ISO Guide

The ISO meaning simply explained. Learn everything you need to know about international standards.

What is ISO?


ISO stands for International Standards Organization. The Organization was established in 1947 to set standards that will help set the benchmark for quality, safety and processes in all industries and regions. This independent non-governmental organization sets internationally recognized standards.


Originally founded in London by 65 delegates from 25 countries, ISO today has its headquarters in Geneva. Since its foundation, the organization has published 22,782 international standards which are recognized by its members in 164 countries.




What is an ISO Standard?


The draft ISO Standards provide a framework, guidelines or requirements that can be followed to achieve an intended purpose. ISO standards help several industries in different regions to implement internationally recognized standards for quality and safety.


Contrary to widespread opinion, ISO itself does not offer certification for the standards it publishes. It is the external auditors who carry out inspections and provide certification for ISO standards. To be "certified" for an ISO standard means that an organization or company has provided sufficient evidence to the external auditors that they have fulfilled the requirements of the standard in question.




Is it an advantage to follow the ISO standards?


Today it is considered a standard by many companies and organizations around the world. Apart from certification, compliance with ISO standards helps to achieve the following goals:


  • Facilitate consensus building between organizations through common benchmarks

  • Keep companies up to date with the latest industry best practices

  • Promote trade and business partnerships around the world through regulatory and industry compliance



How to achieve certification for an ISO standard


There are various approaches to preparing for ISO certification, such as using consultants to obtain advice on certification, or internal preparation before getting help from third parties. Here are 5 steps to prepare for the certification of an ISO standard by external auditors.


1. Get to know the ISO standard.


Choose the ISO standard that is applicable to a company or your industry and is most beneficial. While compliance with an ISO standard is voluntary, there are industries that require organizations to be certified to certain ISO standards. Start by learning the ISO meaning of the most popular standards. Once you have decided which standard you want to follow, it is time to involve the rest of the organization in the certification effort.


2. Implement internal audits in the company


Adaptation to ISO standards, especially for important processes, would require the cooperation of all employees of the organization. The correct dissemination of information on "What is ISO?" and the provision of staff training can help other staff to understand the reason for certification to an ISO standard. Adopting certification will also help to minimize aversion to internal audits, which is a general requirement for certification.


3. Carry out audits consistently


Conducting internal audits helps to identify gaps in current processes, discover areas for improvement and assess the willingness to seek third-party certification. Form a team that conducts internal audits using audit checklists based on the ISO standard for which you wish to be certified. The audit team is responsible for the proper documentation of internal audits, which is a must for ISO certification


4. Follow the ISO standard

 

As soon as internal audits reveal improvement opportunities, it is up to your team to implement them effectively. Always document the changes made and continue to conduct regular audits to track the organization's progress towards compliance with the ISO standard.


5. Continue with external audits

 

Contact reputable external auditors who will conduct certification audits to help your organization achieve certification to the ISO standard.


ISO certification is not a one-time effort and is only valid for three years from the date of certification, after which recertification is required. It is important that you always maintain the processes geared towards the ISO standard and keep yourself informed of any updates. The ISO standards are reviewed every 5 years. Revisions are published by ISO to reflect current industry best practices.



What are the most popular ISO standards?


Of the 22,782 international standards in the organization, 9 are the most popular ISO standards and how they are most commonly used.


1. The Quality Management System


ISO 9001:2015 - The most sought-after international standard, is the ISO standard for quality management systems (QMS). This standard serves as the basis for many international standards such as ISO 13485:2016 and IATF 16949:2016. It is also an optional requirement for other standards such as ISO 17025, and ISO 9001:2015, although optional, has become a requirement for certain institutions.


2. Environmental Management


ISO 14001:2015 - ISO standard establishing a framework for an environmental management system (EMS). An environmental management system based on the standard helps companies and organizations to minimize their negative impact on the environment and to use resources more efficiently. ISO 14001:2015 also helps organizations to meet legal requirements for environmental performance.


3. Information Security Management


ISO/IEC 27001:2013 - The international standard provides a framework for information security management systems (ISMS). The ISO 27001:2013 standard helps organizations, regardless of size, to ensure the confidentiality, integrity and availability of information resources to customers.


4. Food Safety Management


ISO 22000:2018 - The ISO standard for food safety management systems (FSMS) places requirements on organizations that need to demonstrate that they can ensure food safety when handling food. It is the ISO standard to which FSSC 22000, another international food standard, is extended. The older version, ISO 22000:2005, is valid until June 2021, and organizations wishing to continue certification to the ISO standard should upgrade to the latest version by June 29, 2021.


5. Energy Management


ISO 50001:2018 - With this international standard, ISO provides a framework for an energy management system (EnMS). Similar to ISO 9001 and ISO 14001, ISO 50001:2018 provides for the involvement of managers in promoting efficient energy use in the organization through an effective EnMS.


6. Medical devices


ISO 13485:2016 - This ISO standard for the quality management system of companies, is the youngest among the ISO standards. It is aimed at companies involved in the manufacture, distribution, maintenance and disposal of medical devices. This international standard is a revision of the old version of ISO 13485:2003 and is based on ISO 9001. This international standard aims to maintain the safety and quality of medical devices and to follow the latest state of the art and regulatory changes. ISO 13485:2016 must also be complied with by manufacturers who wish to be certified for the Medical Device Single Audit Program (MDSAP) by the International Medical Device Regulators Forum (IMDRF).


7. Testing and calibration


ISO/IEC 17025:2017 -  Laboratorien, die für Prüfungen und Kalibrierungen vorgesehen sind, profitieren von einer Zertifizierung für diese ISO-Norm, die darauf abzielt, die technischen Fähigkeiten der Laboratorien anzuerkennen. Die optionale Voraussetzung für die Zertifizierung Diese ISO-Norm erkennt ISO 9001:2015 für QMS als an.


8. Health and Safety at Work


ISO 45001:2018 - The revised ISO standard for health and safety at work (OH&S) provides a framework that aims to promote safer workplaces in any industry by proactively addressing hazards and involving all stakeholders. This international standard is based on and has replaced BS OHSAS 18001. By March 2021, all companies must move to ISO 14001:2018.


9. Risk Management


ISO 31000:2018 - This international standard provides the framework for the design, implementation and maintenance of risk management in an organization. This ISO standard provides guidance and is not intended for certification.



Standardized Sections of the ISO Standards


An ISO standard always refers to a specific purpose or a specific need of an industry. Despite the unique intention for the development of each ISO standard, the most popular ISO standards have some common sections. Below are the 10 most common sections that can be found in most ISO Standards:


Section 1: Scope


This is a mandatory section which contains the description of the scope and limitation of the international standard, the objective, the organization(s) to which it applies and any special conditions which require particular attention.


Section 2: Normative reference


This mandatory section for all ISO standards includes the document titles of all normative references. According to ISO, these are documents "which are used in the text in such a way that some or all of their content represents requirements for the document".


Section 3: Terms and definitions


This mandatory section defines the terms used in the standard or refers to the title of the document by including the terms and definitions.


Section 4: Context of the organisation


The context helps to confirm whether internal and external problems which may influence the objective of the standard have been identified. This section also shows whether the interested parties and the expectations relevant to the implementation of the standard have been identified.


Section 5: Leadership


The management section emphasizes the responsibility of the organizational management to lead the implementation of the ISO standard. It confirms the commitment to leadership, continuous improvement and provision of resources. Depending on the standard, the participation of employees and the corporate culture are also included.


Section 6: Planning


This section presents plans, procedures, objectives and measures that support the implementation of the standard. Depending on the standard, the planning section also attempts to determine whether the objectives are feasible or whether risks and opportunities are taken into account.


Section 7: Support


The support section usually consists of clauses to raise awareness of the processes contained in the standard, to document staff competence, to communicate internally and externally and to ask whether sufficient resources and support are available to help staff to meet the requirements of the standard.


Section 8: Operation


The purpose of the operations section is to confirm that the organisation has properly planned, implemented, controlled and maintained the processes necessary to meet the requirements of the standard. This section also emphasises the need for documentation to demonstrate that the processes have actually been carried out as planned. Depending on the standard, outsourced processes may also be considered.


Section 9: Performance Evaluation


The section on performance evaluation addresses the need for the organisation to establish monitoring and performance evaluation protocols that ensure valid results. This includes confirming the frequency of assessments, the data to be measured, the method of analysis and the identification of responsible persons. Documentation of the performance evaluation is also highlighted in this section.


Section 10: Improvement


The "Improvement" section, which is of vital importance to ISO, is intended to provide the framework for promoting continuous process improvement. Standards that do not have this section also emphasize the obligation to include processes for continuous improvement.



ISO today


More than one million organizations worldwide are certified for at least one of the ISO international standards. Some of the standards developed by ISO have become fundamental principles in many industries. They have also been extended by other recognized organizations that also publish international standards.


Since ISO was founded more than 70 years ago, it has helped organizations implement processes, create products, develop industry best practices, promote international partnerships, and improve industry benchmarks based on ISO standards, and will continue to do so for the foreseeable future.




Featured templates

ISO 14001 & OHSAS 18001

ISO 14001 & OHSAS 18001

Überprüfe mit dieser Vorlage das Umweltmanagementsystem deines Unternehmens nach ISO 14001 und OHSAS 18001. See template

ISO Container Inspection Checklist

ISO Container Inspection Checklist

Use this template for a thorough inspection of containers. See template

ISO 27001 Checklist

ISO 27001 Checklist

Use this checklist to check whether your company is ready for ISO 27001 certification. See template

ISO 9001:2015 Corrective Action Checklist

ISO 9001:2015 Corrective Action Checklist

This checklist is a detailed step-by-step guide aimed at initiating corrective action at an early stage. See template

ISO/IEC 17025:2017 Checklist

ISO/IEC 17025:2017 Checklist

This checklist can be used to provide a laboratory’s competence in testing and calibration. See template

ISO 13485 Audit Checklist

ISO 13485 Audit Checklist

Use this checklist to find out if the company’s QMS is aligned with the ISO 13485:2016 standard. See template