To implement a Quality Management System there are key steps that every organisation must consider. The following list should be a useful guide but each journey will be different. It is best to speak with someone who has gone through the process before such as an ISO 9001 trainer, a certification body or an ISO 9001 consultant.
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12 steps to implement an ISO 9001 Quality Management System
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12 Steps to Implement an ISO 9001
Quality Management System
www.genesys-training.co.uk
2. 01925 818088
info@genesys-training.co.uk
To implement a Quality Management System there are key
steps that every organisation must consider. The following list
should be a useful guide but each journey will be different. It is best to
speak with someone who has gone through the process before such as
an ISO 9001 trainer, a certification body or an ISO 9001 consultant.
3. 01925 818088
info@genesys-training.co.uk
Step 1: Get a copy of the Standard
The first step is to make yourself familiar with the ISO 9001 standard and
whilst this can be done on an ISO 9001 awareness training course you
will ultimately need a copy of the standard so it makes sense to buy it as
soon as possible. The price may seem a little steep at £90 or £45 for the
PDF version but you need to get a copy at some point.
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Step 2: Review support literature and
software
There are a wide range of quality publications and software tools
designed to help you understand, implement and become registered to a
quality management system.
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Step 3: Assemble a quality management
team and agree your strategy
The standard has always specified that senior management must buy in
to the quality management ethos and whilst having the top person sign
the quality policy usually is enough to demonstrate this, you may also be
asked to demonstrate that the person responsible for quality in the
organisation has a direct channel to board level and has the ability to
influence.
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Step 4: Skills Gap Analysis to Determine
Training Requirements
There is a wide range of ISO 9001 Training courses available and different
people will require different levels of training. Consider awareness
training for senior management and your quality team but then also you
will need to have internal auditors who may also require training in the
art of auditing. You may also wish to consider if you want an IRCA
approved course.
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Step 5: Review Consultancy Options
For some organisations the best route is to get training and learn how to
implement the standard themselves but for others with time and
resources constraints it may be easier and quicker to use a consultant
who has been there before. A consultant can help you to avoid common
pitfalls and costly mistakes and they can no doubt help you with your
first internal audits. You may want to consider internal auditor training
for in house teams in the long run as it will save you money.
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Step 6: Choose a Certification Body
Certification bodies are sometimes called registrars and they are licensed
(accredited) by the United Kingdom Accreditation Service to issue
certificates for meeting the requirements of ISO 9001 and other
standards. They are a 3rd party organisation who will assess your
management system to check that it meets the requirements of the
standard and they will assess the processes of the organisation to check
that the management system is being operated properly. They will
charge a fee for the initial assessment and for the
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Step 7: Develop a Quality Manual
A Quality Manual is a high level document that outlines your intention to
operate in a quality manner. It outlines what your business does and
how you do it. There are misconceptions that a manual has to be a large
bulky document but actually some quality manuals are written on 1 side
of A4!
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Step 8: Develop the Documentation
This typically includes procedures, working instructions and forms but
may include others documents too like a legal register. It isn’t a
requirement of ISO 9001 but it is for other standards and you may wish
to include it in your management system for good practice. Developing
the documentation may simply consist of pulling together the
documents that already exist and just filling in a few gaps.
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Step 9: Implement your Quality
Management System
The key to implementation is communication and training. During the
implementation phase everyone operates to the procedures and collects
records that demonstrate you are doing what you say you are doing.
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Step 10: Consider a Pre-Assessment
Prior to the actual certification body assessment they will offer you a
pre-assessment. It is not mandatory but some organisations find it useful
to check their readiness for the actual assessment. It is likely to be
additional cost which could be better spent.
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Step 11: Initial Assessment
You should arrange your initial assessment with your certification body.
An Assessor will arrange a date to visit your head office or the location of
the management system and site being assessed for approval and the
certification body should provide some form of schedule to let you know
how the days events will proceed.
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Step 11: Initial Assessment
You should arrange your initial assessment with your certification body.
An Assessor will arrange a date to visit your head office or the location of
the management system and site being assessed for approval and the
certification body should provide some form of schedule to let you know
how the days events will proceed.
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Step 12: Continual Assessment
Once you have received registration and been awarded your certificate,
you can begin to advertise your success and promote your business. To
maintain your registration, all you need to do is continue to use your
quality system and look to continuously improve. You
will receive surveillance assessments from your certification body to
check that they system is being maintained.
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Internal Auditor Training call
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