Services
Pre-assessment (Gap Analysis)
An optional readiness check that identifies gaps against the standard before your certification audit. Findings only, with no consultancy or advice.
- Agreed scope and plan for the review
- Review of documented information against the standard
- Interviews and sampling of records
- Factual report identifying gaps against requirements

Overview
An optional readiness check before certification
A pre-assessment is an optional, one-off review carried out before the formal certification audit. It gives you an independent view of how your management system compares with the requirements of the standard, so you can see where gaps remain and decide whether you are ready to proceed to Stage 1 and Stage 2. It is particularly useful when a tender deadline or customer requirement means you need a realistic view of timing.
The pre-assessment is conducted in the same way as an audit. Auditors gather evidence, review documented information and speak to staff, then report where requirements appear to be met and where they do not. Findings are reported factually, which helps you prioritise work and reduces the risk of surprises later in the certification process. The scope of the review can cover the whole standard or concentrate on areas where you feel least confident.
To protect impartiality under ISO/IEC 17021-1, a pre-assessment never includes consultancy. Our auditors will identify gaps, but they will not recommend specific solutions, write documents or tell you how to design your processes. Closing the gaps is a matter for your own team or an independent adviser, and a pre-assessment does not affect the outcome of certification. The later certification audit is a separate evaluation based on the evidence available at that time.

How it works
Pre-assessment (Gap Analysis), step by step
Every stage is planned and confirmed with you in advance, so your team knows exactly who is coming, when, and what they need to see.
- 1
Scope agreement
We agree the standard, scope and the areas to be reviewed, along with the time needed and whether the review takes place on site or remotely.
- 2
Pre-assessment visit
Auditors review documented information, interview staff and sample records in the same way as a certification audit would.
- 3
Findings report
You receive a report identifying where requirements appear to be met and where gaps exist, without recommendations on how to close them.
- 4
Your decision
You decide how to address the gaps and when you are ready to proceed to the formal Stage 1 and Stage 2 certification audits.
- Organisations preparing for their first certification audit
- Businesses with a tender deadline that want to judge readiness
- Organisations adding a new standard to an existing system
- Teams that want an independent view before committing to audit dates
Available for
Pre-assessment for every standard
This service is available for every standard we certify. Choose one to learn more.
Quality
ISO 9001:2026Quality Management
ISO 9001:2026 sets out the requirements for a quality management system. Published in September 2026, it replaces ISO 9001:2015 and keeps the same core approach. It asks an organisation to understand its context and interested parties, plan its processes around risks and opportunities, and show that it consistently provides products and services that meet customer and applicable statutory and regulatory requirements. It is the most widely used management system standard and applies to organisations of any size or sector, from sole manufacturers to national service providers.
- Meet tender and supplier requirements
- Consistent processes
- Fewer errors and complaints
- Risk-based planning

Environment & Energy
ISO 14001:2026Environmental Management
ISO 14001:2026, published in April 2026 to replace the 2015 edition, specifies the requirements for an environmental management system. It helps an organisation identify the environmental aspects of its activities, products and services, understand its compliance obligations, and manage significant impacts through planning, operational control and evaluation. The standard takes a life cycle perspective, so organisations consider stages they can control or influence, such as purchasing, transport, use and end-of-life treatment, as well as their own sites.
- Supply chain and tender credibility
- Structured legal compliance
- Control of significant impacts
- Resource and waste efficiency

Health & Safety
ISO 45001:2018Occupational Health and Safety Management
ISO 45001:2018 sets out requirements for an occupational health and safety management system. Its aim is to prevent work-related injury and ill health and to provide safe and healthy workplaces. The standard places strong emphasis on leadership, the consultation and participation of workers, hazard identification and the hierarchy of controls. It replaced OHSAS 18001 and follows the Harmonized Structure, so it integrates readily with ISO 9001 and ISO 14001.
- Prequalification and tenders
- Worker involvement
- Systematic hazard control
- Clear legal oversight

