VV_4.0QMM – Quality Management Manual

Quality Manual, Policy and Objectives

4.0  Quality Management Systems

4.1  General Requirements

Supply Direct has established and implemented a Quality Management System which is continuously maintained for effectiveness and process improvements:

• The processes needed to operate the Quality Management System have been determined and documented.
• The sequence and interactions of these processes has been determined.
• The criteria and methods needed to ensure the operation and control of these processes is documented and effective. Criterion is defined in the procedures and is in line with the Quality Policy and Quality Objectives. Methods include Internal Audit and Quality Reports.
• Information and resources to support the operation and monitoring of these processes is available. Management is committed to properly resource the Quality System and Information Systems of the company.
• Supply Direct monitors, measures where applicable, and analyzes these processes.
• Based on these measurements and controls Supply Direct will implement actions necessary to achieve planned results and continual improvement of these processes.
• These processes will be managed by Supply Direct.
• Outsourced processes will be identified and controlled when outsourcing is required.
• The quality management system will address customer and applicable statutory and regulatory quality management system requirements.
• The organization validate software applications used in the QMS prior to initial use and as appropriate after changes to such software or its application.

The processes which have been identified as within our QMS and their sequence and interaction in the QMS are shown in the quality plan.

Changes that could affect the QMS are evaluated as part of the change control process of quality system procedures by the document approver.  

The organization is fully responsible for all outsourced activities. All activities outsourced by The organization is monitored and controlled. Controls are assigned proportionate to the risks involved and the ability of the supplier to meet requirements.  
Such outsourced activities include production, transport and storage of finished products. 

Applicable Procedures/Instructions:
Procedure-Quality Management System
Procedure-Logical Security
Procedure-IT onboarding
Procedure-Identity Management

The organization validate software applications used in the QMS prior to initial use and as appropriate after changes to such software or its application. 

Applicable Procedures/Instructions:
Procedure-Process and Software Control
Instruction-Change Control

A risk-based approach is taken to the control of QMS processes and this is conducted as part of the Quality Management Review process.

Periodic assessment of the risk-based approach to QMS process control will occur as part of the Quality Management Review Process and also can be initiated at any time by the CEO or by QA/RA.

Applicable Procedures/Instructions:
Instruction-Management Review

4.2  Documentation Requirements

4.2.1  General

Supply   Direct’s   Quality    Management    System    includes   the   following documentation.

• Supply Direct has defined and documented a Quality Policy and Quality Objectives. See section 5.3 and 5.4.1.
• Supply Direct has prepared a quality manual. See Section   4.2.2
• Supply Direct has documented the procedures and records needed for the effective planning, operation, and control of processes.
• Supply Direct keeps records required.
• Supply Direct employees have access to, and are aware of, relevant quality management system documentation and changes.

4.2.2  Quality Manual

Supply Direct has established and maintains this Quality Manual. The Quality Manual is approved by the Managing Director  of Supply Direct  and  the  Director  of  Quality.  This manual includes a scope and exclusions as defined  in  Section  4.2.2.1  and  4.2.2.2.  In addition to this manual there are procedures required to operate this Quality Management System. In this manual there will be reference to them as appropriate. A full listing of the procedures is available upon request. A description of the interaction between the core processes of the Quality Management System is given in Appendix A.
 

4.2.2.1    Scope

The scope of the Quality Management System is as follows.

Authorized Distributor of Dental Materials, Supplies,<span style=”letter-spacing:

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And includes the facilities located at the following location.
Supply Direct Est.
8290 Kind Abdulaziz Road
Rabea District
Riyadh, 13315-4323 Saudi Arabia
 
WAREHOUSE ADRESS:

4.2.2.2    Exclusions

The following sections of ISO 13485:2016 will be excluded due to the product being stand-alone software:

• 6.4.2 Contamination control
• 7.3 Design and Development
• 7.5.2 Cleanliness of product
• 7.5.5 Particular requirements for sterile medical devices
• 7.5.6 Particular requirements for sterile medical devices
• 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
• 7.5.9.2 Particular requirements for implantable medical devices
• XXXXXXXX Design and Development – Supply Direct does not design or manufacture any of the products it sells.

4.2.3 Medical Device File

The organization maintains a Medical Device File for all medical devices. This file contains all relevant information about the medical devices, to establish that the device meets the safety and effectiveness requirements of applicable regulatory authorities, along with what is required to gain regulatory approvals and to realize and install the devices.
 
 The organization assures that medical devices have labelling that confirms to the relevant regulatory requirements, including – where applicable – language requirements. 

Applicable Procedures/Instructions:
Instruction-Technical File and Medical Device File
Procedure-CE marking in accordance with the Medical Devices Directive

4.2.4 Control of Documents

Supply Direct controls the documents required by the Quality Management System. This is performed through a documented digital and physical document control process.

A master list of Standard Operating Procedures (SOP’s), indicating the current revision levels of documents and their status, is maintained by the QA department and evidence of the individual employees training status, and a list of applicable documents may be retrieved from QA. 

Applicable Procedures/Instructions:
Procedure-Document Control
Procedure-Records Relating to Quality
Instruction-Technical File and Medical Device File
Instruction-Change Control

4.2.5  Control of Records

Records have been established and are maintained which specifically provide evidence of meeting requirements and the effectiveness of the Quality Management System. This will include records of product origin, conformity and shipment in accordance with customer, statutory and regulatory requirements, where appropriate. These records will  remain  legible and will be readily identifiable and retrievable for a minimum of (6) years.

Records are controlled according to a dedicated procedure. This procedure ensures the proper identification, storage, retrieval, protection, retention time and disposition of quality records and that they are available for at least five years after the last product has been manufactured. 
Electronic records are secured by periodic back-up of company servers.

Applicable Procedures/Instructions:
Procedure-Document Control
Procedure-Records Relating to Quality

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