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  The NIST Manufacturing Extension Program for Kentucky

Advantage KY News

Transitioning to ISO 9001:2015

Are you prepared to go through the steps to establish ISO 9001:2015 for Certification in 2016? On September 15th of 2015 the ISO TC 176 released both ISO 9001:2015 and ISO 14001:2015 Standards. This means the clock is ticking and you have 3 years to convert your current documented quality system (QMS) to the new standard and be re-registered. 

“ISO

Issues companies are facing is first, fully understanding what has changed and secondly, not knowing where to turn for assistance. “This is too important to leave to chance … ISO Certification in a small businesses is challenging” says longtime ISO specialist and owner of Diehl and Associates, Tom Diehl. Limited time, budget, and experience with the new regulations necessitates the need to look to outside assistance to gain certification. Tom goes on to say, “In the mid 90’s, we took several groups of companies, through the process together. It was a great way to learn from each other and still gain the objective; Certification!”

By using the same format mastered by Tom in the mid 90’s, AKA has teamed up with Diehl and Associates to lead a group of companies through the processes to establish ISO 9001:2015 starting in January of 2016. Participating companies will be able to share the costs of consulting to achieve the objective of establishing ISO 9001:2015 in their company. This Program includes three 8-hour time-based workshops where attendees learn about the new Standard’s requirements and includes phone and email support. Special attention is given to the process approach, risk-based thinking, and customer perception. PowerPoint presentations, team exercises, presentations by attendees, and pre-workshop preparation are all a part of the program. Attendees should bring appropriate documents from their existing QMS to the workshops so they can be transitioned to the new standard’s requirements, where appropriate.

The Program is broken out into 3 separate workshops where up to 3 attendees from each company can and is encouraged to participate. The Program is expected to take four to six months to complete. Timing is based on the groups’ progress based on the tasks that need to be achieved between workshops. In-between workshop support through email and phone conference will be needed and is included.

A breakdown of AKA’s ISO 9001:2015 Program is below:

Objective:

To assist companies to establish a quality management system (QMS) that meets the requirements of ISO 9001:2015.  This is achieved by several companies learning together what needs to be done in a group setting under the mentorship of a trained ISO specialist.  The Program will be a balance of group and individual learning. Included in the Program, but not limited to:

  1. Understanding the requirements;
  2. Assist with establishing the new requirements for their organization;
  3. Measuring customer satisfaction and/or perception about your organization’s performance to them;
  4. Understanding risk-based thinking and the setting of priorities;
  5. Understanding the Standard’s required process approach;
  6. Understanding and establishing required documented information.

The Learning Process:

The QMS will be established in a group setting that includes learning from PowerPoint presentations, team exercises, workshop preparation, and presentations from the attendees.  The establishment of the QMS is to be achieved utilizing three workshops over a period of time established by the attendees.  Email and phone support is included in the program of work.  This is a step-by-step process where the attendees will systematically establish the QMS at the workshops and at their Company’s location.  It is estimated that it will take between four to six months to complete the process of establishing this new Standard into an existing QMS.  Each workshop will require a full 8 hours of participation.

Attendees will need to have a copy of the new standard with them and if possible their current QMS (electronic copy or hard copy).

All workshop topics are subject to change based on the group’s needs.

Workshop#1

For this workshop, attendees must pre-determine and have documented information that defines the organization’s strategic direction and who are their interested parties.

This workshop will cover, but not limited to, the following subjects:

  1. Overview of the ISO 9001:2015 standard;
  2. Establishing:
    1. Quality policy tied to strategic planning;
    2. Identification of all processes;
    3. Context and scope of the organization (team exercise);
    4. Who are the interested parties;
    5. Determining high-risk processes.

Workshop#2

For this workshop, attendees must pre-determine and have documented information that defines the organization’s quality objectives that are tied to their company’s strategic and production planning, interested parties, and processes.  In addition, documented information covering how performance evaluations are completed at their organization.

This workshop will cover, but not limited to, the following subjects:

  1. Any questions about activities from the previous workshop;
  2. Evaluating risk and actions to address and opportunities;
  3. Quality objectives tied to planning, interested parties, and processes;
  4. Performance evaluations;
  5. Control of externally provided processes, products, and services;
  6. Understanding customer satisfaction and perception (team exercise);
  7. Analysis and evaluation;
  8. Integration of all the processes and their interactions into a system that utilizes risk-based thinking (team exercise);

Workshop#3

For this workshop there is no planned outside pre-work depending on the group’s progress.  This workshop will cover, but not limited to, the following subjects:

  1. Any questions about activities from the previous workshop;
  2. Establishing organizational roles, responsibilities, and authority;
  3. Organizational knowledge;
  4. Operational planning and control;
  5. Production and service provisions;
  6. Design and development requirements;
  7. Information for external providers;
  8. Identification and traceability;
  9. Product belonging to customers or external providers;
  10. Preservation;
  11. Control of nonconforming outputs;
  12. Internal auditing;
  13. Management review inputs and outputs.

By attending each of the three workshops, completing in-between tasks/activities, and learning from other attendees all with an oversight of Mr. Diehl himself, attendees will be able to meet the requirements of ISO 9001:2015 within 6 months if tasks are completed on time.  

Depending on a company’s current QMS and business strategy, some companies may need additional assistance above and beyond the Program. This assistance could be documenting their current QMS or defining their future strategies. “Quite often, we work with companies to bring structure and focus to their strategic direction ensuring the entire senior management team is of one voice” says Scott Broughton, Center Director for the Advantage Kentucky Alliance. Scott goes on to say, “companies without a common voice and direction easily use 50% more resources then those that do”. Unclear direction creates unclear goals. Unclear goals create un-focused and in some cases redundant activities. Having the necessary documentation and business strategies are important elements for ISO 9001:2015 Certification.

DATE: 6/2/2016    LOCATION: Richmond, KY EKU BTC101 Register Here

DATE: 7/14/2016    LOCATION: Central Bank Conf. Rm in Richmond, KY Register Here

DATE: 8/30/2016    LOCATION: Central Bank Conf. Rm in Richmond, KY Register Here

COST: $4,000 (includes up to 3 attendees for each of the 3 workshops and email/phone support between workshops by Tom)

About Tom Diehl

Senior Consultant and owner of Diehl and Associates, Tom Diehl has been working with organizations implementing both ISO 9001 and ISO 14001 since 1991.  Diehl and Associates was one of the first eight companies in the USA to provide ISO 9000 implementation assistance. He has worked with organizations that have transitioned the ISO 9001 standards issued in 1987, 1994, 2000, and 2008 and 1996 and 2004 for ISO 14001.  He has assisted hundreds of companies of all sizes and from most industries.  “Implementation of these standards should always be implemented with the view towards adding value to the organization and minimizing overhead”.

About AKA

Advantage Kentucky Alliance (AKA) specializes in helping manufacturers uncover their problems, create solutions for those problems, and implement change so those problems go away or at least are minimized. For more information about the Advantage Kentucky Alliance, the ISO 9001:2015 Program, ISO 9001/14001 assistance in general, or AKA’s Business Strategy/Direction assistance, contact Scott Broughton, Center Director at 814-505-3786, scott.broughton@wku.edu or visit www.AdvantageKY.org

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