Services
Quality Management
IMS Quality Services
We help you meet your company planned goals by providing cost-effective Quality Management System (QMS) consulting and assistance, tailored for your operations.
We currently provide:
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ISO 9001:2015 for all industries (including Dental Laboratories)
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ISO 13485:2016 for all medical device manufacturers
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ISO 14000 and Compliance Based Environmental Quality Management Systems
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API-Q1 for the heavy steel and pipeline manufacturing industry
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The International Dental Laboratory System (IDLS) to meet the requirements of Federal Regulation 21 CFR Part 820 (See FDA Compliance)
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510(k) Pre-Market Notification assistance for Medical Devices
Our focus is on ensuring employee loyalty and process ownership, while striving to make each internal operation successful, ultimately contributing to the satisfaction and loyalty of your customers.
FDA Compliance
On-Site Consulting
IMS provides extensive service, exceeding what is available in the market. Working with IMS, you gain an additional employee working on your behalf to ensure effective completion of the project.
Our consulting services are priced affordably with payment plans to fit any medical manufacturer’s budget. Medical manufacturers can implement the IDLS system, or secure ISO 9000 certification if your markets are regulated. Both programs can be tailored to compliance with Federal Regulation 21 CFR Part 820 and other International Standards.
510(k) Submissions
IMS is now providing hands-on assistance to medical manufacturers with the 510(k) Pre-Market Notification process for FDA submissions. We have developed relationships with FDA approved vendors for testing and analysis services, and work to make certain that you as the customer have a solid understanding of the 510(k) process, all at a competitive cost and in the timeline you choose.
What's Required By The FDA?
A Quality Management System is the same as FDA’s Good Manufacturing Practices program (often referred to as GMP), and is governed by 21 CFR Part 820. Meeting the regulatory requirements, though involved, need not be expensive or complicated, and should not necessitate extra work.
The minimum FDA requirements are:
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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.
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Maintain records of customer complaints and document lab errors, so that all corrections are available for later review.
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Evidence that your lab is performing internal audits on your QMS/GMP program.
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Records that reflect formal management level reviews of your QMS/GMP program and audit results.
What's most important is that your system accurately documents what you do, and that you do what you document.
Environmental Management
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:
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Provide an environmentally relevant management structure to achieve sustainable compliance with federal, state and local environmental laws and regulations
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Minimize corporate and personal potential criminal and civil environmentally related liability
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Implement your Management's Environmental Management System (EMS) policy
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Proactively manage your facility activities in a manner that will prevent pollution, reduce potential sources of pollution and minimize waste.
The Program Capabilities
Our ISO 14000 and Compliance Based Environmental Systems (CBEMS) are unique in the Marketplace in their responsiveness to regulatory and enforcement agency expectations. These programs provide relatively low development, implementation and sustainability costs and provide assurance that implementation is NOT operationally intrusive or time, systems or labor intense. We achieve these outcomes utilizing these proven strategies:
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We have 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.
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We use your in-place environmental compliance tools, protocols, procedures and operations plans as our starting point. IMS does not scrap your prior efforts.
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We take a straight forward, not operationally intrusive approach by interacting with your Operations Managers and Facility Managers whose activities and production processes are environmentally regulated to assure smooth, efficient and cost effective implementation thereby minimizing cost and assuring implementation over a relatively short time period.