DTI-UKAS memorandum of understanding

Have you ever wondered what the agreement looks like when a government department grants a body a national monopoly that protects it from competition ?  Click here to find out.

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Tolerating Uncertainty — The Next Medical Revolution?

Simpkin and Schwartzstein have written Tolerating Uncertainty — The Next Medical Revolution?  calling for wider acceptance of uncertainty rather than the pretence of eliminating it.

ISO 17025 requires laboratories to consider the uncertainty of their measurements.  This is reasonable.

Image result for tolerating uncertainty

The quality cartel’s inspection bodies get obsessive about it and demands extensive, wasteful work that helps nobody but themselves.  Inspectors need to deal with things as they can be inspected.  Inspecting for the binary of compliance is what they do.  Image result for uncertainty of measurement

Doctors have a more important tasks – including diagnosis, but they can fall into the same trap of seeking deceptive certainty,

Doctors often fear that by expressing uncertainty, they will project ignorance to patients and colleagues, so they internalize and mask it. We are still strongly influenced by a rationalist tradition that seeks to provide a world of apparent security…

“Key elements for survival in the medical profession would seem, intuitively, to be a tolerance for uncertainty and a curiosity about the unknown. Have we created a culture that ignores and denies that requirement? Could our intolerance of uncertainty, in turn, be contributing to the accelerating rates of burnout and the rising cost of health care?…

“- reminding ourselves of Osler’s maxim that “medicine is a science of uncertainty and an art of probability.”  Ironically, only uncertainty is a sure thing. Certainty is an illusion.

Tolerating Uncertainty — The Next Medical Revolution?  Arabella L. Simpkin, B.M., B.Ch., M.M.Sc, and Richard M. Schwartzstein, M.D.  N Engl J Med 2016; 375:1713-1715 November 3, 2016 DOI: 10.1056/NEJMp1606402.

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Organic certification is about inspection, not safety or quality

Foodborne Disease Outbreaks Associated with Organic Foods in the United States

Abstract:
Consumer demand for organically produced foods is increasing in the United States as well as globally. Consumer perception often credits organic foods as being safer than conventionally produced foods, although organic standards do not directly address safety issues such as microbial or chemical hazards. We reviewed outbreaks reported to the Centers for Disease Control and Prevention’s Foodborne Disease Outbreak Surveillance System where the implicated food was reported to be organic. Information collected for each outbreak included the year, state, number of illnesses, pathogen, and implicated food. We identified 18 outbreaks caused by organic foods from 1992 to 2014, resulting in 779 illnesses, 258 hospitalizations, and 3 deaths; 56% of outbreaks occurred from 2010 to 2014. Nine outbreaks occurred in a single state, and nine outbreaks were multistate. Salmonella sp. (44% of outbreaks) and Escherichia coli O157:H7 (33%) were the most commonly occurring pathogens. Eight of the outbreaks were attributed to produce items, four to unpasteurized dairy products, two to eggs, two to nut and seed products, and two to multiingredient foods. Fifteen (83%) outbreaks were associated with foods that were definitely or likely U. S. Department of Agriculture certified. More foodborne outbreaks associated with organic foods in the United States have been reported in recent years, in parallel with increases in organic food production and consumption. We are unable to assess risk of outbreaks due to organic foods compared with conventional foods because foodborne outbreak surveillance does not systematically collect food production method. Food safety requires focused attention by consumers, regardless of whether foods are produced organically or conventionally. Consumers should be aware of the risk of milk and produce consumed raw, including organic.

 

As with laboratory inspections or proficiency testing schemes, data are not collected to enable testing of whether inspection does any good.

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Who’s Spending Britain’s Billions?

You really should watch this.  Jacques Peretti investigates how companies like management consultancies and outsourcers rip off taxpayers through gullible public leaders.  PWC, McKinsey, the usual suspects bringing waste through endless “transformation”.  One shouldn’t expect much from the poorly-qualified managers of the NHS and local authorities who are quite out of their depth.  But it helps you understand how highly-qualified professionals also fall for the mock-scientific flim-flam of UKAS’s ISO “quality” accreditation.

They say things like, “What’s the alternative?”

Drop accreditation.  Things won’t get any worse.

Anybody care to put this to the test?

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ISO ramps up its embrace, extend, and extinguish strategy

Thinkpurpose warns us of ISO 18404.

Still unable to admit that it doesn’t work to manage people as if they were manufactured objects, the ISO has again plagiarised other quality management systems into its latest expensive document.  That will stop a lot of employees doing more useful things.

Embrace Extend Extinguish

Embrace, extend and extinguish “Embrace, extend, and extinguish”, also known as “Embrace, extend, and exterminate”, is a phrase that the U.S. Department of Justice found that was used internally by Microsoft to describe its strategy for entering product categories involving widely used standards, extending those standards with proprietary capabilities, and then using those differences to disadvantage its competitors.

Even the ISO’s embrace, extend, and extinguish strategy was stolen from Microsoft.

Managers everywhere will buy it, believe it and bully each other into becoming accredited to it.

The inspection cartel will continue to spread misery and inefficiency throughout the world.

borgIt’s not science fiction, it’s history.  It’s all in keeping with the one world controlled by an elite as described by Julian Huxley – UNESCO: Its Purpose and Philosophy (1946).   No cost is too high to ensure the subjection of mankind to the rule by its self-appointed best.

Management ISOs have just made this control of humans really easy because they enforce mutual oversight and dominate the workplace as police, legally and practically, cannot.

 

 

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Limits to Personalized Cancer Medicine

As money is prepared to be poured into personalized cancer medicine, the NEJM has published an opinion that the promises of personally-targeted therapy are little better than the promises of ISO accreditation.

Limits to Personalized Cancer Medicine. Ian F. Tannock, M.D., Ph.D., and John A. Hickman, D.Sc. N Engl J Med 2016; 375:1289-1294 September 29, 2016 DOI: 10.1056/NEJMsb1607705.

limits-to-personalized-cancer-medicine-10-1056nejmsb1607705

Current studies show no or little improvement in duration or quality of life.  In fact, sequencing tumour DNA seldom gives information that is useful for treatment.  And tumours are always mutating to find new pathways drugs aren’t blocking.

The authors “suggest that the clinical benefit of personalized medicine as it is currently practiced will be limited.”

They conclude, “We do not suggest abandoning personalized medicine but rather evaluating it in a small number of well-designed collaborative programs, with research programs that recognize and combat the limitations we have described.”

Maybe this will happen but we are still waiting for well-designed collaborative programs to evaluate accreditation.

 

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ISO silent over Volkswagen certifications

A little bit of history:

“Julian Huxley, Aldous Huxley’s older brother is THE GUY who paved the way for the standardization of our everyday lives. He originated the United Nations Education, Scientific, and Cultural Organization or UNESCO. Under the direction of Julian Huxley, UNESCO gave us the International Organization for Standardization. Also Known As the ISO. (Yes, it should be IOS, but iso is Greek for “same” and these folks do want for us to all be the same.)

ISO 2575 Road vehicles – Symbols for controls, indicators and tell-tales only covers the color and artwork for 350+ symbols in our cars. ISO 26000, or ISO SR is the International Standard for Social Responsibility. ISO SR is not yet mandatory as it was first published in 63 A. F. or 2010.

Since ISO 26000 is still voluntary and VW has no way of being certified as being ISO 26000 compliant, the question arises concerning VW’s or even GM’s meeting International Standards for Social Responsibility. Or any other ISO standards like ISO 9001 or the ISO 14001.

Roger Gareth Frost thinks the joke might be on us, “The operation conformed to procedures and was a success. Unfortunately, the patient died.”

http://asia.nikkei.com/Viewpoints/Viewpoints/ISO-silent-over-Volkswagen-certifications

Mr. Frosts statement makes me wonder if there is an ISO standard for press releases after police shootings.

This link takes us to Nikkei Asian Review which presents us with Gareth Frost’s article: ISO silent over Volkswagen certifications.  This is rare insider insight into how the accreditation cartel works:

Roger Gareth Frost

ISO silent over Volkswagen certifications

One aspect of the Volkswagen emissions scandal that has so far escaped attention is the part played, or not played, by the company’s certifications to the ISO 9001 standard for quality management and ISO 14001 standard for environmental management.

     Neither VW nor ISO (the International Organization for Standardization) have replied to the following question: “Volkswagen has worldwide certification to ISO 9001 and ISO 14001. Doesn’t the scandal over VW’s emissions manipulation indicate a failure of certification to the standards, in terms of meeting customers’ quality requirements, customer satisfaction and environmental management?”

      They were not alone. Also silent were TUV Nord, the German certification body that issued VW’s certifications, and a spokesman for both the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The latter two groups promote standards and certification as tools for achieving public policy goals.

     On Nov. 2, ISO jointly hosted a conference in Geneva, Switzerland, on “Using and referencing International Standards to support public policy.” ISO said that the conference “looked at the many ways that standards can benefit policy makers, through providing confidence in technical specifications and safety requirements, as well as helping to implement policy commitments.”    

     For many people, the VW crisis would advise caution against a blind faith in standards. However, ISO and the other protagonists remain silent or dodge the issue. This silence is a matter of serious concern because VW’s certifications are intended to give customers and regulatory authorities confidence that quality requirements and environmental responsibilities are being met.

     One of the objectives of ISO 9001 is to make enterprises more efficient in turning out products that enhance customer satisfaction, by ensuring that these products meet customers’ quality requirements — both stated and implicit. It is unlikely that software designed to cheat emissions tests, as VW has admitted to installing, was a requirement of the 11 million customers who bought the affected vehicles. Clearly, VW’s ISO 9001 systems and certification did not deliver on customer satisfaction.

     ISO 14001 is aimed at enabling organizations to reduce negative impacts on the environment as a result of their activities. It is designed to be a tool for meeting regulatory requirements. Despite VW’s ISO 14001 systems and certification, the company deceived its customers about the environmental impact of the cars they had bought and manipulated the results of regulators’ pollution tests.

     ISO itself does not handle certification. This is performed by certification bodies independent of the organization. However, many of the national standards bodies that make up ISO’s membership do carry out ISO 9001 and ISO 14001 certification, and this activity can represent a sizable portion of their income.

     In practice, ISO has an ambiguous attitude toward certification. On one hand, it states that certification to its standards is not compulsory and not a requirement of the standards. On the other hand, it indirectly promotes certification through The ISO Survey of Certifications, published annually, which provides data on the number of certificates of conformity issued worldwide to ISO 9001, ISO 14001 and other ISO management standards. In ISO’s comments on the survey data, it highlights what it sees as significant increases and downplays less flattering figures.

     It might be argued that such is the stuff of public relations. However, ISO now presents certification to its standards in completely overblown marketing terms.   

Announcing the latest edition of the ISO survey, the organization in September claimed the world is “still under the spell of management systems.” It added, “As the world evolves, it continues to trust ISO management systems standards to keep its organizations performing well.”

     However, ISO’s marketing, communication and information department had “no time” to answer the question on its flagship standards and certification in light of the VW scandal.

Unnoticed irony

ISO’s silence may prove to reveal disastrously poor judgement. This is because more than 1 million ISO 9001 certificates and over 324,000 ISO 14001 certificates had been issued worldwide at the end of 2014 to businesses of all types and sizes, as well as to public-sector organizations. So the question of confidence in standards and certification goes well beyond VW and its customers.   

      Despite the scandal, VW’s website continues to publicize the ISO 14001 certification of its technical department, awarded “for the environmentally compatible development of Volkswagen brand vehicles.”

     TUV Nord, VW’s supplier of certification, is accredited — approved as competent — by DAkkS, the German national accreditation body and a member of the IAF. Shareholders in DAkkS include the German government. On TUV Nord’s website, it continues to display an April press release publicizing its re-certification of VW to ISO 9001, as well as recalling its ISO 14001 certification of the company. Regarding the ISO 9001 certification, TUV Nord says, “The quality management system also fulfills requirements of German and international road traffic legislation ….”

     Apparently, neither VW nor TUV Nord is sensitive to the irony of the above statements in the wake of the scandal.

     A spokesman for the IAF and the ILAC was contacted for comment because the two organizations, along with the Independent International Organisation for Certification, have launched a new website, Public Sector Assurance, promoting standards, certification and accreditation as assets to help government officials and regulators attain policy goals. The IAF is an association of the national accreditation bodies, such as DAkkS, that approve certification bodies as competent according to ISO standards for conformity assessment. ISO, the IAF and the ILAC work closely together on developing ISO standards for conformity assessment activities, such as the accreditation of certification bodies and testing laboratories.

     The spokesman responded with a long-winded general explanation of certification and accreditation, but like ISO, VW and TUV Nord, he did not answer the specific question about the apparent failure of certification.

     The response included the statement, “Accredited certification to ISO 9001 should provide confidence in the organization’s ability to ‘consistently provide product that meets customer and applicable statutory and regulatory requirements.'” Presumably, the important qualifier in this statement is “should.”

     The IAF/ILAC spokesman also stated that, while “accredited certification to ISO 14001 provides confidence in the organization’s ability to meet its own environmental policy, it does not ensure that the organization is currently achieving optimal environmental performance. It is important to note that the ISO 14001 accredited certification process does not include a full regulatory compliance audit and cannot ensure that violations of legal requirements will never occur, although full legal compliance should always be the organization’s goal. Similarly, not all legal noncompliance would also be a noncompliance to a given standard and must also be considered in the context of the scope of certification.”

     Translating these statements into plain English gives something like this: Even though a company has implemented ISO 9001 and ISO 14001 and had its management systems certified by a body accredited by an IAF member, this does not necessarily mean that customers can count on their quality requirements being fulfilled by the company’s products. And regulators cannot necessarily count on the company meeting environmental and other relevant rules.

