ISO 9001:2026 – Key Changes and Support for Medical Device Manufacturers

The forthcoming move from ISO 9001:2015 to ISO 9001:2026 builds on the existing ISO 9001 framework, refining how the standard is understood and applied.

What will ISO 9001:2026 mean for medical device manufacturers? 

For medical device manufacturers operating an ISO 9001:2015 Quality Management System, the transition to ISO 9001:2026 will require consideration of how the revised requirements affect their existing QMS.

How effective is your existing QMS? Do you have the resources to manage the change to ISO 9001:2026?

What are the key changes to ISO 9001:2026?

Key changes include:

• Clearer separation of risks and opportunities for a more balanced approach
• Stronger emphasis on quality culture, values and ethical behaviour
• Improved usability and closer alignment with other ISO management system standards
• Additional Annex A guidance to clarify terminology and the intent of requirements

Transitioning from ISO 9001:2015 to ISO 9001:2026

For medical device manufacturers certified to ISO 9001:2015, areas of your Quality Management System may require further development or additional evidence, and preparing for a revised standard can place additional demands on already busy quality and compliance teams.

If your organisation does not have the time or internal resources to manage the change, QAEC Limited can provide the additional support you need.

We can work alongside your existing team or provide dedicated consultancy support, including:

• ISO 9001:2026 gap analysis
• Quality Management System (QMS) review and updates
• Internal auditing
• Transition readiness support

Our approach is tailored to your organisation, your existing Quality Management System and the level of support you require.

Need support with ISO 9001:2026? Contact QAEC Limited to discuss how we can support your organisation.

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As the transition to the UK Medical Device Regulations 2002 continues, Post-Market Surveillance (PMS) has become a core requirement for maintaining device conformity. The current regulatory environment expects manufacturers to demonstrate ongoing performance and safety using real-world data, with PMS operating as a living part of the quality system rather than an archived document.

For many organisations balancing MDR, UKCA and day-to-day operations, PMS is an area that can lag behind simply because other activities appear more urgent. Data is often available, but the challenge lies in how it is assessed, trended, documented and linked back into technical files and lifecycle evidence.

Where PMS frameworks commonly require attention

When reviewing PMS arrangements for manufacturers, similar themes frequently appear:

• PMS plans created historically but not updated for the UK MDR
• Data collected, but evaluation or trending not recorded clearly
• PMS output not consistently linked back into risk or clinical evidence
• Reporting performed when needed rather than on a defined schedule
• Evidence held in multiple places rather than consolidated for review

These are operational challenges and can lead to additional workload later during audits, renewals or technical documentation updates. Strengthening PMS early is usually more efficient than remediation later.

What PMS must demonstrate under the UK MDR

A compliant PMS system should:

• monitor real-world performance and safety
• support proactive review, not solely reactive reporting
• inform risk management and clinical evaluation
• provide structured PMS reports at planned intervals
• justify the level of surveillance undertaken
• maintain traceability across lifecycle documentation

In practice, PMS should support the evidence narrative of the device throughout its life on the market.

A practical route forward for manufacturers

PMS improvement does not need to be disruptive, but it does need to be purposeful and clearly documented. Manufacturers often benefit from support with:

• reviewing PMS arrangements against UK MDR
• defining proportionate review and reporting frequency
• improving documentation structure for clarity and traceability
• ensuring PMS feeds effectively into CER, PMCF and risk files
• preparing documentation that stands up to regulatory scrutiny

The most effective approach depends on device classification, available data and the maturity of the existing QMS. Tailored support is usually more efficient than generic templates.

Cost-effective PMS support for manufacturers

QAEC Limited works with organisations seeking practical PMS improvement without unnecessary complexity or cost. We support manufacturers with:

• PMS plan updates aligned to UK MDR
• PMS reporting and documentation structure
• Complaint trending and evaluation approaches
• Integration of PMS outputs into lifecycle evidence
• Practical guidance based on real-world implementation

Support is available as a focused one-off review or ongoing assistance.

Need support with UK MDR post-market surveillance? Contact QAEC Limited to discuss your PMS requirements.

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