This document discusses Quality Management Systems (QMS) and the BM QualityMaster software. A QMS documents policies and procedures to produce high-quality products while reducing costs and increasing customer satisfaction. BM QualityMaster is a cloud-based quality management software that helps streamline quality processes, achieve compliance, and reduce risk through features such as non-conformance management, corrective action tracking, document management, and audit management. Using BM QualityMaster can benefit organizations by improving quality, optimizing processes, and meeting regulatory requirements.

1. Quality
Management
System:
What Is It All About?

2. • Quality Management System (QMS)
• Elements of Quality Management System
• Objectives of Quality Management System
• Importance of Quality Management System
• What is the purpose of QMS Software?
• BM QualityMaster
• Why BM QualityMaster?
• Features of BM QualityMaster
• Benefits of BM QualityMaster
• Takeaway
Contents:
An Overview

3. Quality Management System (QMS)
• By definition,
− A system that documents an organization's policies, business processes, and procedures in order to
produce high-quality products while decreasing costs and waste and increasing customer
satisfaction.
− Improves business operations by meeting regulatory & customer requirements.
− Delivers consistent and efficient quality procedures while adhering to good manufacturing practices
and regulatory standards to ensure compliance.
− ISO 9001 is an example of a Quality Management System.

4. Elements of Quality Management System
General elements of QMS include:
− Organizational policies and quality objectives
− Quality manuals
− Procedures, instructions and records (documented)
− Data management methods
− Internal processes workflow
− Quality analysis
− Improvement opportunities

5. Objectives of Quality Management System
• To provide continuous improvement and innovation
• To improve operational excellence and customer satisfaction
• To prevent reoccurring defects
• To take preventive action in case of any non-conformance
• To reduce process, quality, defect, and scrap/re-work costs

6. Importance of Quality Management System
• Understands all business requirements, including licenses, guidelines, client needs, and
system standard(s).
• Ascertains that all the required conditions are met.
• Assures that employees are properly trained in accordance with the quality system's
guidelines.
• Determines processes, their interaction, inputs, and outputs.
• Records or evidence of the all the test cases and changes made are stored in the policies.
• Measures, monitors and reports the QMS performance.
• Takes steps to mitigate the risks and opportunities that arise as a result of the changes
implemented.
• Internally audits the QMS to identify and correct nonconformities.
• Continually improves the functioning of businesses.

7. 7
What is the purpose of QMS software?
• Provides a single point of contact for all customer feedback, issues, policies, suppliers,
documentation, risks, incidents, training records, equipment, audits, and inspections.
• Automatically extracts data from ERP/Mobile applications and sends notifications regarding review
requests, change updates, and alarms, among other things.
• Organizes data such that each person has access to their own to-do list.
• Ensures complete security by granting authorized control access.
• Maintains quality consistency and complies with all regulatory criteria.

8. • A powerful & easy-to-use Total Quality Management Software that helps improve quality,
achieve compliance, lower risk, and reduce complaints by streamlining quality management.
• Provides quality methods and advanced user workflows to help companies manage and track
Quality Management Systems.
• Majorly focuses on:
- Continual business process improvement
- Reduction in overhead cost of maintaining quality at every stage, and
- Bringing superior quality products to the market
BM QualityMaster

9. 9
• Allows swift movement of data from one module to another, launches corrective actions
directly from complaints/adverse events, and tracks data from source to event and back.
• This way, an audit trail of the complete event is created and stored for future reference.
• BM QualityMaster ensures global compliance, mitigates risk, standardizes procedures, and
keeps your employees safe, healthy, and productive.
BM QualityMaster

10. • Transform your quality processes
− Helps in achieving operational excellence by streamlining and integrating your processes.
• Quick to implement & easy to use
− The professional team ensures that the software is implemented quickly and is simple to use
for both quality experts and novice users.
• Scalable to your business needs
− Scales across teams and products to keep your company growing and ensures smooth
business functioning.
• Integrated platform
− Provides a connected platform that incorporates quality data and supports improvement
across the product life cycle.
Why BM QualityMaster?

11. 11
• Supports Cloud technology
− Facilitates complete digitization of organizational quality data and makes it accessible from
anywhere, anytime.
• Empowers workforce
− Drives improvements without compromising the effective management of regulatory
requirements.
• Eliminates paper work trials
− Enhances accuracy, efficiency, and continuous improvement efforts across the enterprise.
Why BM QualityMaster?

