Saturday, 20 May 2017

ISO 9001:2015


ISO 9001:2015 stand for Quality Management System (QMS) is a set of policies, processes & procedures required for planning & execution (production/development/service) in the core business area of an organisation.

ISO 9001:2015 (QMS) refers to the entire system of an organisation. ISO 9001:2015 is nothing more than good Quality Business sense.

ISO 9001 introduced in 1987, first update was in 1987 after that 1994 than 2000 & 2008 as called ISO 9001:2008. ISO 9001:2015 is latest updated version of ISO 9001 update in 15 September 2015 for Quality Management System.


A Complete QMS identify all the requirements of ISO 9001, and more specifically meet the ISO 9001 Documentation Requirements.


Concept of Quality Management System



  • A Quality Management System in its basic concept is quite simple. It seeks to: Recognise the external quality related requirements specified in Licenses to Trade, guidelines, specified customer requirements, and the chosen management system standard(s)
  • Ensure that all requirements have been documented within the management system in the appropriate location in terms of defined specific system requirements
  • Confirm that employees receive applicable training in the quality system requirements
  • Outline performance processes, where applicable, to the quality system requirements
  • Produce records or evidence that system requirements have been met
  • Measure, monitor and report the extent of compliance with these performance procedures
  • Continually monitor and analyse changes to the requirements and confirm that all changes are reflected in changes to the specific requirements when necessary
  • Execute the audit and analyse the system processes and correct them when necessary
  • Include processes that will help continually improve the quality system.
Benefits of ISO 9001
When ISO 9001 is implemented in an organisation
  • Well defined and documented procedures improve the consistency of output
  • Quality is constantly measured
  • Procedures ensure corrective action is taken whenever defects occur
  • Defect rates decrease
  • Defects are caught earlier and are corrected at a lower cost
  • Defining procedures identifies current practices that are obsolete or inefficient
  • Documented procedures are easier for new employees to follow
  • Organisation retain or increase market share, increasing sales or revenues
  • Improved product reliability
  • Better process control and flow
  • Better documentation of processes
  • Greater employee quality awareness
  • Reductions in product scrap, rewords and rejections
  • Reducing Cost

Top reasons given for registration:

  • Internal operational efficiency
  • Lower production costs because of fewer nonconforming products, less rework, lowered rejection rates, streamlined processes and fewer mistakes.
  • Access to new markets
  • Some markets require ISO 9001 Registration, some markets favor companies with ISO 9000 Registration
  • Customer request
  • Many organisations are asked by a customer to obtain registration as a requirement to continue or to start doing business with them.

No comments: