ISO Standards Related to COVID-19 Are Available Free Temporarily

auditing resources Apr 14, 2020
 

Have you noticed many people and organizations are becoming superheroes to help out during this pandemic? In this unprecedented time, we can all use a little help. We want to make sure you know that ISO, the publishers of thousands of standards, is doing their part too. 

ISO standards can typically cost hundreds of dollars, but in response to the COVID-19 crisis, the International Association for Standardization (ISO) has released 28 standards free to support global efforts in dealing with the crisis. 

These standards are temporarily available in a read-only format, without a fee, from the ISO website through the links below.

Many on the list pertain to the medical devices most related to the pandemic, such as Personal Protective Equipment (PPE) and ventilators. However, there are several standards that have universal appeal for risk management.  

Here are the five you may have an interest in downloading while there is no fee. The video above has additional comments about these 5 standards with universal applicability.

ISO 31000:2018, Risk management – Guidelines

This standard is highly referenced and can directly apply to risk-based thinking in ISO 9001-Quality, ISO 14001-Environment, ISO 45001-Health and Safety, ISO 17025-Laboratory and many other standards. It includes:

  • the principles of risk management,
  • a framework for integration into leadership and business processes,
  • design concepts to help you fit the guidelines to fit your needs
  • implementation and 
  • improvement.

ISO 22301:2019, Security and resilience – Business continuity management systems – Requirements

As your organization is needing to implement whatever contingency or business continuity plans you have, this document may help by providing a framework for planning. This may help you identify content needed because of the pandemic that was not originally anticipated. The scope of this standard specifies requirements to implement, maintain, and improve a management system to protect against, reduce the likelihood of the occurrence of, prepare for, respond to and recover from disruptions when they arise.  

ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management

The guidance in this standard includes:

  • principles that communicate the value and explain the purpose of incident management
  • basic components of incident management including the processes and structure, which focus on roles and responsibilities, tasks and management of resources, and
  • working together through joint direction and cooperation.

ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes

This standard is guidance for planning for resilience and can be applied throughout the life of an organization. As you might imagine, it discusses empowered leadership, shared vision, supportive culture, shared knowledge, and more. This directly ties to organizational knowledge in ISO 9001.

ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency

This standard provides guidance for organizations to identify, involve, communicate with and support individuals who are the most vulnerable to natural and human-induced (both intentional and unintentional) emergencies. It also included guidelines for continually improving the provision of support to vulnerable persona in an emergency.

Download these ISO standards while you can, and use this time to develop emergency management and preparedness plans to make your business and community more resilient.

If you have questions, Innovation Training & Consulting, Inc. is available to help your organization effectively manage risks.

Schedule a time to share your challenges and explore how my company can help you.  Book 30 minutes  or Book 60 minutes. We welcome the opportunity to be of service.

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For companies in the medical field, here is the list of additional standards related to COVID-19 that are temporarily available in a read-only format without a fee.

  • ISO 13485:2016Medical devices — Quality management systems - Requirements for regulatory purposes. This is a management systems standard based on ISO 9001 with many additional requirements added.
  • ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk
  • ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
  • ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
  • ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
  • ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 13688:2013, Protective clothing – General requirements
  • ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
  • ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]
  • ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
  • ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
  • ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
  • ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
  • ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
  • ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
  • ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
  • ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
  • ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anesthetic workstation [Including ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]
  • ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
  • ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
  • ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
  • ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
  • ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

This action by ISO has been coordinated with the International Electrotechnical Commission (IEC), who are making complementary standards freely available at the IEC website.

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