Quality Management System

GENERAL POLICY

We believe Manufacturing Products is a responsibility

MHPL's Total Quality Control System consists of chemical, physical and biological control systems from basic monomer to finished products, and in process quality control checks at every production cycle.

MHPL's management philosophy aims to keep patient's care and well being to be the foremost and manufacturing practices to be always emphasizing on an uncompromising quality.

Quality Policy of MECCA HEALTHCARE P. LIMITED

MHPL has established, documented, implemented and maintained a quality management system that is compliant to the requirements of ISO 13485 Standard 2016 and ISO 9001 Standard 2015 for its commercial and standard products.

The Process-Based Quality Management System of MHPL emphasizes three basic inter-related elements i.e. Facilities, Personnel and Processes.

MHPL continuously strives to improve the effectiveness of its QMS by aiming below mentioned GMP Principles:

Stakeholders' Commitment and Customer Feedback

Supplier Management

TQC -Total Quality Control of Products and Processes

Benchmarking

Awards and Awareness

5S

Kaizen

'Management Commitment' - is towards customer focus, leadership, involvement of people, process-based approach, continual improvement, factual approach to decision-making and a mutually beneficial supplier relationship.

'Resource Management' - effective fulfillment of customer requirement by organizing adequate facilities in form of mfg. plant, equipments, assembly premises and competent workforce of qualified and trained personnel.

of the processes used to mfg. & assemble products in accordance with regulatory and customer requirements. Aiming for maximum efficiency from the resources deployed with a uniform quality in every single unit of medical device manufactured and assembled at MHPL.

PROCESS-BASED
QUALITY MANAGEMENT SYSTEM OF MHPL
(3 BASIC INTER-RELATED RESOURCE SUB-ELEMENTS)
- FACILITIES, PERSONNEL & PROCESSES

Quality Objectives

• The quality objectives are aimed to improve the organization's operational effectiveness and customer satisfaction.

QUALITY OBJECTIVES

1. Our overall quality goal is to achieve our quality policy, by maintaining the integrity of our QMS.
2. To seek continual improvement of the QMS in compliance with ISO 13485 Standard 2003 & ISO 9001 Standard 2008.
3. Manage and control facilities, processes, quality systems & personnel to cost effectively produce products and furnish delivery services that meet regulatory & customer needs.
4. Be committed to continuous process improvement by emphasizing reduction of part-to-part variation and the elimination of all waste.

Quality Management System Planning

• The quality management system planning is carried out to meet the general requirements of the QMS, quality policy and the quality objectives.

Quality planning in MHPL encompasses the whole facet of operations with focus on the following:

Þ Identifying of processes needed for the quality management system and their application;

Þ Determining the sequence and interaction of these processes;

Þ Determining criteria and methods needed to ensure that the operation and control of these processes are effective;

Þ Ensuring the availability of resources and information necessary to support the operation;

Þ Monitoring, measurement and analysis of these processes; and

Þ Implementing actions necessary to achieve planned results and continual improvement.

Changes that could affect the quality management system are reviewed and quality planning is carried out through management review process and internal audit process.

In MHPL, quality planning includes identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality.

Quality Control System

Activities of MHPL Quality Control Department