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About insatllation 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 and ISO/IEC 17025
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
Access to a variety of business consultancy disciplines, through the Institute for Independent Business
Industrial Microbiology consultancy

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ISO9001:2000 Update

ISO9001:2000 was released at the end of 2000, and in the last year, a DRAFT revised standard ISO/DIS 9001 has been available for comment. Voting on the Draft ended in February 2008 and it is expected that ISO9001:2008 will be available towards the end of the year. Whereas ISO9001:2000 was a major revision to the ISO9001:1994 standard, introducing some new concepts and requirements and making the standard much easier for nonmanufacturing organisations to implement, the changes to the standard seen in the Draft 2008 version are fairly minor and should not cause too many problems to organisations operating ISO9001:2000. We look at a few of the changes below.

The concept of risk is introduced “The design and implementation of an organisation’s quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment……..” This continues the outward looking focus of the standard that started in the 2000 version.

The definition of product is clarified – it now says “In this International Standard, the term “product” applies to the product intended for, or required by, a customer or the product realisation processes. This applies to any intended output resulting from product realisation processes, including purchasing”. This makes it very clear that all customer deliverables should be part of the standard.

The requirement for appointing a management representative now says “The management representative must be a member of the organisation’s management”. This places the emphasis firmly within the management team and suggests that it cannot be passed on to an outside consultant. Quality Management has to be firmly seen as the responsibility of the organisation.

There have been a couple of small changes in Clause 6.2.2. Competence and training awareness. Personnel must be competent to perform “work affecting conformity to product “, rather than “affecting product quality” thus competency now covers all product requirements. Training also has to be evaluated to “ensure that the necessary competence has been achieved”. This implies that organisations will need to consider how to demonstrate that competence has been achieved.

In Clause 6.3 Infrastructure – “Information systems” have been included in supporting  services, recognising the importance of these systems in modern management.

A note has been added to Clause 6.4 Work Environment that provides guidance as to what is meant “The term “work environment” relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).

There have also been many other changes that aim to improve clarity and understanding. This document is still a Draft, and a full schedule of changes will be

provided once the standard has been released.

 

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