ISO 9001

New ISO 18091 Released - QMS for Local Government

Today, ISO launched their video introduction of the newly published ISO 18091:2019 Quality management systems -- Guidelines for the application of ISO 9001 in local government. Although the ISO 18091 document was originally published in 2014, adoption of ISO 9001 in local government has been slim thus far.

ISO 18091 is applicable to all local government processes at strategic, managerial, tactical and operational levels in order to constitute a comprehensive QMS that focuses on the local government achieving its objectives. This document provides support for local government in providing reliable and effective services to the local customers/citizens. Guidance also includes tools for measuring and monitoring of various processes and their respective levels of maturity.

Message from ISO Secretary General, Sergio Mujica, about the launch of ISO 18091:2019, Quality management systems -- Guidelines for the application of ISO 9001 in local government

This new standard can be purchased directly from ISO at https://www.iso.org/standard/72808.html.

ISO 9001:2015 Documentation Requirements

Here at Concentric, we like change and typically embrace it. However, we are in agreement that several changes to the 2015 release of the ISO 9001 standard are just annoying. Changes that make understanding of the requirements less simple are, well… not simple. One example is the ambiguity associated with how many and what kinds of documented procedures and records are required. Now that the term "documented information" is being used, subscribers have to get out their ibuprofen, highlighters and dig down into the standard looking for clues like the words maintained (document required) and retained (record required). We've decided to create some more user-friendly tools to help you to better understand what's inside this 42-page document.

The following sections may be helpful in better understanding what is required vs. what is optional, for those of us who appreciate simple. All documented information, be it a traditional document or record, must be controlled in accordance with clause 7.5 Documented information. In order to make implementation and auditing simple, we recommend purchasing a printed copy of the standard and highlighting where the terms “maintained” and “retained” exist. The following sections can also be used as a quick reference guide to assist you in locating documentation requirements, examples of documents that may be used “as needed” and matrices to help you map standard references to your own language.

Is your organization ready to adopt ISO 9001:2015?

If your answer is YES, which best describes the motivation for this adoption:

  • This Standard is your industry’s general practice?
  • It is your customer’s request?
  • It is a Marketing initiative to improve your competitiveness?
  • Or simply because you are ISO 9001:2008 and want to keep the registration?

You may acknowledge one or more of the justifications above as genuine enough in your case. However, your organization’s leadership truly believes that the very first statement of the ISO 9001:2015, clause 0.1 Introduction, is valid, and that’s significantly larger than all the justifications above combined!

“The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives”.

The understanding of this Standard’s requirements, recommendations and permissions demonstrates an intuitive and logical rational that concludes that none of the requirements are unhelpful or useless. Indeed, compliance with ISO 9001:2015, means the minimum applied efforts and resources to achieve a better business structure, with more productivity, more competitiveness and, sure, more growth. Let us explain this rational!

ASQ Charleston Partnership with Concentric Global

ASQ Charleston has entered into a partnership with Concentric Global, a local Quality and Improvement consulting firm, to provide educational opportunities for our local ASQ Members at a discount.

By using promo code “ASQ1122”, ASQ Section 1122 members will receive a 10% discount on full-price 2016 open enrollment classes offered by Concentric.  Visit Concentric’s new website to see upcoming course offerings, and check back often to see when new offerings and other free resources are added.  In return, Concentric will pledge 15% of the course fee back to ASQ Charleston.

Note that Concentric is partnering with Trident Tech for the ISO 9001:2015 Lead Auditor class offered on Feb 23-25 2016.  This promotional price is 50% off regular price (limit 2 students per organization), and as such the promo code offer “ASQ1122” is not valid for this event.

Please consider Concentric for your training needs, and be sure to use Promo Code “ASQ1122” when signing up for 2016 full-price open enrollment courses!

Concentric Web Site

ASQCharleston.org

ISO 9001:2015 Forum - October Webinar Posted!

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more).

ISO 9001:2015 Forum - September Webinar Posted!

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more). Visit us online at http://acommoncenter.com for more information about our products and services.

Answers to the 9 Most Commonly Asked Questions about ISO 9001:2015

Answers to 9 commonly asked questions about the ISO 9001_2015 Changes Concentric Quality Management System Experts in CharlestonWe have been abuzz in the Concentric office for months (probably more like a year) on the upcoming ISO 9001:2015 standard changes and have made every effort to get as much information out to you as quickly as we can. So we introduced a monthly webinar series that follows the changes to keep you “in the know”. And we had a few clients that wanted to be on top of the changes so they can swiftly implement new strategies and stay compliant, so we held our first ISO 9001:2015 Lead Internal Auditor Training in August. Between those two platforms we’ve been asked lots of questions on the new standard and have put together a quick guide to answer all those burning questions you might have.  

