North America Office
8757 West Cornell Avenue Suite 4
Lakewood, CO 80227 USA
+1 (720) 635-5563

Mexico Office:
Calle Arthur Ashe No. 40
Raquet Club
San Juan Cosala
Jalisco C.P. 45820 Mexico
+1 (720) 635-5563

FDA 21 CFR 820 QSR Consulting

Develop new QMS
Upgrade or optimize an existing QMS
Conduct second party audits
Assist with certification audits
Implement documentation systems
Fda 21 Cfr 820 Consulting


FDA 21 CFR 820 QSR consulting services

Quality Works offers FDA 21 CFR 820 QSR consulting programs, on-line and on-site, to assist you in developing and implementing an effective Quality Management System (QMS) that meet the requirements of FDA 21 CFR 820 QSR. Our experienced consultants provide a full range of services such as:

  • Development and implementation of new Quality Management Syste

  • Upgrade or optimization of your existing QMS to establish compliance with FDA 21 CFR 820 Quality System Regulations

  • Conduct internal audits

  • Conduct supplier audits

  • Development and implementation of documentation system

On-line FDA 21 CFR 820 QSR Consulting Program:

Our on-line FDA 21 CFR 820 QSR consulting program may be suitable for those companies that need minimum disruption of their operation and would like to save consultant's travel expenses. Our online service is very similar to traditional on-site consulting, except most communication between our experienced consultants and clients is by phone, video-conference, Skype or e-mail.  So to use this service, you will need internet access, an e-mail address and, if you wish, Web cam.  With on-line ISO Consulting we will:

  • Based on information you submit, provide you with a proposal and a firm quote similar to this example

  • Develop an implementation plan similar to this example

  • Include free of charge any of our publications needed to document your QMS

  • Assist you in development of top level documentation: Quality Manual and second level procedures

  • Review your procedures and records

  • Based on the information you provide, issue monthly reports to ensure compliance with the plan and timely completion of your project

On-Site FDA 21 CFR 820 QSR Consulting Program

Our on-site FDA 21 CFR 820 QSR Consulting Program may be added to your on-line consulting service at your discretion to enhance achieved results. In this phase we recommend:

  • Training, such as regulation overview for management

  • Audit of the system

  • Auditor training and others

Affordable FDA 21 CFR 820 QSR Consulting Service

You now have a choice, on-line or on-site. Use our services to best suit your needs: augment your staff, assure compliance with FDA 21 CFR 820 QSR, resolve quality problems, qualify your suppliers, pass your next inspection, or relieve critical resources. Understanding that time is money, our expert consultants will help you get back to business quickly. With Quality Works' on-site or on-line FDA 21 CFR 820 QSR consulting services, you can bring in expert help at a fraction of the price you would pay a full time consulting firm. For a free no obligation proposal and quote, please Call us today to discuss your specific ISO management system needs!

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