ISO Standards – A short introduction

The word “ISO” originate from the Greek word “isos” meaning “equal”.
The ISO organization is originally a union between “the ISO (International Federation of the National Standardizing Associations) and the UNSCC (United Nations Standard Coordinating Committee)” (Isoqsltd, 2017)

The ISO confederation has a presence in over 150 countries and has published over 16500 international standards. Each of the standards is beneficial within its specific industry and the main goals are:

  1. Widen market potential
  2. Compliance
  3. Improve efficiency and cost savings
  4. Higher level of customer service and customer satisfaction

Many of the ISO Management System standards have the same structure, terms and definition.

ISO 9001:2015 – Quality Management

ISO 9001:2015 can be used by any organization and is based on a number of quality management principles and emphasizes strong customer focus.  The standard provides guidance and tools for those organizations wanting to ensure that their products and service meet customer’s requirements and focus on continuously improving their business.

The Quality Management principles are:

  1. Customer Focus
  2. Leadership
  3. Engagement of people
  4. Process Approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship Management

ISO 14001:2015 – Environmental Management System

ISO 14001:2015 can be used by organizations to enhance its environmental performance. It offers guidance to organization to work in a systematic manner to achieve sustainability. By having an environmental management system, the desired outcomes are to fulfill of compliance obligations, achieve environmental objectives and enhance the environmental performance.

ISO 13485 – Quality Management for medical devices

ISO 13495 is a Management Standard for the medical device industry, focusing on safety and quality. In the medical device industry the regulatory requirements are vital throughout every step of a product’s life cycle, including service and delivery.

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