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.

S009 - Section 4.4.1.2: Product Safety


 New-Arrow-Left2 bullet green arrow 25 Identification by the organization of statutory and regulatory product-safety requirements

bullet green arrow 25Customer notification of requirements above

bullet green arrow 25Special approvals for design FMEA (Failure Mode and Effects Analysis)

bullet green arrow 25Identification of product safety-related characteristics

bullet green arrow 25Identification and controls of safety-related characteristics of product and at the point of manufacture

bullet green arrow 25Special approval of control plans and process FMEAs

bullet green arrow 25Reaction plans (see Section 9.1.1.1);

bullet green arrow 25Defined responsibilities, escalation process, flow of information, including top management, & customer notification

bullet green arrow 25Training identified by the org. or customer for personnel involved in product-safety related products & manufacturing processes

bullet green arrow 25Changes of product or process approved prior to implementation, including evaluation of potential effects on product safety

bullet green arrow 25Transfer of requirements throughout the supply chain, including customer-designated sources

bullet green arrow 25Product traceability by manufactured lot (at a minimum) throughout the supply chain

bullet green arrow 25Lessons learned for new product introduction.
   
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S008 - Section 4.4.1.2: Product Safety

 New-Arrow-Left2 bullet green arrow 25 Documented processes for the management of product-safety related products and manufacturing processes  

bullet green arrow 25Process must included, but not limited to (Where applicable) items on the next page  
   
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S007 - Section 4.4.1.1: Conformance of products and processes

 New-Arrow-Left2 bullet green arrow 25 The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2). 


bullet green arrow 25The organization is responsible for the conformity of outsourced processes  

   
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Testimonials

Impactful Training

"Besides learning the auditor skills, it [training] helped me understand the impact a quality system has on the entire company I work for"

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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