 

  1. What is the timeframe for adopting the new version? When should an organization get started with the transition? What is going to be the approach adopted by the registrars once the standard is released?

We know, that’s actually three questions, but we have one answer. The Standard approval process is complete and its release will take place in September 2015 (September 23rd to be exact). There will be a three-year transition period for organizations to have its certification converted to revision 5 (version 2015), giving you until the end of 2018. A well-executed conversion may take between 6 and 12 months, but do not plan to get started by Jan 2018 because if you have issues then you will miss the deadline. Call your registrar now to understand their approach. Registrars will grant first-time certifications post Q2 2018 exclusively under the new revision. But a concentration of converted certifications will happen in Q3/Q4 2018. Furthermore, you may want to call your customers now because some of them may require a shorter timeframe to adopt the new standard. And you don’t want to lose a customer because you started late.

  1. Will registrars’ auditors and organizations’ internal auditors need to be re-trained and certified to the new version? Will auditors need to have a different assessment approach?

Yes, auditors will need to adopt a different approach. Registrars’ auditors may not need to be recertified. But we are strongly recommending that internal auditors, including experienced ones, be re-trained in the 2015 version of the Standard. An example of why is because instead of auditors focusing on documented procedures and records, they will need to watch the processes to look for evidence that may not need to be written anymore.

  1. How many new documents and/or procedures are going to be required? Is it not be six mandatory procedures anymore? Does the new version of the standard give the companies more freedom? Is this an advantage or disadvantage?

The 2015 version is not going to explicitly require any new document or procedure. Giving organizations “more freedom”. A few of the documents will not be required anymore, like the Quality manual for instance. Our recommendation is to use common sense to ensure this “freedom” is to your advantage. Instead of eliminating the Quality manual and some procedures that are not mandatory anymore, we are advising our customers to revise them to confirm its compliance with the new concepts in the new standard. This will ensure they remain valuable tools to support the organization’s management system and ultimately the organization’s business. If they are not adequate to serve at least one of the mentioned purposes, then they can be shamelessly eliminated.

  1. How to sell the QMS leadership to the leadership team? Who is going to be in charge of QMS if there will not be MR (management representative) requirement anymore?

The intent in the new version is crystal clear on this topic. The leadership team has to adopt QMS leadership one way or another and demonstrate that business management has incorporated QMS because it cannot be sustained as a satellite set of processes and procedures anymore. Organizations may decide to keep their MR professional, but her/his roles and responsibilities will be different once the QMS leaders will be the business process owners, therefore, part of the plant leadership team.

  1. If a QMS MR is not required anymore, does that means the whole leadership team (process owners) needs to be trained in QMS and ISO 9001:2015?

We strongly recommend training the entire leadership team. Companies may not want to invest in a full lead auditor training for the entire leadership team, but every process owner should attend at last a QMS and ISO 9001:2015 awareness training to fully understand, engage and implement her/his role adequately.

  1. Who are the interested parties and how do we identify them and their requirements or needs?

The new version brings the expanded concept of customers. Interested parties are the actual customers and many others like internal customers, community, government representatives, suppliers, employees and contractors, in summary, anyone that can somehow express an interest in the organization’s business performance. There will not be a written requirement, meaning a template is not provided to gather the list of interested parties and respective requirements or needs. However, we recommend an internal procedure to facilitate this task. For those companies who already gather customer specific requirements, the same repository may be adapted to collect other interested parties requirements or needs.

  1. How do we demonstrate and provide evidence for risk-based thinking? How is risk-based thinking different from risk management? How do we document the opportunities rather than risks?

Risk-based thinking is simpler than risk management. Auditors will not require documented records, but simply verbal justification that it was performed. The standard will not require the usage of a specific tool or methodology to prove evidence of risk-based thinking, neither for identification of risks and opportunities and nor for the subsequent action plan. Companies, intuitively apply risk-based thinking, which will replace preventive action in the new version of the standard. However, businesses do require risk management and mitigation plans, regardless. There are several common risk analysis tools, most of them listed in the Standard ISO 30010, which we strongly advise adopting for the sake of results effectiveness. Firms may want to use simple tools like SWOT (Strengths, Weaknesses, Opportunities and Threats) Analysis and nine box, or expand the usage of their FTA (Fault Tree Analysis) or PFMEA (Process Failure Mode and Effects Analysis) if you are already using these tools due to your industry or a customer requirement. By the way, the BCP (Business Continuity Plan) is another adequate tool for this information and actions.

  1. How should we document the context of the organization? Is the Quality Policy a good place to describe the new context of the organization?

No, the Quality Policy is not a good place for the context of the organization. The context of the organization can be documented, in the Quality manual, if the organization decides to keep it. While some documents and procedures will not be mandatory anymore they can be kept and serve as a good repository for evidence of compliance to new concepts brought by the new standard version.

  1. Continual or Continuous improvement?

Continuous never stops until perfection is achieved. While continual presumes a set target is to be achieved at a certain point or timeframe, and when achieved, a new target is set and the cycle continues with no concept of perfection. Therefore, Continuous is Theoretical (the continuous improvement program of the company) while Continual is Practical (a specific project of the company). The standard refers to continual improvement in several clauses.

This is an exciting time for Quality professionals. We have a lot of work ahead of us. Our next ISO 9001:2015 Forum Webinar is next Wednesday at noon and we will be addressing many of these questions and updating everyone about the publication. You can register here and find loads of resources on our ISO 9001:2015 Resources page. And, if you would like to learn more about the new version of the ISO 9001:2015 you can find the official announcement here along with other helpful information. As always Concentric is here to help with any questions you may have so please feel free to reach out.

ISO 9001:2015 Forum - August Webinar Recording is Posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more). Visit us online at http://acommoncenter.com for more information about our products and services.

Strong Correlation between Project Management and ISO 9001:2105

Strong Correlation between Project Management and ISO 9001 2015Our General Manager US and Managing Director SA had the pleasure of giving a presentation to The Citadel on Project Management and its correlation to ISO 9001:2015. It was great information and bridges the gap between the two. We thought you would like to see the presentation as well. Please feel free to download the PDF of the presentation slides here.

As always if you have any questions or would like to find out more about how Concentric can help your organization don't hesitate to contact us at info@cmsicharleston.com.

ISO 9001:2015 Forum - July Webinar Recording is Posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO 9001, ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more). Visit our ISO 9001:2015 Resources page for more webinars and key links to resources.

Quality Minds Online Prep Courses

Quality Minds Video Training

Quality Minds is an online training series presented by Concentric. These courses are designed for professionals aspiring to pass a certification exam given by the American Society of Quality (ASQ). After successfully completing a course, you will better understand the body of knowledge required for successfully completing the exam. This will allow you to apply a wide range of quality tools and concepts to your individual work situation.

This online course is an on-demand course where you study at your own pace. Each module contains a subject matter video with narration from Stephen Deas. Stephen is a Concentric Subject Matter Expert that was certified as a Quality Engineer in 1991 and a Six Sigma Black Belt in 2003.

Currently these courses are free to those willing to give feedback on the course materials regarding content and logistics on how the course materials should be distributed. Register below.[ezcol_1quarter]

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Eventbrite - Certified Six Sigma Green Belt Online Prep Course

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Eventbrite - Certified Quality Engineer Online Prep Course

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Eventbrite - Certified Quality Auditor Online Prep Course

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ISO 9001:2015 June Webinar

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

ISO 9001:2015 May Webinar is now posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry specific (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

ISO 9001:2015 Forum - April Webinar

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001). If you want to attend for ISO 9001:2015 - May Webinar register here.

Risk-Based Thinking with ISO 9001:2015

Risk Based Thinking with ISO 9001 2015, AS9100, riskIts projected that starting late 2015 many organizations (thru the quality professional) face the prospect of installing a risk management process into their ISO 9001:2015 quality management system. There are several questions to be answered: [bulletlist]

  • What is risk-based thinking?
  • How extensive does it have to be?
  • How much more work will this be?
  • Could I do this quick enough?
  • How do I get started?

[/bulletlist]

How extensive does it have to be?

Risk-based thinking will be new for ISO 9001:2015. In the aerospace industry, risk-based thinking has been required as a part of the AS-series of standards for years. The federal government and NASA also have standards addressing risk management. The AS9100 standard does not specify how to implement a risk management process.

How much more work will this be?

Actually, risk-based thinking could prove to be a very valuable process for your company. Risk entails a probability and impact of a loss or gain. Some useful risk publications include:

[bulletlist]

  • ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.
  • (Sept, 2012). NIST Special Publication 800-30 revision 1: Guide for conducting risk assessments.
  • Project Management Institute. (2013). A guide to the project management body of knowledge (PMBOK Guide
  • Prichard, C., & Tate, K. (2013). The risk management memory jogger.
  • ISO Guide 73:2009, Risk management - Vocabulary complements ISO 31000 by providing a collection of terms and definitions relating to the management of risk.
  • ISO/IEC 31010:2009, Risk management – Risk assessment techniques focuses on risk assessment.

[/bulletlist]

Can I do this quick enough?

Get started now! There have been some articles on risk-based thinking in Quality Progress (ASQ magazine). See Palmes, P. (Sept 2014). “A new look: 15 things you must know about the upcoming ISO 9001 revision”. Also, there are opportunities to network with experts through ASQ section meetings and through webinars.

How do I get started?

Seek advice from your Registrar about how they are directing their auditors to assess risk. You may want to write a new risk management procedure containing the concepts and body for a risk-based thinking process. It should follow the steps of the standard you want to use, such as NIST SP80-31. (The NIST standard and NASA procedures/ standards are free to the public.)

There will be more blogs on details of risk-based thinking to follow. Of course, Concentric is in place to be the external resource for you to succeed in implementing a good risk-based thinking process. For Glenn's full article register for our upcoming ISO 9001:2015 Forum - January Webinar. You can get update on all the changes including risk-based thinking. Register online here.

ISO 9001:2015 Changes: What It Means for You

ISO 9001, ISO 9001:2015, new standards, international standard changes, change management, planning for change, leadership, tips for preparing for change, QMS changes, quality management, quality systems By now, you’ve surely noticed the buzz around the upcoming changes to ISO 9001. ISO 9001:2015 is projected to be approved and released in Q4 of 2015. If you haven’t heard the buzz, then perhaps you need to subscribe to a blog or two, pick up Quality Digest or raise your head a bit from the rock you’ve been hiding under! All rocks aside, this revision looks to have several significant changes to the standard including the overall structure, basic terminology as well as what is NOT going to make the cut for the new release.

What you can do to start preparing now.

The reality is quite simple. Change happens whether we like it or not. Markets change. Businesses change. Customers change. Nearly everything changes. Most of the time we hate change. Our brains are just programmed that way. We don’t like what we don’t know, but we know what we like. As quality practitioners in particular, our job as change agents tend to be easier when WE are driving the change versus times when we are being asked to change ourselves.

This round of ISO 9001 revisions will undoubtedly be the most significant change to international QMS standard in the past 15+ years. We have seen a draft that gives a little understanding of what to expect with the changes ahead (ref. http://www.acommoncenter.com/iso9001_2015). But what are you doing with the proposed changes, if anything? Are you preparing your organization’s risk management efforts through the use of tools such as the FMEA? What is the appropriate amount of control needed for any process that effects the customer or “other interested parties” (do you know what that means)? Have you appropriated defined expected process outputs by ensuring proper management of customer-specific requirements?

I encourage you to set aside 30 minutes to review this Google+ Hangout video titled ISO 9001 revision - Conversation with Nigel Croft. Mr. Croft is the Chair of the Subcommittee revising the ISO 9001 standard (aka “the horse’s mouth"). Watch the YouTube video here.

Our philosophy is that it is better to be proactive than reactive. While we don’t currently know all of the requirements that will make the final cut, we do have several opportunities to begin to be proaction with the changes ahead. It is at least time to start discussing potential changes to the requirements in order to think strategically about potential impacts and resource needs over the next 3-5 years.

What are some of your thoughts on these big ISO changes that are being proposed in the current draft? How are you preparing for these proposed changes? Let us know in the comments and share with the community. And if you are interested... keep up to date with our upcoming forum and online discussions in September.

ISO 9001:2015 Webinar by IRCA

We would like to invite you to The International Register of Certificated Auditors (IRCA) and CQI’s free webinar on the ISO 9001, generously sponsored by Qualsys. This webinar is a unique opportunity to find out the implications of the changes in light of the recently released Draft International Standard (DIS).ISO Standards Development Sequence

IRCA’s Technical Manager Richard Green will present:

• The revisions timeline and the most significant changes to date • The drivers for change: why move away from the 2008 version? • The importance of Annex SL • How it will affect auditors and quality professionals

Register for the webinar here: http://view6.workcast.net/register?pak=3817722570763174

The webinar will be broadcast on Friday 20 June at 9am (UK time) or 2pm (EST) and will last for approximately 60 minutes.

