What changed in Amendment 1:2011 in the ISO 2859-1:1999?

L

Lily123

#1
Hi there, Happy New Year !!:bigwave:
We are using ISO 2859 standard at Goods In and during in-process quality checks to determine the sampling size to use, there has been an amendment of this standard to ISO 2859-1:1999/Amd 1:2011
Does anyone know what change was in the update ? and if I need review our processes for on-going compliance ?

Thanks for your help in this , Lily
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!
 

SteveK

Trusted Information Resource
#3
Without going into copyright issues by paraphrasing, the amendment accommodates the scoring roles of switching. Note that the section numbers given below are likely to have increased by one digit from previous because there is now an additional section 2 ? Normative references. It indicates the usefulness of the following - ISO 2859-3, ISO 3534-1 and ISO 3534-2.

In 8.1 (Sample selection) it additionally references ISO 24153 with respect to random sampling and also ISO 2859-10:2006 for further details at the end of the paragraph.

In 9.3.3.1a (General) it gives the option that the previous ten lots have been accepted under original inspection assuming approval of the responsible authority.

In 12.5 (Average sample size curves) it now references ISO 3534-2:2006, 4.3.8 at the end of the paragraph.

In 12.6.3 (Producer?s risk tables) at the end of the paragraph it indicates ? in 4.6.4 of ISO 3534-2:2006.

In Table 9 there are additional average sampling size curve plots covering Ac = 7, 8, 10, 12, 14 and 18.

Finally in the Bibliography it additionally references ISO 2859-10, ISO 2859-2, ISO 3951 and ISO 24153.

I think I?ve captured everything.

Steve
 
Thread starter Similar threads Forum Replies Date
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
L GRR for a tolerance that has changed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
Q Change revision number in document when only codification was changed Document Control Systems, Procedures, Forms and Templates 8
B MHRA Unannounced Audits Frequency Changed? EU Medical Device Regulations 2
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
N AIAG 4th ed. FMEA Manual "Fit" Changed to "Appearance" - Fit severity? FMEA and Control Plans 2
T IEC 62366:2015 Annex C - changed parts from 5.1-5.8 --> but what about 5.9? IEC 62366 - Medical Device Usability Engineering 3
A Product status has changed from "tested" to "listed" in the EU Pharmacopoeia EU Medical Device Regulations 1
E Pallets need to be changed when raw materials are transferring from WH to MFG area? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
M FMEA Corrective Action target date changed ISO 14971 - Medical Device Risk Management 1
B Safety & EMC certificate updated when MCU (MIcro-Controller) is changed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Did UL 60601-1 change when the IEC 60601-1 standard changed to the 3rd edition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J PPAP for New Family Revisions when the Part has not changed APQP and PPAP 4
P Losing Accreditation - JAS-ANZ has changed the conditions of non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K EN 13640:2002 number changed to EN ISO 23640:2011 Other Medical Device Related Standards 1
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
B PAS99:2012 - What has changed since the 2006 version? Other ISO and International Standards and European Regulations 6
J Acknowledging Changed Documents and Procedures Document Control Systems, Procedures, Forms and Templates 7
J Training/Notice when a New Document is Released or a Document is Changed Training - Internal, External, Online and Distance Learning 13
Marc Report: Facebook e-mail switch changed address books After Work and Weekend Discussion Topics 2
Z KPI Formula Issue - "Change Requests Managed" = Changed/Total ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B ISO 11607-1:2009 vs. 2006 - What Changed? Other Medical Device Related Standards 2
G Packaging Re-Validation - Sealer machine broke down or was changed to a new one Other ISO and International Standards and European Regulations 11
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
Y How can FDA supervise devices whose manufacturer name is changed US Food and Drug Administration (FDA) 9
Marc 10 Year Time Capsule: When Napster changed the music industry After Work and Weekend Discussion Topics 0
Ajit Basrur Zodiac signs: Has yours changed? Coffee Break and Water Cooler Discussions 12
B Supplier changed their Manufacturing Process - Is a PPAP resubmission required? APQP and PPAP 17
ScottK When do you make your new or changed documents effective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Relative - "The machine that changed the World" Book, Video, Blog and Web Site Reviews and Recommendations 1
J Document Format vs Content Revision - Form changed from MS Word to MS Excel Document Control Systems, Procedures, Forms and Templates 7
ScottK Just Changed Jobs - Ask me anything Career and Occupation Discussions 29
B Auditing Recertification for Changed Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Ajit Basrur Websites that changed the Internet Coffee Break and Water Cooler Discussions 17
I Should We Notify Our Registrar - Has Our Scope Changed? IATF 16949 - Automotive Quality Systems Standard 5
Michael Malis FDA changed the criteria for Certificate to Foreign Government (CFG) on 12/08/09 US Food and Drug Administration (FDA) 1
C 510(K) submission - Is it necessary if we changed from nylon to polyester suture? US Food and Drug Administration (FDA) 4
C 510(k) Submitter Name Change question - Only the name of the company is changed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Marc Has the 2009 Swine Influenza (Flu) changed your travel plans? Travel - Hotels, Motels, Planes and Trains 22
R Obsolete a DoC if NB (Notifying Body) changed EU Medical Device Regulations 3
C Only appearance and PCB are changed - Do we need to submit a new 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Sidney Vianna What should be changed in the ISO 9001:2015 Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 433
I IMDS and Reach - What has changed? RoHS, REACH, ELV, IMDS and Restricted Substances 5
L Is an Audit Checklist a Living Document? When can an Audit Check List be changed? Internal Auditing 12
Wes Bucey How times have changed! My wife refuses to use "disposables." After Work and Weekend Discussion Topics 14
Wes Bucey Google changed algorithms again? After Work and Weekend Discussion Topics 5

Similar threads

Top Bottom