Integrated Management SystemsThe Innovative Approach to Quality Management

Home

About Us

FDA Compliance

QMS

EMS

Recommendations

Contact Us

Home

About Us

Welcome to Integrated Management Systems a nationally recognized quality management system (QMS/GMP) consulting group operating since 2001, developing ISO 9000, API-Q1, ISO 14000 Environmental, AS 9100, and FDA compliant QMS in the petrochemical, manufacturing, medical device, steel and heavy industry, aeronautical, and dental laboratory sectors.

FDA Compliance

IMS has worked with dental laboratories across the US successfully implementing quality management systems (QMS/GMP) since 2004. We have solid experience addressing FDA warning letters and setting up and maintaining QMS/GMPs utilizing ISO 9000 or the International Dental Laboratory System (IDLS).
No Frame

About Us

ABOUT US

SERVICES

IMS is a team of experienced quality (QMS) and environmental (EMS) professionals with demonstrated success leading companies in nearly all business sectors through the QMS/GMP/EMS implementation and certification process. Our professionals also have extensive environmental and FDA remediation experience and can intervene on behalf of your company. Program StructureUtilize our program and you can expect your project to progress as follows:Your assigned consultant will perform an overall systems review. Once your system is understood, your consultant can confirm the amount of time required to develop your documentation and processes to compliance to the QMS/EMS system being implemented and provide tools to expedite and a formal Project Plan to monitor the implementation process. Your consultant will: o Work onsite to assist with implementation. o Follow up and assist personnel with their assignments. o Perform employee and management training and work to develop cooperative resolutions on identified constraints.Once the Project Plan has been completed and the required processes implemented your organization will be ready for certification, should that be your goal.QMS/GMP System MaintenanceRequest QMS/GMP maintenance services and we will assign a Contract Quality Engineer (CQE) who will function like a member of your company, performing scheduled visits for an annual period to support your management representative (MR). Your CQE will actively assist with system development by performing on-site training, documentation maintenance, guiding and assisting with internal and external audits and will ensure your company demonstrates effective QMS/GMP utilization, all at a cost much less than a full or part-time employee.

WHAT WE DO

We provide:On-site training of employees and management on QMS/GMP systems setup, operation and internal auditingEasy, simple to use tools and the manuals needed and consulting services to ensure timely and effective implementation with guaranteed audit resultsQMS/GMP implementation specifically for the Dental Laboratory industry.QMS/GMP maintenance services in all industries at a fraction of the cost of a full or part time employee.Download our brochure here:

Integrated Management Systems Brochure.pdf

FDA Compliance Wheel

WHAT'S REQUIRED BY THE FDA?

A QMS/GMP, though involved, need not be expensive or complicated or create extra work for your lab. What the FDA is requiring are minimally the following:A procedure manual that explains how your lab meets each requirement of Federal Regulation 21 CFR Part 820 (see here), identifying specifically who is responsible for what and how the process flows. That your lab maintains records of customer complaints and documents lab errors so that what was done to correct either is available for later review.Evidence that your lab is performing internal audits on your QMS/GMP program.Records that reflect formal management level reviews of your QMS/GMP program and audit results.What'’s most important before any of this is that you as the lab owner and/or lab manager understand as much as possible so any decision is an informed decision!

FDA COMPLIANCE

DENTAL LABORATORY SERVICES

On-Site ConsultingOur consulting services are priced affordably with payment plans to fit any dental laboratory budget. Dental Laboratories have the choice of either IDLS certification with the FDA guarantee through IMS, or if your needs are more complex, ISO 9000 certification using a third party registrar. Either way we can tailor a program that ensures you meet the changes to the industry using the method that provides your laboratory the results you need.
No Frame

QMS

QUALITY MANAGEMENT SYSTEMS

IMS Quality Services We help you meet your company planned goals cost effectively by concisely implementing a Quality Management System (QMS) that ensures effectiveness in your processes. The new ISO based standards and FDA Regulations expect the use of factual data in planning and decision-making. Our program provides all levels of management with tools to produce performance data that can drive improvement, provide downstream feedback and visibility to the top.The Quality Management Systems we are currently implementing are: ISO 9001:2008 in all industries (including Dental Laboratories) API-Q1 for the heavy steel and pipeline manufacturing industry. The International Dental Laboratory System (IDLS) to meet the requirements of Federal Regulation 21 CFR Part 820 (See FDA Compliance) AS9100, Rev C for compliance in the Aeronautical IndustryIdeally, an effective QMS/GMP program fosters a culture where everyone strives to achieve optimum customer satisfaction, internally and externally. In this culture one process cleanly hands off to the next and cumulatively then to the paying customer. This environment ensures employee loyalty and process ownership, with all striving to make each operation successful, thus contributing to the satisfaction and loyalty of the organization's customers. This is a major part of what IMS will do for you.Call or email us now for additional information or a quote.
No Frame

