ISO 9001:2015 Overview

ISO 9001:2015 – Quality

ISO 9000 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001:2015 is one of the documents in this set.  It states the requirements the organization must meet to be in compliance with the standard.  ISO 9001:2015 is the current version of the Standard. Past versions of ISO 9000 included ISO 9002 and ISO 9003, but those are no longer in use. Companies are now only registered to ISO 9001:2015 from Sep 2018, which superseded ISO 9001:2008.

An ISO 9001:2015 compliant Quality Management System (QMS) is a set of controls developed, implemented and monitored to ensure that the processes used to provide services or to manufacture products meet customer expectations consistently and in the most efficient, cost-effective way.

ISO 9001:2015 start with creating a Quality Policy, which is supported by a Quality Manual and supporting procedures which define management and employee responsibilities and how the processes are controlled. The system is designed to guarantee a company’s service or product quality goals. This QMS provides companies with a method for consistently improving both service and product quality; thereby surpassing customer expectations.

The Standard itself consists of a set of requirements.  These requirements specify what a company must do, but not how.  For example, it says you must plan how you will achieve quality, but it does not say specifically how you must plan, nor specify a format for the planning.

The Standard is based on these 8 underlying principles:

  • Customer focus
  • Leadership
  • Enagagement of people
  • A process approach
  • Improvement
  • Evidence based decision making
  • Relationship Management

Because the standard states generic requirements, and is intended to apply to all kinds of businesses, some interpretation and experience is required to apply it to your particular business.

Most of the requirements are just sheer good business sense. For example, there are requirements that you must know what your customers want, and deliver it to them. You must make sure your people are competent and that they have the right skills, training and experience.  You need processes suitable for producing and delivering your products or services.