ISMS Manual and Scope
Context, interested parties, scope statement and the structure of the management system, with a worksheet for each. Clauses 4.1 to 4.4, 5.1, 5.3 and 7.1.
ISO/IEC 27001 · ISMS Documentation
ISO 27001 Documentation
A complete, customizable ISMS documentation kit aligned with ISO/IEC 27001:2022. On its own for any organization, or integrated with ISO 13485 in one management system for medical device manufacturers.
- 93 Annex A controls mapped
- Statement of Applicability included
- NIS-2 mapping
- Word & Excel, fully editable
MD REGULATORY
ISO 27001
ISMS Documentation
- 21 Procedures + 18 Templates
- Statement of Applicability
- 93 Annex A controls mapped
- NIS-2 mapping included
ISO/IEC 27001:2022
✦ Complete Kit
Get the ISO 27001 Kit →
ISO 27001 Documentation Kit
A complete information security management system, ready to adopt: the management system clauses, the risk process and the Annex A controls, each in a procedure of the same structure with the forms and registers it produces. For any organization, with no medical device content.
21 procedures and policies
10 forms + 8 registers
Statement of Applicability (93 controls)
Risk Register and Treatment Plan
Master Index with clause and control maps
NIS-2 Article 21 mapping
README with the 5-phase implementation sequence
Free updates when the kit is revised
€590
42 files · Word & Excel, fully editable
MD REGULATORY
13485 + 27001
Integrated Documentation
- 42 SOPs + 71 Templates
- Manual + Policy + Master Index
- 9 integrated procedures
- 93 Annex A controls mapped
ISO 13485 · ISO/IEC 27001
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ISO 13485 + ISO 27001 Integrated Kit
For medical device manufacturers: the complete ISO 13485 kit with the information security management system built into it. Nine procedures serve both standards, so there is one document control, one audit programme, one management review and one CAPA process, not two parallel systems.
QM-001 Manual + QM-002 Policy
42 SOPs (4 Core + 26 ISO + 12 ISMS)
71 templates ready to customize
9 procedures integrated for both standards
Statement of Applicability (93 controls)
31 pre-populated KPIs
Document Master List pre-filled (116 documents)
README + Master Index (6 sheets)
€890SAVE €199
vs €1,089 buying separately (ISO 13485 €499 + ISO 27001 €590)
What is inside the ISO 27001 Kit
21 procedures and policies, each with the forms and registers it produces. Filter by area to see what covers what.
Information Security Policy
The signed policy: the commitment of top management and the framework it establishes. Clause 5.2 and control A.5.1.
Objectives and Planning of Changes
SOP + 2 templates: Change Planning Record, Objectives Register (Excel). Clauses 6.2 and 6.3.
Documented Information and Communication
Control of documents and records, the master document list and the communication plan. Clauses 7.4 and 7.5.
Competence, Awareness and Resources
SOP + Competence Register (Excel). Competence per role, the awareness programme and resources. Clauses 7.1 to 7.3 and control A.6.3.
Information Security Risk Management
SOP + 3 templates: Risk Register and Treatment Plan (Excel), Statement of Applicability with the 93 controls (Excel), Risk Assessment Record. Clauses 6.1, 8.2 and 8.3.
Legal and Contractual Requirements
SOP + Legal and Contractual Requirements Register (Excel). Clause 4.2 and controls A.5.31 to A.5.34.
Operational Planning and Control
Process criteria, evidence of operation, changes and external providers, with the annual calendar. Clause 8.1.
Asset and Information Classification
SOP + Asset Inventory (Excel). Ownership, acceptable use, classification, labelling and transfer. Controls A.5.9 to A.5.14.
Access Control and Identity
SOP + Access Review Record. Identity, authorisation, authentication and access review. Controls A.5.15 to A.5.18 and A.8.2 to A.8.5.
Operations Security
Capacity, malware, networks, cryptography and protection of information in operation. Twelve controls of theme A.8, from A.8.6 to A.8.34.
Vulnerability and Configuration Management
SOP + Configuration Baselines Register (Excel). Threat intelligence, vulnerability remediation and secure baselines. Controls A.5.7, A.8.8, A.8.9 and A.8.19.
Secure Development and Change
Security in the development life cycle and control of change to production. Controls A.5.8 and A.8.25 to A.8.33.
Physical and Environmental Security
Perimeters, entry, secure areas, equipment, media and disposal. Controls A.7.1 to A.7.14.
Human Resources Security
SOP + Onboarding and Exit Record. The employment life cycle, endpoint devices and remote working. Controls A.6.1, A.6.2, A.6.4 to A.6.7 and A.8.1.
Supplier and Cloud Security
SOP + 2 templates: Security Clauses for Suppliers, Confidentiality Statement. Controls A.5.19 to A.5.23 and A.8.30.
Incident Management
SOP + Incident Record. Planning, reporting, assessment, response, evidence and learning. Controls A.5.24 to A.5.28 and A.6.8.
Continuity and Resilience
Security during disruption, ICT readiness, backup and redundancy. Controls A.5.29, A.5.30, A.8.13 and A.8.14.
Logging and Monitoring
Event logging, protection of logs, monitoring and clock synchronisation. Controls A.8.15 to A.8.17.
Performance, Audit and Management Review
SOP + 2 templates: Internal Audit Programme and Report, Management Review Minutes. Clauses 9.1 to 9.3 and controls A.5.35 and A.5.36.
Nonconformity and Improvement
SOP + 2 templates: Corrective Action Record, Nonconformity and Corrective Action Register (Excel). Clauses 10.1 and 10.2.