38 Required Records of ISO 9001:2015 (20) & IATF 16949:2016 (18)

QMS - ISO 9001:2015    

    0    4.4 - Confidence (as needed)
    1 - Accurate measurement resources
    2 - Basis used for calibration
    3    7.2 - Competence of people
    4 - Requirements review
    5    8.3.2 - D&D Requirements met
    6    8.3.3 - D&D Inputs
    7    8.3.4 - D&D Controls
    8    8.3.5 - D&D Outputs
    9    8.3.6 - D&D Changes
    10    8.4.1 - External provider (supplier) monitoring
    11    8.5.2 - Unique ID
    12    8.5.3 - Unsuitable customer or supplier property
    13    8.5.6 - Changes to product or service
    14    8.6 - Authorized release
    15    8.7 - Nonconformity & action authority
    16    9.1.1 - QMS performance evaluation
    17    9.2.2 - Audit program results
    18    9.3.3 - Management Review
    19    10.2.2 - Nature & action of nonconformities
    20    10.2.2 - Corrective action results

Automotive QMS – IATF 16949    

    21 - Risk analysis
    22 - Contingency plans
    23 - MSA
    24 - Calibration/verification records
    25 - Calibration/verification validity of previous measurement results
    26    7.2.3 - Internal auditor competency
    27 - QMS documentation - series of documents list
    28 - Engineering specifications
    29 - Review of requirements for products & services - supplemental
    30 - Development of product with embedded software
    31 - Product approval process
    32 - Automotive product-related software or automotive products with embedded software
    33 - Second-party audits
    34 - Verification of job set-ups
    35 - Identification & traceability - supplemental
    36 - Control of reworked product
    37 - Control of repaired product
    38 - Monitoring & measurement of manufacturing processes

New IATF 16949 Documented Policies and Documented Processes

3 Documented Policies required by IATF 16949:2016
#     Clause     Requirement
1       Corporate Responsibilities policies, including (minimum)
                         a.    Anti-bribery Policy
                         b.    Employee Code of Conduct Policy
                         c.    Ethics Escalation (“whistle-blowing”) Policy
2      5.2.1        Quality policy
3     Record Retention policy

21 Documented Processes required by IATF 16949:2016

#    Clause        Requirement
1       Product safety
2    Calibration/verification records
3    7.2.1    Competence - supplemental
4    7.2.3    Internal auditor competency
5    7.3.2    Employee motivation and empowerment
6    Engineering specifications
7    Design and development of products and services – supplemental
8    Special characteristics
9    Supplier selection process
10    Type and extent of control - supplemental (outsourced processes)
11    Statutory & regulatory requirements
12    Supplier monitoring
13    Control of changes - supplemental
14    Temporary change of process controls
15    Control of reworked product
16    Control of repaired product
17    Nonconforming product disposition
18    Internal audit program
19    10.2.3    Problem solving
20    10.2.4    Error-proofing
21    10.3.1    Continual improvement - supplemental


The Ultimate Problem Solving Roadmap

Roadmap for selecting the right problem solving tool

A rational for problem solving by Sidney Porto & Jim Thompson

When the only thing you have is a hammer… everything looks like a nail. But a hammer isn’t always the tool you need to get the job done right. A problem that we see far too often is the use of the wrong tool, or the SAME tool, for each problem or opportunity to improve a product or process.

With enough experience, solving problems can be intuitive. But only through a commonly understood problem solving methodology is it possible to implement effective solutions for a problem or opportunity at hand. Although we all make small corrections every single day, effective implementation of corrective action through in-depth problem solving take correction to a different level – time, money and discipline included. So how do you know which tool to use for each unique problem or opportunity?

Step 1 – Clearly identify the problem

While PDCA (Plan, Do, Check, Act) is common in the world of management systems and problem solving, Robert Kettering said it best: “A problem well stated is a problem half solved.” Instead of using the PDCA Cycle, we frequently use the acronym IDPDCA. ID = Identify. You can have the best root cause analysis and problem solving techniques in the world, but if you’re solving the wrong problem (i.e. low impact or low return), then your efforts may not be worthwhile. Use the worksheet in Figure 1 - 5W2H Problem Definition Worksheet to capture the who, what, when, where, why, how and how many of the issue observed.

  Figure 1 - 5W2H Problem Definition Worksheet

Figure 1 - 5W2H Problem Definition Worksheet

Step 2 – Prioritization based on impact

  Figure 2 - Impact Funnel

Figure 2 - Impact Funnel

Problems, risks and opportunities come in various forms of impact and complexity. The impact of an issue can span from a loss of life or limb through something that simply needs to be done to make the lunch room smell better.  Tools ranging from a SWOT Analysis (Strengths, Weaknesses, Opportunities and Threats) to a C&E Matrix (Cause & Effect) or the FMEA (Failure Modes & Effects Analysis) can assist in giving a value to an issue. The bottom line is this – you can’t do everything at the same time. This of this step as a funnel. You can put every issue in the world into the funnel, but you only have the resources to focus on a few at a time. See Figure 2 – Impact Funnel.

We recommend ranking issues from, say, 1 to 10, using 2 to 3 variables such as cost, impact to the customer and ease of implementation. In some cases, such as QMS requirements in the automotive sector (i.e. IATF 16949:2016), prescribed variables such as severity, occurrence frequency and detection risk are all multiplied together for what is called a risk priority number (RPN) to promote focus on the highest risk characteristics.

Step 3 - Selecting the correct primary tool

  Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity illustrates the relationship between the issue type, issue impact or significance, and the recommended problem solving tool. Simple tools should be used for minor problems that are easy to solve, and where the cause and/or solution may be apparent. Comprehensive tools should be used for complex issues to get to the bottom of what is causing, or may cause, the issue at hand. And comprehensive set of tools should be used for chronic issues such as the methodology found in Six Sigma. Most issues will fall into the category of “solutions unknown” or “complex” and therefore should be solved using the A3, FTA (Fault Tree Analysis), 8D (disciplines) or a variation of two or more of these primary tools.

Step 4 - Selecting the correct secondary tool

In our fourth step, we structure the problem-solving resolution into 3 distinct lanes:

  1. Problem definition
  2. Root cause(s) identification
  3. Corrective action implementation

This sounds simple because it is simple. All fundamental requirements such as containment, validation of alternatives and effectiveness checks will fit into one of these three lanes on the roadmap. See Figure 4 – Roadmap for Problem Solving.

  Figure 4 – Roadmap for Problem Solving.

Figure 4 – Roadmap for Problem Solving.

During the root cause analysis phase, ensure that any data being gathered and analyzed is accurate by conducting a measurement system analysis (MSA). Outputs and effective solutions are only as good as the integrity of the inputs and reasonable bias or measurement error (ideally < 10%).

Like Step 3, the effectiveness of your problem-solving results is highly dependable of the set of secondary problem solving tools you have selected. Figure 4 also suggests which secondary tool(s) to use as well as the sequence of usage for optimal results.


Do you feel this roadmap can guide you on most of the formal problem common solving resolution? Want to learn any specific tool described here. Concentric Global counts on a team of subject matter experts in the USA and South America that can help you on this arena.

Download white paper (PDF)

Purchase Problem Solving Tools & Templates

Do your customers hate you?

Here's a quick challenge and reality check to see how you're doing thus far with your organizational improvement goals.  Take an honest look at your customer-facing processes as if you were the customer. Better yet, actually WALK the customer trail. Put yourself in the driver's seat as if you are a customer and analyze the overall experience.  I'm not talking about "...but our company's internal data for defects per million shows that we're making pretty good parts".  I'm talking about taking a long, hard look at customer perception.  How does your customer perceive the overall quality, service and ease of doing business associated with their relationship with you? Have you seen the television show Undercover Boss? Yeah... do that. Customer satisfaction is not always about facts, figures and statistics.  Sometimes it's all about asking this simple question:  "Dear Mr. Customer - How likely is it that you would actually take the time to recommend me to a friend or colleague?" Think about all of the facets of going out do dinner. You judge your satisfaction with the restaurant based on 

Do you measure customer satisfaction by the number of customer complaints you have?

The lack of a formal customer complaint is not a reliable indicator that the customer is satisfied.  Customer complaints are more often a sign that the customer is so extremely dissatisfied that they feel obligated or angry enough to tell you about it.  What about the other portion of customers that simply turn and walk away?  In most business circumstances, by the time a customer has left you, its too late to regain their trust.  You've lost them and they're not coming back.  In fact, there are a certain set of customers that will spend their nights and weekends talking trash about you, your company and their horrible experiences in dealing with your sorry butt.

Ok... now that I've made you feel like a complete loser, let's at least have a little fun here.  Sit back, grab your cup of coffee and feel the pain associated with being a dissatisfied customer.

Want to gauge your customer's perception of you?  Here are some tips and techniques that we've seen work out in the real world:

SIMPLE & LOW COST:  Ask your customer to help you in getting 100% by partnering with you on the solution of 100% satisfaction.  Rather than asking "Is everything ok?", try asking "What would I have to do in order to receive an A+ or 100% rating?"  This approach invites the customer to give you pointers on improvement rather than the traditional invitation for feedback (i.e. "Y'all doing ok?").  By making it an "Us (you and your customer) against them (bad grades)" you create a partnering perspective with your customers in order to solve the puzzle (how to get an A+) together.

