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A detailed look at the ISO 9001:2015 Quality Management Standard – Part 1

18th July 2016

All management standards issued since 2012 follow the Hi Level structure (HLS) set out in Annex SL of the ISO systems standard and each will have ten identical clauses.  This will make it easier to integrate standards and will simplify documentation. 

The ten clauses are:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

ISO 9001 is a Model for quality management systems. It is a quality system certification scheme where a company’s processes are assessed to a quality standard.  This standard has been agreed in this country, the European Union and Internationally.

The Standard, which is now on its sixth generation, was first known as BS 5750.

Formal assessment of an organisation’s quality management system is carried out by an independent and accredited third party certification body.  If all the requirements are met, a certificate of conformity is issued.  Regular surveillance visits are carried out, subsequently, to ensure that the standard is being maintained.

Accreditation of the Certification Bodies (CB’s)  in the UK is carried out by UKAS (United Kingdom Accreditation Service)  UKAS is the sole accreditor in the UK.

A register of quality competent firms is maintained by the Stationery Office (TSO) under subscription and is used as a reference for purchasing authorities.

The market-place is becoming ever more competitive. It is clear that only the companies providing goods or services of the required quality are going to be able to compete.

Put very simply BS EN ISO 9001 sets out the requirements of a quality management system which supports the delivery of a product or service, through the application of effective and continually improving systems, assuring conformity to customer and applicable legal requirements, whilst enhancing customer satisfaction.

Today’s Global Market means that companies throughout the world are able to offer their goods and services on equal terms.   The use of the internet and E-commerce for business makes it vital that we are able to compete.

        ISO 9001 makes it easier to compete in that market-place.

Product liability laws require a company to prove that it has taken all necessary and reasonable steps to produce safe products that minimise the risk to users.

  • ISO 9001 helps provide such assurance.
  • ISO 9001 requires 7 main sections (4-10) to be addressed before certification can take place.  

The 2015 standard does not allow any clauses to be excluded, unlike previous versions.

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