Case Studies
Who:
Holbrook Tool & Molding: What do you know about ISO 13485:2016
What:
Holbrook Tool & Molding certified their quality management system intending to demonstrate compliance with applicable FDA requirements and ISO 13485:2016.
Problem:
In their quest for growth in the medical device industry, Holbrook Tool & Molding decided to leverage their ISO 9001:2015 certification and gain an ISO 13485:2016 certification. However, ISO 13485:2016 clauses were not updated to ISO 9001:2015 version.
Solution:
Since ISO 13485:2016 follows ISO 9001:2008 clauses, it was decided to update this version which was already updated for the release of ISO 9001:2015. A quality manual was developed with less than five work instructions and training was given to different levels of the organization. Since then, internal audits have been conducted and continue today.
Result:
Fourteen years later, the Quality Manager can successfully maintain and improve a combined ISO 9001 and ISO 13485 quality system. Ownership and commitment have been enabled throughout the organization as the system is now easier to understand.
Who:
Holbrook Tool & Molding: A one-size quality manual does not fit all
What:
A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems.
Problem:
In their quest for QS-9000 certification, a previous consulting company handed them an off-the-shelf, 100-page quality manual and 20 procedures – which the client could not possibly maintain.
Solution:
A policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance training were provided to different levels of the organization.
Result:
Fourteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Ownership and commitment were enabled throughout the organization as the system is now easier to understand. Holbrook Tool & Molding can maintain their ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years.
Who:
Bra-Vor: One good turn deserves another
What:
A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems.
Problem:
Based on a referral from Holbrook Tool & Molding, Bra-Vor also enlisted IQPS to pursue QS-9000 certification and then ISO-9000 certification.
Solution:
A policy and procedure quality manual was developed with less than five work instructions. Appropriate training was provided to different levels of the organization. Guidance was also provided on effective management reviews. Internal audits were conducted and continue today.
Result:
Fifteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Bra-Vor can maintain its ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years.
Who:
Baxter Machine Product: There are two kinds of people – complexifiers and simplifiers
What:
A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems.
Problem:
A former employee developed a 100-page quality manual and 20 procedures – which was impossible to maintain.
Solution:
A policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance were provided to different levels of the organization. Subsequently, an environmental management system (ISO 14001) was integrated into the quality management system (ISO 9001) and morphed into a business management system.
Result:
Ownership and commitment were enabled throughout the organization as it is now easier to understand. Baxter Machine Product can maintain both ISO certifications with no findings and no customer requested corrective actions or incidents for many years.
Who:
Blair Strip Steel: If you can’t beat us, join us
What:
Blair Strip had an established quality system and needed someone to perform its internal audits. After an accredited surveillance audit, Blair Strip Stell hired IQPS to perform internal audits based on QS-9000.
Problem:
Blair Strip had one person in their quality department performing many tasks, which made it hard to maintain independence and expertise.
Solution:
The Quality System was upgraded to TS-16949 and integrated with ISO 14001, and internal audits continued to be conducted.
Result:
Eighteen years later, the Quality Manager can still maintain and improve the quality management system. Blair Strip can maintain its TS-16949 certification with minimal to no findings, and no customers requested corrective actions.
Who:
Belleflex: Join us too!
What:
A new startup company owned by Blair Strip needed to implement a quality management system and obtain ISO-9001 certification as soon as possible.
Problem:
The Bellflex Quality Manager needed guidance in machine shop implementation.
Solution:
IQPS provided guidance through discussions regarding best practices, reviews of the system documentation, and appropriate training for all levels of Bellflex.
Result:
After six months of startup, Belleflex successfully obtained an ISO-9001 certification. Their quality system and performance were recognized by NASA as an approved supplier to produce parts for the International Space Station.
Who
Blind and Vision Rehabilitation Services of Pittsburgh: We need another consultant
What:
A quality management system was developed to allow them to quickly respond to customers, solve problems, and eliminate quality-based problems.
Problem
A previous consultant left them an unfinished quality manual with 20 procedures- which was impossible to maintain. They also needed an ISO-9001 certification to fulfill a Pennsylvania Department of Transportation (PennDOT) supplier requirement.
Solution
A policy and procedure quality manual was developed with only one work instruction for office staff. Appropriate training and guidance were provided to different levels of the organization. Internal audits were conducted and continue today.
Result
Seven years later, the quality system is easily maintained by staff members and the Operations Manager. Blind and Vision Rehabilitation Services of Pittsburgh was recognized as one of the top three non-profit organizations for 2013.