Featured Video
This Week in Quality Digest Live
Health Care Features
Marin Hedin
Limiting shifts improves satisfaction without affecting educational outcomes
Knowledge at Wharton
A ‘different type of chassis’ for improving healthcare delivery
Mike Richman
Work-life balance has never been more important
Chad Kymal
A five-year effort, ISO 45001 is considered a game-changer
Malvina Eydelman
Fast-track program evaluates brain implants for the blind

More Features

Health Care News
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
The FDA’s RMAT designation goes live
New company will focus on technologies for the management and automation of vital clinical processes
Marking and cutting lasers used in manufacturing endoscopic devices and catheters
Technique provides about a sixfold improvement over regular microscopes
Awards help states implement multiyear produce-safety systems
How a hospital restored quality patient care and obtained financial stability using lean

More News

Chad Kymal

Health Care

First ISO Health and Safety Management System Standard Is Released

A five-year effort, ISO 45001 is considered a game-changer

Published: Wednesday, April 4, 2018 - 12:02

ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a lot of celebrations and accolades with the launch of this new standard, the road to its release as an international standard wasn’t as smooth as one might have imagined.

Up till now, the go-to standard for OH&S has been British Standards Institution’s (BSI) OHSAS 18001. Although it’s closely aligned to ISO 14001, OHSAS 18001 isn’t an ISO standard but a consensus standard that is used worldwide by organizations that want an OH&S management system.

Another standard, developed for and used by companies in the United States, is ANSI Z10—Occupational Health and Safety, issued by the American National Standards Institute (ANSI). ANSI Z10 follows the United Nation’s (UN) International Labour Organization (ILO) OH&S guidelines for countries that want to set their own OH&S standards. When Omnex first offered OHSAS 18001 lead auditor training, we tried to teach it based on ANZI Z10 because we believed it was a good standard, and we thought U.S. companies needed to know that there was an alternative approach to registering to an OH&S standard.

History of OH&S standards

Throughout the 1990s: Several unsuccessful attempts to develop a standard for occupational health and safety (OH&S) management by ISO.
1996: ISO’s first vote for an “ISO OH&S” management system fails.
1999: British Standards Institution (BSI) publishes OHSAS 18001:1999 Occupational Health and Safety Management Systems Specification, a management system specification developed by 13 international certification bodies (i.e., registrars) and consultants, modeled after ISO 14001.
2000: Second ISO attempt at an OH&S standard. Voting falls short of the necessary two-thirds majority to pass (29 countries in favor, 20 opposed).
2001: The International Labour Organization (ILO) publishes the ILO-OSH guidelines to countries as a framework to develop country standards.
2005: ANSI publishes the U.S. version of an OH&S standard, ANSI Z10 OHSMS.
2007: BSI publishes a revision of OHSAS 18001 to improve alignment with ISO 14001:2004, introducing new requirements relating to hazard identification, risk assessment, selection of controls, external consultation, worker participation, and clarification of the role of incident investigation.
March 2013: BSI submits another proposal for an ISO OH&S standard.
June 2013: ISO Project Committee (PC) 283 is established.

ISO advises that the future OH&S standard will be ISO 45001 because the number 18001 has already been assigned to a different standard.

Seeds of conflict

The conflict surrounding ISO’s OH&S standard development stemmed from several factors. These included the fact that the UN ILO claimed significant ownership of international OH&S standards. Also, some countries considered that an ISO standard was philosophically wrong. Additionally, aligning ISO 45001 with ISO 14001 and ISO 9001, as well as involving labor as a key stakeholder, caused some conflict.

All of these issues played out in the initial draft international standard, DIS 1. The ILO had major issues with the document. There was general unhappiness with the definitions and the draft’s alignment to ISO 14001 and ISO 9001, which resulted in 3,000 comments. (For more on this, view the March 23, 2016, Omnex webinar, “ISO 45001 Update: ISO’s First Occupational Health & Safety Management System Standard,” presented by Dan Reid.)

The discussion and conflicts on DIS 1 resulted in it failing to becoming a final draft international standard (FDIS). In response, ISO Project Committee (PC) 283 decided to issue a second draft document, DIS 2. This required two meetings to resolve the differences of opinions among the various stakeholders. PC 283 issued this communiqué when it released DIS 2:
“During the editing process, a number of key changes were introduced to the text:
• Emphasize reference to ‘fulfilling legal requirements’ in the Scope;
• “Emergency preparedness’ would be numbered 8.2, to align with ISO 14001;
• Inclusion of a new clause 10.1 and the associated A.10.1, again for alignment with ISO 14001 (and with ISO 9001—“Quality management systems—Requirements”);
• Additional informative and descriptive text in 8.1.6 regarding contractors, to try and resolve problems that a specific member had identified;
• Additional note to the definition of ‘outsourcing,’ as well as revised text for clause A.8.1.4 on outsourcing, to try and resolve problems that a specific member had identified.”

