Case Studies

ISO 13485: Medical Device Standard

Introduction:  Marena is widely recognized as the world’s leading compression garment manufacturer with a vast array of products and representation in many countries around the world. Founded in 1994 by Vera and Bill Watkins, by 2001 the company grew in economic terms to merit the ‘Small Business Exporter of the Year’ award from the state of Georgia. Continued growth resulted in accolades and awards from industry experts and agencies, such as being named apparel manufacturing ‘Grand All Star’ of 2006 by Apparel magazine. 

Situation/Challenge: Marena needed help with transition to new ISO 9001 and ISO 13485 standard and alignment with 21CFR 820 requirements. Documentation structure was not effective in communicating the processes and many department procedures and work instructions were changed as well as not clearly documented. Additional challenge Marena Management faced was its diverse workforce and multilingual work environment. Some operators did not speak English and could not understand the essence of ISO or its importance. 

Since initial certification, Marena’s Management Representative and Quality Manager struggled to manage the system.  

Value Proposition: Integrate the standard and realign the processes to reduce the number of Work Instructions and convert cumbersome WI to visual aids. 

Train the entire workforce by having ISO Training Material translated in 16 languages for the operators and leads. 

Quality:  With 3 months starting April thru June, QMS was integrated, and Marena was recertified to ISO 9001:2015 and ISO 13485:2016 Standards with 21CFR 820 addition. 

Time (Duration): Timeline was 3 months 

ROI: Continued customer satisfaction with the Marena Products and potential of distributors in EU and South America were long-term benefits. 

ISO 17025:2017 Accreditation for Testing and Calibration Laboratory

Introduction:  D&D Lab provides offers Microbial and Chemical Testing of water and dialysate as defined by the AAMI (Association for the Advancement of Medical Instrumentation) Standard for to their customers. The company was founded in 2004 to provide testing for Kidney dialysis clinics, Hospitals/Medical Centers and water purification companies. D&D Laboratory is a Certified Veteran Owned Small Business. 

Situation/Challenge: D&D Lab has always been compliant to AAMI Standards and CLIA certified. Their majority of business comes from Government contract Veteran’s Department. D&D Laboratory’s certificate was expiring in Nov 2019 and had to be certified before that timeframe to ensure the contract terms are continually met. 

Value Proposition: Due to lean operations and shorter timeline it was proposed that Sync QCS is used for Documentation. All existing SOP’s were integrated to the QCS for better alignment and subsequent monitoring as part of maintaining accreditation. 

Quality: D&D Lab was accredited within 5 months with final accreditation in hand without any major finding. 

Time (Duration): Timeline was 5 months 

ROI: Veteran’s contract requirements were consistently met and no lapse in certification happened. Additionally, with ISO 17025 Accreditation, D&D Lab could pursue major contracts with government as well as local Kidney Hospitals. 

ISO 17025:2017 Accreditation for Testing and Calibration Laboratory

Introduction:  Southern Balance is Calibration service provider. Most of the calibrations are done in field on client sites and occasionally in-home office. Troy Peck is the owner and its single person Lab. Occasionally Troy hires contractor to support him on need basis. 

Situation/Challenge: Southern Balance had been accredited to ISO 17025:2005 till Troy decided to drop the accreditation since ROI could not be justified. Just few months before the accreditation expiry due date, few major customers request for the most updated Accreditation letter. Troy decided to renew the accreditation but had a serious time crunch.  

Value Proposition: Due to lean operations and shorter timeline it was proposed that Sync QCS is used for Documentation. All existing SOP’s were integrated to the QCS for better alignment and subsequent monitoring as part of maintaining accreditation. 

Quality: Southern Balance was accredited within 2 months. Final Accreditation was in June 2019 with no major finding. 

Time (Duration): Timeline was 2 months 

ROI: Retained existing clients and secured new clients since having ISO 17025 has become mandatory requirement. 

ISO 17025: Accreditation for Testing and Calibration Laboratory

Introduction: The Forensic Services Department works to validate the authenticity of the Merck Drugs and identify counterfeits by performing various tests utilizing cutting-edge analytical techniques to deliver critical results with unprecedented speed, accuracy and affordability and specific customer testing requirements. 

 

Situation/Challenge: Forensic Service Department is created in year 2016 and has been assigned with the project to be accredited before the end of 2018. 3 other Laboratories in different locations all have to be aligned with this accreditation.  

 

Value Proposition: In order to provide consistent testing results and assuring the quality of testing, it was critical to ensure the Documentation structure is similar in all locations and core management processes are managed from the USA HQ. This allows the other locations only to maintain their specific standard operating procedures. 

 

Quality: Merck’s Forensic Lab Services was accredited within 8 months with final accreditation and no major finding. Their Switzerland location was also accredited within the 8-month timeframe. 

 

Time (Duration): Timeline was 8 months 

 

ROI: Oversight committee is in HQ location and all Management and Support processes are controlled by HQ and provides more flexibility to rest 3 labs. 

ISO 9001 for IT Service Provider:

Introduction: Paramount Software Solution (PSS) is IT Managed Service provider and staff augmentation company located in Milton, GA. PSS has been providing staffing support to various IT Fortune 500 companies in entire USA with focus on providing best support service. They work with cutting edge tools and ensure that the portfolio of candidates is reflective of their vision & mission. PSS is also registered for Federal and State Government Programs. 

 

Situation/Challenge: IT industry has been struggling with more supply of skilled resources than the demand and number of IT staff augmentation companies have increased by 10X (folds) in past decade. Governance by USCIS had tightened the requirements with lot of audits to verify the accuracy of information of Consultants placed by Staffing company.  

 

Value Proposition: Since PSS has a good resource pool and having registered to Federal (GSA Schedule) and State Government Programs (SLED) , their ISO structure needed to be created that can be easily integrated with future RFQ needs of CMMI, ISO 27001, ISO 20000-1, and so on. Additionally, it is very critical that the QMS seamlessly integrates without disruption due to Dynamic nature of their business and segregated team in  geographically separate locations trying to collaborate. 

 

Quality: PSS got certified within record time of 6 months with final certification and no major finding. They can now bid for projects and show ISO certification as their added advantage. They have been able to bid for government projects and secure critical partnerships. 

 

Time (Duration): Timeline was 6 months 

 

ROI: With ISO Certification had a very big impact on their Bid and Proposal Capabilities. Overall Appraisal of PSS is grown due to projects and clients they are working with. 

 

CMMI Level 2 (SVC)

Introduction: TFC helps government entities improve risk management and internal control. TFC’s experience spans all aspects of OMB Circular A-123, Management’s Responsibility for Enterprise Risk Management and Internal Control, including internal control over financial reporting, internal control over operations, internal control over compliance, charge cards, improper payments, financial systems, and acquisition. 

 

Situation/Challenge: TFC Consulting, Inc. was in need of obtaining CMMI Level 2 certification within an ultra-condensed time frame of 30 days. 

 

Value Proposition: Leverage existing ISO 9001 documentation and align with CMMI Level 2 model. 

 

Quality: TFC Consulting was working on the Federal Contract and needed certificate in hand to qualify to bid on the program. 

 

Time (Duration): Timeline was 1 month 

 

ROI: Multi-Year Federal Contract worth millions and ability to work as Prime Contractor with Government. 

IATF 16949: Automotive Quality Management System

Introduction: ZD Metal Products specializes in light-weight castings for the automotive, agricultural, recreational, and commercial industries. 

 

Situation/Challenge: ZD Metals needs to be certified to IATF standard due to Parent Company mandate. ZD suffered a major fire hazard 6 months prior and lot of production is impacted and very limited support due to recent layoffs.  

 

Value Proposition: One of the best things about ZD Metals is very experienced operators and an easy way to have consistent documentation is Work Instructions using flow charts.  

 

Quality: ZD Metals was certified in 8 months with no major finding. 

 

Time (Duration): Timeline was 8 months 

 

ROI: ZD Metals was able to bid on new OEM Proposals and their existing OEM partnerships increased the contracts. 

ISO 20000-1:2018: Service Management System

Introduction: SHR Consulting Group, an 8(a) Small Business, has a successful five year history serving defense and civilian agencies such as The Defense Information System Agency (DISA), Joint Service Provider (JSP), the Office of the Secretary of Defense, the U.S. Army, the U.S. Navy, the Department of Health and Human Services (HHS), and the Federal Bureau of Investigation (FBI). 

 

Situation/Challenge: Certified to ISO 20000-1(SMS) to increase the customer reliability and confidence, open door for Federal Contracting.  

 

Value Proposition: SHR Consulting is fast growing company and business is driven by contract vehicle and their changing needs. So, even though ISO 20000-1 is current solicitation requirement, SHR will need additional certifications in future. Solution provided is a system which can be easily integrated with existing CMMI SVC Level 3. 

 

Quality: SHR collaborates with personnel working in federal government contracts and project have to be performed following the PMP guidelines to provide consistent deliverables, stakeholder/COR reporting and timeline milestones based on the contract or task order requirements.  

 

Time (Duration): Timeline was 2 months 

 

ROI: SHR was able to bid on Federal Contract and subsequently win it. 

ISO 27001:2013: Information Security Management System

Introduction: Cira InfoTech operates with a vision to exceed client’s expectations in IT Infrastructure Managed services and support, by combining deep technical knowledge and skills with a uniquely personalized approach to customer service. 

 

Situation/Challenge: Certified to ISO 27001(ISMS) to increase the customer reliability and confidence, open door for Federal Contracting.  

 

Value Proposition: Cira is fast growing company and business is driven by contract vehicle and their changing needs. ISO 27001 is current solicitation requirement but Cira will need additional standards in future. Solution provided is a system which can be easily integrated with most industry relevant ISO standard and CMMI. 

 

Quality: Cira Infotech collaborates with personnel working in federal as well state government contract and are trained on Cyber security per the awareness program established. 

 

Time (Duration): Timeline was 4 months 

 

ROI: Cira Infotech was able to enter into partnership with a big Law firm and bid on Federal Contracts. 

ISO 9001 for Product Manufacturer

Introduction: American BOA Industrial Division is Manufacturer of Expansion Joints, Bellows and Hoses from its location in Cumming, GA. The company was incorporated in 1956 and began operations in New York and New Jersey. The company relocated and consolidated operations in 1981 in Cumming, GA. American BOA is a subsidiary of BOA Metal Solutions Gmb. The BOA group consists of 20 subsidiaries and other major shareholdings across the world. 

 

Situation/Challenge: American BOA has been making products for big Fortune 500 companies like Airgas, Northrup Grumman, Air liquid, Space X, Lockheed Martin. In order to consistently meet customer requirements BOA had to be compliant to new ISO 9001:2015 standard. Due to change in management the transition standard was not instituted till June of 2017 and existing standard was expiring in November 2017.The new transition not implemented within next 6 months will cost them customer business.   

 

Value Proposition:American BOA has to be compliant to MIL requirements, Pressure Vessel codes B31.3, UL certification & NDT Testing done due to contracts in place with their customers. They have regular supplier audits and a lot of time is dedicated to support the audits. Documentation system was really a critical issue since for various requirements multiple versions of procedures, SOP existed which created confusion and inconsistencies in audits. Customer expectation was to align the process to integrate all the needs as much as possible.

 

Quality: BOA was certified within 7 months with final certification and no major finding. They were able to secure it prior to certification lapse due to transition deadlines. All critical client partnerships are maintained. 

 

 

Time (Duration): Timeline was 7 months 

 

ROI: Integration of documentation and reduction in number of documents maintained has increased the productivity of the Quality Department.