Correlation Matrices

With the official publication of the ISO 9001:2015 International Standard merely weeks away, several veteran auditors and ISO 9001 implementers will be faced with another round of re-learning the new clause structure. Since 1995, I've looked at these various international standards more than any other document in my lifetime. A large portion of the 1987 and 1994 versions are still alive and well in the back of my mind. Memorizing the majority of these standards makes for a tough paradigm shift when a new version comes along - the shifting of the deeply-rooted paradigm. The Bibliography section of the ISO 9001:2015 FDIS (final draft international standard) features a rich source of references, citations and online resources to assist with your transition from 2008 to 2015. One tool that we here at Concentric find particularly useful (i.e. it has been with me daily since the FDIS release) is a document called the Correlation Matrices between ISO 9001:2008 and ISO 9001:2015.

Correlation Matrices

Use this tool to help in the mapping of existing processes, documentation and records (now called "documented information") in order to see how the new standard aligns with your organizational structure. For those organizations that have used the 2000/2008 numbering scheme as the baseline for documentation numbering, note that there is no requirement stating that you have to renumber according to the new structure. In fact, we advise that you build your documentation around the unique processes and internal numbering structure, or other language, that makes sense to you. Until then, the Correlation Matrices can be a useful tool to aid you in your transition.

ISO 9001 Correlation_Matrices from TC176SC02

For other useful resources to assist with your transition, visit our ISO 9001:2015 Resources page featuring recorded webinars, key links, references and other free tools.

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

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.

ISO 9001 & Six Sigma Infographic

Certification and maintenance of ISO-based management systems (i.e. ISO 9001, 14001, etc.) is often a requirement for doing business with certain customers and sectors. While many organizations struggle to find value with respective their certification efforts, those that use international standards in conjunction with improvement tools such as Six Sigma and APQP wonder how they could have ran a business without a formal management system. Each organization must use the requirements and guidelines of various tools and methods that are most suitable to their own unique vision.

Visual communication through ISO 9001 & Six Sigma Infographic

The fine folks at Midlake Products up in the Buckeye state ("O.H.I.O." ...while moving your arms to form the letters, of course), have shared with us their ISO 9001 & Six Sigma Infographic. This visual tools is used at Midlake to outline how their operations, as well as other manufacturers, can grow their business by adopting quality practices and standards. We hope you enjoy this visual aid. Special thanks to Jim Moore for passing this illustration along for us to share with our readers.

ISO 9001 & Six Sigma Infographic

We are eager to receive feedback on the use of this infographic or other visual communications tools that you believe are of value. Comment below with a link on where our readers can find these additional tools. Perhaps you have a tool, blog or other message that you would like us to share with our readers in an upcoming blog? Contact us at

For more information about the ISO 9001 & Six Sigma Infographic or Midlake Products, visit them online at

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 Black Belt Online Prep Course

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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


Lean Leadership Online Training

Online Training Series

Lean Leadership  |  16 one-hour self-paced modules   REGISTRATION OPEN!

[ezcol_2fifth][/ezcol_2fifth] [ezcol_3fifth_end] Advance your career with LeanCor Academy’s online course, Lean Leadership: Building the Lean Culture.

This interactive professional development course enables all leaders to:


  • Leverage lean principles to become a more effective leader, manage people, and drive operational excellence.
  • Improve value stream processes that impact the organization.
  • Learn how to create action-driven measurement systems and build successful teams.


This self-paced, online professional development program allows you to decide when and where to learn.  The course includes 16 modules, each lasting about 1 hour.  Upon enrollment, you’ll have 16 weeks or 4 months to complete all the course. Instead of focusing just on theory, this course will dive deeper into the actual application of the material being presented. It’s based on our years of collective operational experience leading teams and implementing lean supply chains. You’ll be able to use what you’ve learned and see the results first-hand. [/ezcol_3fifth_end]

Self Paced Online Training





Price Per Student
buy $550 Register $520 Register $455 Register
Group Discount Rate
N/A 15% 20% 30%
Continuing Education Units Per Student (CEUs)
1.6 1.6 1.6 1.6

Need to know more first? Learn more about this course and its features here or download the PDF Brochure here.

