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ISO vs. Six Sigma

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  • #48443

    ISO
    Participant

    ISO and Six Sigma – where is the connection? Why do we need both? Can we live without one or the other? Should they both remain as they serve different purposes? Should one yield to the other and integrate before dissolving? What are your thoughts?

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    #163289

    Savage
    Participant
    #163293

    BritW
    Participant

    ISO tells you what you need to do for certification. Some use it as a tool otherwise, but most people utilize the framework for certification because customers require it.  It tells you what to do, but doesn’t prescribe how to do it.  Six Sigma (and other methodologies) can be used as a framework for many of the ISO requirements as they appear in the revised standards.

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    #163299

    ISO
    Participant

    Britw., it may be of interest to you that the certification bodies for healthcare are currently working on integrating the various CAP, AABB standards etc. under the umbrella of the international ISO standards. Within this framework, Lean and Six Sigma will become integrated as the process improvement methodology to support the pre- and post-analytical processes, at least in the clinical lab industry. So don’t be surprised if ISO willl resurface some time soon.

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    #163302

    ISO
    Participant

    AABB Standards?
    CAP Standards?

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    #163318

    ISO
    Participant

    AABB = American Association of Blood Bankers
    CAP = College of American Pathologists
    JCHAO = Joint Commission on Accreditation of Healthcare Systems
     

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    #163324

    fake accrington alert
    Participant

    First  start with  SS ,then  go  to  ISO.
    SS is  a comprehensive process  improvement methodology,while  the  ISO  is  a documented quality  assurance  system.
    Yes  they  are  integrated in  this  sense.
    good  luck  

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    #163329

    Six Sigma guy
    Member

    I have my own opinions on this.. ISO helps you to define a process and follow it consistently and not just a documented activity where as six sigma helps you to improve the existing process…
    ISO defines the process.. Six Sigma improves the process..

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    #163330

    fake accrington alert
    Participant

    Well  said

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    #163334

    BritW
    Participant

    I welcome the structure but not the paperwork, if these bodies future plans are to require ISO certification.  Healthcare is inundated with paperwork justification for CMS, TJC, etc.  Hopefully it will be a smooth transition if it happens.

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    #163346

    fake accrington alert
    Participant

    What do  you  mean  by  “resurface”?

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    #163358

    ISO
    Participant

    Resurface = to move from the back to the front

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    #163359

    ISO
    Participant

    Britw, the idea is not to create a “superbody” with additional paperwork, but to integrate the various standards into a global framework. Global here literally means encompassing the standards of the EU, which is primarily driven by ISO and the US, which is primarily driven by CAP, AABB etc. with the standards of other key countries such as India etc. The idea is quite interesting because its ultimate goal is to eliminate the overlaps and duplications etc. of the various bodies of accreditation. Its a very thoughtthrough approach to extend quality to the pre-analytic and post-analytic phases of clinical testing by combining the various efforts into an overall umbrella.
    ISO, what is your point? Everybody on this forum can look up words in a Thesaurus. If you want expert input, please honor a respectful code of communication. You are not dealing with high school students on this forum!

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    #163361

    ISO Apololgies, please ignor
    Participant

    ISO, my apologies for my sharp response. Please ignore it. I did not read accrington’s question as I am literally on the fly between conferences where the topic of the relationship between ISO, the accreditating bodies of the US and other countries, the US government and the integration of Lean and Six Sigma are discussed in excruciating details. Keep in mind that the integration of these methodologies is highly dependent on the industry and the involvement of the government in these industries as well as their integration in the global economy. Six Sigma professionals sometimes forget about this aspect in their ideas of how to best implement “Lean Six Sigma”. Six Sigma guy is on the mark with his comment as it relates to the industry that is becoming the largest expenditure of state and government funding, i.e. the healthcare industry. His basic outline is becoming the overall consensus in the healthcare industry (Recently, the government official that is the link to the ISO group and the other accreditating institutions used a similar definiton). Thanks for clarifying the meaning of the word “resurface”! Most interestingly, these definitions of ISO vs. Six Sigma etc. (right, wrong or indiifferent)are setting the foundation for the implementation of “Lean” and “Six Sigma” in this industry. The relationship between ISO and Six Sigma is definitely very different in the manufacturing sectors than in government/state/accreditation driven industries.

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    #163378

    Herb
    Participant

    Hi all. We have a National laboratory accreditation system in Australia overseen by NATA (National Association of Testing Authorities).  I noted in another discussion thread on ISO and SS that in the US some work is occuring to bring together indistry standards, ISO, and Lean SS in an over arching framework for clincal laboratories. Am I correct in the assumption that the expectation is Lean SS will be mandated by ISO as the improvement methodology for pre and post anylytical phases for clinical labs?

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    #163380

    ISO
    Participant

    Herb, No. The idea is not to create a mandate but a framework that allows to integrate the practices of quality control and assurance with quality improvements in the pre-analytical and post-analytical processes. If you look at the recent changes to the CAP standards in the US, CAP is looking more and more into pre- and post-analytical processes. Main reason: The two main reasons for errors in test results are related to incorrect specimen handling (data entry errors and misplacement of specimens) in the pre-analytical phase.
    In addition, the trend towards outsourcing is becoming a reality. This will also affect post-analytical processes related to data storage and data exchange. As a result, the various international standards it is unavoidable that the various standards will soon become more coordinated. The key question right now is to what degree the US government and the US accreditation agencies are willing to proceed. There is a general consensus that during the next administration (whoever this will be) we will see some fundamental changes in the way that the US healthcare system will be managed. This could be a Hillary II or a Guiliani Hillary light.

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    #163392

    BritW
    Participant

    I am a proponent of Lean SS, but if ISO mandates any one methodology, I would 1 – be surprised, and 2 – think it would be a major problem.  ISO’s framework does well in laying out expectations and letting the culture and industry, in particular, choose how they can best achieve the standards.  Mandating anything will be a poor choice. Moreover – unless you are in need of the ISO certification, there are other ways to organize the improvment culture – Malcomb Baldrige for example.  In my mind – it’s an ROI decision.  I’ve implemented both and have found ISO a very expensive effort.  But – it has it’s return if the culture accepts the chnage (as per usual).

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    #163397

    fake accrington alert
    Participant

    ISO  is  becoming  basic

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    #163410

    Funding
    Participant

    The US Government still has some trade agreements approvals to make before you’ll see the increase in funding needed to awake ISO again.

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    #163422

    Doc
    Participant

    ISO9000 and TS16949 (auto industry) defines systems that need to be in place in order to ensure  high quality designs, processes, and production. This includes management responsibilities, design systems, purchasing, document control, auditing, corrective actions, etc… Just one of these areas is continuous improvement.
    Six Sigma is a method of continuous improvement – of improving existing processes.

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    #163423

    Hiatus
    Participant

    funding, i am glad to see that there is still an unbridgeable hiatus between the exoteric many (like yourself) who live in the shadow world of the doxa, and the esoteric few who have the noos :-). … si tacuisses …

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    #163424

    Hiatus
    Participant

    nous of course :-)))

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    #163425

    Brandon
    Participant

    Hiatus, a little full of yourself aren’t you?
    PS: The payment’s late for your double-wide.

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    #163430

    Hiatus
    Participant

    brandon, it’s pretty clear that the uninformed, off the hip comment by “funding” goes squarely back to brandon (there is a repeated pattern whereby you post this type of nonsense under a different name, yet, interestingly brandon always responds back). it’s also quite pathetic that a so called six sigma consultant from one of the top 20 consulting companies does not even know the basic functioning of multilateral organizations and obviously confuses the United Nations with the ISO organization. so again, please inform yourself before posting such “dramatic” statements and avoid making a complete fool of yourself.
    attached is a link that clearly shows how uninformed you are in the relationship between ISO and the US government (and obviously the most basic matters of international politics).
    http://www.ofee.gov/ems/training/The_US_Government_and_the_ISO_14001_Series_of_Standards.doc
    .

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    #163431

    Brandon
    Participant

    Hiatus – please review this post string. I have made no comment on ISO. I am not familiar with it nor do I care to be.
    My sole post to this string was in response to your pompous post.
    Re: Other names – I have NEVER posted under another name. Yet I see Hiatus in the last couple days and NEVER before – so who are you posing as?

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    #163432

    Hiatus
    Participant

    Sure brandon, we all believe in Santa Claus :-))))).

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    #163434

    Funding
    Participant

    Right on Brandon, looks like you hit a nerve with this clown

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    #163435

    ISO
    Participant

    Doc, don’t you think that management responsibilities, design systems, purchasing, document control, auditing, corrective actions all have continuous improvement opportunities? I think ISO needs to understand that Six Sigma methods are not a slide of the pie but instead its backbone.

