INNOVATIVE QUALITY PRODUCTS AND SYSTEMS

Case Studies

Who:
Holbrook Tool & Molding: What do you know about ISO 13485:2016

What:
Holbrook Tool & Molding certified their quality management system, with a goal of demonstrating 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 ISO 13485:2016 certification. However, ISO 13485:2016 clauses were not updated to the 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. Guidance was also given on effective management reviews. Since then, internal audits have been conducted, and continue today.

Result:
Fourteen years later, the Quality Manager is able to successfully maintain and improve the quality management system. Ownership and commitment have been enabled throughout the organization, as the system is now easier to understand. Holbrook Tool & Molding is able to maintain their ISO 9001 certification, with no customer requested corrective actions for many years.



Who:
Holbrook Tool & Molding: A one-size quality manual does not fit all

What:
A streamlined 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 combined 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:
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 is able to 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 streamlined 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 combined 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 is able to maintain their 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 streamlined 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 the client's quest for QS-9000 certification, a former employee developed a 100-page quality manual and 20 procedures - which they could not possibly maintain. If there was a long way to take, he took it.

Solution:
A combined 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. Subsequently, an environmental management system (ISO 14001) was integrated into the quality management system (ISO 9001) and morphed into a business management system -years ahead of ISO 9001:2015.

Result:
Fifteen years later, the quality manager was able to successfully maintain and improve the quality management system. Similarly, the Plant Engineer was also able to maintain and improve the environmental system. Ownership and commitment were enabled throughout the organization as it is now easier to understand. Baxter Machine Product is able to maintain both ISO certifications with no findings, 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 internal audits. After an accredited surveillance audit, IQPS was hired to perform internal audits based on QS-9000.

Problem:
Blair Strip had a one man 'quality department' who wore many hats. It was hard to maintain independence and expertise.

Solution:
System was subsequently upgraded to TS-16949 and integrated with ISO 14001, and internal audits continue to be conducted throughout the years. Training is provided to new employees as organization continues to grow, including the new, dedicated Quality Manager.

Result:
Eighteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Blair Strip is able to maintain their TS-16949 certification with minimal/no findings and no customer requested corrective actions for many years.



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:
Bellflex Quality Manager needed guidance in machine shop implementation.

Solution:
Assistance was provided through discussions regarding best-practices and reviews of system documentation. Appropriate training was provided to different levels of the organization. Internal audits were also conducted and continue today.

Result:
After six months of startup, Belleflex successfully obtained ISO-9001 certification. Their quality system and performance was recently 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 streamlined quality management system was developed to enable them to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems.

Problem:
In the client's quest for ISO-9001 certification, a previous consultant left them an unfinished quality manual and 20 procedures - which they could not possibly maintain. They needed ISO-9001 certification to fulfill a Pennsylvania Department of Transportation (PennDOT) supplier requirement.

Solution:
A combined policy and procedure quality manual was developed with one work instruction for office staff. Training is relied upon for the production staff. 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:
Seven years later, the integrity of the quality system could be maintained through staff transitions. The current Operations Manager is able to maintain the quality management system as a way of doing business. Blind and Vision Rehabilitation Services of Pittsburgh was recently recognized as one of the top three non-profit organizations for 2013.

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