Ignoring ‘best practice’: Why Irish software SMEs are rejecting CMMI and ISO 9000

Why are Irish software companies ditching ISO 9000?  Mainly cost.  Read the whole palaver:

Ignoring ‘best practice’: Why Irish software SMEs are rejecting CMMI and ISO 9000

O’Connor, Rory and Coleman, Gerry (2009) Ignoring ‘best practice’: Why Irish software SMEs are rejecting CMMI and ISO 9000. Australasian Journal of Information Systems, 16 (1). ISSN 1449-8618

Full text available as:

[img]

Preview
PDF – Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
408Kb

Abstract

Software Process Improvement (SPI) ‘best practice’ models such as ISO 9000 and the Capability Maturity Model Integrated (CMMI) have been developed to assist software development organisations by harnessing their experience and providing them with support so that they can produce software products on time, within budget and to a high level of quality. However there is increasing evidence that these models are not being adopted by Small to Medium sized Enterprises (SME) and primarily remain the remit of large organisations. This paper presents the results of a Grounded Theory study into why Irish SME software product companies are not using these SPI models. The key inhibiting factor found was the issue of cost. We discuss the findings in relation to cost of process and the factors affecting it, including bureaucracy, documentation, communication, tacit knowledge and organisational creativity and flexibility, and the associated impact on the adoption of SPI best practice models.

 

Advertisements
Posted in Economics, Management, Computing | Tagged , | Leave a comment

Worldview goes shoogly

Scott Adams’ Dilbert understands the ISO scam, even if he doesn’t document the corruption and criminality as thoroughly as Oxebridge. Adams recognizes how another source of cognitive dissonance can work in a TV interviewer:

And here’s the original:

By the end, has she fallen in love with the discombobulator of her previously-unchallenged Weltanschauung?

Image result for how many finger winston o'brien

Believing and loving ISO; cognitive dissonance happens

Posted in Philosophy, Politics, Psychology | Tagged , , , , , , | Leave a comment

ISO 9001’s ongoing decline

Chris Paris has evaluated the 2016 ISO report on ISO 9001’s uptake.  Read his analysis here.

The ISO hasn’t bothered to correct misleading figures designed the inflate the standard’s popularity but it continues its secular trend of decline.

China and Italy have yet to see through it, but many other countries have begun to understand its worthlessness and are rejecting it.

You can understand why it’s so important for UKAS to gain gullible allies to continue the transfer of money from taxpayers to the inspection cartel.  ISO 15189 and 17025 continue to fool the medical and scientific professions and are growing as if they were compulsory.

It’s strange because even if they often lack the access to true price discovery and profit and loss accounts, these professionals have the statistical and investigatory knowledge to be able to prove the wastefulness that UKAS spreads.  Yet in their management and professional societies they push these practices without assessing their value.  They’d think more carefully if it were a new treatment for patients, yet ignore this ethical aspect as if they believe it is unlike other treatments and has no power to harm.  Why might that be?

UKAS hovers around in a safe zone where it’s learning to tell doctors what to do yet is distant enough to ensure it doesn’t get sued when things go wrong.

Things do go wrong and accreditation gives no clear protection.  Many major incidents occur despite (and perhaps because of) ISO accreditation.

Amtrak

Takata

Randox Testing Services

Accreditation won’t form part of the investigation.  UKAS is clean of any responsibility.  The solicitor will be writing to the hospital.

The UKAS Update newsletter tell us,

Working with NHS England to increase uptake of accreditation

NHS England recognises that quality improvement is critical to achieving world class, patient focused, safe, effective and efficient healthcare. Accreditation is one of the tools which provides assurance of standards, supports patient safety and ensures consistency of the quality of services and care that is delivered. UKAS continues to work with the Chief Scientific Officer of NHS England, Professor Sue Hill, and her team to raise awareness of the benefits of accreditation and support Trusts on their journey towards gaining accreditation for their full repertoire of scientific and diagnostic services.

Recently UKAS Senior Assessment Manager, Rebecca Gibbons, co-presented a webinar directed at Trust Lead Healthcare Scientists to provide background information about the different healthcare accreditation programmes that UKAS provides. UKAS’ Business Development Director, Lorraine Turner, was delighted to present to NHSE’s Leadership, Improvement and Advice (LIA) group. The LIA group is a consortium of senior healthcare science leaders from Trusts across England and is chaired by Fiona Carragher in her capacity as Deputy Chief Scientific Officer.

These presentations were aimed at encouraging Lead Scientists to utilise existing quality management expertise held within the Trusts to support the expansion of their scope of UKAS accreditation to cover other areas, and to highlight the similarities of the different accreditation programmes delivered by UKAS: Medical laboratories, Physiological Diagnostics (IQIPS), Diagnostic Imaging (ISAS) and Medical Physics and Clinical Engineering (MPACE).

In response to requests from Trusts and NHS England, UKAS is taking a more joined up approach to the assessment and accreditation of scientific and diagnostic services. This approach could result in improving the efficiency and effectiveness of the systems in place to provide assurance to patients, as well as reducing the overlap and resources required to undertake the UKAS assessments.

UKAS is also able to adopt a similar approach in other UK countries where it would be helpful, please speak to your Assessment Manager or the UKAS Team Leader for Healthcare, Le Tran (le.tran@ukas.com), for more information.

Expanding the scope for UKAS’s income generation in the name of quality.

Some hospitals are pushing ISO accreditation and Deming-based quality improvement at the same time.  They can’t see the contradiction.

They stand less chance of understanding it now that the ISO is trying to rewrite history and say they believed Deming in the first place.

Ask a patient if they notice an improvement because of accreditation.  Ask them if they’d pay their own money for it.

UKAS welcomes new Non-Executive Director

UKAS has recently welcomed Professor Adrian Newland to the UKAS Board as Non-Executive Director. Bringing a wealth of healthcare experience, Professor Newland is currently Professor of Haematology and Honorary Consultant at Barts Health NHS Trust in London and at the Queen Mary University of London. He is also Chair of the National Institute for Health and Care Excellence (NICE) Diagnostic Assessment Programme, co-Chair of the WHO Standing Advisory Group of experts in In vitro Diagnostic Devices and National Clinical Advisor in Pathology to NHS Improvement.

Throughout his career, Professor Newland has been involved in the establishment of standards and accreditation in the Healthcare sector. This began as a council member in the early 1990s when he was involved in the development of the Clinical Pathology Accreditation (CPA) scheme with Professor John Lilleyman for the Royal College of Pathologists. In subsequent years, he remained involved and was instrumental during his time as President of the Royal College of Pathologists (2005-2008) in helping forge closer links between CPA and UKAS. At that time, he also advised the President of the Royal College of Radiology, Dame Janet Husband, on the development of their radiology accreditation scheme, ISAS. Later in his role as secretary of the Academy of Medical Royal Colleges, he became their advisor on accreditation and was chair of the UKAS Healthcare Policy Advisory Forum.

On behalf of the Academy, Professor Newland also helped to develop the Healthcare Quality Improvement Partnership (HQIP) and was a member of its first board. He was also involved in the appointment of the executive team for the first physiological science accreditation scheme, IQIPS, for the Royal College of Physicians. Professor Newland was previously the President of the British Society for Haematology and the President of the International Society of Haematology (ISH) from 2014 – 2016.

Please join us in welcoming Professor Newland to UKAS.

Organisations that become members of UKAS become unable to criticise because they have been complicit in the errors.

Listen to the rest of the world that is rejecting ISO 9001 rather than the UKAS speaker at the dinner!

 

 

 

 

 

Posted in Laboratory medicine, Management, NHS | Tagged , , , , , , , , | Leave a comment

The muddled mind of a UKAS assessor

UKAS’s latest technical bulletin gives further insight into the muddled thinking that lies behind the ISO scheme.

