Performance vs. Effectiveness - ISO 9001:2015 par. 9.1.1

armani

armani

Quite Involved in Discussions
Can somebody tell me a clear difference between performance and effectiveness - e.g. : see ISO 9001:2015 par. 9.1.1 "performance and effectiveness of QMS"?
If a process is effective (vs. objectives established), it doesn't mean is performant? I mean, objectives are established for performance, no?
 
P

pkost

Trusted Information Resource
I interpret this to be: performance is what it is regardless of objectives. e.g. complaints are closed on average in 10 days

If the objective is to close complaints in 5 days the process is ineffective (when considered in isolation).

This is overly simplified for illustrative purposes, but should help
 
armani

armani

Quite Involved in Discussions
But how can I assess performance, if I haven't established objectives? ISO 9001 requires assessing performance...
 
D

dsanabria

Quite Involved in Discussions
armani said:
Can somebody tell me a clear difference between performance and effectiveness - e.g. : see ISO 9001:2015 par. 9.1.1 "performance and effectiveness of QMS"?
If a process is effective (vs. objectives established), it doesn't mean is performant? I mean, objectives are established for performance, no?
Click to expand...

FROM the IAQG Dictionary

Performance = aspects of an item observed or measured from its operation or function.
NOTE 1: These aspects are generally quantified. (EN 13701:2001) [IAQG-history]

Effectiveness = extent to which planned activities are realized and planned results achieved. (ISO 9000:2005) [IAQG-history]
 
tony s

tony s

Information Seeker
Trusted Information Resource
Using the definition of ISO 9000:2015:

3.7.8 Performance - measurable result
Note 1. Performance can relate to either quantitative or qualitative findings.

3.7.11 Effectiveness - extent to which planned activities are realized and planned results are achieved

Performance may not necessarily relate to positive result. Hence the term "poor performance".

Effectiveness has levels such as terms like "to some extent", "to the fullest extent"
 
D

DRAMMAN

So can you now get a non-conformance for not meting metric goals?
 
armani

armani

Quite Involved in Discussions
Back to my original question, can I assess performance without assessing effectiveness and viceversa??
Why ISO specifies the 2 of them if they are so close related?
 
tony s

tony s

Information Seeker
Trusted Information Resource
armani said:
Back to my original question, can I assess performance without assessing effectiveness and viceversa??
Why ISO specifies the 2 of them if they are so close related?
Click to expand...

Looking back at the old standard (i.e. 2008), from clause 1 to 8, the word "performance" is noticeably used not in conjunction with "effectiveness". Even ISO 9000:2005 doesn't have a definition for "performance". Thanks to armani for bringing the issue re: performance and effectiveness.

I've noticed that in 2008 the phrase "improve the effectiveness of the QMS" was mentioned at least 3 times (in clauses 5.3b, 8.1c and 8.5.1) while the 2015 version has no mention of it (from clause 1 to 10).

IMHO the 2015 version would like to give us additional guidance by teaming up "performance" with "effectiveness". As if by saying, "effectiveness can only be determined or evaluated by obtaining measurable results (i.e definition of performance)".

Try to switch "measurable result" in place of "performance" in the statements of the 2015 version. It may bring some pondering.

Hope this makes sense or am I drinking too much coffee?:drunk:
 
D

dsanabria

Quite Involved in Discussions
armani said:
Back to my original question, can I assess performance without assessing effectiveness and viceversa??
Why ISO specifies the 2 of them if they are so close related?
Click to expand...

Yes - you can measure all the performance of a process but you should be looking at the effectiveness of the performance.

or simply put, when you measure the goals of production - (performance), did production meet the goals (effective or nor effective) established by management?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Process Performance Parameters for efficiency and effectiveness Manufacturing and Related Processes 1
N Metrics to Evaluate Performance and Effectiveness of Internal Auditors Internal Auditing 2
Raffy How do I measure Measuring Training Effectiveness? Performance evaluation? Other ISO and International Standards and European Regulations 26
Z Shelf life automatically set to 6 months when no device performance shelf life data provide Medical Device and FDA Regulations and Standards News 5
E Clause 15.4.2.1 d) - Loss of ESSENTIAL PERFORMANCE IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Dazzur Sharing Suppliers Performance Data with Supplier. Supplier Quality Assurance and other Supplier Issues 6
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
L Supplier Performance when your supplier is also the customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
L Supplier performance evaluation Supplier Quality Assurance and other Supplier Issues 8
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
S Performance Qualification and Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna IATF 16949 News IATF Performance Complaint Management System (IATF CMS) within the IATF Database IATF 16949 - Automotive Quality Systems Standard 4
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R SaMD Performance Testing US Medical Device Regulations 5
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Transfer of Performance specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
D Key Performance Indicators / KPI Review IATF 16949 - Automotive Quality Systems Standard 11
Ed Panek Notified Body Performance Trending Poll EU Medical Device Regulations 8
Aymaneh IVDR and Performance Evaluation Plan EU Medical Device Regulations 2
Aymaneh Summary of safety and performance (SSP) IVDR 2017/746 EU Medical Device Regulations 1
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
A How to measure the performance of ISMS? IEC 27001 - Information Security Management Systems (ISMS) 3
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G What does performance specification include? US Food and Drug Administration (FDA) 1
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
MaHoDie IVDR and Performance Evaluation Plan CE Marking (Conformité Européene) / CB Scheme 2
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Performance of high shear mixer (or rapid mixing granulator Qualification and Validation (including 21 CFR Part 11) 4
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
B Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted] Training - Internal, External, Online and Distance Learning 2
F 5520A High Performance Multi-Product Calibrators General Measurement Device and Calibration Topics 0
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4

Similar threads

Top Bottom