What is Quality Management System (QMS)?

A Quality Management System (QMS) is a set of policies, processes, and procedures required for planning and execution (production/development/service) in the core business area of an organization.

A QMS is responsible to coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

The most prominent approach to quality management systems is the ISO 9001:2015, the international standard specifying requirements for quality management systems.

The QMS refers to the entirety of the system.

Quality management systems serve many purposes, including:

• Improving processes
• Reducing waste
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction

The quality management system consists of 8 key elements.

Discover the 9 Quality Management System Concepts

LEARN HOW TO CREATE A QUALITY MANAGEMENT SYSTEM

The most common guidelines suggest establishing a structure is based on the Plan-Do-Check-Act (PDCA) cycle and allows for Kaizen’s continuous improvement to both the product and the QMS.nicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit. Read more information.

Need help or templates to create a quality manual and procedures, visit us,

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT THE QUALITY MANAGEMENT SYSTEM.

For more details on specific FDA expectations and how to create quality management system documents, follow us.

Three (3) Options to Create Quality Management System Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the Quality Management System.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality System Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about QMS, refer to:

httpss://the9000store.com/iso-9001-2015-requirements/what-is-iso-9001-quality-management-system/

httpss://asq.org/quality-resources/quality-management-system

httpss://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf

httpss://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf

httpss://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

httpss://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

httpss://ispe.org/initiatives/regulatory-resources/gmp

httpss://www.fda.gov/media/73141/download

Food and Drug Administration References

1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
5. httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
6. httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References: 

1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (https://www.ispe.org/gamp/)
2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)