What is Quality Management System?

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

2. Contents:An Overview • 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

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 of 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. 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. BM QualityMaster • 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

9. BM QualityMaster • 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 QualityMasterensures global compliance, mitigates risk, standardizes procedures, and keeps your employees safe, healthy, and productive.

10. Why BM QualityMaster? • 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.

11. Why BM QualityMaster? • 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.

12. Features of BM QualityMaster • 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

13. Features of BM QualityMaster • 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

14. Features of BM QualityMaster • 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 each and 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

15. Features of BM QualityMaster • 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

16. Features of BM QualityMaster • 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

17. Features of BM QualityMaster • 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

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.

20. Discover a more powerful yet simple solution to manage risk and compliance Our experts are incredibly responsive to your queries • Get in touch by visiting us on: www.batchmaster.co.in • Or, send your queries or demo requests at: sales@batchmaster.com • Please feel free to call us or contact us on: • BatchMaster Software Pvt. Ltd. • (An ISO 9001:2015 Certified Company)Brilliant Solitaire, Plot 6 – A, Office 201-A to 204-BScheme 78, Part-II, Indore - 452010Ph: +91-731-4008039+91-731-4008070+91-731-4008035 • Fill the form directly on: https://www.batchmaster.co.in/contact.aspx

21. Thank You! Choose your system wisely and implement it to make your business perform extraordinarily.