Information & Technology
ISO/IEC 27001:2022Information Security Management
ISO/IEC 27001:2022 specifies requirements for an information security management system (ISMS). It requires an organisation to assess information security risks to the confidentiality, integrity and availability of information, select controls to treat them and manage those controls through a continual cycle of monitoring and review. Annex A lists 93 reference controls in four themes: organisational, people, physical and technological. Each organisation compares its chosen controls against Annex A and records the outcome in a Statement of Applicability.
- Answer security questionnaires
- Risk-based security
- Supports data protection duties
- Management oversight

Environment & Energy
ISO 50001:2018Energy Management
ISO 50001:2018 specifies requirements for an energy management system (EnMS). It requires an organisation to understand how it uses and consumes energy, identify significant energy uses, set an energy baseline and energy performance indicators, and plan actions to improve energy performance. Unlike some other management system standards, ISO 50001 requires an organisation to demonstrate continual improvement in energy performance itself, not only in the management system.
- ESOS compliance route
- Measured energy performance
- Focus on significant uses
- Cost control

Resilience & Governance
ISO 22301:2019Business Continuity Management
ISO 22301:2019 specifies requirements for a business continuity management system (BCMS). It helps an organisation prepare for, respond to and recover from disruptive incidents when they occur. The core of the standard sits in clause 8, which requires a business impact analysis and risk assessment, business continuity strategies and solutions, documented plans and procedures, an exercise programme and evaluation of business continuity capability. It follows the Harmonized Structure and integrates with other management system standards.
- Evidence for customers
- Clear recovery priorities
- Tested plans
- Understanding dependencies

Sector-specific
ISO 22000:2018Food Safety Management
ISO 22000:2018 specifies requirements for a food safety management system for any organisation in the food chain, from feed and primary production through processing, storage, transport, retail and food service, as well as packaging and equipment suppliers. It combines the Harmonized Structure management system clauses with HACCP principles from Codex Alimentarius, prerequisite programmes (PRPs) and interactive communication across the food chain. The standard uses two linked Plan, Do, Check, Act cycles: one for the management system and one for operational hazard control.
- Structured hazard control
- Applies across the food chain
- Management system discipline
- Communication across the chain

Sector-specific
ISO 13485:2016Medical Devices Quality Management
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It applies to manufacturers and to organisations involved in other stages of the device life cycle, such as design, distribution, installation, servicing, sterilisation and component supply. The standard places particular emphasis on risk management, process validation, traceability and regulatory reporting.
- Supports regulatory submissions
- Supply chain requirements
- Risk management throughout
- Validated processes

Information & Technology
ISO/IEC 20000-1:2018IT Service Management
ISO/IEC 20000-1:2018 specifies requirements for establishing, implementing, maintaining and continually improving a service management system (SMS). It covers the planning, design, transition, delivery and improvement of services to meet agreed requirements. Clause 8 sets out the operational processes, grouped into service portfolio, relationship and agreement, supply and demand, service design, build and transition, resolution and fulfilment, and service assurance. The 2018 edition follows the Harmonized Structure, which allows integration with ISO/IEC 27001 and ISO 9001.
- Procurement credibility
- Consistent service delivery
- Clear service agreements
- Controlled change

Information & Technology
ISO/IEC 42001:2023Artificial Intelligence Management
ISO/IEC 42001:2023 is the first international management system standard for artificial intelligence. It specifies requirements for establishing, implementing, maintaining and continually improving an AI management system (AIMS) within an organisation that develops, provides or uses AI systems. It requires AI risk assessment, AI risk treatment and AI system impact assessment, considering effects on individuals, groups and society. Annex A provides reference controls covering areas such as AI policy, resources, impact assessment, the AI system life cycle, data and third-party relationships.
- Evidence of responsible AI governance
- Structured risk and impact assessment
- Clear roles and accountability
- Life cycle controls