Medical Royal College examinations, Continuing Professional Development, GMC registration, revalidation etc. etc. are all unable to render doctors competent any more.

And UKAS want their cut of the bureaucratic profit through ISO 15189:2012.

“As shown by the range of indicators that might contribute to the assessment of competence, good performance in EQA/iEQA does not automatically demonstrate competence and equally, poor performance does not automatically mean lack of competence.”

So, even though performance in EQA schemes proves little, doctors must still submit to UKAS assessing them though a method they admit confirms nothing.

The old BSI strategy is to maximize the potential points of failure and pretend this is meaningful or helpful.

This self-contradiction will protect UKAS from being sued for defective pathology.

Though note that BSI is in trouble again for continuing with its deceptive advertising when the Advertising Standards Agency told it not to.

UKAS will play its part in squeezing the life out of healthcare purely for its own profit.

The bulletin in full:

» Technical Bulletin – UKAS Position Paper: Assessment of a Medical Laboratory’s approach to the assurance of clinical staff competence and use of EQA

28 November, 2017

Background

This paper is intended to clarify requirements of ISO 15189:2012 and UKAS’ expectations of how a medical laboratory demonstrates the competence of its clinical staff. This paper also includes information on the use of External Quality Assurance (EQA) programmes.

This paper has been developed by the UKAS Medical Laboratory Technical Advisory Committee following some questions concerning the approach to the assessment of clinical staff competence and seeks to provide clarification to laboratories of the information that a laboratory needs to provide to UKAS as part of its assessments.

UKAS accreditation provides independent confirmation of a laboratory’s competence to carry out specified activities. UKAS assessments are conducted to gather objective evidence that a laboratory is competent; assessing the competence of a laboratory will include the competence of the personnel, the validity of test methodologies and the validity of outcomes/test results.

It follows that UKAS must assess the procedures a laboratory has in place to evaluate the on-going competence of all staff and the associated evidence and records that demonstrate implementation. As with all areas of assessment, this will be assessed through a sampling exercise on assessment visits. As stated in previous guidance in this area (Assessor Update April 2015), competence in the provision of clinical advice/opinion is likely to be based on multiple components.

UKAS considers that EQA provides valuable information for laboratories and accreditation bodies that gives assurance about the medical laboratory service, including assurance on clinical interpretations. Participation in EQA is not a compulsory component of the assessment of the competence of clinical staff, however, as evidence of conformity to good medical and scientific practice and continuing professional development, where appropriate schemes exist, laboratories might reasonably expect their clinical staff to participate.

The Assessment

It is the laboratory’s responsibility to define the criteria that it uses to determine the competence of its staff. UKAS uses competent peer assessors that have the demonstrable knowledge, skills and experience to evaluate the laboratory’s approach and assess examples of records to determine that the approach is followed and is effective.

ISO 15189 provides some examples (Clause 5.1.6 Note 1) of how a laboratory can assess the competence of its staff, both initially and on an ongoing basis. A laboratory may choose to use different mechanisms to provide information about the ongoing competence of its staff and this might include the use of EQA where it exists and is appropriate. UKAS understands that there are some limitations to the use of EQA in this way, particularly ’interpretive’ EQA schemes (see below).

ISO 15189 clause 5.1.9 specifies the content of the records to be held for all personnel and requires that the records are readily available. The laboratory should consider carefully how it will retain access to this information, taking into account that some competence information may be held as part of confidential appraisal records or performance reviews. The assessment team needs to assess the evidence that is used to demonstrate competence and the laboratory should seek to provide this without compromising confidential information that is not relevant to the assessment.

