VV_5.0 Management Responsibility

5.0  Management Responsibility

5.1  Management Commitment

Senior Management is committed to resourcing, operating, and maintaining an effective Quality Management System.  The Quality Policy, Quality Objectives, and Management Review serve as evidence of this commitment. Through company meetings, employees learn the importance of meeting customer requirements and having an effective Quality Management System.
Senior Management has established a Quality Council. Members of the Quality Council are as follows:
·       General Manager
·       Business Operations Manager
·       Sales Manager
·       Technical Manager

5.2  Customer Focus

Senior Management employs a number of ways to ensure that customer requirements are identified and properly fulfilled and that customer satisfaction is measured. Product conformity and on-time performance is measured. Appropriate action is taken if planned results are not, or will not be, achieved.

 The organizations management ensures, through communication with our customers and supplier, that customer satisfaction is a continuous focus of our efforts through the sales process.
Applicable Procedures/Instructions:

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Applicable Procedures/Instructions:
Procedure-Sales
Instruction-Complaints Handling

5.3  Quality Policy

Supply Direct’s quality policy was developed by the Quality Council to communicate Supply Direct’s commitment to quality and meeting customer requirements. It  is  considered appropriate by Senior Management. The Quality Policy is revalidated at each Management Annual Review meeting.

Supply Direct Est. is committed to gratifying and astonishing customers with our customer service excellence, order accuracy and on-time delivery. This is accomplished through our commitment to continual improvement of our processes, services, products and our people.

Our Mission
The organization want to develop safe and effective product that can solve unmet medical needs that exist for both patients and medical professionals.
The organization want to secure the intended use is fulfilled by being the producer during the initial sale in some markets in EU and for some products in USA.
We are certified according to EN ISO 13485: 2016 and MDD 93/42 / EEC.
 
Our Policy
We are all responsible for continuously improving the quality of our processes, products and services.
We are committed to comply with all regulatory and quality-related requirements, to maintain the effectiveness of the Quality Management System and to provide the resources needed to manage and implement the system.
We must all help to identify, predict and influence customer and market needs and thus provide the basis for developing and improving products, processes and services.

We will inform our customers about safe handling of products and advise if we become aware of product usages that are not in accordance with legislative requirements.
We will use our Quality management systems to support and ensure the quality of processes, products and services.
We are committed to ensuring that quality objectives are communicated, understood and implemented throughout the company and that the Quality Management System is regularly reviewed at the Management Review meeting for suitability and effectiveness.
Our Vision
It is the vision that the organization will have marketed their product by partnering worldwide.
 

5.4  Planning

5.4.1    Quality Objectives

Executive management has set strategic top-tier quality objectives for the company, see below. They are consistent with the Quality Policy. Sub-tier quality objectives are established on processes where it is warranted to establish effectiveness of the process. Quality objectives will be measureable.
Total Customer Satisfaction Customer Service Excellence On-Time Delivery
Order Accuracy
Continual Process Improvement

5.4.2    Quality Management

The Managing Director and Director of Quality have planned the establishment of the Quality Management System. This planning will show up in Management Review or Corrective or Preventive Action Plans.  Changes to the Quality System are planned.  Each manager initiating a change will do so only after careful analysis and planning. Major changes will be planned, controlled and documented.
 

5.5  Responsibility, Authority and Communication

5.5.1    Responsibility and Authority

Responsibilities and authorizations are documented in this manual, procedures, work instructions and Job Descriptions.
 

5.5.2    Management Representative

The Managing Director has appointed the Director of Quality as Management Representative for Supply Direct. The Management Representative has the authority and responsibility for:
a. Ensuring processes needed for the Quality Management System are established, implemented, and maintained.
B. Reporting on the performance of the Quality Management System to management and any need for improvement.
c. Promoting awareness of customer requirements throughout the organization.
d. And has the organizational freedom and unrestricted access to top management to resolve quality management issues.
 

5.5.3    Internal Communication

The Quality Council has established the following communication channels to ensure the performance and effectiveness of the Quality Management System are communicated to the employees of Supply Direct:
·       Management Meetings
·       Department Meetings
·       Performance Metrics (via online/offline channels)

5.6.  Management Review

5.6.1.           General

A Management Review meeting is held at least once per year.
 
The QA Manager must chair the management review meetings. At the management review meeting the Function responsible reports on the performance of the QMS, along with the opportunities for improvements and need for changes, to ensure the current suitability and effectiveness of the QMS is satisfying the requirements.
The QA Manager or the designee maintains records of each review.
 

5.6.2.           Review Input

To ensure that the entire QMS is covered, a consistent approach should be followed to cover at least the following points:

• Review of the quality policy
• Review of the quality objectives
• Customer feedback
• Complaint handling
• Reporting to regulatory authorities
• Monitoring and measurements of processes
• Monitoring and measurement of products
• Result of audits
• Status of preventive and corrective actions,
• Follow-up actions from previous management reviews,
• Changes that could affect the QMS,
• Risk based approach to the control of QMS processes
• Recommendations for improvements,
• New or revised regulatory requirements, especially focusing – but not limited to – the regulatory requirements listed in scope

 
Minutes from the management review will be documented and distributed to all relevant functions.

Applicable Procedures/Instructions:
Procedure-Corrective and Preventive Actions (CAPA)

5.6.3.           Review Output

The output from the management review includes a statement regarding the suitability and effectiveness of the QMS and any decisions and actions related to:

• Improvement needed to maintain the suitability, adequacy and effectiveness of the QMS and its processes,
• Improvement of products related to customer requirements,
• Changes needed to respond to new or revised regulatory requirements
• Resource needs.

Applicable Procedures/Instructions:
Instruction-Management Review