ISO 13485 + ISO 14971 Integrated Compliance Pack

Who This Kit Is For

Organisations that want an integrated approach to ISO 13485 and ISO 14971, with harmonised procedures and templates.

The Compliance Problem It Solves

• Separate QMS and risk documentation that do not talk to each other.
• Audits questioning linkages between process controls, risk controls and decision-making.
• Complexity managing updates when ISO 13485 and ISO 14971 requirements change.

What You Get In This Kit

• Integrated SOP set mapping ISO 13485 processes to ISO 14971 risk activities.
• Cross-referenced templates for risk management, design, PMS and CAPA.
• Matrix showing clause-level alignment between the two standards.

How This Kit Reduces Your Audit Risk

• Demonstrates a single, coherent system for quality and risk management.
• Reduces duplication and gaps between QMS and risk files.
• Simplifies updates and training when regulatory expectations evolve.

How To Implement It (Step-by-Step)

1. Download the pack and review the clause alignment matrix.
2. Map your existing procedures to the integrated SOPs, identifying gaps.
3. Adopt or adapt the integrated documents, ensuring cross-references in risk files and QMS procedures.
4. Train staff on the integrated model and update training records accordingly.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 and ISO 14971:2019.
• Typical use: new system implementation or remediation of fragmented QMS/risk documentation.
• Document type: integrated compliance pack.