The assessment of the laboratory’s approach to evaluating clinical staff competence may include assessment of, but not necessarily be limited to, the following:

  • Qualification records, experience, knowledge, appointment process, induction, training sign off
  • Records of EQA participation
  • Mechanisms to monitor on-going competency internally and associated records
    • Any competency assessment programme would have defined acceptance criteria, including for clinical staff. It would be expected that such an on-going programme is suitably robust to cover all of the staff member’s scope of activity, at sufficient frequency.
  • Records of knowledge sharing, for example MDT involvement, case review discussions, case handovers, on call involvement
  • Suitability of competency programme acceptance criteria
  • CPD (e.g. College CPD, external meetings, course evaluations, iEQA)
  • Review of test reports
  • Coverage of all areas by internal audit
  • Minutes of meetings aimed at service improvement

It is acknowledged that information relating to a doctor’s competence is essential for the GMC revalidation process and will be gathered and reviewed as part of the regular appraisal process. Competence records held by the laboratory may be used by clinical staff to generate evidence for appraisal and vice versa. This should be conducted in such a way to preserve the confidentiality of information that is not relevant to the assessment.

UKAS Position on External Quality Assurance Participation

Technical EQA schemes

ISO 15189:2012 (clause 5.6.3.1) requires the laboratory to participate in interlaboratory comparison programmes (such as EQA or proficiency testing) appropriate to the examination and interpretation of results. UKAS Publication TPS 47 Policy on participation in proficiency testing contains more information to support the implementation of ISO 15189 and recognises that it is for the laboratory to judge the suitability of an EQA scheme to meet their needs. A laboratory may be able justify non-participation in an available scheme based on its suitability and/or other factors. The laboratory can also consider alternative approaches to providing assurance. It may be necessary to look beyond the UK for EQA scheme availability and laboratories may refer to the EPTIS database to assist with this process [http://www.eptis.bam.de/].

Interpretive EQA Schemes

UKAS understands that not all interpretive EQA (iEQA) schemes are suitable for use in demonstrating the performance of the laboratory and/or individuals, and that participation may solely be for the purpose of CPD. It is for the laboratory to determine which schemes it will participate in and for what purpose. Where a laboratory is not participating in an existing scheme there needs to be justification for this; where a valid justification is not provided, a suitable finding will be raised.

Where individual staff participate in iEQA for the purposes of their own CPD, evidence should be included in their CPD records.

 

Assessment and Reporting

UKAS understands that participation in EQA/iEQA is primarily to provide information to develop and improve processes, knowledge and understanding, and to assure outcomes, and does not simply aim to achieve a specific result or answer. However, where unexpected results are encountered and any necessary action is identified, this should be progressed through the laboratory’s own governance system to consider opportunities for improvement.

While participation in EQA/iEQA may provide evidence of a positive approach to quality assurance, it is recognised that there is a strong educational component and EQA/iEQA scheme reports will often contain advisory and educational components to achieve this aim. As shown by the range of indicators that might contribute to the assessment of competence, good performance in EQA/iEQA does not automatically demonstrate competence and equally, poor performance does not automatically mean lack of competence.

Where UKAS identifies nonconformities, it is the responsibility of the laboratory to specify its improvement/corrective action, this is not something that is specified by the assessment team. It is usual for the laboratory to discuss its proposals with the assessor(s) and there is usually some discussion about the possible routes to take and the impact of each. Should the laboratory reconsider its original proposal and develop an alternative solution to an agreed improvement that addresses the finding, such evidence can be submitted and would be considered by UKAS.  

Download printable version of this Technical Bulletin

 

Posted in Bureaucracy, Laboratory medicine, Medicine | Tagged , , , | Leave a comment

Accredited forensic fakery – how assured are you feeling?

Herbert Edelhertz defined white-collar crime as: any illegal act or series of illegal acts committed by nonphysical means and by concealment or guile, to obtain money or property, to avoid the payment or loss of money or property, or to obtain business or personal advantages. Gilbert Geis defined upperworld crime as: a label designed to call attention to the violation of a variety of criminal statutes by persons who at the moment are generally not considered, in connection with such violations, to be the ‘usual’ kind of underworld and/or psychologically aberrant offenders.

We have seen previously how Randox was fleeced by UKAS in paying for the false assurance of accreditation to ISO 17025.  It didn’t stop “rogue scientists” altering forensic results.

