Standards Blog

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

QMS - ISO 9001:2015    

    0    4.4 - Confidence (as needed)
    1    7.1.5.1 - Accurate measurement resources
    2    7.1.5.2 - Basis used for calibration
    3    7.2 - Competence of people
    4    8.2.3.2 - 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    6.1.2.1 - Risk analysis
    22    6.1.2.3(g) - Contingency plans
    23    7.1.5.1.1 - MSA
    24    7.1.5.2.1 - Calibration/verification records
    25    7.1.5.2.1(d) - Calibration/verification validity of previous measurement results
    26    7.2.3 - Internal auditor competency
    27    7.5.1.1 - QMS documentation - series of documents list
    28    7.5.3.2.2 - Engineering specifications
    29    8.2.3.1.1 - Review of requirements for products & services - supplemental
    30    8.3.2.3 - Development of product with embedded software
    31    8.3.4.4 - Product approval process
    32    8.4.2.3.1 - Automotive product-related software or automotive products with embedded software
    33    8.4.2.4.1 - Second-party audits
    34    8.5.1.3(e) - Verification of job set-ups
    35    8.5.2.1(d) - Identification & traceability - supplemental
    36    8.7.1.4 - Control of reworked product
    37    8.7.1.5 - Control of repaired product
    38    9.1.1.1 - Monitoring & measurement of manufacturing processes

New IATF 16949 Documented Policies and Documented Processes

3 Documented Policies required by IATF 16949:2016
#     Clause     Requirement
1      5.1.1.1       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    7.5.3.2.1     Record Retention policy


21 Documented Processes required by IATF 16949:2016

#    Clause        Requirement
1    4.4.1.2       Product safety
2    7.1.5.2.1    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    7.5.3.2.2    Engineering specifications
7    8.3.1.1    Design and development of products and services – supplemental
8    8.3.3.3    Special characteristics
9    8.4.1.2    Supplier selection process
10    8.4.2.1    Type and extent of control - supplemental (outsourced processes)
11    8.4.2.2    Statutory & regulatory requirements
12    8.4.2.4    Supplier monitoring
13    8.5.6.1    Control of changes - supplemental
14    8.5.6.1.1    Temporary change of process controls
15    8.7.1.4    Control of reworked product
16    8.7.1.5    Control of repaired product
17    8.7.1.7    Nonconforming product disposition
18    9.2.2.1    Internal audit program
19    10.2.3    Problem solving
20    10.2.4    Error-proofing
21    10.3.1    Continual improvement - supplemental
 

 

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!

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.

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.

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 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.

Strategy

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.

Communication

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.

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.