SERVICE PROVISION OPERATION
1. Purpose
This document provides the process for Product / Service Realization.
This document covers the procedure for the practices that must be followed for compliance of ISO13485
2. Approval
(Version at end of page)
Signed V9 AA 24.08.2021
3. Scope
The process covers all documents and process and products as defined in the SOP
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis
Changes: Author of the document, Alexi Arhondonis
5. Definitions
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
Rework - the action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging / labelling / out of specification) mainly in regards to disposable products
Repair - is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again
Maintenance - this is required for preserving the condition of an item (infrastructure, machinery, products)
Refurbishment - the process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors)
6. Abbreviations
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action
SOP – Standard Operating Procedure
7. References
ISO13485 Clause 7.5
SOP Non-Conformance, Deviations and Concessions & Corrective Action
8. Procedure
8.1.1 Planning of Product/ Service realization (7.1)
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 - refer Flow Diagram
Process
Supplier Principal Stock Receipt
Stock Management
Marketing and Sales
Sales Order Processing
Advertising
Financial Transaction
In planning product realization within 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.
8.2 Related Procedures
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 as the company is not a manufacturer
7.4 Purchasing / External Providers - applicable
7.5 Production and service provision - not applicable as not a manufacturer
7.5.1 Control of production and service provision - not applicable as not a manufacturer
7.5.2 Cleanliness of product - not applicable as not the manufacturer of sterile products
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 as not the manufacturer of sterile products
7.5.6 Validation of processes for production and service provision - not applicable as the company is not a manufacturer
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems - not applicable as not a manufacturer of sterile products
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
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
9.1 Trend Analysis and Continual Improvement
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.
10. Revision History
Revision 9, 24.08.2021 - AA - updating flow diagrams and relinking
Revision 8, 19.08.2021 - AA - Amending inserts and addition of 4 new definitions
Revision 7, 01.07.2021 - TNA - updating responsibilities
Revision 6, 03.05.2021 - AA Approved
Revision 5, 28.04.2021 - TNA - New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new google site format. Amending of Links and forms
Revision 4, Digitally signed on 05.12.2019 by AA
Revision 1-3, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Refer relevant SOP or work instruction Google Site indefinite n/a