This procedure outlines the requirements for control of measuring and monitoring equipment.
(Version at end of page)
Signed V4 RB 15.07.2024
This Standard of Procedure applies to all equipment used in the manufacture of Medical Devices, including but not limited to production equipment, test equipment, and measure equipment.
Approval: Author of the Document, Marelize Robertson
Changes: Author of the Document, Rachel Belcher
SOP – Standard Operating Procedure
QMS – Quality Management System
7.1. ISO 9001: 2008 Requirement 7.5.1.
7.2. ISO 13485 Clause 7.6. (Monitoring and measuring equipment)
7.2. Product and Service Realisation
7.3. Control of Documents
7.4. Control of Records
7.5. Internal Audit
7.6. Control of Non-Conforming Product
7.7. All Related Work Instructions
Equipment Calibration: Equipment is calibrated according to manufacturing specifications or applicable industry standards. Calibration should only be performed by trained personnel using calibrated equipment.
Equipment Maintenance: Equipment is maintained according to manufacturer specifications or applicable industry standards. Maintenance is only performed by trained personnel using the appropriate equipment.
Equipment Repair: Repairs is done by qualified personnel using the appropriate equipment and procedures. All repairs is documented, and the equipment is re-calibrated and re-validated as necessary.
Equipment Validation: All new equipment is validated before use. The validation includes an evaluation of equipment performance and a review of calibration and maintenance records. The validation is documented.
Monitoring of Equipment: Equipment is monitored regularly to ensure its functioning properly. Monitoring can include, but is not limited to visual inspection, functional checks, and review of calibration and maintenance records.
Equipment Identification: Refer to equipment serial number or unique identification number. Refer to the Monitoring and Measuring Equipment List.
Non-Conforming Equipment: Non-conforming equipment is identified, segregated and dispositioned according to established procedures. Disposition may include repair, calibration or removal from service.
Equipment used in production will be serviced and calibrated as indicated by standards available and recorded.
8.1.1. All Production Service Records can be found on the Production cloud drive under service level agreements.
8.1.2. The Trello "Renewal" Board will be used to remind the Office Coordinator to schedule all the necessary services and assist with indicating the calibration / service status such as the next due date.
8.1.3. Should equipment or certain tests be done that does not comply with the required specifications it shall be booked in for repairs or retesting can be done, depending on the nature of the deviation.
8.1.4. To ensure that equipment is protected from damage during the handling and maintenance only competent employees may use them and with regards to services make use of accredited providers. No other person will be allowed to service the machine for example the Technician onsite may not service the machine as it does not fall within his scope of practice.
8.1.5. SOP0042P - Production Asset Management is available on the Production cloud drive to assist with performing calibration in accordance with the documented procedure available.
8.1.6. Should measuring results not conform a non-conformance should be logged via the NCCA procedure - The Production QA and RA Manager is responsible for recording any critical measures during the Production phase
8.2.1. The production works orders are available in the production office (no electronic copies available)
8.3.1. Use of suitable equipment
8.3.1.1. All the equipment (Software and hardware) is maintained according to office rules
8.3.1.2. Availability of monitoring and measuring equipment such as the ''Keller". A reminder of the measuring equipment for Technical is also available on the Trello "Renewal" board
8.3.1.3. All devices used during testing and installation as per the Standard Operating Procedures available on the Technical cloud folder.
8.3.1.1. SOP0120 - Installation
8.3.1.2. SOP0126 - Device asset management
8.3.1.3. SOP0129 - Annual Service
8.3.1.4. SOP0131 - Pre-delivery inspection
8.3.1.5. SOP0132 - Routine service
8.3.1.6. SOP0133 - Service Planning
8.3.1.7. SOP0135 - Repairs
Surgical platforms installation documentation can be found on the cloud drive within the Technical Department
8.4.1. The Production QA and RA Manager is responsible for checking feedback reports
8.4.2. The Office Coordinator is responsible for proper documentation, scheduling and making sure services for production are being carried out on time (Maintain the equipment list and equipment files).
8.4.3. The Technical Service Manager is responsible for the surgical platforms.
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.
Revision 4; 15.07.2024 - RB - Change over to SharePoint Site
Revision 3; 2023.03.07-MR - 2023.03.07 - DK - Updated Purpose, 3. Scope updated, 7. Heading Updated, 8. Procedure updated,
Revision 2; Populate SOP from the frame provided
Revision 1; new 19.10.2021
Records are maintained for equipment calibration, maintenance, repair, validation, monitoring, and non-conformance. Records are retained in accordance with established procedures.
9.1. Non-conformance register
9.2. Input into the Management review meetings
9.3. Analysis of these records also serves as input for Preventative and Corrective action
9.4. Monitoring and Measuring Equipment List.