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Quality Management Systems:

 

Increasingly businesses are finding that there are major benefits to be had by working to a Quality Management System that ensures that their work processes will consistently provide the same end product or service. A well-implemented system reduces the need for constant checking and supervision and can free up staff for more productive work.

In certain industries compliance to a formal Quality Management System is effectively mandatory and increasingly notified bodies involved in process of CE marking products are expecting to be able to audit the organization processes against a recognised standard.

Generally applicable, simple, non-prescriptive, can be moulded to suit the organization, relatively small "overhead", limited documentation. Covers all aspects of an operation. Links into H&S, product regulatory, environmental etc. Major emphasis on continual improvement.   ...  More

​This has a common ancestor with ISO 9001 ,  but is a standard in it own right. Focused on maintaining the process and keeping records. Fairly prescriptive. Increased burden of documentation. Satisfying the a vast majority of requirements of this standard is effectively mandatory for CE marking of medium and high risk medical products .... although certification is not. .... More

Various

There are a range of industry specific systems that can be stand-alone or add-ons to ISO9001.

Example of an add-on is the new EN ISO 80079-34:2011 (replacing EN 13980:2002) which provides additional requirements for organizations involved in the production of products for use in potentially explosive environments.

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EN ISO 9001:2015 Quality Management System

Increasingly businesses are finding that there are major benefits to be had by working to a formal Quality Management System that ensures that their work processes will help to provide a consistent product or service and which helps them to improve overall. A well-implemented system reduces the need for constant checking and supervision and can free up staff for more productive work. Many businesses register their Quality Management System to ISO9001, the International Standard for Quality Assurance.

In this past a major driver for this has been market and client pressure, such systems were effectively put in under duress and in many cases failed to provide the business with the advantages that it was expecting. The old joke about “consistently producing rubbish” is well known in industry.

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ISO 9001:2015, the current version of the standard is designed for use in the modern world and actively encourages the business to continually improve its products and processes. This change in focus ensures that a properly designed and implemented system will not only suit your business, imposing little in the way of unnecessary paperwork, it will also add value and aid you in your endeavours to improve the effectiveness of your operation.

 

It is however very important to approach the implementation in the right way. Just "going for the badge" may mean less work in the short term but will cause much more grief in the long run. Our approach ensures that you will gain the maximum benefits from the process.

The Process Approach: The current ISO 9000:2015 standard promotes the adoption of a process approach when devising, implementing and improving a quality management system (QMS). The process approach acknowledges that a desired result is achieved more efficiently when activities and related resources are managed as a process. ISO 9001:2015 stresses the importance for an organization to identify, implement, manage and continually improve the effectiveness of the processes that are necessary for the quality management system, and to manage the interactions of these processes in order to achieve the organization's objectives.

This approach ensures that a properly designed and implemented ISO 9001:2015 Quality Management System will not only suit your business, imposing little in the way of unnecessary paperwork, it will also add value and aid you in your endeavours to improve the effectiveness of your operation. Our approach ensures that you will gain the maximum benefits from the process.

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EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes


Manufacturers and distributors of Medical Devices are subject to a range of regulations and requirements that can be complex and confusing.

    
ISO 13485 was devised with the aim (hope?) of harmonizing the requirements across the various markets around the world. It is harmonized with the various EU Medical Devices directives and is cited as one of the route to ensure compliance.

 

It is a stand-alone standard but is based on a previous version of the ISO 9001 standard (ISO 9001:2000) and is written in such a way that it is easy to see what additional requirements are imposed (as in some cases what requirements are excluded). Although it is based on the process approach, to satisfy the additional requirements for traceability etc., ISO 13485 is more prescriptive that 9001 and requires a number of additional documented procedures and understandably, the management of risk is a key element.

 

ISO 13485 is rapidly becoming the expected route to demonstrate compliance with the various Medical device directive (Medical Device CE mark) for the higher risk devices (class IIa and above). In most cases certification against the standard is not mandatory but Notified bodies involved in assessment will carry out there review based on the points in the standard.

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