East of England, England
ISO certification in Cambridge
Cambridge is an internationally recognised centre for life sciences and deep technology, built on the University of Cambridge and decades of spinout and investment activity. The surrounding science parks host businesses from early-stage startups to global headquarters.
- On-site audits across Cambridgeshire
- No location premium on fees
- Auditors matched to your sector
- Integrated multi-standard audits
Cambridge and 76 other Hexa locations
The Cambridge economy
Certification shaped around Cambridge businesses
The Cambridge Biomedical Campus brings together Addenbrooke's Hospital, AstraZeneca's global headquarters and research centre, and the MRC Laboratory of Molecular Biology. The Wellcome Genome Campus at Hinxton, home to the Wellcome Sanger Institute, lies to the south. In technology, Arm is headquartered in the city, and the Cambridge Science Park, St John's Innovation Centre and other sites host semiconductor, software, AI and engineering firms. Contract research, diagnostics and medical device companies form a large part of the business base, supported by specialist laboratory, facilities and professional services providers.
Medical device and diagnostics companies frequently pursue ISO 13485 to meet regulatory and distributor expectations, while pharmaceutical and research buyers often ask software and data suppliers for ISO 27001.
Key sectors we audit in Cambridge
- Life sciences and biotechnology
- Medical devices and diagnostics
- Semiconductors and deep technology
- Software and AI
- Higher education and research
- Laboratory and facilities services
Most requested in Cambridge
ISO standards for Cambridge organisations
The first tabs show the standards Cambridge organisations ask for most often. Every standard is available locally, on site.
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 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
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
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
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
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
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
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
Why it matters locally
What certification does for a Cambridge business
Win and keep contracts
Public bodies and larger buyers advertising on Find a Tender and Contracts Finder frequently ask for certified management systems at pre-qualification. A certificate answers those questions with independent evidence.
Show control to regulators
Organisations in Cambridgeshire answer to the Health and Safety Executive (HSE) and the Environment Agency. A certified system demonstrates that risks, legal duties and incidents are managed systematically.
Strengthen supply chains
For life sciences and biotechnology and medical devices and diagnostics suppliers, certification reduces repeated customer audits and questionnaires, and makes onboarding faster.
Run a better business
Clear processes, measured objectives and regular internal audits help teams across Cambridge work consistently, reduce errors and improve year after year.
How it works
Getting certified in Cambridge
- 1
Application and quotation
You tell us your scope, sites, headcount and standards. We calculate audit duration using the accreditation rules and send a fixed quotation for the full three-year cycle.
- 2
Stage 1 audit
Your auditor reviews your documented information, scope, legal and regulatory awareness, internal audit and management review, and confirms you are ready for Stage 2.
- 3
Stage 2 audit
An on-site evaluation of how your management system works in practice. The auditor interviews people, observes activities and samples records against every requirement.
- 4
Certification decision
Any nonconformities are closed with evidence. A qualified reviewer who did not take part in the audit makes the certification decision and your certificate is issued.
- 5
Surveillance and recertification
Surveillance audits take place at least once a year to confirm continued conformity. A recertification audit before the third anniversary renews your certificate.
Services in Cambridge
Certification services in Cambridge
- 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
- Pre-assessmentAn optional readiness check before certificationLearn more
- Management System TrainingPublic awareness and internal auditor coursesLearn more
- Certificate VerificationConfirm a Hexa certificate is genuine and currentLearn more
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.
FAQs
ISO certification in Cambridge: FAQs
Do you carry out ISO certification audits in Cambridge?
Yes. Hexa Certifications audits organisations in Cambridge and across Cambridgeshire, including Trumpington, Cherry Hinton, Chesterton, Histon. Stage 2, surveillance and recertification audits are normally carried out on site at your premises, with some Stage 1 and document review activity completed remotely where the scheme rules allow it.
Which ISO standards are most requested by Cambridge businesses?
Demand follows the local economy. In Cambridge we most often see interest in ISO 13485, ISO 27001, ISO 9001, ISO/IEC 42001, reflecting sectors such as life sciences and biotechnology, medical devices and diagnostics, semiconductors and deep technology. Many organisations combine two or three standards into one integrated audit to save time on site.
How long does ISO certification take for a company in Cambridge?
Timescales depend on how ready your management system is, rather than where you are based. An organisation that has run its system for a few months, completed an internal audit and held a management review can usually move from Stage 1 to a certification decision within six to twelve weeks of booking.
Will the auditor visit our site in Cambridge?
Yes. Certification audits need objective evidence gathered where the work happens, so your auditor visits your Cambridge site for Stage 2 and for each surveillance audit. Travel is planned in advance and included in the fixed quotation you receive before you commit.
How much does ISO certification cost in Cambridge?
Audit fees are set by audit duration, which is calculated from your headcount, the number of sites, the standards in scope and the complexity of your activities. We do not charge a location premium for Cambridge. Request a quote and you will receive a fixed, itemised proposal covering the full three-year certification cycle.
Can you certify organisations with several sites around Cambridge?
Yes. Multi-site organisations can be certified under a single certificate where the sites operate under one management system with central control. We use sampling rules to decide which sites are visited at each audit, so a head office in Cambridge and branches elsewhere can be covered efficiently.
Does ISO certification help Cambridge companies win public sector work?
Often, yes. Many buyers using Find a Tender and Contracts Finder ask suppliers for evidence of quality, environmental, health and safety or information security controls. A current certificate is a clear, independently verified way to answer those questions and can shorten pre-qualification for local authority, NHS and prime contractor supply chains.
Do you help write our management system in Cambridge?
No. As an independent certification body we cannot design or write the management system we later certify, because that would compromise impartiality. We can carry out an optional pre-assessment that shows where you stand against the standard, and you remain free to use any consultant or in-house resource to close gaps.
Areas we cover around Cambridge
- Trumpington
- Cherry Hinton
- Chesterton
- Histon
- Girton
- Great Shelford
- Sawston
- Cambourne
Start your certification
Get your Cambridge 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.