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October 08, 2026
Global Manager Group Launches ISO 14155:2026 Document and Training Kit
Global Manager Group has launched its comprehensive ISO 14155:2026 documents kit, designed to help medical device manufacturers, clinical research organizations, sponsors, investigators, and healthcare organizations establish documented processes aligned with the requirements of ISO 14155:2026 and Good Clinical Practice (GCP).
ISO 14155:2026 establishes principles for the design, conduct, recording, and reporting of clinical investigations involving human subjects and medical devices. Implementing these requirements effectively requires appropriate manuals, procedures, SOPs, forms, records, checklists, and documented controls. The package provides editable resources that can help organizations develop and customize their clinical investigation documentation more efficiently.
ISO The documentation package includes more than 95 editable Microsoft Word files, covering important areas of ISO 14155:2026 documents and supporting efficient implementation. Key resources include:
- ISO 14155 Quality Manual with 10 chapters and an annexure covering standard requirements
- 21 Quality Procedures for key clinical investigation processes
- 5 Standard Operating Procedures (SOPs) for defining operational controls
- 7 Exhibits with sample documentation in Word and Excel formats
- 49 editable forms and templates for maintaining records and implementing documented controls
- ISO 14155 Audit Checklist containing more than 400 audit questions
- ISO 14155:2026 Document Compliance Matrix for mapping documentation to applicable requirements
In addition to the ISO 14155:2026 documents, the kit includes professionally developed awareness and training presentations covering ISO 14155:2026 awareness, requirements, document and record control, and implementation steps. Supporting literature, practical workshops, and a case study are also provided to help users strengthen their understanding of Good Clinical Practice and clinical investigation requirements.
All documentation is written in clear and simple English and supplied in editable Microsoft Word format, allowing organizations to customize the content according to their clinical investigation activities, organizational structure, responsibilities, and existing processes. The PowerPoint presentations can also be adapted for internal awareness sessions and personnel training.
By combining manuals, procedures, SOPs, forms, templates, exhibits, audit questions, compliance mapping, and training resources, the ISO 14155 documents helps reduce the time and effort required to develop documentation from the beginning. The ready-to-customize resources can support consistent implementation, documentation control, internal evaluation, and personnel awareness.
The resources are suitable for medical device manufacturers, clinical research organizations (CROs), sponsors, investigators, healthcare organizations, and consultants involved in clinical investigations. Global Manager Group provides a FREE DEMO of the ISO 14155:2026 documents, allowing users to review the document index and sample materials and assess their suitability before making a purchase decision.
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