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.

Lean Healthcare: Standard Work is Not So Standard

Lean Healthcare Standard Work is Not So StandardIn lean healthcare, it’s amazing how often standard work is missing. Observe the workers and note the variability of the processes. One shift does a task a certain way or an individual has developed their own technique; this variability in healthcare at times is seen as a badge of pride and honor. There are areas in healthcare where individuality can shine but in many areas, standard work should be imperative. One example of process variability that should have a healthcare facility concerned would be the sterilization/instrument decontamination area. If this area cannot produce a written standard work, then the instrument cleaning process more than likely is only as good as the last trainer. That should concern the surgeon as well as the whole operating room staff. Things as easy as labeling blood vials could use a standard work. Do you circle the date or write the date? Does the collector put three initials or just two? I bet most would say that’s all common sense, but do a Gemba and observe the variation. If there is a lot of variation in the simple but important tasks of labeling vials, then it can be assumed variation exists at some magnitude for the more difficult tasks of the decontamination process. Maybe its time to evaluate or start creating standard work. So how does the standard work get developed? One way is to research best practices.

  1. Write the standard work: By putting it in writing, it is more likely to become the standard and remain the standard.
  2. Train to standard work: No more as good as the last trainer. It’s the standard!
  3. Post it: You do not want, “out of sight, out of mind.”
  4. Audit: It enforces, “It’s the standard.”

Have the staff and subject matter experts involved from the start, writing the standard work. Communicating the “why” is paramount when developing and sustaining the standard work. Minimizing process variability which leads to process predictability is great for the patient, the provider and the payer.

Once the variability is gone, then true continuous process improvement can start.

Concentric has SMEs in Quality Healthcare so if you are looking for a healthcare quality assessment or training in lean in healthcare please feel free to reach out and see how we can help.

PRESS RELEASE: Concentric Congratulates Jim Thompson and the Compliance+ Team

Ronii Bartles Concentric

Concentric Congratulates Jim Thompson and the Compliance+ Team Compliance+ selected as part of CoHort 3 the Harbor Accelerator Program

Charleston, SC, January 29, 2015 — Concentric announced today that one of its affiliate start-up companies, Compliance+, has been selected by the Harbor Entrepreneur Center as one of eight companies for its CoHort 3 business accelerator program. Jim Thompson, the owner of both Concentric and Compliance+ was quoted by saying “I’m so pumped for this incredible opportunity”. CoHort 3 has officially already begun and Compliance+ is already hard at work.

As to why Jim and Concentric are excited about this opportunity for Compliance+, Jim says “Concentric was interested in developing a scalable digital product that would improve our consulting and training services. The majority of our team members are certified auditors, so it just made sense to create a mobile auditing checklist. With the wave of changes to ISO 9001 later this year, we know that this standard is where we want to be. With over 1.2 million companies certified to this quality standard globally, Compliance+ is a perfect fit for our initial focus.”

For additional information or to schedule an interview with Jim Thompson, please contact Ronii Bartles at (843) 452-5259 or e-mail Ronii at

Concentric is a Quality Resource HUB based out of Charleston, SC. We have partnered with companies to provide you with a holistic solution for your Quality Management Systems. Though products, trainings and implementation resources, Concentric helps organizations perform better through requirements management, process design, management system implementation, lean operations, problem solving and ISO certifications (i.e. ISO 9001, ISO 14001, OHSAS 18001, ISO/TS 16949, AS9100 series, ISO 27001, ISO 50001 & others). We are built up of subject-matter experts (SMEs) in Six Sigma, Lean, ISO standards, business law, operations, leadership and strategic planning. We work for you. You will increase your competitiveness and profitability when working with our SMEs because we provide consultation and training services that result in reduced waste and risk, increased customer satisfaction and increased profitability.

Compliance+ is a cloud­based mobile application used to improve process performance, meet requirements of industry standards and improve bottom line.

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Job Posting: Quality/Reliability Maintenance SME

Concentric is in need of a Quality/Reliability Maintenance subject-matter expert to provide a module-based curriculum for Reliability Maintenance Certification. The certification will be part of a Workforce Continuing Education (CE) program suitable for university and technical college application. Scope of Project: Vibration Analysis a. Cause and Effect of machine vibration b. How to measure vibration c. Establishing a baseline d. Hands-on

Thermography a. Establishing a baseline b. Equipment for measuring c. NFPA 70E d. Hands-on

Laser Alignment a. Gear Alignment b. Pulley Alignment c. Shaft Alignment d. Hands-on

Oil Analysis a. Viscosity b. Contaminants c. Lubrication selection

Precision Bearing installation and rebuild a. Overview of bearing selection b. Contamination c. Proper installation techniques d. Hands-on

Hydraulics and Pneumatics a. How the systems work b. Troubleshooting c. Hands-on

Preventative Maintenance and DFMEA for Reliability a. Building a PM system that focuses on cost effectiveness i. Machine life expectancy 1. Rebuild or replace ii. Critical components iii. Inventory iv. DFMEA and how it pertains to maintenance

The purpose of the project is to build a program focusing on Reliability Maintenance. The person(s) would be responsible for the course content per the outline above. The hands-on part of the class should represent 25 - 35% of each class with predefined exercises.

Charleston’s Talent Demand

In mid-2014, The Charleston Metro Chamber, along with several other local community and higher education organizations, commissioned and participated in a study to compare the higher education offerings in our region with the needs of our employers. National consultants from Avalanche Consulting, as well as the Council for Adult and Experiential Learning (CAEL) worked to identify the region’s higher education gaps. The results of the three phase analysis will help determine where potential gaps exist between the output of local educational institutions and the skills needed by employers, as well as, how to fill both the short- and long- term demand for workforce and skills in the Charleston metro region.

View Report:

One of the strategic focal points for the Charleston ASQ Section in 2015 will be on the regional needs for talent, and how the section and it’s members can help to support this need. In order to fill the gaps and provide the appropriate level of talent for regional businesses, industry leaders and associations alike must come together quickly.

In the fall of 2014, various projects were kicked off by members of the ASQ Charleston Section Leadership, including participation on the CEJC (Charleston Engineering Joint Council), presentation to SME (Society of Manufacturing Engineering) and a presentation to the Citadel’s School of Engineering. That presentation can be viewed here: The importance of engineering, systems & quality for Charleston’s future

For more information on how you can contribute to the talent demand efforts, contact or

Reposted from ASQ Charleston

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?


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:


  • 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.


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 14001: Morphing Towards Quality

ISO 14001 Morphing Towards QualityThe new ISO 14001 version is currently in a draft form and voyaging through the standard approval process. This Standard provides the criteria needed to establish an Environmental Management System (EMS). Reports are in conveying that the Standard will be rolled out in 2015, and there are many changes in store for the Standard, and for those that apply the criteria to their business processes. As observed in the 2004 version, we are seeing a general movement towards the elements in the ISO 9001 quality systems Standard. There are even reflections of the Baldrige Criteria for Performance Excellence in this new version. I believe this is a wonderful improvement, as a company’s ‘big picture’ viewpoint is needed to put things into their proper macro perspectives. A major change in the structure of the ISO Standard will occur, as all new ISO standards will follow the Annex SL (Guide 83) elements approach. The design of this new structure involves the institution of 10 elements within all new ISO standards. There will also exist sub-elements to many of the 10 elements. This could (and probably will) require a restructuring of an organization’s ISO 14001 architecture to accommodate the new element numbering scheme.


It is expected that there will be more of an emphasis on aligning business strategies (strategic planning and deployment) with deployment of the Standard’s elements. This move should properly align an organization’s environmental policy with their business strategy (a very good thing!). Additionally, there will be even more of a focus on the business environment that a company operates in as relates to an organization’s environmental aspects and impacts. This change will require a greater emphasis on the prevention of pollution and continual improvement.

