Industries · Healthcare & Life Sciences
ISO certification for healthcare & life sciences
ISO 13485, ISO 9001 and ISO/IEC 27001 certification for medical device organisations, care providers and healthcare suppliers in the UK.
- ISO 13485 medical devices quality
- ISO 9001 quality
- ISO 27001 information security
- ISO 14001 environmental
Overview
Certification for device makers, providers and suppliers
Healthcare and life sciences organisations operate in closely regulated environments where patient safety, data protection and product quality are central. Management system certification can help demonstrate disciplined control to customers, partners and the NHS supply chain, while regulatory approvals remain with the relevant authorities. The right standard depends on whether you make or supply devices, provide care or support the sector with services such as software, logistics or facilities.
For medical device organisations, ISO 13485 sets quality management system requirements covering design, production, risk management, traceability and post-market activities. It is widely expected by distributors and partners. Certification to ISO 13485 by a management system certification body is separate from UKCA or CE conformity assessment, which is carried out by UK Approved Bodies or notified bodies under medical device regulations overseen in Great Britain by the MHRA.
Care providers and healthcare service organisations are regulated by bodies such as the Care Quality Commission in England. ISO 9001 can support consistent processes, and ISO/IEC 27001 helps protect sensitive patient information, but neither replaces regulatory registration, inspection or the NHS Data Security and Protection Toolkit where it applies. Auditors will, however, expect your system to identify and address these regulatory obligations.
Recommended
- ISO 13485
- ISO 9001
- ISO 27001
Sector challenges
Where certification makes the difference
The pressures organisations in healthcare & life sciences face most often, and how a certified management system helps answer them.
Regulatory interfaces
Organisations must meet MHRA, CQC and other regulatory requirements, and their management systems need to reflect these obligations clearly.
Medical device quality
Device organisations must control design, risk management, production, sterility where relevant, traceability and complaint handling under ISO 13485.
Patient data protection
Health data is special category data under UK GDPR, so information security controls and supplier management are critical.
Supplier control
Critical suppliers and outsourced processes must be selected, monitored and controlled, particularly where they affect product safety.
Staff competence
Clinical, technical and support roles require documented competence and training to deliver safe services and products.
Recommended standards
Standards most requested in healthcare & life sciences
Choose a standard to see what it covers. Several can be combined into one integrated audit.
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
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 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 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
How it works
Your route to certification
- 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.
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
Healthcare & Life Sciences: certification questions
Is ISO 13485 certification the same as UKCA marking?
No. ISO 13485 certification confirms that your quality management system meets the standard. UKCA and CE marking of medical devices involve conformity assessment under the relevant device regulations, carried out by a UK Approved Body or an EU notified body where required. Hexa Certifications is not an Approved Body or notified body and does not issue product conformity marks.
Who needs ISO 13485?
ISO 13485 applies to organisations involved in one or more stages of the medical device life cycle, including design, manufacture, distribution, servicing and suppliers of components or services to device makers. Many distributors and contract manufacturers are asked for it by device manufacturers as part of supplier approval.
Does ISO 9001 replace CQC registration?
No. Registration with the Care Quality Commission and its inspections are statutory requirements for regulated activities in England, and similar arrangements apply in Scotland, Wales and Northern Ireland. ISO 9001 can help structure processes and improvement, but it is a voluntary standard and does not replace regulatory registration or inspection.
Is ISO 13485 based on ISO 9001?
ISO 13485:2016 is related to ISO 9001 but is a standalone standard with its own structure and requirements tailored to medical devices. It places strong emphasis on regulatory requirements, risk management, documentation and traceability. It does not follow the harmonised structure used by most other ISO management system standards.
How does ISO/IEC 27001 help healthcare organisations?
Healthcare organisations hold sensitive personal data, including special category health data. ISO/IEC 27001 provides a risk-based framework for protecting the confidentiality, integrity and availability of that information. It supports, but does not replace, UK GDPR obligations or the NHS Data Security and Protection Toolkit.
Can private clinics and laboratories be certified?
Clinics and service providers can be certified to ISO 9001 and other management system standards. Medical laboratories seeking recognition of technical competence often use ISO 15189 accreditation, which is a separate scheme operated by an accreditation body rather than a certification body. We can explain which route suits your aims.
Do you offer MDSAP audits?
No. The Medical Device Single Audit Program is operated by participating regulators and uses specially recognised auditing organisations. Hexa Certifications certifies to ISO 13485 as a management system standard but does not conduct MDSAP audits. If a regulator in one of your target markets requires MDSAP, you will need a recognised auditing organisation for that programme.
Will auditors need access to patient information?
Auditors aim to minimise access to personal data. Where records need to be sampled, they can often be reviewed in a redacted or anonymised form, or viewed on screen without copies being taken. Our auditors are bound by confidentiality obligations, and we can agree specific arrangements before the audit.
Other industries we audit
All industries
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.
