, only ISO 9001 is a certifiable standard (i.e. ISO9001 is the only standard that you can be assessed against), with the others being for guidance and information purposes only.

Change in emphasis

The major proposed change is from a system-based to a process-based management approach, which is seen as a logical progression in line with other contemporary management initiatives.

In emphasising measurement, customer satisfaction and continual improvement, the ISO 9000:2000 series demonstrates that it does not pursue quality for its own sake - but acknowledges it as an essential requirement for the achievement of customer satisfaction. 

The Process Model

Any activity or operation which receives inputs and converts them to outputs is a process, which covers almost all product and/or service activities and operations. For organisations to function they have to define and manage numerous inter-linked processes.

The process model for ISO 9001 shows its four main elements following the Plan-Do-Check-Act cycle. It is simply a way of representing an organisation's quality management system in relation to customer's requirements and the achievement of customer satisfaction.

A diagram of the process model of ISO 9001:2000

 

Further Revision of  ISO 9001

ISO 9001:2008 was published 15th November 2008

There have been a number of clarifications in the introductory chapters  (details of the changes)

How to Contact LCCS

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