BS EN ISO 9001 - Quality Management

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QUALITY MANAGEMENT - ISO 9001:2008 & ISO9001:2015

What is ISO 9001?

ISO 9001 is a standard for identifying the control of a 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 meeting customer requirements and work towards customer satisfaction through continuous improvement and to error prevention.

ISO9001 helps an organisation introduce the tools to implement and maintain continuous improvement programmes that will ultimately translate into good product and service quality.

ISO9001 is 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 any business that the Company should consider when developing a management system.

ISO9001 implementation is an investment into the future. Its disciplines create a useful 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 full benefits of introducing such a system can take time to be fully realised.


Changes Made When The 2008 Version Was Issued

The latest version of the standard has made some significant changes:

  • Continual improvement
  • More customer focus
  • Easier 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.
  • Supports “CE” Marking when a Quality Management System is required.


Changes Made When The 2015 Version Was Issued

The latest version of the standard has made some significant changes. For current systems it must be implemented by September 2018: For new systems there is a choice for the next 12-18 month of either the 2008 or 215 versions, after which you will have to implement under the 2018 issue of the standard.

  • Increased Management Commitment is required
  • Systems to be risk assessed, this to include both your supply chain and customer base.
  • Preventive Actions removed as this is your risk assessment prior to implementation
  • Requirements to obtain customer/user feed-back remain.
  • Process approach remains
  • Removed the need a for a Quality Manual but the existing requirements for the content of a Quality Manual remain. Either maintain an existing quality manual or produce a number of separate documents under the same control
  • Supports “CE” Marking when a Quality Management System is required BUT may no longer support the base standard 13485 for Medical Devices which may become a self contained independent standard.