Certification
ISO 13485 Medical Devices
ISO 13485 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.
Medical and Life Science
Kiwa supports medical and life sciences organizations worldwide in navigating the complex regulatory landscape to ensure patient safety, product quality, and seamless global market access. Our tailored auditing, verification, and certification services are designed to meet the high medical industry requirements, from active equipment and implants to reusable instruments, materials, and software, ensuring compliance with critical safety and performance standards essential for human use.
Industry specific auditing and certifications solutions
We certify to globally recognized standards that underpin regulatory compliance and operational excellence. Key certifications include ISO 13485:2016 for Medical Device Quality Management Systems and ISO 22716:2007 for Good Manufacturing Practices in cosmetics. Supporting these are ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018, which reinforce quality management, environmental stewardship, and occupational health and safety across your operations.
Digitalization and sustainability solutions
Information security and privacy are everyday priorities in healthcare, and Kiwa helps organizations meet these important needs through well-recognized certifications. Our auditing and certification solutions include ISO 27001:2013 for managing information security and ISO 27701:2019 for privacy management, ensuring sensitive health data is protected. We cover cloud-specific security with ISO 27017:2015 and offer the complementary ISO 27018:2019, which focuses on protecting personal data in cloud environments.
Additionally, Kiwa offers certification in ISO 42001:2023, providing guidelines for responsible and ethical artificial intelligence (AI) governance. Our portfolio also includes ISO 20000:2018 for healthcare infromation technology service management, ensuring that infromation technology services are reliably planned, delivered, and continuously improved to support organizational goals.
On the sustainability front, we support commitments with ISO 14064:2018 for greenhouse gas emissions accounting, ISO 14068:2023, which guides organizations in achieving credible carbon neutrality.
Why choose Kiwa?
Kiwa combines global expertise with in-depth knowledge of the medical and life science sector. Our auditing, certification and assurance services help you demonstrate compliance with international standards and regulatory requirements, while supporting quality, safety and trust throughout your organization. With an international network of specialists and a pragmatic, client-focused approach, Kiwa helps you move confidently from compliance to continuous improvement.
Key Solutions for the Medical and Life Science Industry
Complimentary Business Assurance Services
Certification
ISO 9001 Quality Management
ISO 9001 is the international standard for quality management systems. Kiwa has extensive experience with ISO 9001 certification. With auditors active in a wide range of industries, we have all the sector knowledge needed to make your certification process a success.
Certification
ISO 14001 Certification: Environmental Management Certification
ISO 14001 provides an internationally recognized framework for establishing an Environmental Management System (EMS). It helps organizations identify and manage environmental impacts, improve resource efficiency, reduce waste and demonstrate a clear commitment to continual environmental improvement.
Certification
ISO 45001 Health and safety at work
ISO 45001 is a tool to systematically fulfill the legal obligation for employers to ensure the health and safety of employees and to pursue a policy aimed at achieving the best possible working conditions.
Certification
ISO 27001 certification: protect your business’ data
Working in accordance with the ISO 27001 standard helps you take a structured approach to information security. Kiwa’s experts have everything you need to prepare your organisation for ISO 27001 certification. We have extensive experience with this standard, from developing a step-by-step information security plan to implementing a full Information Security Management System (ISMS).
Certification
ISO 27017 Information security for cloud services
Are you a provider or customer of cloud services? With certification against the international standard ISO 27017:21 you can demonstrate your stakeholders that you are aware of the security risks of storing and processing information in the cloud and that you have taken measures to minimise these risks.
Certification
ISO/IEC 27018 certification: Protection of Personally Identifiable Information (PII) in Public Cloud Environments
Organizations increasingly rely on public cloud environments to process personal data. This requires demonstrable and careful protection of personally identifiable information (PII). ISO/IEC 27018 is the international standard for cloud providers acting as PII processors and shows that privacy is structurally and transparently embedded. With ISO/IEC 27018 certification by Kiwa, you demonstrate that your cloud services comply with internationally recognized privacy principles.
Certification
ISO 27701 Certification Privacy Management System
ISO/IEC 27701 – an extension of the ISO 27001 standard – contains specific management measures for the protection of privacy-sensitive information. Based on ISO 27701, organisations that already work with an Information Security Management System can upgrade their system to a Privacy Information Management System.
Certification
ISO 20000: The standard for professional IT service management
ISO 20000 is the international standard for Service Management Systems (SMS). It helps organizations set up an effective IT service management system that meets the needs of both the business and its customers. Kiwa supports you throughout the ISO 20000 certification process with expert guidance, a hands-on approach and years of experience in IT certification.
ISO 42001 Certification for AI Management Systems
With the rise of artificial intelligence (AI), managing and controlling AI applications responsibly has become increasingly important. The ISO/IEC 42001 standard provides an internationally recognized framework for establishing, implementing and maintaining an AI management system. The standard focuses on effectively managing the risks associated with using AI in products and services and helps organizations ensure proper compliance.
Whitepaper: The Revised ISO 9001 Explained
A revision of ISO 9001 is underway. The upcoming version introduces notable updates, including new requirements, revised or removed elements, updated terminology, and structural improvements.
This whitepaper provides a clear, business oriented overview of the most impactful changes, explaining their practical implications to help Quality Managers ensure a smooth and efficient transition to the new standard.
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