SERVICE PROVISION OPERATION

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

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

OEM - Original Equipment Manufacturer

7. References

ISO13485 Clause 7.5

SOP Non-Conformance, Deviations and Concessions & Corrective Action

SOP Purchasing / External Providers

8. Procedure

8.1 Product / Service realization (7)

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

Process- see below flow chart.

In planning product realization, the organization flow 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

7.4 Purchasing / External Providers

7.5 Production and service provision

7.5.1 Control of production and service provision - refer Manufacture

7.5.2 Cleanliness of product - covered by Sourcelink in Manufacture

7.5.3 Installation activities & 7.5.4 Servicing activities

activities include Supply, delivery, installation and servicing only of curtains

Installation servicing on a 12 week cycle to customers. ie every 12 weeks pmb attend to the hospital to check: Hooks are in place, Runners are in place, Tighten any loose screws if any on the curtain track
a maintenance checklist that the installer goes through when conducting the service which the customer sign to acknowledge the service was done.
PMB then scan and email the checklist to the client for their records.
Once done with installing the curtains and curtain track, the customer signs the delivery note as acceptance to workmanship.

7.5.6 Validation of processes for production and service provision- not applicable as the products are quality control check in manufacture

refer to SOP 7.5.8 Identification,

7.5.9 Traceability,

5.10 Customer property,

7.5.11 Preservation of product,

refer SOP 7.6 Control of monitoring and measuring equipment - not applicable as this is done by SourceLink

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 Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews for 8.5 Monitoring or Processes, and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis

The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

In the event of and non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action

is followed

10. Revision History

Revision 3 NJG 01.10.2025 inclusion of installation and servicing 8.2 7.5.3 & 7.5.4 and 7.6 not applicable

Revision 2 NJG 07.05.2025 Change of ownership.

Revision 1 New HJM 5.09.2024

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Refer relevant SOP or work instruction Google Site indefinite n/a

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