Latest Reporting, Editorials & Guidance Documents
News
Japan Accreditation Board, IAF Refuse to Explain Japan Data Falsification Scandal
Officials from JAB and IAF have refused to answer questions related to their role in Japan’s increasing data falsification scandals.
New ISO TC 176/SC2 Chair Opens LinkedIn Group to Communicate with Users
ISO TC 176 Subcommittee 2, responsible for ISO 9001 development, has opened a LinkedIn discussion group.
FLIR Company Forced to Pay $30M After 347 ITAR Violations, Still Holds AS9100 Certification
FLIR Surveillance Inc. was charged with 347 violations of ITAR and forced to pay $30M in penalties, even as it held AS9100 certifications from three separate ANAB-accredited CBs.
Oxebridge White Paper: Proposal for a Collaborative Standards Development Model
Oxebridge has published a White Paper on a “collaborative standards development model” for adoption by ISO.
ISO 9001 Certified Defense Contractor Pays $1.5M for Violations of Buy American Act, ITAR
Defense contractor Seiler Manufacturing held ISO 9001 from Preferred Registrar Group despite paying $1.5M in forfeiture for violating ITAR and the Buy American Act.
ASQ Sells Ownership Share of Accreditation Body ANAB
ASQ has sold its ownership stake in ANAB, as the former organization faces increasing financial difficulties.
Forensic Data Manipulation Scandal Ensares UKAS
UKAS is at the center of a scandal involving two accredited laboratories who falsified forensics data, resulting in potential child welfare crises, and the possible release of criminals.
FDA Cited Multiple QMS Deficiencies at Canadian Firm Certified by BSI to ISO 13485
The FDA has cited a company with multiple QMS violations, despite holding ISO 13485 certification by BSI.
Registrar TUV Rheinland Ordered to Pay Over $2 Million to Victims in PIP Breast Implant Scandal
Registrar TUV Rheinland has been ordered to pay over $2 million to victims in PIP breast implant scandal.
BSI Granted CE Mark for Spinal Implants That Are Dissolving Inside Patients
Certification body BSI granted CE Mark to a company whose spinal implants are now dissolving inside patients, forcing them to undergo additional surgeries.
Opinion
US TAG 176 Committee Members Given Only Seven Days to Comment on Annex SL Revision
Key US TAG 176 members were given only seven days to comment on the upcoming revision to Annex SL, which will impact on every ISO management system standard.
CBs Rewarded the Company That Destroyed Peru’s Government and Still Remain Unaffected
As Peru struggles to rebuild a corrupt government, the company at the heart of it continue to boast multiple ISO 9001 certifications issued by CBs who don’t care what their clients do.
Broken Public Trust: Lab That Faked Forensics Data Throws UKAS Under the Bus
Randox Testing Services has come close to overtly blaming UKAS for the fact that forensic test fraud happened on its watch, claiming it is “new” at this, but that they thought things were fine because UKAS never cited them.
Chris Paris in “Japan Today”: The Single Point of Failure in Japan’s Data Falsification Scandals
The international Japanese news journal Japan Today is running an op-ed by Chris Paris on the Japanese data falsification scandals.
Op-Ed: Consultants and Their Impact on Quality Systems
Phyllis Naish provides a look at QMS consultants and their impact on their clients’ quality systems.
UK Certificate Mill Operator Pals Around with Alcumus ISOQAR, Then Republishes Entire ISO 9001 Standard
UK consultant Craig Willetts has republished the entire ISO 9001 standard as his own work, while offering an improper discount for anyone who uses UK registrar Alcumus ISOQAR.
Incoming TC 176 Chair: CBs Unaware of Auditing Guidelines
A poll found that CB auditors didn’t know anything about ISO’s auditing practices publications, to the surprise of exactly no one.
It Gets Worse: ISO Stripped Out ISO 19011 As a Requirement for CB Auditors
ISO/CASCO secretly removed a requirement that auditors comply with the auditing standard ISO 19011.
Three Questions the IAF Didn’t Answer Last Week
The IAF was queried on three important issues relative to the accreditation scheme, and refused to answer any of them.
Without Evidence, IAF Claims “93%” of ISO 9001 Users Have Upgraded
The IAF has claimed that 93% of ISO 9001 users have upgraded, but the figures don’t add up.