Value Chain

Ensuring process steps add value to the internal and external customers is paramount in any organization. The new version will include a lifecycle perspective to ensure all phases of the products’ and/or services’ ‘life’ are being considered. Value-added activities will include: design, development, purchasing, marketing, sales, etc. By considering these additional inputs, the perspectives of stakeholders will have an increased emphasis in ISO 14001 program improvement.

Legal and Other Requirements

An ‘approach’ methodology, similar to the expectations seen in the Baldrige Criteria, will be prevalent in the new standard. This means the organization will describe their systematic process for achieving legal compliance. Also, an increased emphasis will be placed on compliance reporting, transparency, and accountability.

Objectives, Targets, and Programs

Continuous improvement programs will also be aligned with the company strategy, and SMART goals should be used (Specific-Measureable-Attainable-Relevant-Time-bound) to execute the strategy. Along with current considerations, the new Standard will factor in the following for the selection and prioritization of continuous improvement programs: risk analysis, sustainability, climate change, biodiversity, ecosystem restoration, etc.


We’ll skip this; it’s not THAT important. Just kidding! Communication (or the lack thereof) is typically the number one complaint from workers at any organization. The new Standard will require the organization to develop a communication strategy that addresses communications with all stakeholders and external parties. This includes identifying the needs and expectations of these stakeholder groups. Also, in line with the Baldrige Criteria, a systematic process will be needed to engage stakeholders (as applies to environmental issues).

Pause -- Okay, the term ‘will’ has been used quite a bit so far and the new version hasn’t even been released, so, things may still change regarding these new requirements. (Stay tuned.)

Operational Control

Many new factors have been introduced in this area. We’ll restate (and reemphasize) value chain and lifecycle thinking here. Also, the upstream and downstream processes will be addressed, along with the organization’s approach to design, marketing, and procurement.

Monitoring and Measurement

Finally! An increased importance will be placed on the use of performance measures (KPIs/PIs, metrics, performance measurement)! As I always say (along with many others), “What gets measured gets managed, and what gets managed gets done!” When organizations put measurement as a top priority, accountability and efficiency increases, process deficiencies are identified, and the right things get corrected – those with the greatest impact on profitability and long-term sustainability.

The final rollout of ISO 14001:2015 is almost here so get ready! As a result of the international meeting that took place in Panama over the 2014 Memorial Day weekend, a Draft International Standard is going to be released by the Technical Committee (TC) 207 for public review and comment this coming Fall 2014. The next international meeting is scheduled for February 2015 in Tokyo, and as an outcome of that meeting TC 207 is expecting to issue a Final Draft ISO 14001 International Standard, with the new International Standard currently scheduled for issuance in June/July 2015. So, that’s the update.

Unofficially, it is anticipated that the timeline for transitioning from ISO 14001:2004 to the new version will be three years. This duration should allow organizations adequate time to align with the new ‘High Level Structure’ (Annex SL, 10 elements) and the resulting new requirements.

Does your organization follow the ISO 14001:2004 standards? How are you preparing for the changes? What areas are your still looking for help with? Leave us a comment and let’s all share our experiences with the changes so that we can learn from each other. We might even feature your questions in our upcoming FREE ISO 9001:2015 Changes seminar on September 19th. Register here.

3 SEATS LEFT for ISO/TS 16949:2009 Internal Lead Auditor (32hrs)

Folly Beach - Charleston BeachesLast call for our Fall 2014 Automotive Quality Series with our ISO/TS 16949:2009 Lead Internal Auditor Course. We have THREE seats remaining. The courses will be held at the aLoft Charleston Airport & Convention Center. Learn by day. Hit the beach after class. Why not make the most of your professional development? Don't just take a class - experience business differently. Price includes all course materials, parking, wifi, light breakfast, lunch & afternoon snacks. Dozens of food and entertainment options are within blocks from the hotel.

Register & pay online here or by calling 843.469.8279.

Description:   This advanced internal auditing course caters to the full spectrum of auditor responsibilities – from process auditing to audit program management. This course will teach you the fundamental tools necessary to conduct audits using the automotive process approach while providing vital strategic information to top management. Case studies and scenarios make this course fun. If you are looking for a Lead Auditor course for internal processes or supplier quality development, look no further. This course is for you. NEW: We will also discuss the TS Rules 4th Edition and draft of the proposed ISO 9001:2015 standard. Get a jump on what to expect with the changes and it’s potential effect on your management system implementation.

Designed for:  Audit Program Managers, Lead Auditors, Advanced Audit Team Members, Supplier Quality Engineers & Managers, Process Improvement Managers, Quality Directors, Continuous Improvement Managers, Organizational Development Directors, Management Representatives

This course meets or exceeds the training requirements for:

  • Ford Customer-specific Internal Quality Auditor requirements
  • General Motors Customer-specific Internal Quality Auditor requirements

Length:  4 days/32 hours   CEUs:  3.2    A certificate will be given upon successful completion of all course requirements.

The instructor for this course will be Jim Thompson, President of Concentric and Exemplar Global (formerly RABQSA) Accredited QMS Lead Auditor. Register online here, contact us by email at or by calling 843.469.8279.

Day 1
▪    Introduction & Welcome
▪    Gathering of Student Goals & Expectations (CSRs)
▪    Overview of ISO 9001 & ISO/TS 16949 – Part I
▪    Selling QMS to Top Management
▪    The Automotive Process Approach
▪    Overview of ISO 9001 & ISO/TS 16949 – Part II
Day 2
▪    Use of Turtle Diagrams for Process Mapping
▪    ISO/TS 16949 Requirements – Clause 4.0, Quality Management System
▪    ISO/TS 16949 Requirements – Clause 5.0, Management Responsibility
▪    ISO/TS 16949 Requirements – Clause 6.0, Resource Management
▪    Overview of AIAG Core Tools (APQP & CP, FMEA, MSA, PPAP & SPC)
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
Day 3
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
▪    ISO/TS 16949 Requirements – Clause 8.0, Measurement, Analysis & Improvement
▪    Audit Objectives & Auditor Attributes
▪    Process Auditing Breakout
▪    Writing Audit Findings – NCRs & OFIs
Day 4
▪    Reporting Audit Findings
▪    CAPA – Corrective Action & Preventive Action
▪    Closing Out Audit Findings
▪    Closing the Audit Cycle
▪    Evaluating Audit Effectiveness
▪    Final Review/Q&A
▪   Student Goals & Expectations (Reviewed)
▪   Course Examination

Lean: A Prescription for Improved Healthcare

Lean HealthcareBased on the common symptoms of waste, delays, errors, redundancy and lack of employee engagement, Healthcare has begun looking to “Lean” methods for the solution. The symptoms were exacerbated with changes in financial reimbursements, the public reporting of quality measures, social media, and the need for employee engagement in healthcare as well as the growing demand from consumers for a better product. For healthcare organizations to remain competitive in the coming years, lean as the treatment plan must become the culture to allow healthcare to flourish. Optimizing financial reimbursements can be thought of as the lifeblood of the healthcare industry. In the past, reimbursements were based on volume without regard to outcomes and often at a higher price. Studies have shown that higher prices for a procedure do not translate to better outcomes. Some practitioners refused to use “Best Practices” because standardization of treatment had not been established and the services were disjointed or described as siloes. For certain diagnoses, if an individual was hospitalized a second time in less than 30 days for the same illness, reimbursement for the second hospitalization maybe denied. All this changed when reimbursements from some payers were established based on best practices and outcomes.

Over simplified but the point remains, for best outcomes the treatment must be standardized, coordinated and thorough with a clear plan after discharge. Without these lean principles in place the financial losses quickly accumulate. Currently, the discharge plan should start the moment the patient is admitted to decrease the chance of a readmission. The lean approach includes such things as checklists, decrease delays in starting antibiotics, standardizing treatments to include best practices and following a plan on discharge that includes access to their treating physician with minimal delays. This is good for the payer, good for the hospital and great for the patient.

