What is ISO9000 ?
"Quality Management System - Requirements"
BS EN ISO 9001:2000
The standard comprises:
- 13 (thirteen) pages
- 5 Quality System Requirements
- up to 5 written procedures but a documented system is required. This can be achieved by flow charts, forms, or written processes.
It is not the standard that causes the difficulties but the interpretation given to it by many users and many who have failed in the attempt to introduce it.
The larger business use it as a Company Administration System, consequently it can be voluminous to cater for all the possible variations that could be met. They need it to ensure that all staff operate in a similar way to give continuity to their Customers.
The smaller businesses have learnt from their larger contemporaries that it can lead to bureaucracy and are somewhat put off.
The implementation of the standard can be simple. Its primary function is to ensure that the Customer gets what he or she wants when they want it. Most Companies already achieve this. The system is often your existing operating procedures written down.
Say what you do and do what you say
The long term benefits are now being realised. The implementation provides a marketing tool for bigger and specialist customers. All businesses will receive long term benefits. Some recent studies suggest a pay back period of 3 years with further improvements from year 5 when the staff are fully acquainted with the requirements of the system and follow it without a second thought.
Changes in 2000
There were several expected changes to the standard for its year 2000 update. ISO9002 and ISO9003 disappeared and be part of the new ISO9001 with any non-relevant sections of section 7 being excluded. The standard has moved to more of a process based standard. There are requirements for continuous improvement and staff skills competence monitoring.
You want to know the 14 step route to ISO9001 assessment?
You want a cost effective hands-on solution to achieving ISO9001?
THE PROCESS TO ISO9000/ISO13485 IMPLEMENTATION Including Software Quality Assurance to ISO90000-3
- Establish the scope and extent of the BE EN ISO9001 ISO13485 specifications that is to be complied with.
- Identify existing procedures and work practices throughout all areas of the operation
- Produce a draft quality manual which can be used not only to support the procedures but for use as a sales tool for the marketing department
- Produce draft quality procedures based on the in-house discussions with all members of staff and the requirements of the standard. NB the standard is a guide, the company should document its procedures and compare them to the standard not vice versa
- Carry out staff discussions to consider the draft documentation produced to ensure it has their support and accords with requirements and existing practices
- Finalise the quality procedures following staff discussions and issue as firm documents. NB procedures must be simple, easy to follow and readily available
- Produce the Quality Management System manual as a firm document.
- Produce final drafts of the forms to be used
- Implementation of procedures and associated forms
- Carry out QMS induction training and instruction on internal audit techniques
- Carry out an internal audit to verify the systems are in place for a successful accreditation visit. A pre-assessment audit can be beneficial.
- Submit the manuals and the company to a government approved organisation to seek registration to the relevant standard
- The certification company reviews the quality documentation and visits the company to confirm it operates to its documented system and the requirements of the relevant standard. When satisfied, it will issue the relevant certificates
- The certification company will revisit every six months to confirm on-going compliance by the company
Where do we go from here ?
Atlantic Bridge or one of its associate companies such as PHW Business Services can provide you with a cost effective solution to any or all the above standards.
With Fixed cost contracts we can have your certificate on the wall faster and cheaper than you could possibly do it yourself.
Atlantic Bridge Limited ..........and............ PHW Business Services
PO Box 4800
Earley
Berkshire RG5 4GB
England
Tel: +44 (0) 118.969.7047
Fax: +44 90) 118 901 4411
Email: info@atlanticbridge.co.uk
If you already have ISO9001 registration but need some help to:
- Maintain the registration (staff too busy for internal audits etc).
- Want to implement changes.
- Need a part time Quality Manager.
- Want to increase scope of registration.
Contact us and we can provide the extra assistance that you need.