Guidance Documents
The Only Acceptable Way to Write an Audit “Opportunity for Improvement”
Most ISO 9001 and AS9100 auditors hide their consulting under “opportunities for improvement,” and thus violate the accreditation rules. This article describes how to write an OFI without crossing the line into consulting.
Oxebridge ISO 9001 Template Kit Version 1.10 Released!
Oxebridge has released version 1.10 “The Awesome Audit Update” of the Oxebridge free QMS template kit.
Your Lowest Cost Options for ISO 9001 or AS9100 Implementation
The range of costs for ISO 9001 or AS9100 implementation is vast, depending on the level of service you want. For tiny companies, this can be intimidating; Oxebridge breaks down the costs of each level of consulting available.
How To Ensure Your Registrar Uses the Right Industry Codes, and Why It’s Important
ISO 9001 and other registrars are required to assign the right SIC, NACE and IAF codes relative to your scope of business, to ensure the right auditors are assigned to your contract; here’s how to check if they’ve done it right.
Implementing the ISO 9001:2015 “Process Approach”
Since it was first made part of ISO 9001 in the year 2000, the “process approach” has confused readers; this comprehensive article aims to decipher the process approach requirements of the latest standard, ISO 9001:2015.
COTO Interruptus: The Missing ISO 9001 Clause on Strategic Direction
An excerpted chapter from Surviving ISO 9001:2015, regarding the need to develop a “strategic direction” despite ISO 9001 lacking a firm requirement to do so.
Great Third-Party Sources of Info to Support the Trickier AS9100 Clauses
These third-party websites may offer some help in supporting your approaches related to AS9100 Rev D’s trickier clauses.
Free ISO 9001 Template Kit Updated to v. 1.9: Includes New Training Presentation
Oxebridge has updated its free ISO 9001:2015 QMS Template Kit, which now includes improved audit and CAR logs, and a 60-slide training slide deck for employees.
Updated AS9100 Template Kit version 1.1: The “Awesome Audit Log Update”
Oxebridge’s free AS9100 template kit has been updated to version 1.1.
Everything We Thought We Knew About ITAR Is Wrong
Companies are ignoring, dismissing or underestimating the impact of ITAR’s latest flowdown push; the risks of failing to implement ITAR properly include jail for those involved, so it’s worth getting educated, fast.
Humor & Everything Else
ANAB’s New Org Structure Goes Flat, But Like REALLY Flat
ANAB’s new organizational structure is a flat sea of Vice Presidents, ensuring the organization’s ability to manage is crippled.
ISO’s “Brand Integrity” Goal is a 1980 Softcore Incest Porn Movie
In the Azores, the ISO 9001 Brand Integrity met and things got icky.
CQI Awarded the Guy Who Invented Risk-Based Thinking, Plus China and (Ahem) Amway
Britain’s CQI gave awards to the guy who invented risk-based thinking, while throwing a bone to China and — inexplicably — Amway.
Happy Halloween, IAQG Has Dozens of “Ghost Auditors” Roaming the Planet
Analyzing the total auditor figures in the IAQG OASIS database reveals a horde of undead zombie auditors roaming the world, just in time for Halloween. Boo!
Cartoonist Goes Nuclear on ISO 9001
Nuclear expert Martin Wakeman has published a cartoon series criticizing ISO for relying on consultants to develop its standards.
Oxebridge Launches New Merchandise Site, Snarky FOD Posters Released
Oxebridge has launched an official merchandise website at www.oxebridge.biz, with the first set of products being a line of snarky FOD posters for aerospace companies.
Get Ready for Oxebridge’s FOD Posters
Oxebridge is getting ready to release a set of snarky, hilarious FOD posters for aerospace companies.
New to Nadcap Audits? Here’s What to Expect
Nadcap special process accreditation is being flowed down to more and more aerospace manufacturers; here’s what you need to know.
Which Brave ASQ Section Wants to Book “Three Steps ASQ Must Take To Become A Member-Focused Organization?”
Oxebridge is challenging any ASQ Section to host his discussion on “Three Steps ASQ Must Take To Become A Member-Focused Organization.”
Nominate Oxebridge’s Chris Paris For “Crosby Medal” Just To Piss Off ASQ
ASQ is seeking nominations for the Crosby Award, and Oxebridge’s Chris Paris wants you to nominate him.
