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Updated June 12, 2021

Template: SOP Human Resources Administration

Sven Piechottka
ISO 13485

This is a free template, provided by OpenRegulatory.

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Related Records

The following templates are records of this template. That means that this document mentions them somewhere and you need to fill them out to actually implement whatever this document proposes.
Beginning of template
Regulatory Requirement Document Section
ISO 13485:2016, sections 6.2 and 7.1 All

Summary

This SOP provides instructions for the management of personnel in the organization.

It covers the onboarding and offboarding of employees, initial and continuous employee training, and feedback processes between supervisors and team members. Thereby, this process shall ensure that the organization retains sufficient qualified and motivated staff.

NOTE: As your organization grows, the following updates to this process can be considered:

  • Job descriptions are formulated as part of a general template and respective records instead of sections in the quality manual.
  • Team compositions and hierarchies are outlined as part of an organizational chart instead of a table section in the quality manual.
  • Design of a competency matrix assigning each role its required training.

General Considerations

1.1 Role Description and Role Assignment

Each employee of the organization is assigned a specific job role for which respective tasks and responsibilities as well as the required qualifications are outlined as part of the quality manual. Team leaders / supervisors are responsible to ensure that the employees working in their team are trained and qualified for the tasks assigned to them. Employee qualification is reviewed against predetermined requirements every time before an employee assumes a new task or role.

The QMO, together with an HR Manager, determines the training and qualification requirements per individual role that are outlined in the quality manual.

1.2 HR File

The organization keeps certain records on every employee, which combined make up the employee’s HR File. These include:

NOTE: such files are subject to stricter data protection requirements and should be made available to external parties (e.g. auditors, authorities) only upon request. You may want to add instructions on how the files should be protected (for example: access limited to HR staff only).

1.3 Training

Training Provision and Documentation

Training may take different forms as deemed most suitable by the instructing employee. Training methods may entail:

The QMO should be involved anytime alternative training methods are chosen, in order to ensure appropriate training evaluation is guaranteed.

Completed training is documented as part of the organization’s training documentation. For external seminars, respective training records (e.g. certificates) are saved as part of the HR file (see 1.2.) of each employee and should include at minimum: employee name, training method and content, date and signature of instructor.

NOTE: in a larger organization, consider creating a template for a training form that employees can use to document their training.

Completed training is evaluated to ensure effectiveness of training and that employees are qualified to perform their job. For effectiveness evaluation, different methods can be used:

Effectiveness is typically confirmed by the supervisor after completion of training and also documented by the QMO.

NOTE: some collaboration tools like Google Workspace allow you to set up questionnaires through which you can test and document(!) your colleague’s self-study success quite easily.

Role-Specific Training

Training needs may arise from specific roles within the organization:

Person Responsible for Regulatory Compliance (PRRC)

Before assuming his/her role, the PRRC is instructed by the QMO on the tasks and responsibilities of this role according to Art. 15 of the Medical Device Regulation. Specifically, the QMO checks if the candidate’s qualification meets all the requirements.

Medical Device Consultants

Employees speaking to a professional community or instructing on the handling of the organization’s medical devices may be subject to Chapter 6 and §83 of the German MPDG. They must receive training on their tasks and responsibilities and regulatory requirements according to the law as well as product-specific training that should be repeated regularly or based on substantial product changes. The QMO is responsible to keep a list of the organization’s trained medical device consultants including the date of their latest training.

Process Steps

NOTE: depending on your current processes in place, feel free to add provisions for:

  • The recruitment of employees (for example: are you using software tools like BambooHR or Personio for the application process? How do you document hiring decisions? What kind of data protection requirements, like data deletion periods, must be met?)
  • Onboarding checklists for HR staff / new employees (including, for example: onboarding meetings a new hire should complete with relevant coworkers, social insurance registration that HR managers must complete for new employees)

2.1 Onboarding of New Employees

Upon a signed employment contract and before the start date for a new employment, the HR manager is responsible to perform administrative onboarding for the new employee, including:

Upon the first day, the direct supervisor or team leader is responsible to ensure that the new employee receives and completes initial training. QMO is responsible for determining required QMS training. Completed training is documented as part of PTR-LIS-TDC. Initial training must be completed within the first week.

   
Participants New employee
HR Manager
Team Lead / Supervisor
QMO
Input Signed employment contract
Output Completed onboarding process

2.2 Continuous Training

Besides initial onboarding, new training need may arise from one of the following:

   
Participants QMO
Employee
Team Lead / Supervisor
Input Additional training need
Output Updated training documentation

2.3 Employee Development

At minimum once per year, supervisors schedule meetings with their employees to exchange feedback, to discuss the employee’s personal development and also to identify additional training needs required to reach development goals.

   
Participants Employee
Team Lead / Supervisor
Input Development interview due
Output Interview records (e.g. protocol)

2.4 Offboarding of Employees

Upon notification that an employment contract is terminated, the HR Manager is responsible to perform administrative offboarding. This includes:

   
Participants HR Manager
Input Termination of employment
Output Removal of access rights
Updated documentation: deleted data

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Please don’t remove this notice even if you’ve modified contents of this template.

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