This document provides the the process for Product / Service Realization.
This document covers the procedure for the practices that must be followed for compliance of ISO13485
(Version at end of page)
Signed V15 ML 15.10.2024
The process covers all documents and process and products as defined in the SOP
This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, (“POPI”), the Company POPI Policy, PAIA Manual. And processing of personal information envisaged under this Policy must be done in accordance with the aforementioned
Approval: Author of the document, Monica Lucas
Changes: General Manager
Product/ Service realization - Enabling the service process or workflow to be realized through quality assurance, quality control and following a documented and recorded quality management system
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action
SOP – Standard Operating Procedure
ISO13485 Clause 7.5
SOP Non-Conformance, Deviations and Concessions & Corrective Action
The organization plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system and one or more processes for risk management in product realization may be documented within the SOP or separately
Process
Supplier Principal Stock Receipt
Sales Order Processing (through sage refer SOP point 4)
Financial Transactions / Administration (no specific SOP)
In planning product realization, the organization the following is determined, as appropriate and documented below:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents and to provide resources specific to the product, including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
The output of this planning is documented within the google site for the organization’s method of operations.
Located in Operational Procedures TAB
refer SOP 7.2 Customer-related processes;
7.2.1 Determination of requirements related to product &
7.2.2 Review of requirements related to Product
refer SOP 7.2.3 Communication
7.3 Design and development - NOT APPLICABLE
7.4 Purchasing / External Providers
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities - NOT APPLICABLE
7.5.4 Servicing activities - NOT APPLICABLE
7.5.5 Particular requirements for sterile medical devices - NOT APPLICABLE
7.5.6 Validation of processes for production and service provision - NOT APPLICABLE
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems - NOT APPLICABLE
refer to SOP 7.5.8 Identification,
7.5.11 Preservation of product,
refer SOP 7.6 Control of monitoring and measuring equipment
In the event of and non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action is followed
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 internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis 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 15; 05.10.2024 - CR - Removed Repairs of Instruments 8.1.1 - Checked and Digitally Signed by ML
Revision 14; 19.06.2024 - PM - Added Repairs of Instruments to 8.1.1 and added hyperlink
Revision 13; 20.11.2023 - ML - Checked and Confirmed. Digitally signed by ML
Revision 12; 25.10.2023 - SCR - Correction of NOT APPLICABLES
Revision 11; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 10; 02.08.2021 - ML - POPI information included. Digitally signed by ML
Revision 9; 10.05.2021 - ML - Digitally signed by ML
Revision 8, 04.05.2021 - TNA - New format with Approval / Scope /Responsibilities, Risk based approach and Records and revision history added and new googlesite format. Amending links and Forms
Revision 7, Digitally signed on 02.11.2020 by ML
Revision 1-6, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Refer relevant SOP or work instruction Google Site indefinite n/a