Efficacy of ISO 9001:2015 - Survey

A

asheshsaraf

#1
Hello! I am working on a research related to Efficacy of ISO 9001:2015 and its use to gage the operational performance and its impact on suppliers process management. Thank you for your participation and help!

This research is both confidential and anonymous. The results of this survey will be aggregated with other survey responses and presented publicly at Metropolitan State University. The survey should only take about 10 to 15 minutes of your time. If you would like to receive the results of my survey, please send me an email ([email protected]) with your email address.

The survey can be accessed @ https://stcloudstate.co1.qualtrics.com/jfe/form/SV_08Ryvy2P0tESafH
 
Last edited by a moderator:
Elsmar Forum Sponsor

Randy

Super Moderator
#2
1 - you're too early in the life of ISO 9001:2015 to get any real information

2 - it isn't the ISO 9001:2015 standard that needs to be surveyed, it's the organizations using it as their quality system model/blueprint

3 - very few folks actually track or care about creating any value added metrics on the subject

I have to utilize a client survey on nearly every audit I do (and that's all I do 40-50 weeks a year) and the most frequent answer I get is "I don't know" or a blank stare.
 
A

asheshsaraf

#3
Hi Randy, thank you for your insights. I appreciate it. There are multiple aspects of ISO 9001:2015 that I am assessing as part of my research from implementation models, to performance, etc. I agree organizations are still in infancy phase as it pertains to adoption or alignment to the new standard. But there are nuances that need to be in core of the organizations choosing to take on as value proposition for any certification. This survey is one piece of multilevel qualitative and quantitative study. I hope you will fill the survey and provide your insights. Thank you for your help in advance.
 

Randy

Super Moderator
#4
OK here's what you'll find out .... the vast majority (90+%) do it because a customer says do it or else, the rest do it to demonstrate, to whomever, whatever it is they are trying to prove, a really small smathering will implement ISO 9001 because they really want to get some value out of the effort and the last little bit because they'll get a warm fuzzy feeling and gain some bragging rights.

This survey stuff gets done 100 times over and the data you seek is already out there, and it's still too early, give it 2, 5 or 6 years to mature.

There are also very few real differences between 9K08 & 9K15 and organizations that really know what they are doing and about just have only to do some minor tweaks to make everyone happy.
 

Stijloor

Staff member
Super Moderator
#5
Hello! I am working on a research related to Efficacy of ISO 9001:2015 and its use to gage the operational performance and its impact on suppliers process management. Thank you for your participation and help!

This research is both confidential and anonymous. The results of this survey will be aggregated with other survey responses and presented publicly at Metropolitan State University. The survey should only take about 10 to 15 minutes of your time. If you would like to receive the results of my survey, please send me an email ([email protected]) with your email address.

The survey can be accessed @ https://stcloudstate.co1.qualtrics.com/jfe/form/SV_08Ryvy2P0tESafH
One of your questions is about standards the respondent is registered to.
A Standard that is listed is ISO 31000. This Standard can not be used for certification purposes.

From ISo_Org:

ISO 31000:2018, Risk management – Guidelines, provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.

Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment.

However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using it can compare their risk management practices with an internationally recognised benchmark, providing sound principles for effective management and corporate governance.
 
A

asheshsaraf

#6
Hi Randy, you are correct that majority of certifications are due to customer pressure or requirement (real or percived) to get further business and the true adopters are drawfed. You are also correct there are 100s of papers done in the past on different revisions of ISO and also looking at from different perspectives.

Thank you for your insight.
 
A

asheshsaraf

#7
Hi Stijloor, thank you for the feedback. I now understand ISO 31000 cannot be used for certification. The main idea of including that standard was to see if there could be correlation between company focused to the explicit risk-based thinking and their understanding to ISO 31000.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
This survey is one piece of multilevel qualitative and quantitative study.
As far as I could tell the questions focus on a respondent PERCEPTION on the different aspects surrounding an organization's implementation of ISO 9001:2015. There is no request for verifiable data confirming the perceptions.

The likely respondents for this type of surveys are the people responsible for the implementation of the standard in their respective organizations. So, I suspect, there is a tremendous likelihood of bias confirmation that the standard would enhance the organization's performance.

Perception surveys, such as this one, are very questionable in my estimation.

I would be interested to know what quantitative studies will be done in addition to qualitative surveys such as this one.
 
A

asheshsaraf

#9
Hi Sidney, thank you for your feedback and insight. I appreciate it. I am addressing your questions you have as part of my research. I can definitely send you my findings once my research is complete.
 

jmech

Trusted Information Resource
#10
The survey may produce some interesting results. However, I don't know how much the results will relate to ISO 9001:2015 (even assuming that respondents' perceptions are accurate). For example, risk-based thinking might be common in a company due to the employees being of at least moderate intelligence, not due to the vague references in ISO 9001:2015 to risk-based thinking.
 
Thread starter Similar threads Forum Replies Date
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H Safety and efficacy study for CE marking CE Marking (Conformité Européene) / CB Scheme 1
B Efficacy of Q-Das system integrated with PC-DMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
J Safety and Efficacy study for a medical device in US Other US Medical Device Regulations 5
Q When to issue a Customer Complaint related to efficacy of a Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 3
W FDA Requirements for Disinfectant Efficacy Test of iPhone Other US Medical Device Regulations 8
Ajit Basrur ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Sidney Vianna The Aerospace ICOP Scheme - Concerns over the Scheme's Efficacy/Effectiveness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 39
W The value of an assessment approach to measuring processes efficacy General Auditing Discussions 3
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 8
Ron Rompen ISO 9001 Sanctioned Interpretations and FAQs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
S Do ISO certs require an Apostille? ISO 13485:2016 - Medical Device Quality Management Systems 13
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 2
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
R What are the new changes in EN ISO 11137-1:2015+A2:2019? Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Sidney Vianna ISO 14001 News ISO 14001 Continual Improvement Survey ISO 14001:2015 Specific Discussions 0
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 30
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom