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 instruction 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 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 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:  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:  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.