Management Solutions Group • 2879 Hoag NE • Grand Rapids, MI 49525 •  Phone: (616) 365-9822

Management Solutions Group

Experts in: ISO 9001, AS9100, ISO 14001, IATF 16949, ISO 13485, ISO 17025

Management Systems for Registration and Certification

Project Management

Onsite Workshops

Online and Public Training

Internal Audit Services

Management Representative & Management System Improvement

Contract Quality Management Services

Leadership Development Coaching

Speaking Engagements

Business Improvement, Coaching, and Strategic Planning

Brandon Kerkstra“We are hands-on consultants who work along side our clients to teach them the best ways to approach quality and project management processes – using their everyday work as examples to study."

Brandon Kerkstra - President

Since 1999, Management Solutions Group Inc. has helped hundreds of companies to ready themselves for ISO 9000 and other certifications with programs that can be implemented practically and sustained readily for future audits and improvements. MSG prides itself on its hands-on approach to designing and implementing quality programs that can add value for companies serving the manufacturing, medical device, environmental management, information security, aerospace and telecommunications industries.

Based in Grand Rapids, Michigan, MSG helps small- and medium-sized companies to navigate the narrow straits of implementing and maintaining programs that satisfy the registrars’ requirements for certification and allow companies to meet those requirements with limited resources.

With a combined experience of more than 60 years in quality and project management, MSG President Brandon Kerkstra and his team of seasoned consultants understand clearly the essentials of the registration process because they have conducted audits for some of the world’s largest registrars.

S069 - Section 8.5.1.3: Verification of job set-ups

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  bullet green arrow 25 Verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requires a new set-up;

bullet green arrow 25Maintain documented information for set-up personnel;

bullet green arrow 25Use statistical methods of verification, where applicable;

bullet green arrow 25Perform first-off/last-off part validation, as applicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-off parts in subsequent runs;

bullet green arrow 25Retain records of process and product approval following set-up and first-off/last-off part validations.


   
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S067 - Section 8.5.1.1: Control plan (continued)

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  bullet green arrow 25 review control plans, and update as required, for:

astricks-20The organization determines it has shipped nonconforming product to the customer

astricks-20When any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A)

astricks-20After a customer complaint and implementation of the associated corrective action, when applicable

astricks-20At a set frequency based on a risk analysis


   
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S066 - Section 8.5.1.1: Control plan (continued)

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  bullet green arrow 25 Items required in the control plan:

astricks-20controls used for the manufacturing process control, including verification of job set-ups;

astricks-20first-off/last-off part validation, as applicable;

astricks-20methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the customer and the organization;

astricks-20the customer-required information, if any;

astricks-20specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically unstable or not statistically capable.


   
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Testimonials

Outstanding Learning Experience

"Just wanted to send a note thanking you for the hard work and effort given to our company to help obtain ISO13485 & 9001. We successfully passed the initial registration audit two weeks ago. The auditor was impressed with how we integrated both systems and said it should be used as a model for other companies attempting to do the same. Linda’s work was outstanding and we learned a lot about our company and where our shortfalls are. Without her help and assistance we never would have achieved this goal"

Micro Star Innovations
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We review your requirements, then give you a menu of options to meet your budget and schedule.  MSG helps you determine:
  • Goals and objectives
  • Which certifications or standards are applicable
  • What individuals should be involved to tailor your training
  • A time schedule
  • Resources necessary to ensure a successful program launch