EMS

ENVIRONMENTAL MANAGEMENT SYSTEMS

Environmental Services by IMS We can help you solve any of your environmental matters with an in-depth analysis of your situation, giving you a "to the point" Action Item list that enables you to tackle the outstanding issues and problems in order of priority, with no wasted effort. We can suggest solutions that will enhance your environmental practices, and overcome or minimize any liabilities you have or may incur.The Key Benefits are designed to: Provide an environmentally relevant management structure to achieve sustainable compliance with federal, state and local environmental laws and regulations Minimize corporate and personal potential criminal and civil environmentally related liability Implement your Managements EMS policy Proactively manage your facility activities in a manner that will prevent pollution, reduce potential sources of pollution and minimize waste.The Program Capabilities:Our Compliance Based Environmental System (CBEMS) is unique in the Marketplace in its responsiveness to regulatory and enforcement agency expectations. The program provides relatively low development, implementation and sustainability costs and provides assurance that implementation is NOT operationally intrusive or time, systems or labor intense. We achieve these outcomes utilizing these proven strategies:IMS team of professionals has already developed a CBEMS generic platform responsive to the 12 elements of the National Enforcement Investigation Center (NEIC) and United States Environmental Protection Agency (USEPA) compliance-focused model; which we use to build-out your facility-specific CBEMS [you DO NOT pay for our learning curve].We use your in-place environmental compliance tools as our starting point [IMS does not scrap your prior efforts, we build on them].We fit our CBEMS platform to your existing environmental compliance protocols, procedures and operations plans [we do not reinvent the wheel!].We deploy our pre-developed CFEMS generic model by interacting with your Operations Managers whose activities and production processes are environmentally regulated [this preserves the integrity of your facility operation processes and vests your managers in implementation as we build out the CBEMS].We take a straight forward, not operationally intrusive approach by partnering with your Facility Managers and encouraging their assistance to assure smooth, efficient and cost effective implementation thereby minimizing cost and assuring implementation over a relatively short time period.
No Frame

Recommendations Multi Chat

RECOMMENDATIONS

We chose Integrated Management Systems (IMS), above all other vendors, to ensure our compliance with the FDA regulations that govern our industry. IMS did a thorough analysis of the regulations and presented me with all of the compliance options that were available at that time. We elected to use the ISO Quality Management System for our company and tasked IMS with the complete training and implementation. IMS did a great job of explaining what the project would consist of with regard to the commitment of our people and appropriation of our resources as well as developed a timeline. We passed our ISO audit on-time and on budget with no surprises. I would highly recommend the great people at IMS to anyone needing an effective quality management system and regulatory compliance.Dave LeshPresidentDale DentalWe retained the services of Integrated Management Systems to help us implement a quality management system that would pass an ISO certification audit. I am happy to report that their services have been professional, timely, and successful in allowing us to pass this certification audit on the first attempt, with no adverse findings. We have been particularly impressed with their detailed knowledge of the key elements of the standard, the ability to communicate effectively to our staff and management, and the informal and non-confrontational manner in which IMS has carried out this assignment. We would not hesitate to recommend their services to anyone wishing to achieve not only successful certification, but also to improving the caliber and quality of their operation, from improved customer relationships to significant operational cost reductions.Kurt RosePresident Hydro USAWhen we first contacted IMS, Carter Thompkins visited our facility, to determine how IMS could assist us in our transition. It was immediately obvious that Carter had both the professional credentials and the experience to successfully guide us through this transition. Initially, IMS quickly revised and rewrote both our Quality Manual and Procedure Manual, provided a to do list of the items that needed completion, and next trained our internal auditors. As testimony, after completing the surveillance audit, the external auditor even stated that he was impressed by our progress toward the transition to the new standard. I highly recommend IMS and the services they can provide. They delivered a professional product in a timely and thorough manner. In addition, they have continued to stay in contact with us, as a follow-up to their service. This does not appear to be an extraordinary event, but the way IMS does business.John GulleyManager of the Analytical Section ofResearch and DevelopmentActive Organics Mr. Thompkins was very knowledgeable on the subject matter, and his delivery of the material was superb. He tailored his training to our specific environment and pointed out to us many improvement opportunities. I would recommend him to any company who needs ISO training. This was one of the best classes we have taken in years. Mr. Thompkins is an excellent instructor. We walked away from the class with a ton of helpful and applicable information.Ha SmithAvayaWith input from the company, Mr. Thompkins wrote our Quality Manual, and Quality Procedure Manual. He prepared some forms and graphs for the company, and provided quality instruction to a group of employees on the new ISO system. Mr. Thompkins also consulted with us during our first internal audit on the procedures and expectations of external auditors. When not on site, he was accessible to answer questions and provide advice. Overall the services provided were good, and we would continue to use IMS. Cindy Skrobarcek General ManagerAnimal Technologies, Inc.
Contact Us

CONTACT US

We are centrally located just outside of Dallas TX, USA and have consultants available at strategic locations throughout North America. For your convenience and to ensure the most relevant and prompt response we have established multiple methods of contact to address any inquiries you may have. Client Operations -- carter.t_ims-quality.comÞ For any questions related to QMS/GMP requirements and interpretationsÞ For confidential discussion of FDA compliance matters and resolutionsÞ For consultant mattersSales -- sales_imsqms.comÞ For inquiries or to receive a proposal for consulting or QMS/GMP maintenance services for all industries (except Dental Laboratories)Dental Laboratories -- labinfo_imsqms.comÞ For information about QMS/GMP consulting, maintenance or training services and CEU credits for FDA complianceAdministration -- admin_imsqms.comÞ For any Accounts Payable or Receivable mattersÞ For matters related to contractual adjustments, i.e.: discounts or specialsAdministrative address: 1209 Northwest Highway #320Garland, TX 75041Phone: (972) 671-9590 Fax: (972) 278-0306

We establish partnerships with you the client to enhance your existing systems with efficient, practical and relevant quality management system tools, utilizing excellent communication and hands-on involvement to ensure that each of your operational goals are met in a timely and cost effective manner. If you are under pressure from prospective customers, regulatory or governmental agencies, or just want to elevate your organization to a competitive edge, we can help.
earth copy

More on Integrated Management Systems

IMS quality of services and reputation for identifying operational cost reductions consistently surpasses client expectations in the areas of responsiveness to need, work product accuracy and overall effectiveness.