Documentation under ISO 9001:2026 – what’s changing and what documents does the new standard actually require?

One of the most common questions we hear from companies preparing to transition to the new version of the standard is a very practical one: what exactly do I need to have on paper? ISO 9001:2026 does not revolutionise the approach to documenting a quality management system, but it clarifies several areas which were formulated rather generally in the 2015 version – and it is precisely in these areas that non-conformities most frequently arise during audits.

The principle remains the same: documentation is there to serve the organisation, not the other way round

For years, the standard has been moving away from a rigid list of mandatory procedures towards the concept of ‘documented information’ – that is, the amount of records and procedures that is actually necessary for the system to function efficiently within a given organisation. ISO 9001:2026 maintains this approach but clarifies the criteria by which a company should assess for itself what needs to be documented and what does not. A full comparison of changes between the versions can be found in the article:  Key differences: ISO 9001:2015 vs ISO 9001:2026. In practice, this means less discretion than before – auditors will expect decisions to be justified, rather than simply invoking the ‘flexibility of the standard’.

What remains mandatory

Several elements of documentation remain explicitly required, regardless of the organisation’s size or sector:

• the quality policy and quality objectives, together with evidence of their review,
• the scope of the quality management system, including justification for any exclusions,
• records of management reviews,
• results of internal audits,
• evidence of the competence of personnel affecting quality,
• records relating to the control of non-conforming products and corrective actions.

What’s new in ISO 9001:2026

The new version of the standard places greater emphasis on documenting the organisation’s context and how risks are managed in a traceable manner – it is no longer sufficient simply to state that risks have been identified. The auditor will expect records showing how a specific risk has influenced a decision or action within the organisation. This is one of the reasons why, as we explain in the article ‘Why is the update to ISO 9001:2026 more than just a change to documentation?’, the revision of the standard affects the actual functioning of the organisation, and not just the content of documents. The situation is similar with regard to data on suppliers and subcontractors – there is a growing expectation for documented criteria for their assessment and a history of cooperation, particularly in supply chains involving multiple entities.

A second area gaining in importance is the documentation of the use of digital and automated tools in quality-related processes – if a company uses IT systems to manage documentation, oversee records or monitor indicators, the standard expects the method of overseeing these tools to be just as transparent as that for paper-based documentation.

What can be simplified

The good news is that the standard still does not require complex, separate procedures for each process. Small and medium-sized enterprises, which have hitherto produced excessive documentation ‘just in case’, can – and should – simplify it significantly by combining related procedures into a single, coherent document, provided that clarity is maintained and the process can be traced. The key term here is ‘traceability’ – it is this, rather than the length of the document, that is the focus of the auditor’s assessment.

Practical recommendation

Before you begin updating your documentation to comply with the new version of the standard, it is worth reviewing your current system and answering one question for each document: would its absence genuinely make it difficult to trace a decision or action? If the answer is ‘no’, then the document is likely a candidate for simplification or merging with another. If the answer is ‘yes’ – these are the areas that require particular attention when transitioning to ISO 9001:2026.

We help companies navigate the process of updating their QMS documentation step by step – from auditing the current state, through identifying gaps, to preparing provisions compliant with the new version of the standard. Please contact us to discuss the scope of work for your organisation.