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    #163442

    Hiatus
    Participant

    how much more pathetic can it get: funding/brandon has no clue what the difference between the UN and ISO is. Brandon/funding does not even know what ISO is. you talk about a total lack of even the most basic general education let alone a knowledge of basic approaches to quality! well, brandon/funding so much so for your credibility … no matter how “street smart” you try to turn it :-))))))).

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    #163443

    Funding
    Participant

    please name the 1 thing i said that was incorrect and while your at it, perhaps you could explain how you’ve become such an authority?

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    #163446

    fake accrington alert
    Participant

    Correct

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    #163449

    Hiatus
    Participant

    “The US Government still has some trade agreements approvals to make before you’ll see the increase in funding needed to awake ISO again”. … you may want to evaluate your own statement after reading the information of the various funding procedures for ISO, the WTO and the UN.
    A: ISO and the WTO are independent organizations.
    B: ISO is primarily self-funded through its publications and the receipts from it publishing arm.
    C: The WTO is currently not underfunded by the US.
    D. By contrast, it is the UN where the US has the largest outstanding dues (relative to the total budget).
    US funding of UN
    The United Nations and all its agencies and funds spend about $20 billion each year, or about $3 for each of the world’s inhabitants. This is a very small sum compared to most government budgets and it is just a tiny fraction of the world’s military spending. Yet for nearly two decades, the UN has faced a financial difficulties and it has been forced to cut back on important programs in all areas. Many member states have not paid their full dues and have cut their donations to the UN’s voluntary funds. As of March 31, 2007, members’ arrears to the Regular Budget topped $1,355 million, of which the United States alone owed $785 million (58% of the regular budget arrears).
    US funding of WTO
    The United States is the largest single country donor of trade capacity building assistance. Total U.S. funding for trade capacity building activities was $752 million in FY 2003, up from $638 million in 2002—nearly an 18 percent increase. Regional funding in 2003 totaled $174 million in the Middle East and North Africa; $150 million in Latin America and the Caribbean; $133 million in sub-Saharan Africa; $92 million in Asia; $84 million in the former Soviet Republics; $65 million in Central and Eastern Europe; and $53 million for non-targeted global projects.
    The United States today issued a summary report of the approximately $750 million in trade capacity building assistance it has provided this year. “U.S. Contributions to Trade Capacity Building: Improving Lives through Trade and Aid” outlines U.S. programs across 35 categories that help developing countries make the most of open global markets.
    In conjunction with the report, U.S. Trade Representative Robert B. Zoellick announced an additional $1.2 million for trade-related technical assistance (TRTA) to the World Trade Organization (WTO. This new multilateral contribution augments $1 million given earlier this year, bringing total U.S. TRTA for the Doha Development Agenda to $3 million since the launch of negotiations in November 2001.
    “The $1.2 million announced today doubles the U.S. contribution to the WTO and bolsters our efforts in Geneva to focus on three priorities: trade-related technical assistance, the Integrated Framework, and the International Trade Centre,” said Zoellick. “These U.S. trade capacity building efforts stem from the conviction that trade and globalization are critical to the growth of developing and developed countries alike.”
    “Trade capacity building stands at the nexus of trade and development,” added Zoellick. “All nations gain when developing countries are able to harness the power of trade and openness to boost economic growth and accelerate poverty reduction. The United States is committed to more than just negotiating open markets. In partnership with developing countries, we are crafting practical solutions that enable them to actively participate in—and benefit more fully from—the global trading system.”
    Funding of ISO
    ISO’s national members pay subscriptions that meet the operational cost of ISO’s Central Secretariat. The subscription paid by each member is in proportion to the country’s Gross National Income and trade figures. Another source of revenue is the sale of standards.
    However, the operations of ISO Central Secretariat represent only about one fifth of the cost of the system’s operation. The main costs are borne by the member bodies that manage the specific standards development projects and the business organizations that provide experts to participate in the technical work. These organizations are, in effect, subsidizing the technical work by paying the travel costs of the experts and allowing them time to work on their ISO assignments.

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    #163451

    Brandon
    Participant

    Very impressive Hiatus, honestly.
    I, however, don’t have the luxury of working at such a macro level and imagine, even if I made the effort, would be able to have little impact on the performance of any of these three entities.
    So I just do my little part to keep capitalism alive and well in 2 or 3 companies at a time. It’s dirty work but somebody has to do it.

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    #163466

    Hiatus
    Participant

    My key point is: Six Sigma is a little fish in a big pond. While Six sigma professionals somewhat rightly assume that their work constitutes the backbone of quality, the reality is that in highly government regulated industries, six sigma is perceived as subordinated to ISO as a tool to support improvement. Six sigma is driven by consulting companies who do not have the leverage of an organization such as ISO. Havea great day.

