ISO Compliance for Every Industry
Navigate ISO certification with confidence. Understand what ISO 9001, ISO 13485 and ISO 27001 require, and how digital tools simplify the journey from gap analysis to certification.
Understanding the Standards
ISO 9001:2015
Quality Management
The globally recognised standard for quality management systems. Demonstrates your organisation delivers consistent, high-quality products and services.
Key Requirements
- Context of the organisation
- Leadership & commitment
- Planning for risks and opportunities
- Support & resources
- Operational planning and control
- Performance evaluation
- Continual improvement
Who Needs It
Any organisation in any sector: manufacturers, engineering firms, technology and SaaS companies, logistics operators, construction, professional services and healthcare providers.
ISO 13485:2016
Regulated Products QMS
The quality management standard for medical devices and other tightly regulated products. Essential for CE/UKCA marking and MHRA regulatory submissions.
Key Requirements
- Design and development controls
- Risk management (ISO 14971)
- Purchasing and supplier management
- Production and service provision
- Traceability and identification
- Post-market surveillance
- Regulatory documentation
Who Needs It
Device and component manufacturers, contract manufacturers, distributors, service providers and any organisation in a regulated product supply chain.
ISO 27001:2022
Information Security
The international standard for information security management. Critical for any organisation handling customer data, intellectual property or business-critical systems.
Key Requirements
- Information security policies
- Asset management
- Access control
- Cryptography
- Physical and environmental security
- Operations security
- Incident management
Who Needs It
SaaS and technology companies, financial and professional services, suppliers to enterprise and public sector customers, and any organisation handling sensitive data.
The Certification Journey
A typical path from deciding to pursue ISO certification to achieving it.
Gap Analysis
Assess your current processes against the standard's requirements to identify what's missing.
System Design
Build or refine your management system: policies, procedures, processes and documentation.
Implementation
Roll out the system across your organisation with training, awareness and operational adoption.
Internal Audit
Conduct internal audits to verify the system works as designed and identify improvements.
Management Review
Leadership reviews system performance, audit results and improvement opportunities.
Certification Audit
External certification body audits your system (Stage 1 documentation, Stage 2 implementation).
Frequently Asked Questions
Understanding the ISO standards that matter most to modern organisations.
For most organisations the core three are ISO 9001 (quality management), ISO 27001 (information security) and, for regulated products such as medical devices, ISO 13485. Many also integrate ISO 14001 (environment) and ISO 45001 (health & safety) into one management system.
Start Your ISO Journey Today
Take our free assessment to see where you stand, or explore how DMG digital tools can accelerate your path to certification.