This document provides the written procedure to describe the actions, approval and information required in the event of a proposed change. The purpose of the procedure is to ensure that all aspects of the Quality System and regulatory consequences of the system, infrastructure, environment, procedures and/or regulatory requirements are considered and addressed in the event of a change in compliance of ISO 13485.
(Version at end of page)
Signed V11 RB 15.07.2024
The process covers all quality management system, processes, activities, products and regulatory requirements.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Dean Kowalski
Change Control - A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.
SOP – Standard Operating Procedure
QMS – Quality Management System
Change Management (ISO 13485 Clause 5.4.2)
This process is used a change that affects the quality management system and/ or products safety and performance and/ of regulatory compliance; and not limited to:
A Product by the Supplier,
A Product by the Organisation
Material or Process related to the QMS,
Organisation or Staff,
The Improvement or Correction of the QMS,
Infrastructure/ Environment,
Any Other Change.
Information and activities are detailed on the form to ensure that sufficient supporting data is generated to demonstrate that the revised situation will result in a product or system of the desired quality and product safety, consistent with the approved regulatory requirements.
The likely impact of the change of facilities, process, systems and equipment or Infrastructure/ Environment on the product/ QMS should be evaluated, including product and/or quality risk analysis/ assessment.
To initiate a change fill in a Change Request Form, and attach a risk assessment that has been completed using the template in the file section at the bottom of the page
The contents of the form populate the Change Control Register.
Approval consists of the QMS administrator reviewing the change request, checking "reviewed" and formulating an action plan on the QMS Trello Board which is then used to conduct follow-up.
The relevant Manager goes to the Change Control Register.
The Administrator periodically reviews ACTION plans follow up and emails parties as required.
If required, the Administrator Generates a Corrective Action from Non-Conformance Corrective Action.
The Administrator INPUTS the DATE of closure input by NAME of relevant authority.
Change control is the act of reviewing a proposed change, change management refers to the entire implementation and handling of that change.
There are numerous elements that make up a well-functioning change management system: documented processes, clear communication and coordination, traceability, and accountability.
Each element of the change management process should work in tandem to provide full visibility of all related activities for the quality team, product managers, and executive level stakeholders.
Complete oversight allows the business to function properly to accurately scope the project details, address the changes in a timely manner, and manage the changes effectively and accordingly.
Change management refers to the way a company manages modifications to products and processes within their medical device business.
A change can be triggered throughout the lifecycle of a product or organisations, including:
1. New or modified products, as well as any subsequent change to those products.
2. New or modified processes for how you conduct business.
3. New or modified Documents, such as FORMS, technical documentation, regulatory documentation etc.
New products, processes, or relevant Documents require change management practices. A change can involve:
• Modifications to records and procedures in your design controls, production, distribution, marketing or sales, or your device master record (DMR).
• Need for additional verification, validation on a device.
• Changing external providers, suppliers, or regulatory bodies.
When a trigger for change occurs, the person responsible for the proposed change must first document it, then make a proposal for change to the quality team. Change control is the practice of reviewing those proposed changes and determining the appropriate next steps for either creating a plan to implement the change or denying the change request entirely.
To implement any change, you will need to do the following, refer Change Request Form:
• Describe the change you’re making.
• Justify the reason for the change.
• Identify what business outcomes will be affected.
• Identify the people who need to be involved to assess and implement the change.
Every step in effectively managing change begins and ends with communication. To make sure the change is managed efficiently and accounts for both stakeholder and compliance impact, facilitate clear communication between internal and external stakeholders being impacted by the change.
There are numerous types of events that can be classified as triggers for change, but the most common ones include:
• Product changes: e.g. substitute materials, updating process documents, or adding a new or altered feature to your device.
• Updated regulations or standards which may require product and/ or process, infrastructure, organisational structure alteration.
• Control document changes, which are required to meet regulatory best practices and requirements, as well as the requirements of the QMS.
1. Describe the change and define the reason for the change, cite the benefits.
2. Identify the business outcome, involving people from multiple departments putting experience, skill and knowledge together to hypothesize the possible outcomes.
3. Identify the people who need to be involved.
4. Assessment criteria for consideration in the change management process:
A. Scope: The scope of a change to determine how much time and money required. Select individuals that should be included in discussions and determine “big” or “small” change to set foundation for management activities and regulatory strategy, if required.
B. Description: Communication aspect of change management to avoid ambiguity in describing procedures, processes, and product specifications. Define proposed change and identify any internal procedures or documents to be altered.
C. Justification: To explain, internally and externally, reasons for making a change to demonstrate the necessity and value to the company, employees and customers at the product lifecycle stage. Ensure referencing by the team for potential review by regulators and ensure that the justification is unambiguous and to the point and includes supporting objective evidence.
D. Impact: The impact of a change could touch one or multiple areas. E.g. biocompatibility testing, review existing manufacturing specifications, reconsider the standard operating procedures for manufacturing, reassess the design in relation to the change. Map out the impact in advance to allow carefully plan of the change.
E. Risk: Determine whether or not follow-up activities are necessary to assess the risk of the change. Risk assessment may be necessary to evaluate the hazardous situations that the change could pose.
F. Regulatory: Changes may require regulatory submissions and determine whether or not the change will require a submission to the regulator, communication with a notified body, or the equivalent methods in other target markets.
Products undergo design changes for various reasons. Anytime a regulation is updated, standards shift, or your device goes through a redesign, you need to update your procedures and work instructions as well as train employees on whatever was updated.
No matter the reason for the change, product design changes—which take place in both pre-market and post-market—require nuanced change management and change control to keep things running smoothly and avoid costly mistakes.
Pre-market changes often occur during design or development for a number of reasons: innovations made to an existing device, a material supplier changes, updates to regulations or standards go into effect, and so on.
No matter the reason for the change, you will need to update TECHNICAL DOCUMENTATION.
Post-market product design changes occur once the device is distributed into the marketplace. End users will provide customer feedback on your device, resulting in opportunities for change with improvements or cost-saving modifications.
Much like pre-market design changes, post-market design changes must undergo a similar proposal, review and approval process. One major difference being that post-market changes require additional consideration by necessary stakeholders beyond the design review process. As a general rule of thumb, form, fit, and function should be considered when making any post-market changes.
Form, Fit, and Function (FFF)
FFF refers to the identifying characteristics of the parts or components of your device:
• Form refers to the shape, size, dimensions, and other visual or physical parameters of components.
• Fit describes the way a part physically connects to or interacts with another part of your device.
• Function refers to the action that an individual part is designed to perform
A Risk based approach for any changes should be considered and the following used as a guideline
The need for, and the extent of, re-qualification and re-validation should be determined
The need for, and the extent of, notification to the customer and/ or regulatory authority is determines and actioned. The regulatory route is determined through contact with the regulatory body or ministry of Health, any published regulations or website notice.
In the event of non-compliance follow SOP Non-Conformance Corrective Action.
The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.
The analytical reviews of internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the 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 11; 15.07.2024 - RB - Change over to SharePoint Site
Revision 10; 14.10.2021 - MR Updated & Corrected audit findings
Revision 9, 05.08.2021 - MR - Website reviewed
Revision 8; 22.06.2021 - TNA - updating forms and links
Revision 7; 18.11.2019 by WJW
Revision 1-6; unknown due to google site classic change to google site new format
Name Retained in Retention period Hard copies Destroyed by
Change Request Form Microsoft Forms indefinite N/A
Change Control Register SharePoint indefinite N/A