Don’t we all love shortcuts! They save time and money and make it easier to get the job done. ISO 9001 and ISO 45001 integration is one such shortcut that companies can take. Yet when it comes to implementing multiple ISO standards, we choose to implement them one at a time rather than use an integrated approach.
The International Organization for Standardization (ISO) has for over a decade been publishing management system standards using the harmonized structure. This means all standard such as ISO 9001 and ISO 45001 have the same 10 clause structure. Nearly 60-70% of the standard’s requirements are aligned based on the standards selected.
Management system integration allows the organization to implement combined audits that save time and reduce the burden on the workforce. Integrating QMS+OHSMS requirements into one management system also allows for easier compliance to regulatory standards including OSHA compliance. In this article we explore the benefits to using an integrated approach to conforming to both these standards.
Why should U.S. factories consider integrating ISO 9001 and ISO 45001?
U.S. Factories can benefit from better recognition among potential clients by pursuing a path to certification to ISO 9001 and ISO 45001. ISO standards are globally recognized as the baseline for delivering a quality product consistently as also a systemic approach for creating a safe work environment.
While certification is not a requirement and the ISO standards allow you to self-declare conformity, companies can benefit from the system approach to continual improvement and enhancement of customer satisfaction. Additionally using this integrated and systemic approach allows companies to address non-conformities systemically thus reducing compliance costs. Various studies have shown how compliance costs reduced from the introduction of these standards.
For instance, the ISO Survey (2023) shows that there are over 837,978 ISO 9001 certificates and 185,166 ISO 45001 certificates worldwide, with the U.S. holding 1,687 ISO 45001 certificates. (Source: Enhesa) This demonstrates the growing recognition of these standards and the push towards dual compliance.
Additionally, personnel in the company are seeking clear guidance and direction and the leadership can provide this to them using the system thus increasing efficiency over time.
What are the key differences and overlaps between ISO 9001 and ISO 45001?
A read of the two standards will evidence that the requirements for Clause 4 – context of the organization, Clause 5 – Leadership, Clause 7 – Support, Clause 9 – Performance evaluation and Clause 10 -Improvement are for the majority quite similar. So, companies can meet the intent of the standard through a common integrated policy, integrated audits and an integrated management review. By having a common process for document and record control for both standard as also a common process for addressing non-conformities.
The key differences in the standard lie in the requirement of Clause 6 – Planning and Clause 8 – Operations. ISO 9001 here has a focus on controls required to deliver a conforming product meeting customer requirement. Companies use the requirements in the standard to build quality processes that work well time after time. ISO 45001 has a focus on identifying and addressing significant risks to employee safety.
How do you map common requirements between ISO 9001 and ISO 45001?
While someone new to the standards may find the process of mapping the requirements of the standard to the requirements of their system, QMII’s ISO 45001 Lead auditor training provides the needed coaching to overcome this challenge.
However, before you begin down this path the first step is to get leadership buy in for the process. This will be important to ensure that the project is a success. At QMII, we have experienced clients where the implementation of these standards stalled and did not progress until the buy-in from leadership was received.
A gap analysis is always a great start to see what it is that you are doing that meets the intent of the standard and what does not. Remember that it is important that you meet the intent of the standards since the ISO standards are not prescriptive in their requirements. They provide a high-level structure for achieving continual improvement.
What step-by-step process can factories use to integrate the two systems?
To integrate the two systems following the gap analysis put together a project plan and identify who will be responsible for each stage/step. Assign clear and reasonable deadlines to track project completion. The first step following buy-in is capturing the core process of the business, defining the scope of the system and defining the unified policy. Leadership plays a key role in each of these steps.
As companies begin to document their system keep in mind the following:
- Document the system for the users – Keep it simple so they understand the process and know what to do.
- Don’t over document the system – The system must be documented to the extent needed to give the leadership confidence that the processes are being carried out as planned.
- Documentation is a weak control layer – build controls into the software, the infrastructure and into the chain of command as documentation is a weak control.
Further actions to be considered are combined trainings and integrated audits.
What benefits do factories gain from dual compliance?
Dual compliance allows factories to lower audit costs, for external audits and for internal audits as well (where a consultant may be used for this). Companies that have implemented ISO 45001 have reported improved safety metrics with some reporting a decrease in reportable lost time injuries.
For example, a U.S. aluminum manufacturer implementing ISO 45001 alongside ISO 9001 reported a 50% reduction in injuries after implementation.
Companies that implement ISO 9001 also report an increase in efficiency as also better continuity of operations. Employee engagement and morale too increase as a result of streamlined processes and lesser mistakes. The system provides better requirements and objectives (goals) for them to work towards.
Recognition among the client base is also improved and there is a reduced customer oversight as a result of certification to these two standards.
Case study: How integration reduced incidents in a U.S. factory
A QMII client that implemented a safety management system (ISO 45001) was able to reduce their reportable lost time injuries year over year to zero where five years prior to the implementation of the standard this would not have been thought of as achievable. It began with an increase in near-miss reporting. Each of these incidents were investigated and the data over time of causes analyzed to determine the actions needed to improve safety awareness overall. Seeing leadership commitment and involvement, personnel started reporting risks as they perceived/observed them as also stopped unsafe acts/condition when they observed them. This led to over time a reduction in accidents.
This aligns with broader industry data where companies adopting ISO 45001 saw significant reductions in both frequency and severity of incidents. In fact, over 370,000 workplaces globally are now ISO 45001 certified, with studies showing measurable improvements in productivity and profitability due to safer, more efficient systems. (NCBI Study)
How can U.S. manufacturers get started with integration today?
Perhaps the easiest step a company can take is to educate personnel on the standards and the interpretation of the requirements. QMII lead auditor trainings are a good option to achieve this. Additionally, QMII also provides gap analysis services where our experts analyze your system and provide you with a project plan of actions to be taken to achieve conformity to the two standards.
Looking to start your integrated management system journey today? Call a solutions advisor at QMII or reach out at info@qmii.com today.