MIDDLE OF THE ROAD:  Use a process to measure how likely your customers to "promote" your organization called by using a grading scale called the "Net Promoter Score".  Learn more about this process here.

NPS-Definition copy

COMPLEX & HIGHER COST:  If you are in an organization that can spare a few more bucks, consider using a product like Online Survey Software from Qualtrics.  It is complex software on the back end but simple for your customers to complete on the front end.  Questionnaires and data from survey results are kept on a cloud for simple analysis, quick feedback on-going monitoring of key metrics.  www.qualtrics.com/survey-software-video

Transition Upgrade Packages

Transitioning to ISO 9001:2015, ISO 14001:2015, IATF 16949:2016 & AS9100:2016 and more...

Clients and their needs vary from one end of the spectrum to the next. We've worked with clients on simply providing a 1-hour overview of a technical specification or standard all the way to creating an entirely new system from the ground up. Regardless of whether the implementation work is done using internal or external resources, we've identified these distinct 10 steps that must be taken to get from start to registration... and beyond. (Please... we hope you go well beyond certification.)

Step 1 - Gap assessment
Step 2 - Implementation planning & action assignments
Step 3 - Deployment of Management System Architecture (12 Tools)
Step 4 - Documentation creation & modification
Step 5 - Organization training & development
Step 6 - Internal auditing & program development
Step 7 - Management review facilitation & improvement
Step 8 - Readiness review
Step 9 - Guidance during 3rd-party auditing
Step 10 - Assistance with closure of post-audit findings

Need assistance transitioning to the latest standards? Let our experts and quick transition tools get the job done on-time, on-spec and on-budget. We focus on integrating ISO standard requirements with your existing business management processes. We specialize in integrated management systems and overall organizational excellence using a SQDCME approach. We teach process owners how to own with confidence.

2-Day Transition Packages starting at $3,195

  1. Step 1 - Gap assessment (2 days)

5-Day Transition Packages starting at $7,995

  1. Step 1 - Gap assessment (2 days)
  2. Step 2 - Implementation planning & action assignments (2 days)
  3. Step 5 - Training & development (1 day)

10-Day Transition Packages starting at $15,995

  1. Step 1 - Gap assessment (2 days)
  2. Step 2 - Implementation planning & action assignments (2 days)
  3. Step 3 - Deploy of MSArch Tools (2 days)
  4. Step 4 - Documentation modification (1 day)
  5. Step 5 - Training & development (2 days)
  6. Step 6 – Internal auditing & program development (1 day)

Chat with us below for question or more info.

Pursuing Excellence Through Workforce Development

In an article published by SC Manufacturing Magazine titled Quality - A Top Business Priority for Manufacturers[1] spoke to me as a quality and process improvement practitioner. One statement that I had earmarked was, “Manufacturers across value chains face competitive and market pressures, customer demand, and complex products and value chains that necessitate a broader approach to how products are designed, delivered, and serviced.” A focus on cost reduction or product quality alone is no longer enough to compete in today’s global market place. Just as cup holders and electric windows are no longer enough to win you over as an automotive consumer, organizations must pursue excellence in more aspects than ever in their quest to produce happy and loyal customers. What is the key to quickly improving organizational performance you ask? Optimization of the performance of each player on the team.

I remember as a kid reading about how a man literally ate an airplane[2]. How did he do it? One tiny bite at a time. This same concept can be applied to the sum of individual performance and its effect on overall organizational performance. The bridge that connects individual performance to optimized process performance, and on to overall organizational performance, is workforce development. Figure 1 illustrates the path from individual development plans (IDP) to organizational excellence (OE).

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


Celebrating 13 Years!

Happy Anniversary Concentric!

To celebrate our 13th birthday we are launched a new website! We are still working through some content to bring you a better experience but you definitely can get the feel for who we are and what we do.

Today we all took a little time out of the day for a celebratory lunch to reflect on our successes.

Look at how good we look? ;)

FOR IMMEDIATE RELEASE: Concentric at the BIOMEDevice

FOR IMMEDIATE RELEASE Contact: Ronii Bartles, Marketing Manager Concentric Management Systems, Inc. (843) 452-5259 | acommoncenter.com ronii.bartles@cmsicharleston.com

Concentric at the BIOMEDevice Sidney Porto will represent Concentric at BIOMEDevices Conference in San Jose, CA

Charleston, SC, November 17, 2015 — Concentric Management Systems, Inc. is excited to announce its most recent partnership with TFS Consultants to boost the expansion of business development in the medical devices and in-vitro diagnosis.