Another forensic company has been drawn into the investigation.  Trimega Laboratories boasted of the prestigious UKAS accreditation it gained in 2013.  Here’s the press release in case it disappears in embarrassment:

 

Trimega Labs Drug and Alcohol Analysis

Since the acquisition of Trimega Laboratories last year, Ingemino have invested more than £1 million in developing our new laboratory

Trimega Laboratories, specialists in testing for illegal drugs, alcohol and DNA, are pleased to announce that hair drug testing analysis at its newly enlarged Manchester laboratory, has been accredited to the ISO/IEC 17025:2005 international standard by the United Kingdom Accreditation Service (UKAS). The accreditation was granted on July 10th. 

“This is great news and a credit to the hard work of the new management team. Since the acquisition of Trimega Laboratories last year, Ingemino have invested more than £1 million in developing our new laboratory and the supporting systems that go with it. As part of this process, we have developed an improved quality system and the UKAS accreditation is the ultimate seal of approval” says Fiona Begley, Director of Trimega Laboratories, and Executive Chairman of the Ingemino Group.

UKAS themselves explain the significance of accreditation on their website: 
“Accreditation is the only mechanism that determines the technical competence and integrity of the organisations offering testing services. ISO/IEC 17025 not only contains requirements for the quality management system of the organisation but they also include detailed and specific technical criteria for the operation of the technical service including ensuring the competence of personnel.”

The accreditation schedule for the testing of hair samples comprises the confirmation and quantitation of a total of 10 analytes and metabolites: Amphetamine, Methylenedioxymethylamphetamine (MDMA),
Cannabis: Delta 9-THC, Cocaine, Benzoylecgonine, Methadone, EDDP, Opiates: Codeine, 6 Monoacetylmorphine and Morphine. Trimega’s schedule of accreditation is published on the UKAS website. 

Frank Whitfield, recently appointed as the Trimega Laboratory Operations Manager following fours year with Roche Diagnostics, in describing the process of accreditation, said: “To gain accreditation, Trimega Laboratories had to undergo independent, rigorous audits by UKAS to establish not only that the analytical processes meet the standards, but that those standards are sustainable. We have rigorous checks in place at every stage of the testing process. Each sample that enters the laboratory can be traced via a chain of custody audit trail and can be tracked from the moment it enters the laboratory through to the issuing of the result.” 

As with all accredited laboratories, the processes will now be regularly audited by UKAS to ensure Trimega continues to meet the ISO 17025 standard. 

This latest accreditation adds to the ISO 14001 ‘environmental management system standard’ already awarded to the company and the ISO 9001 quality assurance certification awarded to the Client Services department based in Germany.

The prestigious ISO 17025 accreditation reflects the laboratory’s rigorous approach to testing and laboratory processes, to help ensure consistent calibrated, accurate results. By analysing a sample of hair from a donor, Trimega is able to develop a picture of the habit underpinning harmful substance misuse for up to a year prior to the date of the test. 

–END–

Editor’s Notes
Perfectly Picked communications
Tel: +44 (0) 1491 636262
Email: tellmemore@perfectlypicked.com

About Trimega Laboratories

http://www.trimegalabs.com

Established in London in 2005, Trimega Laboratories is a specialist in the legal testing for substance misuse and in paternity testing. Its core business is laboratory-based analysis of hair samples that provide accurate historical records of alcohol or drugs dependency over a one to 12 month period. In the UK, Trimega’s clients include: family law specialists, law courts, and social services.

Trimega Laboratories was acquired by the Ingemino Group in 2012 and since then the business has undergone a complete overhaul with new management and investment. Fiona Begley, Director of Trimega,Laboratories and Executive Chairman of the Ingemino Group is a renowned expert in this industry and former CEO of Concateno plc, the owner of Trichotech laboratories.

