Compass Health SOP: Competence and Training

Study Notes

Document: This document is a Standard Operating Procedure (SOP) for Competence and Training at Compass Health.
Date of Issue: 02 January 2024
Version: 1.0
Document Number: QMS-SOP-0005
Authors: Tenzin Yangzom, Head of QA/RA, and James Baskin, COO
Scope: Applies to all training programs for Compass Health personnel, whether regular, full-time, or part-time.
Purpose: The SOP outlines processes and responsibilities for identifying employee training needs, providing required training, assessing competence, and maintaining training records.
Quality Objectives: Employee training is linked to quality objectives.

Standards: ISO 13485:2016 Section 6.2 Human Resources and TG(MD)R Sch3 P1 1.4(5)(b).
Training Record Form: QMS-FRM-0011

Functional Managers: Determine additional training needs for employees and ensure training completion.
QA/RA: Verify compliance with training procedures.
New Employees: Participate in QMS orientation to understand quality policies and objectives.
Current Employees: Ensure they have the training to perform their tasks effectively.

Hiring Process: Evaluates employee qualifications, experience, and competency.
Documentation: Maintains records in the employee's personnel file.
Job Description: Contracts are signed to acknowledge job responsibilities, including those affecting quality.
QMS Orientation: All new employees must complete QMS orientation training which includes the company's quality policies.

Training Matrix: QMS-LOG-0006 outlines mandatory QMS training and job-specific training for employees.
Maintenance: Training Matrix is regularly updated for changes to QMS processes, organization, and materials used.
Functional Manager Responsibility: Determines necessary training for team members.
Training Completion: All training must be completed within the specified timeframe.

Evaluation: Training effectiveness is evaluated at least every 18 months during performance reviews.
Ongoing Evaluation: Evaluated through different methods including written assessments, internal audits, etc..
Retraining: Employees may need retraining for revised procedures or policies. Retraining is the responsibility of the functional manager.

Necessary Changes: Retraining is required when QMS/policy procedures change.
Documentation: Retraining is documented in the SOP Impact Assessments Log.

Training Requirements: QA-RA or HR personnel ensures all employees meet minimum training requirements.
Personnel Files: Documents the training records and ensures sign-off and recording.
Quarterly Report: A quarterly training report highlights the completed training.

Training Records: Include internal forms (QMS-FRM-0011) and external course completion documentation.
Training Matrix: Outlines training requirements for specific job roles.
Waivers: There can be waivers if a manager determines that an employee already has the needed competencies.