Resilience & Governance
ISO 37001:2025Anti-Bribery Management
ISO 37001 specifies requirements for an anti-bribery management system. It helps an organisation prevent, detect and respond to bribery, whether by the organisation, its personnel or business associates acting on its behalf, and bribery of the organisation. Requirements include an anti-bribery policy, top management and governing body oversight, an anti-bribery compliance function, bribery risk assessment, due diligence, financial and non-financial controls, gifts and hospitality controls, and processes for raising and investigating concerns. The second edition, ISO 37001:2025, was published in February 2025.
- Supports adequate procedures
- Risk-based controls
- Due diligence on third parties
- Clear governance oversight

FAQs
Pre-assessment (Gap Analysis): your questions
Is a pre-assessment required for certification?
No. A pre-assessment is entirely optional. Many organisations go straight to Stage 1, which itself reviews readiness. A pre-assessment can be useful where you are unsure how close you are to meeting the standard or where you want an earlier independent view before committing to a timetable for certification.
How is a pre-assessment different from Stage 1?
Stage 1 is part of the formal certification audit and its findings carry into Stage 2. A pre-assessment sits outside the certification process and does not affect the certification decision. It can be scoped more flexibly, for example to focus on particular clauses or sites, and helps you judge readiness before formal audits begin.
Will your auditors tell us how to fix the gaps?
No. ISO/IEC 17021-1 prohibits certification bodies from providing consultancy to clients they certify. Our auditors will explain what the requirement is and where your evidence falls short, but they will not propose specific solutions, write procedures or design your processes. You remain free to use an independent adviser if you need help.
Can we have more than one pre-assessment?
We normally offer one pre-assessment per standard before initial certification. Repeated pre-assessments could start to resemble a consultancy relationship, which would threaten impartiality. If significant time has passed or your scope has changed substantially, we can discuss whether a further review would be appropriate.
Will the same auditors carry out our certification audit?
They may, as pre-assessment does not prevent an auditor from conducting the later certification audit, provided no consultancy has been given. We consider impartiality risks for each assignment. Some organisations value continuity, while others prefer a fresh view, and you are welcome to tell us your preference.
Do findings from the pre-assessment carry into the certification audit?
No. The pre-assessment is separate and its findings do not count as nonconformities in the certification audit. The certification auditors will make their own evaluation at Stage 1 and Stage 2 based on the evidence available at that time, so you should not assume that an area found adequate earlier will be accepted without review.
How long does a pre-assessment take?
Duration depends on the standard, the size of the organisation, the number of sites and how much of the system you want reviewed. A focused pre-assessment for a small organisation may take a single day, while a larger or multi-site organisation may need longer. We will confirm the time needed when we agree the scope.
Can the pre-assessment be done remotely?
Parts of it often can, particularly document review and interviews. Where operational activities need to be observed, such as production, laboratory or site work, an on-site visit gives a more reliable picture. We will agree the most suitable approach with you based on your activities.
Certificate verification
Check a Hexa certificate
Need to know whether a supplier's certificate is current? Customers, buyers and other interested parties can ask us to confirm the details held in our records.
We confirm the organisation name, certificate number, ISO standard, certified scope, status, and issue and expiry dates.
More services
Explore our other services
- Initial CertificationIndependent Stage 1 and Stage 2 certification auditsLearn more
- Surveillance AuditsAnnual audits that keep your certificate validLearn more
- Recertification AuditsRenew your certificate for a further three-year cycleLearn more
- Certificate TransferMove an existing accredited certificate to HexaLearn more
- Integrated Management SystemsCombined audits for several ISO standardsLearn more
- Management System TrainingPublic awareness and internal auditor coursesLearn more
- Certificate VerificationConfirm a Hexa certificate is genuine and currentLearn more
Start your certification
Get a fixed, three-year certification quote
Tell us about your organisation and the standards you need. We will confirm audit days, scope and dates in writing, with no obligation.
