Audits

About

Camneteq can perform both internal audits and supplier audits for medtech organizations by aligning its methodology with the principles and guidance of ISO 19011:2018 (Guidelines for auditing management systems). We can also assist your company during inspections or audits from authorities and third parties.

Examples

Camneteq can support internal audits for standards like ISO 13485, MDR, and related QMS requirements.

2Audit Planning

We follow your audit programme but can also suggest changes improvements based on the need in your organization:

- Regulatory requirements (e.g. EU MDR, FDA 21 CFR 820)
- Process criticality (e.g. design controls, CAPA, risk management)
- Previous audit results and nonconformities

Audit Preparation

Review:

- Quality manuals and procedures
- Previous audit findings
- KPIs (objectives, complaints, deviations, CAPA trends)

Prepare audit checklists based on your templates or tailored to medtech processes:

- Design & Development
- Supplier Management
- Production & Validation
- Post-market surveillance

Conducting the Audit, following your procedures and with a risk based approach

Audit Reporting

Classify findings:
Ensure:

- Objective evidence is documented
- Clear linkage to requirements

Supplier Audits

Supplier audits: outsourced processes and critical suppliers.

Audit Planning

On-site or Remote

Audit Execution

Evaluate supplier’s:

- QMS implementation
- Process validation
- Traceability systems
- Change control procedures
- Complaint handling

Assess:

- Compliance with contractual and regulatory requirements
- Sub-supplier controls

Reporting and Decision-Making

Following the audit, Camneteq provides a clear and structured audit report documenting findings, objective evidence and relevant observations. Audit results are linked to applicable regulatory and quality requirements, enabling informed decision-making and effective follow-up activities.

We also support management teams in evaluating findings, prioritizing corrective actions and making decisions related to supplier qualification, process improvements and ongoing compliance activities.

Competence and Auditor Qualification

Camneteq ensures auditors meet ISO 19011 competence requirements:

Knowledge of:

- ISO 13485 and medtech regulations
- Risk management (ISO 14971)
- Auditing techniques

Skills:

- Interviewing
- Evidence evaluation
- Report writing

Experience:

- Medtech industry processes

Telephone

+46 705 61 25 88

Email

tomas.camnell@camneteq.se

Address

S:t Göransgatan 13, 621 55 Visby, Sweden