ISO Standards explained

Introduction

In my previous post, I defined the meaning of a Quality Management System (QMS), its importance and benefits to an organization or a business as well as the various forms in which organizations can implement Quality Management Systems.  I mentioned ISO standards and how popular they have become worldwide.

This post which I have called ‘ISO standards explained’ aims to demystify ISO standards, some of which make up the most widely used Quality Management Systems in the world. My goal is to explain what ISO standards are and how they are developed. This background information will make it easier to understand the ISO/IEC 15189 standard which is the focus of this blog.


Who/What is ISO

ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. Contrary to what it seems ISO is not an acronym but rather derived from the Greek word isos which means “equal”.

 

Founded in 1947, it is a voluntary organization consisting of 164 members who are recognized authorities on standards. Each member represents one country. These members (standard institutes in each country) are coordinated from a central office in Geneva, Switzerland. Membership can be grouped into three, see figure 1 below:

1. Full members or Member bodies are national bodies and the only members of ISO that have voting rights and therefore influence standards development and strategy. They can sell and adopt ISO standards

2. Correspondent members are countries that do not have their own standards organization. They attend technical and policy meetings as observers but have no voting rights. However,they can sell and adopt ISO standards

3. Subscriber members pay reduced membership fees and can follow the development of standards but they do not sell or adopt ISO International Standards nationally.

ISO member countries, Correspondent members,   Subscriber members


The development of ISO Standards

ISO has published more than 20 000 International Standards covering almost all aspects of technology and business. The development of standards involves many parties. ISO’s role is only that of a co-ordinator.

Industry, Consumers or other stakeholders– Recognize the need for a specific Standard and makes a request to ISO

Technical Committees– These are groups of experts responsible for a specific subject area. There are more than 250 technical committees in every sector you can imagine. Technical committees will use their understanding of their sector to create a draft standard that addresses the identified need.

ISO members- Once the draft has been circulated member states can participate in the development through offering comments and advice or voting on the standard at various stages of its development, depending on the type of membership as outlined above.

ISO Secretariat-Coordinates the various bodies involved in standard development and publishes the final standard once a consensus is reached

What are ISO standards

The fundamental goal of building a management system is defining requirements and processes according to the needs of a particular organization. ISO standards lay out the framework for creating a management system to address needed controls and requirements. Its important to note that
ISO Standards don’t lay out specific requirements or detailed descriptions they only provide a framework for creating a Management System.


ISO standards are directive and not prescriptive
. They will tell you the minimum requirements but will not define for you how to achieve those requirements. This is important because no two organizations are the same, organizations can design and implement systems in a way that best meets their particular needs. This generic nature of the standards makes them universally applicable to a wide range of organizations, regardless of size or business model.

Whilst the focus of this site is to discuss ISO standards with regard to Quality Management Systems, please note that there are various other groups of standards that address other Management Systems. Below are some non-Quality Management ISO standards just to give you an idea, remember there are over 20 000 ISO standards

  • ISO 22000 Food Safety Management-Inspires confidence in your food products
  • ISO 14000 Environmental Safety Management -Improves environmental performance
  • ISO 45001 Workplace Health and Safety-Reduces workplace risks and ensures safety in the workplace
  • ISO 31000 Risk Management -Manages the risks that could jeopardize a company

Quality Management System Standards

There are several ISO QMS standards but the most widely adopted is the ISO 9001. It is estimated that over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. We will dwell on the ISO 9001 standard in up coming posts so that we understand why it is so popular and how an organization can implement this Standard, we will also see how this standard is related to the ISO/IEC 15189 Standard which is the QMS standard which specifies requirements for quality and competence in medical laboratories. Other standards related to medical testing are:

  • ISO/IEC 17025 Testing and Calibration Laboratories- Testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods
  • ISO 13485 Medical Devices-Manages quality throughout the life cycle of a medical device with ISO 13485.
  • ISO 22870 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO/IEC 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization

Conclusion

ISO/IEC 15189 is just one of more than 20 000 standards developed by ISO Technical Committee (TC) 212 following the process defined above. The ISO/IEC 15189 standard is focused on the medical laboratory, and its goal is the customers’ satisfaction. In future posts we will explore how this standard is related to ISO 9001 and also to ISO/IEC 17025 which is closely related.

 

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