     What is more, according to IAF/ILAC, despite noncompliance with regulations, the company may still be awarded a certificate because legal noncompliance does not necessarily mean noncompliance to a standard.

The joke’s on us?

This situation seems analogous to the medical joke: “The operation conformed to procedures and was a success. Unfortunately, the patient died.” However, it is doubtful that many of the 11 million purchasers of VW cars with manipulated emissions devices would find the joke amusing.

     In the circumstances, these customers might consider complaining to ISO and the IAF. On ISO’s website, it states: “ISO is interested to hear from you if you feel that any ISO standard, including ISO 9001 or ISO 14001, is being misused.” Likewise, the IAF declares on its own website: “The IAF Board treats any complaints with the utmost concern and will deal with them expeditiously and in confidence. All complaints involving IAF members or certification/registration bodies accredited by IAF members are regarded as extremely serious.”

     Hopefully, ISO will find the time to answer and the IAF will stop hiding behind generalities. Otherwise, the confidence of customers and regulators in standards, certification and accreditation could be seriously dented by the VW crisis.

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IYI

We wouldn’t say those that developed ISO management accreditation were intellectuals. Nor would we apply the word to those that assess other human beings to these standards. However, Nassim Nicholas Taleb‘s essay, The Intellectual Yet Idiot, provides some insight into the minds of those who do live by inspecting others.

“The IYI pathologizes others for doing things he doesn’t understand without ever realizing it is his understanding that may be limited.”

Image result for intellectual yet idiot

and I can do the ISO accreditation magic!

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Antibacterial soaps banned because they do nothing – why not ban ISO 17025?

Soap and water works: FDA says antibacterial soaps do nothin

Bacteria are good at making babies.

So next time you see an advert claiming the product removes 99.9 per cent of bacteria, talk to a microbiologist who will say that’s a 3-log reduction, we look for 5-7 log reductions.

Maggie Fox of NBC News reports the U.S. Food and Drug Administration says antibacterial soaps do little or nothing to make soap work any better and said the industry has failed to prove they’re safe. Companies will have a year to take the ingredients out of the products, the FDA said. They include triclosan and triclocarban. Soap manufacturers will have an extra year to negotiate over other, less commonly used ingredients such as benzalkonium chloride.

“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” the FDA said in a statement. “Some manufacturers have already started removing these ingredients from their products.” Triclosan used in 93 percent of liquid products labeled “antibacterial” or “antimicrobial” – at least 2,000 different products, according to the FDA. “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water”.

In 2013 FDA gave soap makers a year to show that adding antibacterial chemicals did anything at all to help them kill germs. It made the rule final Friday.

antibacterial.soap

So why has laboratory accreditation not been banned?  We have no scientific evidence that it is any better than just being a professional scientist.

It does nothing but kill 99.9% of common sense.

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A billion, billion monkeys typing

Fred Reed presents his calculation:

“- a monkey typing randomly on a keyboard would eventually write all the books in the British Museum. This sounds plausible and, in a purely mathematical sense, is true. What are the odds?

Consider a fair-sized book of 200,000 words that, by newspaper average, would contain about a million letters. To make it easy on the monkey, we will ignore upper case and punctuation and let him work with an alphabet of 26 letters. What are his prospects of getting the book in a given string of a million letters?

The chance of getting the first letter correctly is 1/26 times the chance of getting the second letter, 1/26, and so on, making the chance of getting the entire book 1/261,000,000. Since 26 equals 10log 26, (log 26 being about 1.41) the chance of getting the entire book is 1 in 10 log 26 x 1000,000 or about 101,400,000. Innocent  looking numbers like this are remarkably intractable. For example, a billion billion monkeys (more monkeys than Iwant) typing a billion billion characters a second for a billion billion times the estimated age of the universe (1018 seconds ) would  have essentially zero chance of getting the book.

To give our monkey a fighting chance, let’s ask whether he would get even the title of a book, for example On the Origin of Species by Means of Natural Selection, or the Preservation of Favoured Races in the Struggle for Life, which Microsoft Word tells me contains 119 characters. The monkey’s chance of getting the title in a give string of 119 is one in 10119 x x 1.41 or 10168 Thus our billion billion monkey at a billion billion characters a second for the life of the universe is essentially zero.

Is the chance of accidentally forming a living Crittter a similar problem? We don’t know, especially since evolutionists cannot tell us what the First Critter was. But it is their responsibility to tell us, first, what of what complexity formed and, second, why the odds are not astronomically against it. The point to take away is that the invocation of long  periods of time can mean  little when speaking of the probability of complex yet unspecified events.”

It’s easy to accept such urban myths without doing the calculations, even when they’re straightforward.

Image result for monkeys typing

See the lengths of improbability even scientists will go to in order to preserve their foundational dogma from anything better?

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