12. I. Non – Conformance (NC)
• Capture, manage, and track non-conformances from internal/external sources
• Perform in-depth root cause analysis
• Maintain records of all the activities undertaken to resolve the nonconformity
• Maintain and track nonconformity records
II. Corrective and Preventive Actions (CAPA)
• Track the impact of Corrective and Preventative Actions, and measure reduction over time
• Identify quality-related issues, execute containment actions, mitigate recurrence, and verify the
effectiveness of root cause elimination
• Actively review and suggest actions for improvement
• Easily associate the appropriate reason for CAPA
Features of BM QualityMaster

13. III. QMS Cockpit
• Streamlines quality processes and offers reporting and analytics capabilities
• Allows viewing, cancelling, approving & rejecting approvals, releasing documents, etc.
• Select multiple documents, or even all the documents, and release them altogether
• View and verify change requests
IV. Complaint Management
• Manage, and track quality-related customer interaction & complaint
• Categorize complaints in logical groups. E.g.: documentation issue, product issue, and service issue, etc.
• Associate degree of severity of a customer issue
• Maintain the source of complaints
Features of BM QualityMaster

14. V. Training Management
• Manage training process, its requirements, and track training records
• Helps to plan, schedule batches, and associate trainers/guest trainers
• Create, manage, conduct, track, and monitor all training batches
• Helps to generate certifications based on the evaluation
VI. Change Management
• Establish a proper workflow for documenting changes
• Automate and manage every step of change control process
• Maintain, track, and approve the changes
• Prevent redundant data entry by including number of default change types
• Offers the ability to define priority, nature, CAPA, and source
Features of BM QualityMaster

15. 15
VII. Document Management
• Store, create, track, retrieve, and manage organizational documents
• Maintain the audit trail of viewed document, and keep a record of its modified form also
• Secure the document through a selective restriction of access via passwords, e-signatures, etc.
• Generate alert for the specified electronic distribution list of the document released
VIII. Compliance Management
• Automate alerts on any potential issue
• Track and control compliance-related activities such as documentation, planning, reporting, audit, etc.
• Measure, demonstrate, and comply with the regulations
• Offers regulatory reporting options and control risks related to non-compliance across processes
Features of BM QualityMaster

16. IX. Advanced SOPs and Policy Configuration
• Store, track, and provide access to SOPs/Policies at a single click
• Associate related guidelines and formats
• Restrict access to organizational, departmental, personal, and other levels
• Increase audit-preparedness
X. Audit Management
• Automate and streamline the audit process
• Easy planning of audits, with simplified flow for execution of audits
• Define different audit categories such as Departmental Audit, Documents Audit, Financial Audit,
and Organizational Audit, etc., and specify whether or not the audit requires approval
• Specify the different requirements that constitute an audit checklist
• Generate automatic audit reports to meet relevant compliance requirements
Features of BM QualityMaster

17. XI. Risk Management
• Identify, assess, categorize, and document future risks and their impact
• Visualize and better manage risks by gaining insight into the operations
• Get a proactive approach to control the risks, and deal with challenges
• Better maintain compliance with standards set by different relevant regulatory bodies
• Drive continuous process improvement through risk control and mitigation
Features of BM QualityMaster

18. Benefits of using BM QualityMaster
• Streamlines operational processes to improve quality
• Optimizes improvements to products and service
• Measures real-time results and implements CAPA plan
• Reduces expensive mistakes in production
• Assigns accountability to increase employee involvement
• Meets compliance and reduces product recalls, and fines
• Increases customer satisfaction

19. Key Takeaways
− BM QualityMaster is a cutting-edge enterprise cloud platform that provides flexibility, ease of
use, risk mitigation and compliance.
− A one stop quality management hub, where manufacturers can gain actionable insight into
performance, cost and risk-related metrics, production, and customer satisfaction.
Still Thinking?
This customizable Cloud-based software for Nonconformance Management, CAPA Management, Document
Management, Change Management, Inspection Management, Training Management, Supplier Quality
Management, Complaints Management, and more, makes it a must-have to manage your organization’s quality
processes.
Simply register for a demo and know about all the capabilities it possesses.

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• Or, send your queries or demo requests at: sales@batchmaster.com
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