Informational "Context of the Organization" in ISO 9001:2015 Clause 4.1

Sidney Vianna

Post Responsibly
Staff member
Admin
#41
Re: "Context of the Organization" in 4.1 of ISO 9001

so its "NEVER" "ALWAYS" been about manageing risks.
If you were looking specifically for the word risk, then you would be correct, but, if you understand the term "managing risks" as identifying the critical aspects that could lead to a failure and prioritize the use of the resources wisely, then ISO 9001:2008 is full of examples for that line of thought.

I will offer one example. In ISO 9001:2008, we have the following requirement
An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.
the bold font clearly indicates a "risk-based" approach to develop an audit schedule and the intent is clear to identify processes/areas which represent a higher risk to product conformity and customer satisfaction, and prioritize, emphasize, scrutinize, etc. such processes/areas with a higher intensity, frequency, depth, etc.

In my mind, this is a typical case where the authors of 9001:2008 wrote a requirement using a risk-based mindset, without using the word risk. So, from that perspective, I am in the field of those who believe that, (if well understood) ISO 9001 has always been supposed to be a risk-based approach to managing quality.
 
Elsmar Forum Sponsor

Randy

Super Moderator
#42
Re: "Context of the Organization" in 4.1 of ISO 9001

Please excuse my ignorance I'm still trying to move up on the learning curve.
 
J

JoShmo

#44
Re: "Context of the Organization" in 4.1 of ISO 9001

If you were looking specifically for the word risk, then you would be correct, but, if you understand the term "managing risks" as identifying the critical aspects that could lead to a failure and prioritize the use of the resources wisely, then ISO 9001:2008 is full of examples for that line of thought.

I will offer one example. In ISO 9001:2008, we have the following requirement

the bold font clearly indicates a "risk-based" approach to develop an audit schedule and the intent is clear to identify processes/areas which represent a higher risk to product conformity and customer satisfaction, and prioritize, emphasize, scrutinize, etc. such processes/areas with a higher intensity, frequency, depth, etc.

In my mind, this is a typical case where the authors of 9001:2008 wrote a requirement using a risk-based mindset, without using the word risk. So, from that perspective, I am in the field of those who believe that, (if well understood) ISO 9001 has always been supposed to be a risk-based approach to managing quality.
And before 2008? ISO existed before then and never made such requirements (before 2000 actually). Plus, how come registers allow one/two internal audit a year, by their clients, if it's about risk? Risks don't happen on some kinda planned schedule (not in my book anywhoo)
 

Randy

Super Moderator
#45
Re: "Context of the Organization" in 4.1 of ISO 9001

And before 2008? ISO existed before then and never made such requirements (before 2000 actually). Plus, how come registers allow one/two internal audit a year, by their clients, if it's about risk? Risks don't happen on some kinda planned schedule (not in my book anywhoo)
CB's don't allow internal audits, they just verify the effectiveness of them. (I detect a dislike of CB's, but I could be wrong)
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#46
Re: "Context of the Organization" in 4.1 of ISO 9001

how come registers allow one/two internal audit a year, by their clients, if it's about risk? Risks don't happen on some kinda planned schedule
The fact that organizations don't use the risk-based approach requirement to plan their internal audit schedules and that "takes a pass" by their respective CB's has been discussed numerous times in this forum. For example in the Internal Audits - Can I do them all? thread.
 
J

JoShmo

#47
Re: "Context of the Organization" in 4.1 of ISO 9001

CB's don't allow internal audits, they just verify the effectiveness of them. (I detect a dislike of CB's, but I could be wrong)
They "allow" a client to do one or two a year, is what I mean. I displike register auditors who have no clue what "effectiveness" looks like and use the CB process as a measure - asking for "all elements to be covered once a year/2 yers/cycle or whatevers. I don't dislike registers, I dilsike meaningless audits.
 

LUV-d-4UM

Quite Involved in Discussions
#48
Re: "Context of the Organization" in 4.1 of ISO 9001

They "allow" a client to do one or two a year, is what I mean. I displike register auditors who have no clue what "effectiveness" looks like and use the CB process as a measure - asking for "all elements to be covered once a year/2 yers/cycle or whatevers. I don't dislike registers, I dilsike meaningless audits.
Then you need to have a conversation with your CB to change your auditor. Be factual when you do that.
 
I

isotexas

#49
Re: "Context of the Organization" in 4.1 of ISO 9001

Well said. I think the boss will understand it, said this way.

Thanks
 
Thread starter Similar threads Forum Replies Date
Q Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
S ISO 27001:2013 - How to document Context Of the Organization IEC 27001 - Information Security Management Systems (ISMS) 13
Q IATF 16949 organization context IATF 16949 - Automotive Quality Systems Standard 7
J What to add to our QMS for Clause 4 Context of the Organization AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
A Risk Assessment Technique that fits the Context of the Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
somashekar ISO 9001 Certification, School context - Students are...? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
Q Closing Out Negative Issues in Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
U Spreadsheet Context, interested parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Context SWOT tie to ISO 9001:2015 Cl. 6.1 Risk and Opportunities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Tie in Context - Interested party - Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Introducing an existing product into automotive context - DFMEA needed? IATF 16949 - Automotive Quality Systems Standard 8
Q ISO 9001:2015 - Extent of Policy and Scope with Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Risk Analysis - Same Risk Treatment for Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q To include Context and Interested Parties in Process Map? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Developing procedure for Determining Company's Context And Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 53
S Is this Quality Policy acceptable in the context of ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 24
X Definition What is the difference between appoint and designate in the context of ISO/TS 16949? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
M Reference a MAF outside the context of a US FDA submission? US Food and Drug Administration (FDA) 1
U Manufacturing vs. Production for Medical Device Software in a FDA context 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Continual Improvement in the context of ISO 22000:2005 Preventive Action and Continuous Improvement 2
quality1 Definition Design Responsible - Good Definition in the context of AS 9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
K Nonconforming Products in the context of ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 6
K When should validation be carried out in the context of ISO 22000? Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S Definition Inputs vs. Resources in the context of a Process - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 21
O Difference between Configuration Management Procedure / Plan in IT context? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Risk Management in an FDA Context - Extended definition of "harm" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
Chennaiite What is meant by 'Lesson Learned' in the context of Problem Solving Quality Tools, Improvement and Analysis 6
M Definition Definition of 'Disposition' when used in the context of ISO 9001 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
L Definition Bench Test - Definition (in FDA context) and its difference with Clinical Study? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
M What is unit testing in the context of IT/Computer programming? Software Quality Assurance 2
Ajit Basrur Break up and Breakdown - which is the correct term to use in Financial Context? Coffee Break and Water Cooler Discussions 10
B Validation vs. Confirmation in the context of an Analytical Laboratory General Measurement Device and Calibration Topics 10
H How do you see the "Risk Analysis" issue in the ISO 9001 context? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A What is the difference between Validation & Verification in the context of ISO9000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Traders in the context of sub-contractor development QS-9000 - American Automotive Manufacturers Standard 13
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
S World Quality Day 2019, November 14 - Build Quality Awareness in the organization ASQ - American Society for Quality 0
F Position of Quality Manager - Can the organization's Quality Lead be shown as Quality Manager of the lab as well? ISO 17025 related Discussions 5
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
T QMS Training for my organization - IATF16949 and also AS9100 or 9145 Manufacturing and Related Processes 2
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
Similar threads


















































Top Bottom