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    #163468

    Hiatus
    Participant

    brandon, btw, the payment for the double-wide went out on time. I asked my wife and she confirmed it. … never new I had the luxury to living in a double-wide. always thought it was the standard size :-).

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    #163470

    Ed
    Participant

    Your too full of yourself and your opinions are not even that strong. The US does not need to pay any $ to the UN when they have robbed billions from us with the food for oil scandal. Last thing the world of business needs is ISO that things Six Sigma is a set of tools it can use to sell more of its documentation approach. I vote to burn ISO with a Six Sigma bon fire.

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    #163472

    Hiatus
    Participant

    Ed, you are entitled to have your opinon. But in order for your emotionally charged suggestions to turn into action Six Sigma has to come up with its own strategy to position itself vis-a-vis the existing institutions that set the agenda for quality. Currently, Six Sigma is very self-centered and fragmented. As a result, there are no bodies that would give Six Sigma the type of international recognition and muscle it needs to go head to head with ISO as you suggest. For little Don Quichotes who have problems grasping the whole picture of the real world every strategic thinker must be perceived as “full of himself”. I take  it as a compliment that I am not living in your childish little world of “bon fires” and other hocus pocus.

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    #163473

    Ed
    Participant

    No Hiatus, every stratigic thinker is not “full of themselves” while you surely are and Six Sigma is not fragmented? It’s in every industry and business function both commercial and federal – and more are practicing its mthodology than they are ISO. Six Sigma can prove results – now show me the ROI of ISO – your assumptions are hocus pocus.

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    #163478

    Hiatus
    Participant

    No need to further discuss. Have a successful day.

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    #163480

    Brandon
    Participant

    Ed, I appreciate your passion and fully agree with you that SS is impactful…and by some miracle it has spread worldwide.
    However, it is fragmented. We continue to debate and question certification when there is no certifying body, no standard practices…the measurement system is flawed.
    I have no experience with the impact of ISO yet I can grasp its beneficial approach thru documentation and standards of practice. The SS industry would be benefited greatly were we ALL to agree to a centralized body with SME committees, course standardization and approved requirements for various levels of certification.
    Right now one cannot deny we are hodge-podge.

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    #163490

    Ed
    Participant

    I got certified at GE and its legit – I don’t need another piece of paper from a plastic certification board to increase its value – I’m getting paid plenty from the value the GE cert has provided.

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    #163495

    Brandon
    Participant

    Ed, I really don’t mean to be argumentative but what’s “legit” – who says?
    A GE certification is whatever GE says it is. A BMG certification is whatever BMG says it is. Stan’s Wonderful World of SS certification is whatever SWWSS says it is.
    We have no standards.

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    #163522

    Ed
    Participant

    GE’s certification is legit, been around the longest, set the same guidelines used by ASQ and ISSSP. Dozens of Fortune 1000 business follow the same formula. The Certification involves 160 hrs of technical instruction; completion of 2 MBB approved DMAIC projects, 1.5 years in the role and passing of the exam. While variation exists, such as the lack of time in the role or Kaizens events etc… For the most part the minimum standards are in place everywhere. Those that cannot meet the above criteria – usually are not getting hired to the next level.

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    #164035

    af
    Participant

    When we have made an improvement (eg. with six sigma), we need that improvement to be sustained (Quality Assurance with ISO).
     

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    #164042

    ISO
    Participant

    Why do we need ISO to sustain when Six Sigma provides a more rigorous Control Phase?

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    #164043

    Brandon
    Participant

    ISO, I’m not so sure you care about an answer as much as you might care about the battle. If I’m incorrct, I apologize.
    Also, I am not claiming to be an expert, certainly not in the ISO field, however here is my view.
    SS has a Control Phase that yields a Control Plan for each project – thus controls are in place  – ON A PROCESS BY PROCESS BASIS. ISO addresses the company at a macro level providing a framework for all processes to be in control – or at least linked as to their impact on each other. ISO is more a defined, macro project mngt framework while SS is a micro process improver.
    Sure I’ll get some flack but that’s my view. They each have their place.

