ISO 10011 Dead - 19011 Is Released - A summary of differences

R

rrramirez

#11
I wish to share with all in the list, the response from the ISO people regarding the status of the ISO/CD1 190011:

Subject: Re: ISO 19011
Date: Wed, 01 Mar 2000 14:29:27 +0100
From: Frost Roger
References:1

Reinaldo,

There is no secret. The document is under development and a publicly available draft will be published in November-December.

Best regards,
Roger Frost

> Why is so secret for the public the developing you´re doing in the ISO
> 19011?
> Where can get a basic information as to be "aware"?
> I have been auditor for more than 20 year and it is the first time I can get any information regarding my job.
> In my country it´s really impossible to get this information.
> Regards,
> Reinaldo Ramirez
> Caracas, Venezuela

------------------
Senior Member ASQ (1986)
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#12
Some Related Links:

ISO 9001:2000 DIS?

ISO 10011 Dead - 19011 Evolves

CD1-ISO 19011

Outsourcing Internal Audits

ISO 19011 and the Definition of Observation

Edited 9 October 2001

I can't re-lookup and change every old link to posts in the old forums. Most of them *should* still be there. If you want to find the post in the New forums, if the link to the thread in the old forums works (most of them should...), look at the thread (topic) title and what forum it is in. Then back here in the New forums - go to that forum and look for the thread topic title - OR - do a Search for the key words from Title (Note - you can search entire threads or just the 'subject' or 'title' - if you look in the Forums search page you'll see the options.

Call me lazy...
:rolleyes:
 
P

Paul Stefanson

#13
My sources tell me to attend the 8th ISO 9000 Conference and the ISO 14000 Conference in Reno March 19 - 22, 2001. Shared issues like ... the ISO 19011 auditing standard will be examined in joint sessions March 20 & 21.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#14
One Year later...

OK gang - What's the latest here - Anyone have any current info?
 

Randy

Super Moderator
#17
Marc I forgot who is pushing it, but I can tell you that I overheard a conversation last week (1 side of a phone conference actually) by a person who is on the reviewing committee for 19011. There is quite a bit going on about the requirements for internal auditors as compared to 3rd party types (like me) as well as some other issues with the proposed standard (they slip my mind right now). The person I listened to was at the location I have been doing the 14K project performing our Phase 1 assessment (only 3 minors noted).

Wish I could help more.:bigwave:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
Re: ISO 10011 Dead - 19011 Evolves

What's the status on this? Anyone up-to-date?
 

Randy

Super Moderator
#19
Re: ISO 10011 Dead - 19011 Evolves

I think we've already hit this one in another thread. It has be official for 14-15 months now. Every lead auditor course and internal auditor course presented by providers discusses it.

Done deal...
 
Thread starter Similar threads Forum Replies Date
Geoff Cotton What is ISO 19011? Has it superceded ISO 14010, 14011, 14012 & 10011? General Auditing Discussions 6
D ISO 10011 Status - OBSOLETE STANDARD General Auditing Discussions 11
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom