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| Quality Assurance Standards |
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| Quality Assurance Standards |
BS EN ISO9001:2000
"QUALITY MANAGEMENT SYSTEM REQUIREMENTS"
The latest version of the standard has made some significant changes:
- Continual improvement
- More customer focus
- Better for non-manufacturing companies to understand and interpret.
- Requirements to obtain customer/user feed-back
- Process approach
- Requires a documented system as opposed to a set of procedures.
THE PREVIOUS QUALITY ASSURANCE STANDARDS WERE BS EN ISO9001:1994 AND BS EN ISO9002:1994
They remain current until December 2003 by which time companies should have upgraded to 9001:2000. Assessment against the 1994 version will still be possible until mid 2003.
EN 46000 series is the
"Specification For The Application Of EN 29000 (Now ISO9000) To The Manufacture Of Medical Devices" They will still be based on ISO9001:1994 until a new draft is available (target Mid 2002).
EN 928
This is the interpretation of the EN46000 and ISO9000 series of Quality Management Systems to suit the In-Vitro Diagnostic Medical Devices Directive Requirements.
ISO9000-3
"Guide to the application of ISO9001 to the development, supply and maintenance of software."
QUALITY SYSTEMS- EN ISO 9000 & EN 46000Some sort of quality system is necessary for any manufacturer to achieve an assured consistency in production.
Within Europe the internationally recognised standards for Quality Systems are: EN ISO 9001 and, for medical equipment, the EN 46000 (ISO13485). The manufacturer can choose which quality system is the most suitable, but in the case of medical equipment or In-Vitro Diagnostic Medical Devices, EN 46000 (ISO 13485) is usually mandatory. If a Quality System is a requirement of the Directive, it usually must be independently certified by a Notified Body recognised by one of the countries within the European Union.
Notified Bodies are responsible for examining technical files, verifying that products have been made to the technical files and that both files and products meet the requirements. They will also carry out any assessment of the Quality System and the follow up surveillance required.. For each product type the notified body has specified responsibilities for ensuring products have been properly tested and examined. The notified body must be based in Europe and approved by a government of the European Union.
Competent Bodies must be based in the European union and listed by the relevant government agency. (In the UK this means approval by UKAS-United Kigndom Accreditation Service). Their primary function is to examine and test products to EU standards and review technical documentation to verify that products meet the CE requirements.
Competent Authority is the regulatory body for the approval of Notified Bodies for Medical Devices. Additionally, when a company chooses NOT to introduce a quality system to EN46000 their primary function is to examine and test products to EU standards and review technical documentation to verify that products meet the CE requirements and to monitor product reports and customer feedback from the Medical devices Vigilance System which it is mandatory to introduce. In the UK this is the responsibility of the Medical Devices Agency headed by the Secretary of State for Health.
ISO 9001 is a guide for documenting and maintaining an effective quality management system. It is an international standard subscribed to by the UK, USA, Japan, Europe and most of the rest of the World.
Its purpose is to demonstrate an organisation's commitment to quality, their capability to meet customer requirements and work towards total customer satisfaction through continuous improvement and to error prevention.
ISO9000 helps an organisation introduce the tools to implement and maintain continuous improvement programmes, that will ultimately translate into good product and service quality.
ISO9000 is a common sense written down and provides the framework to manage, co-ordinate and control all aspects of the business.
The standard contains clauses identifying areas of a business that the Company should consider when developing a quality administration system.
ISO9001 implementation is an investment into the future. Its disciplines create a useful and demonstrable structure from which continuous improvement programs can be implemented and progressed. The monies spent on implementing and maintaining the disciplines of ISO9001 are recovered when the organisation uses the standard as intended...a tool for continuous improvement. The benefits of introducing such a system can take up to five years to be fully realised.
BENEFITS OF QUALITY ASSURANCE ?When a company has been satisfactorily assessed to ISO9001, EN460001, they will be able to display the certification Body's logo on their correspondence and provided the Body is approved by the relevant government agency an additional logo can be used. In the UK this comprises of a box with a crown and a "
"
Sales and Marketing Benefits:
- The logos will increase the stature of the Company in the Market place and help to enlarge the customer base.
- It will satisfy the larger businesses that the company operates to a controlled system which will result in fewer customer audits needing to be carried out to confirm the on-going commitment to getting it right first time.
- It will reduce one of the hurdles to entering an approved supplier list run by a potential customer.
- ISO9001 is an international standard and it will open international doors not just those locally.
- The Quality manual is a separate document and can be used as a sales and marketing tool, it will both describe the company commitment to quality and customer requirements and promote the company to new customers
INTERNAL BENEFITS
- A properly implemented system should gradually reduce production errors and in the longer term lead to a reduction in rectification works required.
- The reduced rectification works coupled with a controlled list of suppliers and sub-contractors should lead to reduced warranty works as the product becomes more reliable.
- The initial implementation will give the Company a one-off opportunity to fully assess its management systems to ensure they are efficient and effective. It will also give the staff the opportunity to assist with the production of the system to in this way get the staff to subscribe to the system and treat it as their own.
- The regular internal reviews required will make the Company look hard at itself to ensure there are fewer areas where errors could occur.
- Staff will be better aware of their responsibilities and the need to show customer care.
- In certain areas the introduction of a suitable system could suggest to an insurance company that there is a reduced problem with regards to negligence and lead to reduced insurance premiums.
- It will provide an improvement in communications both internally and to customers.
- An opportunity for the management to introduce those procedures and other requirements it has been trying to introduce for a long time but without the full support of the employees.
IS QUALITY ASSURANCE NECESSARY ?
In addition to the specific requirements of the CE Directives, the list of customers who prefer QA Registered suppliers and sub-contractors is growing; in the future it is probable that only those companies with certification or registration to ISO9000 will be eligible to tender in certain business sectors.
For the company, implementation of an effective Quality System should provide easier entry into new markets, improved efficiency, and an enhanced reputation. It will lead to reduced costs, and a more competitive position in the marketplace.
Atlantic Bridge Limited,
Atlantic House, PO Box 4800, Earley, Reading, Berkshire, RG5 4GB, England. Email: info@atlanticbridge.co.uk
Telephone : +44 (0) 118.969.7047 Fax : +44 (0) 118.901.4411 Devizes Office
Telephone : +44 (0) 1380.848170 Fax : +44 (0) 1380.840152