In May 2017, I attended PC 283 DIS 2 discussions as the Omnex representative. More than 164 comments had been made by representatives from the U.S. technical advisory group (TAG) that had to be addressed, and there were only two days to reach a consensus within the U.S. TAG. A very democratic voting process was followed to settle each comment. The U.S. TAG boiled down the comments to 54, which were either editorial in nature or involved changes in the document’s Annex. There were three key issues:
1. Eliminate “Hazards and Hierarchy of Controls”
2. Worker and “under the control”
3. Outsourcing

These three issues and other key changes will be explained in the Quality Digest webinar, “ISO 45001 Released As an International Standard,” scheduled for Tuesday, April 10, 2018.

Reaching consensus

At the end of the meeting, the U.S. TAG voted overwhelmingly to move DIS 2 to FDIS status. Whether other countries would go along was unknown at the time; many TAG members believed that it would be a close call. However, DIS 2 moved to FDIS on Nov. 30, 2017, with a final vote held Jan. 25, 2017, on whether it would be approved as an international standard (IS).

After the agreement on DIS 2, there was a general alignment of views between the international stakeholders. The meetings and discussions between the different parties brought about a successful outcome. Both the FDIS and IS votes were overwhelmingly in favor of the ISO 45001 revisions.

ISO 45001 was published March 14, 2018. It is fully aligned with the “High Level Structure” seen in other standards such as ISO 14001 and ISO 9001. It has been accepted by the UN ILO and generally acceptance globally.

The standard is being touted internationally and is gaining wide acceptance. Jerry Laws, writing for Occupational Health and Safety News, says, “I’ve been hearing this standard described as a true and much-needed game-changer for workplace safety and health. Last June, as Tom Cecich, CSP, CIH, was ending his year as ASSE president at Safety 2017, one of the accomplishments he cited was the society’s investments to be ready to help companies comply with ISO 45001, which Cecich said is likely to be the most significant safety standard of the past 50 years.”

EHS Today quoted Vic Toy, the U.S. TAG chair, as saying, “ISO 45001 is one of the most significant developments in workplace safety over the past 50 years, presenting an opportunity to move the needle on reducing occupational safety and health risks. The goal was to create a widely accepted standard that can produce a highly effective safety and health management system for an increasingly interconnected world, regardless of an organization’s size, location, supply chains, or nature of work.”

Industrial Safety and Hygiene News had this to say: “A highly anticipated global standard aimed at creating safer workplaces everywhere will be published on March 12.”

Experts in the OH&S field are seeing the ISO 45001 as a game-changer, a best-in-class practice. There is a general feeling the standard will gain wide acceptance in the United States.

Let’s now try to understand some of the standard’s key changes. ISO 45001 includes:
• Alignment with the high-level structure and requirements for leadership to integrate “with business processes”
• Interested party expectations and context
• Role for leadership, who need to take “ownership”
• Risk-based thinking
• Definition of workers as those “who work under the control of the organization”
• Addition of the word “outsource”
• The need to “eliminate hazards and to reduce risks”
• Expanded role of non-managerial staff for “participation and consultation”
• Documented information (no more “records” or “documents”) and the addition of the “process approach”
• Changes in the identification of hazards
• Organization of work: social factors such as workload, work hours, victimization, harassment and bullying, leadership, and culture

This list isn’t exhaustive but highlights some of the topics that will be covered in the Quality Digest webinar, “ISO 45001 Released As an International Standard,” presented Tuesday, April 10, 2018, at 11 a.m. Pacific, 2 p.m. Eastern. Register here.

Discuss

About The Author

Chad Kymal’s picture

Chad Kymal

Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization headquartered in the United States. He is also president of Omnex Systems, a software provider of ISO 9001, ISO 14001, and ISO 27001 management systems. He developed and teaches auditor training for ISO 9001, IATF 16949, ISO 14001, and ISO 45001, as well as an Integrated Management Systems Lead Auditor training course where all three standards are combined in a single audit.

Kymal is also on the ISO/TC 176, ISO/TC 207, and PC283 committees for ISO 9001:2015 (quality), ISO 14001:2015 (environmental), and ISO 45001 (health and safety) management system development.