UKAS Accreditation:
http://www.ukas.org/testing/schedules/actual/4583Testing%20M…
Confirmation and Quantitation of:
• Amphetamine
• Methylenedioxymethylamphetamine (MDMA)
• Cannabis: Delta 9-THC
• Cocaine
• Benzoylecgonine
• Methadone
• EDDP
• Opiates
• Codeine
• 6 Monoacetylmorphine
• Morphine

https://pressreleases.responsesource.com/news/78707/trimega-laboratories-gain-ukas-accreditation-to-iso-17025/

ISO accreditation is no security against false results.  Maybe the “rogue scientists” are solely to blame.  Maybe the unnecessary pressure it creates drives staff to faking results.  Either way, accreditation provides no assurance.  It is merely a confidence trick.

Let’s hope the solicitors of those falsely-convicted are gearing up to include UKAS in the writ.

The scientists will be prosecuted.  The UKAS senior managers will continue to walk free – the get-out clause is, “our assessment is only a sampling exercise.”

These events show their accreditation is as worthless as it is expensive.

Posted in Forensic science, Medicine, Science | Tagged , , , , , , | Leave a comment

Essential Services Laboratories

If you’ve read John Seddon you will know that the front office – back office arrangement will be a disaster.  It may have been sold promising economies of scale and a new computer system, neither of which will work out well.  Workers need to be able to help customers solve their problem from beginning to end, not pass it on to someone who doesn’t understand.

Telemarketing Outsourcing

Lord Carter of Coles gave the NHS a version of front office – back office for pathology labs.  It’s called the Hub and Spoke model:

An external file that holds a picture, illustration, etc.Object name is cbr29_1p7f1.jpg

Illustration of the hub and spoke or disseminated laboratory medicine network. Numbers 1 to 5 represent laboratories on different sites that share common equipment, reference ranges and quality management system. All laboratories provide a common core service and specialised laboratory services are rationalised in line with clinical services. Small black circles represent centres outside the laboratory where laboratory testing is performed using point of care testing.

 

You can read Graham Beastall’s description of the plans here:  The Modernisation of Pathology and Laboratory Medicine in the UK: Networking into the FutureClin Biochem Rev. 2008 Feb; 29(1): 3–10.

It separates patients from the pathologists equipped to solve their problems.  You can work out some of the consequences of the misunderstandings and delays that are inevitable.

Professionals and their organisations largely went along with it because they didn’t have more persuasive ideas, quality had to be improved (though there was little evidence of problems) and the war cries of management that shut down critical discussion – “economies of scale”, “not fit for purpose”, “the status quo is not an option!” etc.

Some of these network management schemes have failed on a large scale.  Now the Royal College of Pathologists has released this document, Essential Services Laboratories – NHSI Oct 2017.  It is much better than some earlier professional opinions which mostly accepted the authority of the Carter proposals.  The College paper draws on experience of the destruction of services that will be brought about by the new arrangements when the labs of hospitals in England are reduced to 29 networks of “Essential Services Laboratories”.

Take note or watch the next disaster unfold…

Posted in Bureaucracy, Laboratory medicine, Management, Medicine, NHS | Tagged , , , , , , | 2 Comments

ISO – in the swamp

Oxebridge try to make ISO 9001 workable and would like to save it.  The ISO management standards are inadequate, a fraud and facilitate corruption.  We say, let them die.

Oxebridge have a sense of humour that’s unusual in those having to deal with the ISO.

ISO knows it can’t sue when its logo is used for purposes of editorial parody, but we still expect Wrigley candy company to sue for having their brand tainted by proximity to ISO.

More helpfully, they give a sample list of major scandals that ISO certification has been implicated in.

The Final Step to Saving ISO 9001

The problems facing the ISO 9001 and AS9100 certification schemes are many, and complicated. While auditing bodies and standards developers deny such problems, the evidence is irrefutable: ISO 9001 is not providing confidence in the quality of companies that adopt it, and the both the certification scheme and standards development process is dominated by a handful of private consultants who use their positions to enrich themselves. ISO’s customers – the users of ISO 9001 – have little to no say in developing the content of the standard, nor in how certifications are issued and accredited. The CBs and their oversight Accreditation Bodies have abdicated their duties in enforcing the rules, and allow routine bad behavior, the most egregious of which is overt consulting by certification auditors. After Enron, the finance world learned of the problems this arrangement poses, and took action; in the ISO certification arena, those lessons are being ignored or fought outright, even as similar scandals loom on the horizon.

In the United States, Oxebridge estimates the ISO 9001 industry in the United States to be between $1.5 to $2 billion dollars annually, much of which is flowed down to consumers and taxpayers. This does not include lost productivity and expenses associated with implementation and audit support efforts. In addition, the impact on a poorly run ISO certification industry has a direct impact on the public health and safety. We have since learned that the companies involved in the Takata airbag scandal and the DeepWater Horizon oil spill were certified by accredited ISO 9001 certification bodies. Likewise, well-publicized fiascoes related to the production of the F-35 Joint Strike Fighter, the doomed Shuttle Columbia, the 787 Dreamliner battery fires, the PIP breast implant scandal and the Volkswagen/Bosch emissions defeat scandal involved ISO certified supply chain actors.

Within the US, a single entity holds sway over both standards development and the certification scheme: the American National Standards Institute (ANSI).Yet for the past few years, ANSI representatives and executive management have ignored or resisted outright all calls for improvement, reform or even informal internal introspection. In short, they deny there are any problems. As an entity that derives revenue from the sale of standards and through certification activities, this is not unexpected.

In 2012, the CEO of ANSI – Joe Bhatia – testified before the US Congress, and promised the Federal government that all was well regarding ANSI, the ISO 9001 development process, and the ISO certification scheme. The testimony included statements that have since been proven to be untrue, and were likely untrue when the testimony was given.

Given the impact of the failures of ISO 9001, it is imperative that the Congress and American people have equal access to true and current information, including the dangers and costs the current system presents, as well as ANSI’s failures to adhere to its responsibilities. Congress must then take suitable steps to demand explanations from ANSI, and – if it deems it appropriate – investigate thoroughly. The goal should be to restore the trust in third party ISO 9001 certifications, and the standard itself, for the purposes of reducing waste and fraud, and reducing the risks to public health and safety…

Make sure you click through and read the testimony of ANSI’s CEO .

“If a legal case can be made that Bhatia misled the government, then it could be argued that both ANSI and ANAB are involved in a literal conspiracy to defraud the United States government.

Are things any better with BSI, UKAS and other cartel members who lobby politicians outside the USA?

Posted in Bureaucracy, Cartel, Economics, Management, Politics | Tagged , , , , , | Leave a comment

Kobe Steel – ISO 9001 certification of corruption

b-kobesteel-a-20171020-870x510

KOBELCO_JAPAN_2020

Kobe Steel.  You can download their recent ISO 9001 certificate here.

UKAS.  IAF.  Lloyd’s Register LRQA.  It’s got all the jealously-protected logos.

Yet the company has been falsifying quality data for its products for over a decade.  Kobe even have memos on how far deviations are permissible from the stated tolerances.

The Japanese automakers say the metals are actually OK.  Were certified standards too tight in the first place or are all the companies lying?

Certification obfuscates.  For all the talk from the inspection cartel about anti-corruption, it cannot prevent it.  Maybe it obliges deception because its standards are so impractical to meet.

Why should the industrial companies be more at risk than the quality cartel’s well-protected branding?

The Bank of Japan protects the corporate deceivers (they made political campaign donations).  It buys Kobe’s corporate bonds and spreads the losses to the taxpayers and pensioners.

Just like the cartel’s inspectors are never to blame and never experience the consequences of their failures.

