This document provides the process for establishing competence, proving awareness and communication and defines the provision of adequate resources, recruitment, performance management and training and provision of Production and Service facilities.
(Version at end of page)
Signed V40; 14.10.2024 ML
The process covers requirements for staff and interested parties that impact the QMS and regulatory requirements
Approval: Author of the document, Monica Lucas
Changes: Human Resources Management
Training - Organized activity aimed at imparting information and/or instructions to improve the recipient's performance or to help him or her attain a required level of knowledge or skill.
Competence- The quality of being competent or capable of performing an allotted function. The quality or condition of being legally qualified to perform an act. The mental ability to distinguish right from wrong and to manage one's own affairs.
Communication - the act or process of using words, sounds, signs, or behaviors to express or exchange information or to express your ideas, thoughts, feelings, etc., to someone else. human communication. nonverbal communication
Interested parties - this could be contractors, community workers, customers
Internal Training - Training done in house e.g. SOPs
KPI - Key Performance Indicators
NCCA - Non Conformance Corrective Action
QMS - Quality Management System
SOP - Standard Operating procedure
n/a - not applicable
HR - Human Resources
ISO13485 clauses 6.1, 6.2, 5.5.3
The resource requirements are reviewed in the management review.
Job functions and roles are defined under responsibility and within the procedures of SOP’s (Standard Operating Procedures) and in the letters of appointment – refer Letter of Appointment
ALL staff can refer to FORMS, POLICIES & OTHER PROCESSES with a TAB HR POLICIES and HR FORMS.
Management recruit suitable staff as required for the roles to be performed and KPI's are established and agreed.
Management are responsible for ensuring that the training needs of their employees are identified and actioned as per SKILLS DEVELOPMENT PLAN, or any other training identified during performance appraisals.
On-the-job training is to be supplied by Managers and training records are kept in the Electronic Training Record or Training file.
The Organization
determines the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
ensures that these persons are competent on the basis of appropriate education, training, skills or experience;
where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
retains appropriate documented information as evidence of competence with;
progress of all training and development recorded and competence determined – refer Training Record or Training file.
3. ensures employee competence is achieved through step-by-step training workflow process
i. An INDUCTION is followed on the HR Policies, on their role on the quality and safety of is provided to newly recruited personnel. The ACKNOWLEDGEMENT PROCESS can be used to verify the activity.
ii. Training appropriate to the duties assigned to employees is identified and provided by the Manager to make sure new employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
iii. The concept of Quality Assurance and measures put in place to ensure an understanding and implementation mechanisms provided by the relevant Manager in consultation with management representatives assigned to maintain the system.
iv. Training could be conducted through the use of consultants or service providers as experts in the specified area.
v. Visitors or untrained personnel are escorted by trained employees where appropriate, the prescribed protective clothing requirements are ensured by following the standard Operating Procedures, where applicable.
vi Temporary staff included in the same process.
a) Training is planned and recorded in the SKILLS DEVELOPMENT PLAN.
b) Policies and other relevant training is completed by making use of documents such as Training Record/Attendance Register. For policies the ACKNOWLEDGEMENT PROCESS is used for record keeping purposes.
c) Types of TRAINING:
If in-house training then a TRAINING RECORD is completed and concluded.
If off-site training then certificates or proof of payment is provided as evidence of training.
The process to acknowledge understanding and implementation:
Save or Move Word or pdf into HR POLICIES in Google DRIVE.
If Word, go to > “Open with” > open in Google Docs. OR If PDF, go to > open with Google docs.
Go to "More Actions" (top right hand corner). > Click "Share" > Insert an email address (either in the address book or enter the email address). The attachment will be already on the email template.
Add in “Message” and paste the Google link to FORM – refer point (5).
To get the Google “FORM” in the HR POLICIES in the google DRIVE, click and open the ‘Form’ if not in PREVIEW then click Preview (picture of an eye) top right hand corner or go to the ‘HR POLICIES in the google DRIVE and open / click on the Response “Sheet” then go to> “live form”
Highlight and copy the http// at top of the form in Google and paste into “Message” block after your message e.g. please read the attachment and if understood please complete the form herewith – if you do not understand then call me and once we are complete you can complete the form, kind regards …
Close all Google tabs. Complete.,
A list of acknowledgements will be populated in the Google ‘Sheet’ ACKNOWLEDGEMENT PROCESS in the google DRIVE.
Records of training are found in TRAINING FILE or ELECTRONIC RECORD.
Some training records are an ATTENDANCE REGISTER which is scanned and filed in a Training file.
An option is also to keep a copy of PROOF OF PAYMENT and/or invoice, where applicable
Training Records can be saved as a pdf or filed in Personnel file
REFER to Google Drive TRAINING
Type of assessment (as determined by the Manager dependent on the significance of the Training in regards to the effect on the QMS)
Assessment methods such as test (Te) - oral or written, on-the-Job observation (Otj) to determine competence.
For a written or oral test, a pass mark is set at not below 80%, if not achieved, the rewrite/retraining is done until the required pass mark is achieved.
A record for the above assessment is recorded into a Competency Assessment form, Certificate (Ce), Attendance Register.
Where the result indicates not yet competent, the above process is repeated or retraining is done until a required result of competency is achieved.
Persons doing work under the organization’s control are aware of the following from awareness induction:
the quality policy and relevant quality objectives;
their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
the implications of not conforming with the quality management system requirements.
The organization determines the internal and external communications relevant to the quality management system through SOP Internal & External Communication
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
The analytical reviews of supplier performance, and any other quality related matters, are reported to management and as part of the Data Analysis input to management review
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 41, 25/06/2025-FN- Skills Development links updated under 8.2 & 8.4.1 to the new 2025/2026 Skill development Plan.
Revision 40, 11/04/2024 HJM - 8.1 - Correction of clause from 7.1.2 to 6.2 Human Resources -14.10.2024 Digitally Checked and Signed. ML
Revision 39; 23.11.2023 - FN - Added electronic training record link, updated training record (responses), updated employee training process, made changes on 8.4 ii, iv, 8.4.1 b, c
Revision 38; 31.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 37; 10.10.2021 - ML - Digitally signed by ML
Revision 36; 07.10.2021 - TNA - amendment to link
Revision 35; 10.05.2021 - ML - Digitally signed by ML
Revision 34; 21.04.2021 - TNA - New format with Approval / Responsibilities / Scope / Revision History. Changes to Risk Based Approach. Updating links and forms.
Revision 33; Digitally signed 10.11.2020 by ML
Revision 1-32; unknown due to Google Site change to new Google site
Name Retained by/ in Retention period Hard copies Destroyed by
Training Records in Training Files HR 5 years past leaving HR
refer Google Drive Google DRIVE indefinite n/a