Quality

Illinois BIS full-time consultants have guided hundreds of companies to registration since 1987. Illinois BIS quality consultants are certified quality auditors with extensive manufacturing experience. Illinois BIS has a long proven and successful track record. We have guided over 600 companies to ISO registration. Our experienced, highly-qualified, full-time consultants are committed to providing expert guidance at the lowest possible cost. The implementation of a Quality Management System is a strategic decision and should be undertaken with the intention of achieving results far beyond the actual certificate. We have the knowledge and commitment to help you succeed. Training includes:

This three-day training provides the knowledge necessary to audit a Quality Management System based on ISO 9001:2015. The auditing methodology presented is based upon ISO 19011, Guidelines for Auditing Management Systems. Participants will receive a copy of the ISO 9001:2015 Standard.

The new automotive QMS Standard, IATF 16949:2016, requires a documented process to verify that internal auditors are competent. The Standard also identifies the required competencies for Quality Management System Internal Auditors, Manufacturing Process Auditors, Product Auditors, and Second-Party Auditors (now REQUIRED for supplier evaluation) specifically:

  1. Understanding the automotive process approach for auditing, including risk-based thinking
  2. Understanding applicable customer-specific requirements
  3. Understanding applicable ISO 9001:2015 and IATF 16949:2016 requirements
  4. Understanding applicable core tools
  5. Understanding how to plan, conduct, report and close out audit findings
Any audits performed for the transition to IATF 16949 must be performed by auditors with these competencies or they will not be recognized by the Certification Body. This training will provide the necessary competencies for auditors.

The instructor for this training is Global Exemplar Certified to ISO 9001 and IATF 16949, including Auditor and Audit Team Leader.

This training provides participants with an introduction to advanced quality planning and control plans. Participants will gain the tools and techniques needed to develop and document advanced quality planning in design and manufacturing and understand the elements and requirements for advanced quality planning and control plans.

Participants will learn the logic behind FMEA. This one-day workshop provides participants with an understanding of FMEAs (Failure Mode and Effect Analysis) and how to get the most out of them.

This training provides participants with an understanding of the new 4th edition of PPAP published by the automobile industry. Topics include: the purpose and intent of PPAP, a detailed review of the specific requirements and PPAP submission status.

This training provides participants with an introduction to the tools of measurement systems analysis. These topics apply to every company performing measurement of quality characteristics, and are required for all companies registered to ISO/TS 16949.

This is a hands on course designed to provide students with confidence to perform and interpret Measurement Systems Analysis Studies using the user friendly tools found in Minitab Statistical Software Assistant menu.

Continual Improvement is no accident with Design of Experiments! Traditionally, DOE has been performed by statisticians. This 2-day, hands-on course will give participants the necessary skills to handle various forms of DOE without being a statistician.

This training includes defining QFD and listing potential benefits to the design and development process, identifying possible applications of QFD, requirements for success in using QFD, developing a list of customer requirements, performing market research related to customer requirements and product development.

Learn a systematic method to identify the true root causes and implement permanent corrective actions, understand the difference between solving a problem and identifying the root cause of that problem, learn a proven step-by-step methodology that will make your analytical skills more effective and efficient and have the ability to critique and support root cause analysis carried out by others.

Statistical Process Control is a powerful tool that can be used to predict percent conformance to specifications and help improve quality throughout a company. Learn a straightforward approach to setting up and maintaining an effective SPC program in your company. Participants will be able to apply these techniques immediately.

Understand the major changes in the new AS9001D, the differences between AS9100D and AS9100C, new terms and definitions, the process approach, and the changes in requirements.

This training will provide insight into the many changes in ISO 9001:2015, and the details of the requirements of IATF 16949. Participants will receive a copy of the ISO 9001:2015 and IATF 16949:2016 standards! The instructor for this training is Global Exemplar Certified to ISO 9001 and IATF 16949, including Auditor and Audit Team Leader.

IATF 16949:2016 was formally released on October 1, 2016. A departure from previous Automotive standards, IATF 16949 is no longer a stand-alone document. It MUST now be used in conjunction with ISO 9001:2015, which was updated in September 2015. The clock is now ticking for currently registered organizations to make the transition from ISO/TS 16949:2009 to both ISO 9001:2015 and IATF 16949:2016. As of October 2017, any new registration, surveillance, and/or triennial recertification audits will be against IATF 16949. As of September 2018, all ISO/TS 16949:2009 certificates will be invalid.

With the major implications of this transition, now is the time to start planning for how you will upgrade your Quality Management System to compliance with both these new standards.

ONSITE GAP ANALYSIS AUDITS FOR IATF 16949 ALSO AVAILABLE!

The 2016 revision of ISO 13485 was published on March 1, 2016. Although the 2003 revision will still be valid until early 2019, it is not too soon to start planning for how you will make the transition to the new revision. This training will provide valuable insight for anyone responsible for leading the efforts to upgrade their existing Quality Management System to comply with the new requirements. Transition planning strategies will also be discussed.

ISO 9001:2015 has been published. Now is the time to start planning for how you will upgrade your Quality Management System to the new revision. If you are currently registered to any other ISO 9001-based standard, such as ISO/TS 16949, ISO 13485, AS9100, and others, these changes will eventually affect your organization as well. By reviewing the details of ISO 9001:2015, this workshop will provide insight into the many changes.

This training is designed as a prep course for those individuals planning to take the ASQ's CQE® Certified Quality Engineer examination. It is also for participants interested in enhancing their Quality Engineering skills. Topics include: Applying for Certification, ASQ CQE Body of Knowledge Full Review, Exam Simulation Tests, Exam and Preparation Strategies.

RoHS 2
In December 2008, the European Commission published its proposal for a revised RoHS (Restriction of Hazardous Substances) Directive, named RoHS 2. RoHS 2 became effective on January 2, 2013.

REACH
(Registration, Evaluation, Authorization and Restriction of Chemicals) is a set of regulations developed by the European Union in 2006 and became law in June of 2007. Manufacturers and importers will be required to gather information on the properties of their chemical substances.

Conflict Minerals
In August, 2012, the Securities and Exchange Commission adopted a new rule and form, as mandated by Section 1502 of the Dodd-Frank Act, to require companies to publicly disclose their use of conflict minerals that originated in the Democratic Republic of the Congo or an adjoining country.

ISO 14001 is the new internationally accepted standard that offers guidance on how to put an effective Environmental Management System (EMS) in place. The standard is designed to address the delicate balance between maintaining profitability and reducing an organization's environmental impact - an increasingly important issue across the globe.

(Risk-based Thinking for ISO 9001:2015)
With the introduction of risk into the newly published ISO 9001:2015 and other revised Quality Management System standards, this training addresses how to create a risk management system. The use of risk techniques can be expanded to different objectives of an organization such as, strategic, company-wide, local, project, product/service and processes.

ISO 45001, Occupational Health and Safety Management Systems - Requirements with Guidance for Use, is making its way through the final draft stage, on schedule for release as an International Standard in late 2016. Replacing the existing Occupational Health and Safety Standard OHSAS 18001, this document goes beyond the OSHA requirements to address the leadership side of safety. It follows the new Annex SL High Level Structure format to allow easier integration with ISO 9001:2015.

We can provide instruction and assistance in understanding the requirements for CE Marking.

  • Conduct CE Overview training to provide a basic understanding of CE Marking.
  • Conduct detailed training on the requirements of the applicable EC Directive(s).
  • Conduct training on the documentation required for CE Marking.
  • Conduct training in risk analysis methods required for meeting the applicable product directive requirements.
  • Provide implementation assistance to assist client in documentation preparation.