Latest Reporting, Editorials & Guidance Documents
News
Former TAG 210 Member At Center of Medical Device Recall, FDA Investigation
A former member of the US TAG to ISO TC 210, responsible for the ISO 13485 medical device manufacturing quality standard, is at the center of an FDA investigation for medical device failures which led to at least one death.
Two Arrested at AS9110 Certified Army Depot for Falsification of Helicopter Repair Records
Two employees at the Corpus Christi Army Depot, which holds AS9110 certification by SAI Global, were arrested on charges they knowingly falsified repair data on UH-60 Blackhawk helicopters
TUV Rheinland Found Culpable by French High Court in PIP Breast Implant Scandal
The highest court in France has found the ISO registrar TUV Rheinland culpable in the Poly Implant Prothèse (PIP) breast implant scandal.
Arrest in Aerospace Trade Secret Conspiracy Highlights ASQ’s Lax Attitude Towards China
A Chinese national was arrested on charges of conspiring to steal aerospace industry secrets from GE Aerospace, even as ASQ continues to play down the role China plays in international intellectual property theft.
Report: UK “Risk-Based” Healthcare Auditing Scheme Ineffective
A report funded by the UK government found that ISO 9001-style “risk-based” audits of British healthcare firms are largely ineffective, and ignored by consumers.
Equifax Held ISO 27001 Certification At Time of Massive System Hack
Equifax held third-party ISO 27001 certification at the time of their massive breach of private consumer data.
ISO Survey 2017 Shows 5% Drop in ISO 9001 Certificates Worldwide, 18% Loss in US
The latest ISO Survey data has been released, and shows a massive drop in both international and US adoption of ISO 9001 certificates.
Pushing Pro-China Policy to State Run Media, ASQ Board Chair Misleads on IBM Piracy Position
ASQ Board Chair Elmer Corbin defended the group’s pro-China marketing push while claiming his employer IBM has “safeguards” in place for intellectual property theft, even as IBM has been a worldwide victim of such crimes.
NSF-ISR Has Monetized Nonconformities, Charges Clients $90 per Finding
ISO and AS registrar NSF-ISR is charging $90 per audit findings, thus incentivizing auditors to write bogus findings.
ISO 19011: 2018 Published
ISO has released ISO 19011:2018 - Guidelines for Auditing Management Systems, the latest version of the standard designed to provide minimum requirements for first-, second- and third-party audits. The new standard can be purchased directly from ISO (here) for $159....
Opinion
QA Director Arrested in PIP Breast Implant Scandal Is Working As An ISO Consultant Now
The Quality Director responsible for the PIP breast implant scandal was sentenced to two years in French prison, but is now working as an ISO consultant in the medical device industry, because of course she is.
QMS Software Vendor Calls VW Emissions Scandal A “Software Glitch”
Software vendor IQS is marketing its QMS packages to the automotive industry by falsely claiming the VW emissions scandal was due to a “software glitch” and “poor software quality,” which they imply their software could have prevented.
Help Complete This Survey on ISO Remote Auditing Techniques
Quality assurance expert Mike Gospodinsky is asking ISO auditors and auditees complete a short 5-minute survey on their experiences with “remote auditing techniques.”
Oxebridge Analysis of ISO Survey Data 2017
Oxebridge releases its annual analysis of the ISO Survey Data, this one for the 2017 survey.
ASQ Updates Support of White Nationalist, While Punishing Oxebridge for Asking It To Denounce Racism
ASQ once against promotes a conference featuring white nationalist Bill Levinson, while working to ban events by Oxebridge apparently out of spite for calling on them to denounce racism.
British Ad Watchdog Agency Contradicts Own Rulings to Defend BSI
The UK’s Advertising Standards Authority has ruled that BSI’s marketing of ISO 9001 is just fine, even though that ruling contradicts an ASA ruling on the exact same complaint from 1997.
ASQ Ignores Offer to Resolve Oxebridge Conflict Out of Court
ASQ has continued to ramp up defamation against Oxebridge, while ignoring an attempt to resolve the conflict at no cost, out of court. Now the organization seems destined to suffer a court battle, likely using Section funds to do so.
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.
IAQG Support Materials on Project Management Appear Partially Taken from PMI, Don’t Address Aerospace
The IAQG Supply Chain Management Handbook guidance on the “project management” requirement of AS9100 not only doesn’t address aerospace at all, but seems partially lifted from materials published by someone else.
OP-ED: Astronaunts for First SpaceX Dragon Crew Announced, and I’m Worried
SpaceX announced the eight astronauts that will ride in Crew Dragon, and Oxebridge’s founder is worried.
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
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.
Deadpool’s Sidekick Is Trolling LinkedIn, and It’s Hilarious
Deadpool sidekick “Peter W” is posting on LinkedIn, and the idiots on that network don’t know they’re getting trolled.
Looking Back at Some of Oxebridge’s Humor Graphics – Part IV
Another look at Oxebridge’s sometimes-hilarious editorial graphics.
Watching Daryl Guberman Debate IAQG’s Buddy Cressionnie is Comedy Gold
Cage match! Certificate mill operator Daryl Guberman battled IAQG genius Buddy Cressionnie, and neither man came out smarter than when they went in.
Put Any Image on the Cover of Quality Progress With ASQ’s “QP Yourself” Campaign
ASQ came up with a campaign where anyone can add any photo to the cover of Quality Progress. What could go wrong? Oxebridge shows you exactly what.
Looking Back at Some of Oxebridge’s Humor Graphics – Part III
Another look at Oxebridge’s sometimes-hilarious editorial graphics.
Read The Most Hilarious Management Junk-Jargon Post Ever
A risk management guy likes boardroom jargon. So much so, it becomes unintentionally hilarious.