With offices in Charleston, SC and in Sao Paulo, Brazil - and counting on flexible experts to serve the whole Americas' territory - Concentric offers management systems products and services, primarily in the manufacturing supply chain. Concentric sells and implements best-in-market software and mobile applications for quality, environmental, occupational health and safety, productivity improvement, and regulatory compliance. Concentric is comprised of dozens of experts in the implementation of international standards (ISO 9001, ISO 14001, ISO 45001, AS9100, ISO/TS 16949, etc.). Implementation services include the performance of internal audits, training and qualification of hundreds of lead auditors, advising clients in lean manufacturing projects, root cause analysis and the standardization of best practices. To learn more about the team at Concentric, visit http://www.acommoncenter.com.

TFS Consultants is a company formed by a group of professionals with diversified knowledge within the Health Sciences global marketplace. Their expertise, gained over 20 years in the market, guarantees a high level of service to assist companies interested in developing and/or expanding their international IVD & Medical Devices business. More information on TFS Consultants can be found at http://www.tfsconsultants.us/home.html.

With a combined expertise of nearly 40 years, the partnership between Concentric and TFS Consultants continues to bring best-in-class practices in the world’s most competitive industries to the medical device and IVD sector.

For additional information, or to schedule an interview with Sidney Porto, contact Ronii Bartles at ronii.bartles@cmsicharleston.com.

Concentric is a Quality & Improvement Resource HUB that leverages the power of Baby Boomers to support improvement projects, making the best companies in the world even better. Through digital products, training, consulting and implementation resources, Concentric helps organizations perform better through leadership development, requirements management, process design, management system implementation, lean, Six Sigma, problem solving and various ISO certifications (i.e. ISO 9001, ISO 14001, ISO 45001, ISO/TS 16949, AS9100 series, ISO 27001, ISO 50001 & others).

# # #

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).

12 Strongly Recommended Tasks for Your Risk-Based Thinking / Approach That Will Pass All Audits and Improve Your Business

12 Risked Based Thinking Approach to Pass All Your Audits Concentric ISO ConsultantsHow should manufacturers manage risks on endless challenges to product and process requirements? ISO 9001:2015 is bringing to the overall market; product and service providers, the concept of risk-based thinking / approach with the intention to create the culture of prevention and make it a habit.

Within medical devices, pharmaceutical products, automotive components, and aerospace systems manufacturers there are some product and process requirements which technical acceptance levels are challenging to reach and have been becoming continuously more restrictive for multiple reasons. Some specific examples are the Sterility Assurance Level (SAL) in the medical industries and the Cleanliness Level (CL) in automotive and aerospace. Both requirements are related to contamination.

Different in nature, the medical / pharmaceutical industry deals with biological microorganisms while automotive / aerospace deals with microscopic debris. However, both are very similar from the target standpoint. ZERO is the ideal, unattainable goal; therefore very restrictive acceptance levels are required, standardized, and regulated at the edge of the available knowledge and technology. All around it’s a thousandth fraction of a unit in terms of probability of occurrence or actual mass (ANSI/AAMI ST 67 and ISO/TC 198/WG15 to be released).

Risk management techniques are not new and are standardized by ISO 31000 (General) and ISO 14971 (Application to Medical Devices). So what is the importance of the new concept for risk-based thinking / approach? It is to diligently pursue the more restrictive acceptance levels preparing the way for new products that can make people's life even better. And there is no magic formula other than real, hard work.

The risk-based thinking / approach suggests some "easy to state but difficult to execute" tasks for during a risk assessment:

1. Focus on the intended use of the product.

2. Bring knowledgeable professionals to the assessment (risk assessment itself) and the actual product and actual processes.

3. List of all the known risks to all interested parties: patient, service providers, operators, and estimate the degree of effects.

4. Gather all knowledge about the risks and the likelihood of occurrence.

5. Ensure capable methods of measurement of biological contamination or cleanliness level.

6. Select reliable methods of risk evaluation.

7. Prioritize the risks: rank them according to what is acceptable and what is not.

8. Maximize the availability of suitable manners to eliminate, avoid, reduce or mitigate the risks.

9. Define the validation process for risk mitigation.

10. Ensure comprehensive, detailed, and complete assessments of the designed or implemented manufacturing process. Recognition of the biological and physical limitations for further improvement.

11. Ensure the effectiveness of all actions taken.

12. Ensure there is a robust control plan to sustain the intended process and product performance.

The risk-based thinking / approach is not new to the standards, but in the new ISO Standards revision, it is structured so that it is better incorporated. How is your organization approaching risk assessments? Leave a comment and let us know what best practices you are looking to implement.

If you have any questions or need help in implementing a risk-based approach, Concentric has a solution that will get your organization on the right track to passing your next audit with flying colors.

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.

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 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.

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 info@cmsicharleston.com.

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