What is Quality Management System?

Quality Management System: What Is It All About?

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

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.

Elements of Quality Management System General elements of QMS include: −

Organizational policies and quality objectives

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Quality manuals

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Procedures, instructions and records (documented)

− Data management methods −

Internal processes workflow

− Quality analysis − Improvement opportunities

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

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.

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.

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Ensures complete security by granting authorized control access.

• Maintains quality consistency and complies with all regulatory criteria.

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.

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Provides quality methods and advanced user workflows to help companies manage and track Quality Management Systems.

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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 • 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.

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.

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.

Features of BM QualityMaster 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 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 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

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

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

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

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

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.

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-B Scheme 78, Part-II, Indore - 452010 Ph: +91-731-4008039 +91-731-4008070 +91-731-4008035 • Fill the form directly on: https://www.batchmaster.co.in/contact.aspx

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