SBS - The best value in QMS software

Identifying context for every process in an organization

A

armani

Involved In Discussions
#1
#1
One of the guidance lines of our AB is that the CB auditors must look for the identification of context NOT only for organization, but for every process when auditing an organization??.....
It seems to me a over over exaggerating approach!! What do u think?
 
Last edited:
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
somashekar

somashekar

Staff member
Super Moderator
#2
#2
Hii... Throughout the standard the context is about context of the organization. Which guidance to CB auditors are you referring about. Is it possible that you can attach or post the complete details...
Thanks.
 
J

JoShmo

#3
#3
armani said:
One of the guidance linces of CB is that the CB auditors must look for the identification of context must be NOT only for organization, but for every process when auditing an organization??.....
It seems to me a over over exaggerating approach!! What do u think?
Click to expand...
Whatever CB gave you that "guidance" has no clue what they're saying.
 
E

Eredhel

Quality Manager
#4
#4
I'd ask them to "show me the shall". If you could tell us what exactly was said it might help with troubleshooting. So far it sounds like someone is trying to require more than is actually necessary.
 
A

armani

Involved In Discussions
#5
#5
somashekar said:
Hii... Throughout the standard the context is about context of the organization. Which guidance to CB auditors are you referring about. Is it possible that you can attach or post the complete details...
Thanks.
Click to expand...
Well, there is no documented guidance....but observation when attending an audit as observer from AB!::((
But I do not agree with it at all! It's organization's context, not process context. I know...organizations are all about processes, but still....
Eredhel, you are right too!
 
J

JoShmo

#7
#7
Kronos147 said:
Maybe a little strong! More than a few of us are going to be struggling with this, CB and organization alike.

The Context of the Organization, not the context of the process within the organization (that has context).
Click to expand...
Yes, organizations might. But when a register auditor says such a thing, they need to go back and discover ehat the message has been for the past 12 months or more! This isn't the 1994/2000 change over!
 
L

LUV-d-4UM

Quite Involved in Discussions
#8
#8
armani said:
One of the guidance lines of our AB is that the CB auditors must look for the identification of context NOT only for organization, but for every process when auditing an organization??.....
It seems to me a over over exaggerating approach!! What do u think?
Click to expand...
Beware of CB Auditor made rules! ISO9001:2015 makes no requirements to identify the context of NOT only for organization but for every processes when auditing an organization.

During our stage 1 audit, we entertained the auditor with our Business Plan, or journey, SWOT, Interested parties and their requirements, QMS processes, risks, etc... They I watch the "Fireworks" fly with rules that are not even found in the standard. Good luck to you.
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#9
#9
JoShmo said:
Yes, organizations might. But when a register auditor says such a thing, they need to go back and discover ehat the message has been for the past 12 months or more! This isn't the 1994/2000 change over!
Click to expand...
You appear to have a negative attitude toward CB Auditors. May I ask you a question that really doesn't have any thing to do with this thread. Are you a Consultant by chance? :notme:

As for the CB Auditor's interpretation, at times there are CB Auditors that may interpret something differently. Their job is to review, analyze, document results and any findings. It is up to the organization to challenge this during the closing meeting, show your facts, and they show you their facts. Come to a resolution with documented results. If no resolution is agreed upon then your responsibility is to elevate to the CB itself. Then they will determine who has the correct facts.

Just my take on this.
 
B

BoardGuy

#10
#10
As the Client of the audit it boils down to this; when the auditor or his organization seems to be making up the rules you must ask:

1) Show me within the standard were it is required
2) Show me within the ISO/TC 176 Approved Interpretations Against ISO 9001:2015 were it is required
3) Show me within the ISO/IAF ISO 9001 Auditing Practices Group documents were it is required.

[FONT=&quot]If the auditor insists you simply thank him/her and ask who within his/her organization to address the audit finding appeal in accordance with ISO 17021-1 CB requirements. Draft your formal appeal and send it [FONT=&quot]in[/FONT]. If they do not address your appeal, or appear to be incorrect, you then should go to ANAB and ask for a clarification.[/FONT]
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
T "Indication for Use" Identifying Specific Procedures US Food and Drug Administration (FDA) 2
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Audit NC - Not identifying our Customer Specific Requirements - TS16949 (7.3.6.3) General Auditing Discussions 7
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
V Identifying Significant Factors - Regression Analysis vs Correlation vs ANOVA vs DOE Quality Tools, Improvement and Analysis 7
F Requesting Help in Identifying Ford Suppliers Supplier Quality Assurance and other Supplier Issues 6
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
A Identifying the Clean Room Requirements for a Medical Device in US and EU ISO 13485:2016 - Medical Device Quality Management Systems 3
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
F Identifying Calibration on Small Tools (Measurement Equipment) General Measurement Device and Calibration Topics 2
C Identifying Response Times for CAPAs (Corrective and Preventive Actions) Nonconformance and Corrective Action 2
J Need help identifying nonconformities in internal audits Internal Auditing 2
A Identifying trends in QMS Nonconformities Quality Manager and Management Related Issues 1
B Looking for a Standard identifying SME's (Standard Measuring Equipment) General Measurement Device and Calibration Topics 1
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7
M Identifying Rework in Maintenance or Craftsman Operations Lean in Manufacturing and Service Industries 12
R Identifying "or equivalent" Test Equipment when written in a Procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
N Sheet Metal Identification Ideas - Best Practices for Identifying Raw Material Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom