| Regulatory Requirement | Document Section |
|---|---|
| ISO 13485:2016, Sections 6.2 and 7.1 | Entire Document |
Overview
This SOP outlines procedures for managing personnel within the organization.
It details processes for onboarding and offboarding employees, conducting initial and ongoing training, and facilitating feedback between supervisors and team members. These measures aim to ensure the organization maintains a workforce that is qualified, motivated, and sufficient to meet its goals.
Note: As the organization grows, consider the following process enhancements:
- Create standardized job descriptions as templates and maintain records outside the quality manual.
- Include organizational charts to outline team compositions and reporting hierarchies.
- Develop a competency matrix that maps required training to specific roles.
| Process Owner | \ |
| Key Performance Indicators | \ |
Key Considerations
1.1 Role Definition and Assignment
Every employee is assigned a defined role within the organization, including specific tasks, responsibilities, and required qualifications documented in the quality manual. Supervisors are responsible for ensuring that their team members are adequately trained and qualified for their assigned tasks. Employee qualifications are reviewed against pre-established requirements before they take on a new role or task.
The Quality Management Officer (QMO), in collaboration with the HR Manager, defines the required qualifications and training for each role as outlined in the quality manual.
1.2 HR Files
Each employee’s HR file contains essential records, including:
- Employment contract and related agreements
- Health insurance documentation
- Identification records (e.g., passport copy)
- Payroll documents
- Proof of qualifications (where applicable)
Note: HR files are subject to strict data protection regulations. Access should be restricted to HR personnel and only shared with external parties (e.g., auditors, authorities) upon request. Include specific instructions for securing these files.
1.3 Employee Training
Training Provision and Documentation
The primary objective of employee training is to ensure staff competence in their roles and awareness of how their work contributes to the organization’s quality objectives (ISO 13485, Section 6.2). Training methods may include:
- Internal or external workshops
- Media and self-study materials (e.g., videos, documentation)
- Supervised on-the-job training
The QMO should review and approve any alternative training methods to ensure proper evaluation. All completed training is documented. For external training sessions, certificates or related documents are stored in the employee’s HR file. Training records must include at least the employee’s name, training content, method, date, and instructor signature.
Tip: For larger organizations, consider creating a standard training form template to streamline documentation.
Evaluating Training Effectiveness
Training effectiveness is assessed to confirm employees are equipped for their roles. Evaluation methods may include:
- Tests or questionnaires
- Job performance monitoring
- External certification
When no formal evaluation is part of the training, the supervisor confirms effectiveness post-training, with documentation added to the organization’s training records.
Role-Specific Training
Some roles may require tailored training:
- Person Responsible for Regulatory Compliance (PRRC): Before assuming the role, candidates receive QMO-led training on their tasks and responsibilities, ensuring compliance with Article 15 of the MDR.
- Medical Device Consultants: Employees engaging with professional communities or providing product training must comply with Chapter 6 and §83 of the German MPDG. This includes task-specific and product training, updated regularly or when significant product changes occur. The QMO maintains records of trained consultants and their most recent training dates.
Process Steps
2.1 Onboarding New Employees
Before a new hire begins, the HR Manager performs administrative onboarding tasks, including:
- Creating the employee’s HR file
- Completing health and social insurance documentation
- Setting up payroll
- Ordering necessary hardware (e.g., laptop, phone)
- Configuring access to relevant software tools (granted only after contract signing)
On the employee’s first day, the supervisor ensures they complete initial training, as determined by the QMO. All initial training must be completed and documented within the first week.
| Participants | New Employee HR Manager Team Leader QMO |
| Input | Signed employment contract |
| Output | Completed onboarding process |
2.2 Continuous Training
New training needs may arise due to:
- Annual requirements set by the QMO
- Role changes necessitating specific training
- CAPAs identifying training gaps as root causes of nonconformities
- Regulatory or organizational updates requiring further training
| Participants | Employee Team Leader QMO |
| Input | Identified training need |
| Output | Updated training documentation |
2.3 Employee Development
Supervisors conduct annual feedback meetings with employees to discuss performance, career development, and additional training needs.
| Participants | Employee Supervisor |
| Input | Development discussion due |
| Output | Feedback and development records |
2.4 Offboarding Employees
When an employee exits, the HR Manager ensures a smooth offboarding process, including:
- Revoking software and premises access promptly
- Adhering to data deletion schedules:
- Payroll data: Retain for 10 years (§257 HGB).
- Administrative data: Retain for 3 years (§195 BGB).
- Email account: Suspend and delete after 60 days.
- Personal data: Delete immediately unless otherwise required.
- Informing third-party processors of data deletion.
| Participants | HR Manager |
| Input | Employment termination notice |
| Output | Access rights removed, data deleted per regulations |