Background

A manufacturer developing healthcare products planned to expand their existing team for designing, manufacturing, and marketing and sought to register their products in the markets worldwide. However, they were concerned about the description of job requirements, the candidate shortlisting process, the training process to be followed after the onboarding of employees, and maintaining respective training records. Further, the manufacturer sought Elexes’s support in establishing a hiring and training process for their organization in line with the requirements of Clause 6 of ISO 13485:2016, Clause 7 of ISO 9001:2015, Clause 3 of ISO 22716:2007(EN) or other standards as applicable.

Problem Statement

To establish a hiring and training procedure at the manufacturer’s organization in line with the regulatory requirements.

Approach and Solutions

1. Development of a Training SOP 

Elexes’s QMS team drafted a Training SOP in line with the requirements of applicable ISO standards which majorly covered the following:

2. Establishing the competence requirements

• The hiring requirements were drafted in a Form template for the Job Description which covered the education and experience required for the specific job role
• The objective evidence for fulfilling the job requirements stated in the job description records i.e. CVs of employees, experience certificates, and educational degrees were collected and maintained
• The position or job-specific training requirements were listed in a competency matrix. The matrix outlining a few skill sets required for the respective job titles is depicted below

• The training on Quality Procedures established within the organization was listed in a training matrix. The training matrix outlining the procedures and some key personnel who need to be trained on those procedures is depicted below

3. Determining the Training Requirements and conducting trainings

• The training requirements for each employee were listed in the training matrix and competency matrix.
• The training was conducted for all the employees through the following methods based on the criticality of the work performed by the employee
  • Self-reading of Quality Procedures
  • On-the-job training (e.g. product servicing)
  • External training (certification)

4. Evaluating the effectiveness of training

• The following methods were established for evaluating the effectiveness of trainings undergone by the employees:
  • Tests or Quizzes
  • Internal Audits/External Audits
  • Customer feedback on products or services provided

5. Documentation of Training Records

• Once the training was completed and the effectiveness of the training was verified, the training record was officially signed by the trainer and trainee respectively and records of training were maintained.

Key Takeaways

Establishing a procedure for the training of employees is a mandatory requirement according to Clause 6 of ISO 13485:2016, ISO 9001:2015, and Clause 3 of ISO 22716:2007(EN) (whichever is applicable). This helps the manufacturer hire the most suitable and qualified talent for a specific job role and regularly trains the employees.

Are you looking to set up a procedure for hiring and training for your emerging healthcare organization?

Look no further, Elexes is here to help you. Our dedicated team of Quality professionals with years of experience is ready to support healthcare companies throughout the hiring and training process. If you have any questions, please email us at jennifer@elexes.com.