How to Create a Quality Management System in 7 Steps?

How to create a quality management system in 7 steps

 

This article describes how to create a Quality Management System QMS in seven (7) steps using the PDCA approach.

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.

Quality Management System - Plan-do-check-Act
Quality Management System – Plan-Do-Check-Act

 

The basic seven (7) steps to implementing a quality management system are as follows:

  1. Design
  2. Build
  3. Deploy
  4. Control
  5. Measure
  6. Review
  7. Improve

Design and Build

The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation.

Make sure that every need of the organization and the needs of its customers are a driving force behind the systems development.

Deploy

The deployment will be shared in portions educating staff on documentation, education, training tools, and metrics.

Control and Measure

Control and measurement are two areas of establishing a QMS that is accomplished through routine, systematic audits of the quality management system.

Review and Improve

Review and improve detail on how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.

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

brought to you by CIQA logo

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT HOW TO CREATE A QUALITY MANAGEMENT SYSTEM.

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

Quality procedures templates

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 how to create a 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.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about How to create a 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)
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!