MANAGEMENT RESPONSIBILITY
One key criticism of ISO
9001's previous versions has been that management had a minimal role that didn't
require them to move beyond maintenance into the improvement arena. In fact,
the 1994 version of ISO 9001 is often viewed as a foundation only and isn't
considered a vehicle for moving a company to world-class status.
ISO 9001:2000's section 5, Management Responsibility, is designed to transfer
the responsibility for the quality management system from quality assurance
to top management. This ensures that customer satisfaction is achieved, customer
requirements are fully understood and met, planning activities include objectives
at each relevant function and level within the organisation, internal communications
are established, and information within the system (e.g., analysing data, internal
audit results, corrective and preventive action, customer measures) is used
to facilitate improvement.
RESOURCE MANAGEMENT
Organisation's
must determine and provide, in a timely manner, the resources necessary to implement
and improve the quality management system processes and to address customer
satisfaction.
Organisation's
must identify, provide and maintain facilities necessary to achieve conformity
of their products.
Organisation's
must identify and manage human and physical factors in relation to the work
environment.
The requirement
for organisation's to keep training records has been expanded to include records
of education, experience, training and qualifications.
Employees
must understand the relevance and importance of what they do and how they contribute
to the achievement of the quality objectives.
Organisation's
must evaluate the effectiveness of the training they provide.
PRODUCT [SERVICE] REALISATION
Another criticisms of ISO
9001:1994 was that it focused on the organisation rather than on the customer.
Certain customer requirements must be determined, such as specific product requirements,
availability, delivery, support requirements, noncustomer-specific product requirements,
and regulatory and legal requirements.
Organisation's must now identify and implement communication "arrangements"
(methods) with their customers. Again, many organisation's probably do this
currently but may not have formalised their processes. The information between
the organisation and its customers is related to products, enquiries, contracts,
order handling, changes, complaints and feedback.
MEASUREMENT, ANALYSIS AND IMPROVEMENT
I SO 9001:2000's section
8, Measurement, analysis and improvement, will challenge most organisation's.
Although most understand that management review, internal audits, and corrective
and preventive action form an important integrated triangle for evaluating quality
systems, many have done only a fair or inadequate job of facilitating improvement
activities from the information within their systems.
As with section 5, Management responsibility, management must play an active
role in section 8, which requires making decisions about key measures and analyzing
the results of information from sources such as audits, corrective and preventive
action, customer feedback and analysis of other information relating to products,
trends and suppliers performance.
Requirements within this section are customer
satisfaction, analysis of data, improvement, planning, internal audits, measuring
and monitoring or processes and products, control of non conformity, corrective
and preventive action.
The maturity of an organisation's measurement systems will determine the amount
of effort and development required. If organisation's have measurements in place,
they will need to evaluate those measurements and the results they will provide.
The opportunity now exists to use a best practice
model as a basis for continuous process improvement ensuring effective,
practical and focused business results.
NB! - ISO 9001:2000 focuses on using measurements and their results to drive continuous process improvement.