Combining ISO 45001 with ISO 9001

Many organisations need both quality management and occupational health and safety. Combining ISO 9001  and ISO 45001  in one integrated system offers significant benefits. Both standards follow the High Level Structure . On this page, we explain how to approach this.

Why combine ISO 45001 and ISO 9001?

ISO 9001 and ISO 45001 follow the same structure: the High Level Structure (HLS) . The chapter layout is identical, the terminology largely matches, and many elements are similar. This makes integration logical and feasible.

The benefits are concrete. You need less documentation because you can share many parts. You can combine audits, which saves time and money. Employees only need to learn one system. And you avoid quality and safety operating as separate silos, while in practice they are connected.

An efficient process is often better for both quality and safety. Conversely, quality problems can introduce safety risks. An integrated approach recognises this connection.

What can you share between ISO 45001 and ISO 9001?

The overlap between the two standards is substantial. You can set up these elements once and use them for both certifications.

Context of the organisation (chapter 4)

Both standards ask for an analysis of your context: internal and external factors, interested parties and their requirements, and defining the scope. You can do this in one analysis that covers both quality and safety factors.

A client that expects reliable delivery is a quality factor. The same client that requires you to work safely on its site is a safety factor. Both belong in the same stakeholder analysis.

Leadership and policy (chapter 5)

Top management must be involved in both systems. You can create one policy statement that includes both quality and safety commitment. Or you can have two separate policy statements that are managed and communicated together.

You can define roles and responsibilities in an integrated way. The quality manager and the prevention officer (preventiemedewerker) can be the same person, or work closely together within one role.

Planning (chapter 6)

Both standards ask you to identify risks and opportunities and to set objectives. An integrated risk analysis looks at risks from both perspectives.

A supplier that does not deliver reliably is a quality risk. A supplier that delivers unsafe products is a safety risk. By looking at both in one analysis, you get a more complete picture.

Support (chapter 7)

Competence management, awareness, communication and document control can largely be combined. The competences you track then cover both quality and safety aspects. The document control system is one system for both standards.

Performance evaluation (chapter 9)

You can integrate the internal audit process. One audit programme covers both standards. Auditors check both quality and safety requirements. This is more efficient than two separate audit rounds.

The management review can be combined. You discuss the performance of both systems in one session. The required input and output largely overlap.

Improvement (chapter 10)

The process for handling nonconformities and corrective actions is identical. A nonconformity can be a quality problem, a safety problem, or both. One handling process is enough.

What is specific to each standard?

Despite the overlap, some parts are specific to each standard.

Specific to ISO 9001

The requirements on customer focus, customer satisfaction and customer communication are specific to quality. The same applies to the requirements on design and development, production and service provision, and the release of products and services.

Specific to ISO 45001

The requirements on hazard identification and risk assessment are specific to safety. The same applies to the requirements on worker participation, emergencies with a safety impact, and incident investigation.

You do not fully integrate these specific parts, but you do manage them within the same overarching system.

Practical approach

If you already have ISO 9001

Do you already have a working quality management system? Then the step to ISO 45001 is relatively small. You extend your existing system with the safety elements.

In practice, this means you identify hazards and assess risks, extend your policy with a safety commitment, add safety objectives, organise worker participation, set up emergency procedures with a safety impact, and extend your audit programme with safety requirements.

You already have the structure and processes for document control, competence management, internal audit and management review. You only need to extend these, not set them up again.

If you already have ISO 45001

The reverse works in a similar way. You already have a management system with the HLS structure. You add the quality-specific elements: customer focus, product control and customer satisfaction.

If you start from scratch

Are you starting with both standards at the same time? Then design an integrated system from the start. This saves you the work of merging them later.

The process takes longer than for one standard alone, but less time than two separate processes. You create the documentation once and set up the processes once.

The combined ISO 45001 and ISO 9001 audit

With an integrated system, you can combine the certification audits. One auditor or audit team assesses both standards in one audit visit.

The audit takes less time than two separate audits would. Because the standards overlap, the auditor only needs to check many elements once. The saving is typically 20-30% of audit days.

The conditions are that you have both certifications with the same body, or with bodies that work together. The auditor must be qualified for both standards.

Documentation structure

There are several ways to structure integrated documentation.

One manual that covers both standards. For each topic, you describe how you have set it up, with references to the requirements of each standard it covers.

A modular structure with a shared basis and standard-specific modules. The basis covers the shared elements, the modules cover the specific requirements.

Per process, where you indicate for each process which requirements of each standard it covers. This works well if you put processes at the centre of your documentation.

There is no single best way. Choose what works for your organisation. As long as it is clear which requirements are covered where, and the auditor can find their way.

Synergy in practice

An integrated system creates synergy that goes beyond efficiency alone.

Quality problems can signal safety risks. If a machine keeps breaking down, that is not only a quality problem but possibly also a safety risk. By looking at this in an integrated way, you see the connection.

Safety incidents can contain quality lessons. A near miss can also point to a process problem that affects quality. Integrated incident investigation brings this to light.

Improvement projects can serve both goals. Redesigning the workplace can improve both efficiency and safety. By looking at this together, you optimise both.

Costs and timeline for ISO 45001 and ISO 9001 together

An integrated process for ISO 9001 and ISO 45001 together does not cost double the price of one standard alone. Because of the synergy, you can expect an extra cost of 50-70% on top of the cost of one standard.

The lead time is longer than for one standard, but shorter than for two separate processes. Expect one and a half to two times the lead time of a single process.

Points of attention

Keep the focus

A risk of integration is that topics get buried. If the organisation is mainly focused on quality, safety can end up being neglected.

Make sure both topics get enough attention in objectives, audits and management reviews. An integrated system does not mean that everything gets lumped together.

Competence

In an integrated system, someone must understand both standards. The system owner needs both quality and safety knowledge, or there must be good cooperation between specialists.

Auditor competence

In a combined audit, the auditor must be competent in both standards. When choosing a certification body, ask about the auditor’s background.

Next step

Also see how you can combine ISO 45001 with ISO 14001 for a complete integrated KAM (quality, OH&S and environment) system, or read the frequently asked questions.