Management Systems

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European Regulatory Support for Business since 1995
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Quality Systems - EN ISO 9001:2008/2015 & EN ISO 13485:2003/2012

A Management system is beneficial for any manufacturer to achieve an assured consistency in production and to meet customer requirements.

Within Europe the internationally recognised standards for Quality Management Systems ( QMS) are: EN ISO 9001 and, for medical equipment, ISO 13485.

For all medical equipment, including In-Vitro Diagnostic Medical Devices, ISO13485 is usually mandatory.

If a Quality System is a requirement of the relevant European Directive, usually it must be independently certified by a Notified Body recognised by one of the countries within the European Union.

Compliance to ISO13485 can also be instrumental in obtaining Canadian certification (CMDCAS).

 

Is Quality Management Necessary?

In addition to the specific requirements of the CE Directives, the list of customers who insist on ISO9001 Registered suppliers and sub-contractors continues to grow; Only those companies with certification or registration to ISO9001 are often able to tender in certain business sectors for major customers.

For the company, implementation of an effective Quality Management System should provide easier entry into new markets, improved efficiency, and an enhanced reputation. It will lead to fewer defects, reduced costs, and a more competitive position in the marketplace.

Whatever your business, Atlantic Bridge can assist you to select the right QMS, work with you to install a QMS, continue to maintain your QMS and help you select the most appropriate Notified Body for assessment.

Many European based assessment bodies have overseas offices and or links wit other bodies to operate on the mutual recognition basis, in in doubt please contact us for advice.

 

External Benefits

When a company has been satisfactorily assessed to ISO9001 or ISO13485, they will be able to display the certification Body's logo on their correspondence and provided the Body is approved by the relevant agency an additional logo can be used. In the UK this comprises a box with a crown and "√" supported by UKAS (United Kingdom Accreditation Service) or equal. 
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 standards and customer requirements as well as promoting the company to new customers.

 

Internal Benefits

A properly implemented system reduces production errors and, in the longer term, leads to a reduction in necessary rectification work.

The reduced rectification work coupled with a maintained list of suppliers and sub-contractors leads to reduced warranty work 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 give the staff the opportunity to assist with the production of the system. This leads to staff to subscribing to the system and treating 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. The UK Corporate Governance requirements suggest the implementation of a recognised quality management system.

It will provide an improvement in communications both internally and to customers.
It provides 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.