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    #164044

    ISO
    Participant

    Brandon, I was responding to AF’s comments and not looking to battle with you. What would make you think I was looking for a battle?
    We do have different opinions regarding SS, while I agree that SS projects can be done at a micro level, they can also be done at macro level too. Control plans are not the only output of a Control Phase, there are many additional outputs such as Control Charts or SPC, documentation, escalation/responses, updated roles and responsibilities, and many more depending on the process needs.
    The ISO QC does not have the rigor that SS Control phase places on a process.
    Plus with SS there is an organizational structure that monitors and verifies controls and processes where ISO has no supporting infrastructure. I appreciate your throwing in your 2-cents but suggest before you comment on the ISO/SS question, you learn a little more on the ISO subject and perhaps the SS side as well.

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    #164045

    DMAICin me CRAZY
    Participant

    I have long considered ISO as a key component of the “C” in DMAIC. ISO is a great control mechanism. Lean down your processes, eliminate variation, then lock it down with ISO. Kinda like sitting on your suitcase then zipping it all up.Scott

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    #164046

    ISO
    Participant

    Ok Scott, fair response, can you provide an example of how you have locked down your control with ISO?
    Are you inferring that the SS control phase is incomplete? Perhaps we need to modify Control phase to build in the ISO best practices you’re applying. Are they best practices? How?
    I am unclear as to what ISO elements your packing into that suitcase in order to make the SS control phase different. Please share more.

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    #164047

    “C”
    Participant

    Let’s leave it at the letter “C” comes before the letters “I”, “S” and “O”. 

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    #164048

    Brandon
    Participant

    Crazy – I agree; in fact, believe I was trying to say the same thing.
    ISO – unless a deployment is properly managed SS can be a number of random acts improving processes based on the greatest pain or greatest opportunity – nothing in SS says DMAIC is applied to end-to-end processes. SS as a set tools is very powerful yet my expereince has been SS training companies are deficient at training for deployment mngt. – lot of lip service but little traction. Much of that is attributable to the fact that those who began SS training where from the factory floor – excellent at application but very few businessmen among them.
    My view of ISO standards is that they address organization throughout the company top to bottom, side to side. Are all processes documented?
    So SS gets processes “right”, ISO provides a system to assure all processes are viewed.

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    #164049

    ISO
    Participant

    I have not experienced a SS deployment where they treat the deployment as a set of tools. I did see that with TQM and agree it probably still exists in pockets but do not believe SS will survive if thinking reverts back towards the TQM days of thinking. I have only worked SS as an end-to-end; customer-to-customer approach. Tools with no direction will get you somewhere but probably not where you needed to go so agree that is a risk to manage. I am assuming your following the SS deployment practices as most businesses do.
    Again, before you respond to a post, try to know something about the topic. Go read up on ISO and then come back and comment.

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    #164050

    “C”
    Participant

    Okay, after reading up in order to “know something about the topic”, let’s try to summarize it again: “C stands for “Control”,  “ISO” stands for “International Standards Organization” … of course “ISO” also stands for the name of someone who “tries” to know something about the topic. The International Standards Organization may not care much about what that “ISO” has to comment about the topic. But I am sure we will soon read up on what he has to say very soon. After all, he has the knowledge to put the alphabet into a logical, sequential order: “C”, “ISO”, “SS”, “TQM”. I am still confused though if “SS” stands for “Six Sigma” or “Sesame Street”.

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    #164051

    “C”
    Participant

    Thanks for the enlightenment. The things one can learn if one only asks the real experts:-))))).

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    #164055

    SS
    Member

    “Sesame Street” is about as good a definition as I’ve seen for six sigma … a collection of ridiculous kid stuff that anyone with half a brain would laugh at. 
    It is hard to believe that idiots are still publishing that 3.4 dpmo rot.

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    #164059

    fake accrington alert
    Participant

    Good question

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    #164060

    fake accrington alert
    Participant

    No
    It  stands for “See Sonia” 

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    #164062

    fake accrington alert
    Participant

    ISO is  equal  to limited  accounting  system
    SS is  equal to  comprehensive accounting  system
    If  you  apply  SS  successfully you  don’t  need  the ISO
    If you  have  the  ISO you  still  need  to  implement  the SS 
     

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    #164063

    fake accrington alert
    Participant

    aGREE

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    #164064

    fake accrington alert
    Participant

    No
    It  means  that  the  ISO procedure can  be  used  as  part  of  the  control  phase  ,to  maintain  the  achievements

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    #164065

    fake accrington alert
    Participant

    If  implemented  correctly

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    #164109

    SONIA
    Member

    Hi sweetiepie,
    No, the SS are six sigma nazis …

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    #164111

    Brandon
    Participant

    SS – would be so kind as to post the name of the company you work for?
    I wanna short a bunch of its stock!

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    #164120

    New MB
    Participant

    It  stands  also for “Super Sonia”

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