During the webinar, you can type in your questions. Experts will be available to answer as many as possible during the event. You can also email your questions to mailbox@irca.org in advance of the webinar.

If you can’t attend the live event, the webinar will be available to watch afterwards on the irca.org website.

We look forward to seeing you on the 20th!

Posted By Mayuko Tanno, IRCA Marketing Team

2014 Training Schedule

Lead Auditor Training, ISO 9001:2015 & Management System Academy

Sick of this crazy winter weather? Why not plan a trip to sunny Charleston, SC all while gathering the skills needed to improve customer satisfaction and the process performance? We have just released our 2014 dates for classes, forums & our NEW Management System Academy. As you make your 2014 organizational and professional development plans, we hope that you will consider us as a partner in helping you reach the next level of performance. Be it in a public class, onsite or via an online course, we hope that you will join us in 2014!

Register and pay by Friday, February 14th and save BIG on our March ISO/TS 16949 Lead Internal Auditor Course. Pre-pay by February 14th using promo code "3FOR2" and when you SEND 2 STUDENTS, THE 3rd STUDENT IS FREE!

2014 Public Classes

March 11th-14th  |  Charleston, SC  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs) 

March 21st  |  Charleston, SC  |  9am-12pm Forum on expected changes to ISO 9001:2015 (Part II)

Eventbrite - ISO 9001:2015 Forum March

September 19th  |  Charleston, SC  |  9am-12pm Forum on expected changes to ISO 9001:2015 (Part III)

Eventbrite - ISO 9001:2015 Forum September

September 23rd-26th  |  Charleston, SC  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs)

December 9th-12th  |  Location TBD  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs)

Custom-fit educational solutions based on your specific needs

We believe that customizing your training plan should be simple and completely suitable to your specific needs. We developed the Management System Academy with this in mind. Based on budget (time & expenses), you pick the courses & learning method that works best for you. Itsyour professional development. Make the most of it. Let us help you build the right plan for you and your team. Contact us today to learn more about Management System Academy.

CHOOSE YOUR LEARNING METHOD 1-on-1 Personal Training Onsite Consultation & Mentoring Web-based Classes Video & Tele-Conference Onsite Classes & Workshops Public Classes & Workshops Purchase Course Materials for Self-Study or Train-the-Trainer

Forum on changes to ISO 9001:2015

Calling all Quality Professionals | Forum on Changes to ISO 9001:2015

Quality Professionals from Charleston, SC and the surrounding region are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum will be the first in a series of updates from local subject-matter experts aimed at assisting regional organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

Let the voice of your organization be heard

We will also be joined by Denise Robitaille, core member of the United States TAG (Technical Advisory Group) to discuss the latest Committee Draft, global feedback thus far and the next steps in the updating process. Her participation in this forum also allows each participant to voice their questions, comments or recommendation related to proposed changes.

AGENDA
8:30am    Check-in & Networking (Light breakfast buffet included)
9:00am    Introduction
9:15am     Keynote presentation by Denise Robitaille from US TAG
10:00am  Overview of significant changes
10:15am   Industry-specific breakout sessions
11:00am  Participant Voice of Customer (VOC) feedback for US TAG
11:15am   Recommendations for action moving forward
11:30am  Adjourned (end of forum in conference space)
Noon        Lunch discussion with panelists (interested attendees are invited to an open lunch at their own expense in the restaurant)
 
LOCATION
Harbor Breeze (next to Omar Shrine Temple)
176 Patriot's Point Blvd
Mount Pleasant, SC 29464
(843) 606-2110
 

Denise Robitaille HeadshotAbout the Keynote Speaker:  Denise Robitaille is the author of The Corrective Action Handbook and The Management Review Handbook, as well as numerous articles on quality. She is a consultant, writer and trainer.  Denise is also a RAB Certified Lead Assessor and CQA.  Much of her work involves assisting companies implement and maintain ISO 9001 systems.  An international speaker, she has given talks on a variety of quality issues. Denise is a member of the executive committee of ASQ Boston Section and an instructor for the ASQ Boston Education Program. Her work has encompassed companies in a variety of markets, including machine shops, printed circuit board industries, bio-pharmaceutical devices, packaging industry, distributors, navigational instrumentation, and power transmission manufacturing. She holds a Bachelor’s Degree from the University of Massachusetts at Amherst. Eventbrite - ISO 9001:2015 Forum