Read more here:

The hidden chapter of Atlas Shrugged

and here:

Japan’s automakers issue reassurances as global bodies urge freeze on Kobe Steel products 

283_8364_IMG

 

 

Posted in Cartel, Economics, Management, Politics | Tagged , , , , | Leave a comment

Randox rogues show ISO doesn’t balance

We saw before that Randox Testing Services paid UKAS for ISO accreditation of forensic testing.  Accreditation couldn’t stop employees rendering the results unreliable by falsifying QC results.  Randox called in the police.

The Daily Mail reports on the continuing investigation,

Dr Tully also raised the possibility that the problem may spread wider than just Randox.

She said: ‘The organisation concerned held accreditation to the appropriate quality standard, but the malpractice was not discovered by the usual quality checks. 

‘This raises a number of questions, including: a, whether or not malpractice is more widespread than at one organisation; and b, whether or not the quality standards need to be strengthened.’

But she went on: ‘No reasonable set of quality standards could guarantee to prevent determined malpractice by skilled but corrupt personnel and the inevitable cost of adding additional safeguards should be balanced against risk.’

Randox said last night it is paying for the retesting to be carried out in independent labs. (emphasis added)

Dr Tully is correct: balance safeguards against risks.  ISO doesn’t balance.

Once again, accreditation isn’t paying for the increase in costs its obsessive collection of evidence demands.

Maybe we need a new ISO standard that’s more oppressive.  Maybe the inspectors should be fired because they didn’t do their jobs well enough (though nobody is asking).  Maybe the RTS needs to improve its management to get the best out of its staff.  Maybe without accreditation, staff would have not felt so oppressed that they had to resort to deception.  Time will tell.

The ISO is catching up again by putting anti-corruption and risk assessment into its latest version of ISO 17025.  Will anyone assess the risks from wasting resources on accreditation?  It’s just to provide fodder for keeping the cartel running and inspectors employed, as jobs in real science vanish.

Randox: you run your own EQA scheme; take up the challenge – produce a simpler, better system of quality assurance that lets labs dump UKAS.

 

Posted in Forensic science, Laboratory medicine, Practical problems | Tagged , , , | Leave a comment

ISO 9001: in need of further compulsion

ISO 9001 is slowly withering.  ISO 17025 is popular among science managers and legislators.  Therefore the new revision of ISO 17025 contains a mandatory nudge towards ISO 9001 to inject a bit of vigour into it.

UKAS explains:

» ISO/IEC 17025 Standard Revision Update

» ISO/IEC 17025 Standard Revision Update

–>12 January, 2017

The Draft BS EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is now available on the BSI website for public comment.

For the past couple of years, ISO/CASCO Working Group 44 have been busy preparing this new version of ISO/IEC 17025.

This standard, first produced from EN 45001 and ISO Guide 25 back in 1999, underwent just a minor revision in 2005.

The present revision addresses the need to align it with the other more recent ISO 17000 series standards, as required by ISO CASCO and to modernise the standard, recognising advances in technology and business practices.

There are no significant technical changes and presently compliant laboratories are unlikely to have any significant issues with the new standard. The biggest difference is in the structure of the Standard, which is completely revised, having distinguished “resource” from “process” and acknowledging the possible role of an ISO 9001 based management system.

Work in the UK on the revision is being undertaken by BSI’s UK WG44 Mirror Group, the secretary is sarra.cheyne@bsigroup.com. It is chaired by Trevor Thompson from UKAS and contains representatives of laboratories and stakeholders.

Trevor would be pleased to receive any comments for consideration by the UK mirror group, or you may comment direct to BSI as instructed on their website. UKAS has set up a mailbox 17025.review@ukas.com if you wish to contact the UK mirror group.

Please bear in mind that the restructuring of the standard is mandatory, as is the inclusion of the ISO 9001 option. Please make any comments only on the online form, and only when suggesting replacement text on the form. BSI have set a public comment closing date of 22 February 2017.

It is presently expected that the Standard will be published at the end of 2017 and it shall have a three year implementation period. We shall, of course, be in touch with affected customers, later in the year.

Posted in Cartel, Science | Tagged , , , | Leave a comment