Services

Quality Management Systems

Quality Management Systems

Our consultants help you deliver quality products and services through QMS mastery and excellence. Get in touch!

Quality and Strategy Consulting

Quality and Strategy Consulting

Leverage Lean QA strategy to fast track your organization's desired Future State and meet objectives. Get in touch!

Business and Skill Training

Business and Skill Training

Explore a wide range of skills for professional development through exciting, live, instructor led courses.

Business and Skill Online Training

Fifth Dimension Online Training

Connect virtually from your office or home on your own schedule with our unique and engaging online  courses.

MAKE SUCCESS AND GROWTH A PRIORITY

Are you ready to work Smarter?

Quality Standards

ISO 22000

This standard establishes the requirements for an effective quality management system…

Read More

ISO 9001

This standard establishes the requirements for an effective quality management system…

Read More

AS 9120

AS 9120 is a standard geared towards Aerospace Distributors. This certification provides…

Read More

AS 9110

AS 9110 was developed by the International Aerospace Quality Group (IAQG) with maintenance…

Read More

AS 9100

AS 9100 is a standard geared towards Aerospace Manufacturers. An organization with an…

Read More

ISO 14001

ISO 14001:2015 lays out the criteria for an environmental management system. It maps out a framework…

Read More

ISO 13485

ISO 13485 is a quality system standard designed specifically for medical device companies…

Read More

​Lean QA Programs based on the standards above

Full Training
on Changes

10 week course based on all of the changes as applicable – These courses are not only trainings on the standards they also provide personal development (called Human Sourcecode) activities individuals can use to organize their own lives and reach their full potential

  • Introduction to the standard – Quality Management Principles, change
  • Plan Do Check Act, Risk Mitigation
  • Clause 4 Context of the Organization
  • Clause 5 Leadership
  • Clause 6 Planning
  • Clause 7 Support
  • Clause 8 Operations
  • Clause 9 Monitoring and Measuring
  • Clause 10 Improvement
  • Conclusion - How to Implement effectively

Implementation

  • Gap Analysis of documents and process
  • Process Training on Clauses 4-10
  • Revised Documentation (Quality Manual, Procedures) based on clauses 4-10
  • Internal Audit – Conducted by Lean QA
  • Help with closing out Corrective Actions
  • Management Review

Gap analysis

  • Gap Analysis on Documentation
  • Gap Analysis on Processes
    • Gap analysis report
    • Details all the gaps
  • Provides a list of recommended solutions to improve the gaps
  • Action item report and prioritization based on severity of gaps
  • Remote coaching and check in’s to see progress on action items. (Timing/Length will be determined and agreed upon based on contract with customer)

Documentation
Upgrade

  • Working with the key process owners to establish or upgrade the quality manual
  • Working with the key process owners to establish or upgrade the procedures based on clauses 4-10.

Internal Auditor
Training

  • 3 day full internal auditor training
    • Standard clause by clause detail
    • Audit Techniques
    • Audit Report writing
    • Mock Audit
  • 2 day internal audit
    • Witness audit
    • Overseeing auditors conduct some of their audits
      • Feedback from instructor on audits that were overseen.
  • Certification as an Internal Auditor