Our Simple 6-Step Path to Building a Compliant and Scalable Quality Management System
We’ve developed a simple yet meticulously crafted comprehensive 6-step plan to help you build a compliant and scalable Quality Management System. There are three tailored packages to choose from depending on the size and progression of your business. PnS Med Health will support and guide your personal roadmap towards compliance.
Which package is right for me?
| Feature Area | Self-Starter | Guided Set-Up | Fully Supported |
| ISO 13485 SOPs | ✔ Editable templates | ✔ Editable templates | ✔ Customized to business |
| Forms / Records templates | ✔ Included | ✔ Included | ✔ Included |
| Quality Policy and Objectives template | ✔ Included | ✔ Included | ✔ Included |
| Risk management templates | ✔ Included | ✔ Included | ✔ Included |
| Design and development templates | ✔ Included | ✔ Included | ✔ Included |
| Document Management and Control | DIY | assisted | Fully Implemented |
| Supplier / Purchasing Controls | templates | Review and support | Supplier Evaluation Included |
| Training on ISO 13485 Requirements | – | ✔ Group / online sessions | ✔ Dedicated Support |
| QMS Implementation Support | – | Scheduled check-ins | On-going support |
| Internal audits | DIY | optional | Conducted by us |
| Management Review | |||
| PMS | templates only | guidance | active support |
| Vigilance | – | – | |
| External Gap Analysis with Report | – | – | Included |
| Certification Readiness Review | – | – | Included |
PNS MED HEALTH 