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Standards exist because many large organisations will not buy from suppliers
who cannot give them assurance that they have systems which support quality.
These large organisations include Government Defense Departments, Health
Departments, car manufacturers such as Ford, Toyota, and General Motors,
and Aerospace companies such as Boeing and Lockheed.
Until the mid 1980's
these large organisations published their own standards or codes for suppliers
to follow, and their staff would audit supplier companies regularly to
make sure they followed the code. It was not unusual for a supplier to
be audited separately by a number of larger customers, all with their
own quality system codes. In some instances suppliers hosted 30 or 40
quality system audits a year from all their major customers. To reduce
the number of audits to which individual suppliers were subjected, the
International Organisation for Standards (ISO) published a series of standards
in 1987 known as ISO 9000. Most large purchasing organisations accepted
this worldwide standard and ceased to issue their own codes. They also
ceased carrying out their own audits and accepted the findings of independent
audit companies engaged by supplier companies to check their systems against
the ISO 9000 standards. This allowed supplier companies to reduce the
number of audits to two or three per year.
Some of the independent
audit companies operating in Australia are Lloyds Quality Assurance Services,
Quality Assurance Services (QAS), Bureau Veritas, Benchmark Certification,
SGS QA Services, and National Assocation of Testing Authorities (NATA).
ISO 9000 is the name
of a series of QA standards recognised by over 200 countries around the
world and adopted as their national standards for QA. In Australia this
series has been named the AS 3900 series, but this will change in mid
1995 to the AS/NZ/ISO 9000 series to identify it more closely with the
international standard. AS 3900 and ISO 9000 have identical contents.
The most important
document in the ISO 9000 series is ISO 9001. This is the code against
which audits are actually carried out (two other documents, ISO 9002 and
ISO 9003, can also be audited against but these are 'cut down' versions
of ISO 9001 for companies which do not need to comply with the entire
code). All the other documents in the ISO 9000 series provide guidelines
and explanations for how to apply ISO 9001.
The principal features
of ISO 9001 are that it,
- takes the basic
principle of QA (the need for documented systems to support QA), and
adds requirements to control system documentation to make sure it is
kept up-to-date
- requires companies
to carry out their own internal audits of their QA system to make sure
it is working properly
- requires the QA
system to be constantly monitored to ensure that it is effective, and
that changes are constantly made to improve it
These requirements
are illustrated in the diagram below.
In addition, ISO
9001 requires organisations to include documented systems in their QA
system to cover all aspects of:
- basic quality
control (inspection, testing, test records, traceability, etc.)
- a product's life
cycle from the time negotiations start with the customer, through the
design process, purchasing of raw materials, production, storage, and
final delivery
The basic principle
of QA - working out the best course of action beforehand and communicating
it reliably to all those concerned - should be applied whenever a planned
process is complex, has implications for other processes, or has wide
or repetitious application. Beyond this, the decision to follow the specifications
in a comprehensive published QA standard rests on your organisation's
answers to the following questions:
- Is your organisation
prepared to invest the time to follow the formal discipline required?
- Does the law require
your organisation's compliance with a specific standard (pharmaceutical
manufacturers must comply with the Code of GMP)?
- Do your customers
insist on your organisation's compliance with a standard (many large
companies and
- Government Agencies
and Departments have a policy of preference for suppliers with QA Certification)?
You can implement
quality assurance in a general way by identifying the tasks, processes,
or systems critical to the business and writing clear guidelines and instructions
for staff. Use these guidelines and instructions for training and day-to-day
reference. For the tasks, processes and systems covered, this will reduce:
- the number of
errors
- waste of time
and materials associated with errors
- the number of
customer complaints
- the number of
problems to fix
- the time spent
on giving day-to-day instructions
- the time needed
to improve processes and systems (by establishing a stable base)
You can then take
this general principle of clearly documenting tasks, processes and systems
to the next level by using ISO 9000 (or another appropriate QA system
code) as a model for covering all aspects of quality, and for establishing
formal disciplines for controlling information accuracy, and reviewing
and improving systems. The two levels of implementation are summarised
in the table below. The table also lists the additional things you can
do to make your quality assurance easier to apply and even more effective.
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