Also, Medicare requires public reporting of certain healthcare metrics. These metrics measure a patients’ perspective of their hospital care, if care was timely and effective, as well as the readmission rates for specific diagnosis and certain complications. Having the information available to the consumer encourages more informed decisions and the ability to shop for healthcare based on the metrics. Currently, payers and vendors are probably the biggest user of this information. Consumers will be slow to change but change will occur. Using standardize processes, eliminating waste and utilizing the voice of the customer tools will enhance the metric scores and make it a truly patient centered experience.

Reported metrics for hospitals can be found at

Similar to most other industries, social media has become relevant. A large portion of the population admits to using social media to guide choices of physician and/or hospital. Wait times, duplication of questions and poor quality provides the substance for social chatter that can reach hundreds of people in a short length of time. Through scripting, eliminating waste and focusing on the value added services, consumer chats turn to recognition of exceptional service. Defining exceptional service should be a priority in the continuous improvement process.

Marketing says, “no one ever remembers the status quo,” so plan to excel to get noticed because people talk and they talk on social media.

Finally, employee engagement can determine the success of Lean. Research shows that increasing employee engagement has a direct correlation on the quality of service. A facility looking to increase quality because it leads to higher reimbursement and increased customer happiness would seem to be a “no brainer.” Lean provides the mechanism for employees to contribute, problem solve and align to the values and expected behaviors of a facility.

[Tweet "“Lean” appears to be right treatment plan for the healing of the healthcare industry."]

As with any treatment plan, the user must determine if it’s right for them. If waste, delays, duplications and poor work practices are evident on your next visit to a healthcare provider, then you might want to ask if this is the right facility for you or is this a “Lean” job opportunity.

A lean practioner should be hearing the chants of process mapping, voice of the customer, waste elimination, standardizing, scripting, checklist and many other lean tool opportunities. All of these lean tools lead to increased reimbursements, better publically reported healthcare scores, better social chatter and improved engagement of employees.

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. 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.

OHSAS 18001 being replaced by ISO 45001

Let's begin by clarifying that ISO 18001 currently is a standard, but it has nothing to do with Occupational Health & Safety. ISO 18001 is actually a standard for radio frequency identification.

BS OHSAS 18001

The 18000 series of standards were developed outside of the world of ISO (International Standards Organization) as a British Standard (BS), therefore the official reference to the standard a site can be registered to is "BS OHSAS 18001". Furthermore, "OHSAS" is an abbreviation for Occupational Health & Safety Advisory Services in reference to the Occupational Health & Safety Advisory Services Project Group. This group first published the multi-national standard in 1999. OHSAS 18001 represents the standard with requirements for registration where OHSAS 18002 is the guidance document for establishing, implementing or improving a management system.

The purpose of OHSAS 18001 is to provide organizations with standard elements for developing a formal health and safety management system. The layout has been updated in recent years for easy integration with the ISO 14001 Environmental Management System standard. The OHSAS & EMS standards are nearly identical, the greatest difference being the elements that an organization manages, controls and improves. The term frequently used to describe an integrated system encompassing both OHSAS & EMS elements is Health, Safety & Environment (HSE).

Assuming planned timelines are adhered to, the OHSAS 18001 standard should be retired and replaced by ISO 45001 in late 2016 resulting in the release of "ISO 45001:2016".


“Annex SL” is, in short, a standard for how standards are developed. Annex SL contains rules governing the development of all ISO management standards. The structure of future standards, including ISO 9001, ISO 14001 and ISO 45001 will be as follows:

Annex SL management system integration ISO 45001

ISO 45001

The ISO community and HSE practitioners are hopeful for a more global adoption and recognition of the health and safety standards once published and released. It is estimated that poor health and safety management costs represent approximately 4% of the Global Gross Domestic Product. Proper management of health and safety elements is not only a recommended approach to a socially responsible organization, doing so typically has significant positive financial impacts.

Projected timeline & stages for standard development: OHSAS 18001 transition to ISO 45001

To monitor the progress of ISO/PC 283, the Technical Committee working together to publish the ISO 45001 standard, visit their page online.