Auditing of D&D (Design and Development) - ISO 9001

V

vijaysonawane

#1
I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Auditing of D&D

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line, and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year organization not done any minor design related change in their product, design is completely same as registration audit, now I want to do design audit during follow audit, now what I have to see. :applause:
The new standard is ISO 9001:2008. No new requirements....;)

When you do the D&D audit again, you'd expect to see the same process and that the D&D folks still understand the process as designed. That's it.

Stijloor.
 

Ajit Basrur

Staff member
Admin
#3
Re: Auditing of D&D

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:
Hi Vijay,

If thats the case, its time to sit back and relax :tg:

Btw, you can have a look at all your records relating to 7.3 viz.

7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions

Additionally ensure that no changes have been effected to the previous design :)
 
#4
Re: Auditing of D&D

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:
So, why do your want to audit it? If nothing's changed, and I mean nothing - no product changes, no personnel changes, nothing, then why are you doing it? You will be wasting their time and yours.

Of course, if you are auditing them to see if anything's changed, that's different!

If they are responsible for installation, I'd be interested in that activity. It's 'close' to the customer! Unless they haven't done any installations!

BTW - why are you doing this audit?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Either from an internal or external audit perspective, processes scheduled to be audited should take into account the status of the activity.

If the process was deemed conforming during the last audit and no additional design & development work has taken place since then, there is no value re-auditing it.
 
N

neelu

#6
Either from an internal or external audit perspective, processes scheduled to be audited should take into account the status of the activity.

If the process was deemed conforming during the last audit and no additional design & development work has taken place since then, there is no value re-auditing it.
What Sidney has mentioned is certainly one of the sources based on which auditor can confirm whether any change has actually taken place with respect to design. If one has time, you can also look up:
1. Masterlist of docs to find out whether any amenment has been issued during the review period.
2. Customer feedback to find out whether any design-related comment has been received and auditee has taken appropriate action.
3. Nonconformity reports to find out whether any design-related NCs have been recorded.
There can be a few more like these.
 
#7
What Sidney has mentioned is certainly one of the sources based on which auditor can confirm whether any change has actually taken place with respect to design. If one has time, you can also look up:
1. Masterlist of docs to find out whether any amenment has been issued during the review period.
2. Customer feedback to find out whether any design-related comment has been received and auditee has taken appropriate action.
3. Nonconformity reports to find out whether any design-related NCs have been recorded.
There can be a few more like these.
This would be good input for a management review (well the second two would), but since the OP says there's been no D & D activity, there's basically no point - what you describe needs to be taken into account in a corrective action, but we'd still have to wait for implementation of something.........
 
N

neelu

#8
This would be good input for a management review (well the second two would), but since the OP says there's been no D & D activity, there's basically no point - what you describe needs to be taken into account in a corrective action, but we'd still have to wait for implementation of something.........
I guess we are discussing what an auditor should do if the auditee in D&D says 'No change, buddy, since last audit' (and not about 'mgmt. review'). Do we expect auditor to say 'ThanQ' and go back or you expect auditor to verify what auditee has said. In my mail, I suggested that apart from what Sidney suggested(IR reports), a few more docs could be added,scrutiny of which may provide the evidence to confirm whether any change has occurred in design or not!
 

Raffy

Quite Involved in Discussions
#9
I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:
Hi vijaysonawane,
welcome to the cove. :bigwave:
With regard to Clause 7.3 D&D, there could be no change, however, as per Clause 4.2.3 b) to review and update as necessary and re-approve documents. This means though there were no changes in 7.3, there should be an evidence that the documents pertaining to Clause 7.3 has been reviewed.
Hope this helps.
Best regards,
raffy:cool:
 
V

vijaysonawane

#10
Re: Auditing of D&D

Hi Vijay,

If thats the case, its time to sit back and relax :tg:

Btw, you can have a look at all your records relating to 7.3 viz.

7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions

Additionally ensure that no changes have been effected to the previous design :)
Thanks sir ,

But the followup audit perticularly in repeat (recertification )audit we have to cover all the process then we have to right same sample model as objective evidence,

One thing i got from all you that i should not do audit, here i want to do the audit as mendatory requirement as mentioned above , i have to cover all the process including design in the repeat audit with objective evidence and sample taken for design audit.:argue:
 
Thread starter Similar threads Forum Replies Date
L Auditing Design and Development in ISO 9001 (Internal Audit) Internal Auditing 1
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
K Process Auditing Clause 7.3 Design and Development Internal Auditing 11
B The task of Auditing Clause 7.3 Design & Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Determining Legal& Statutory requirements while Auditing Design & Development process Design and Development of Products and Processes 8
A Seeking Checklist for Auditing 7.3 Design Development for TS 16949 - pls help! Design and Development of Products and Processes 2
A Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separately? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Internal Auditing Reports / Documents - Design and Content Document Control Systems, Procedures, Forms and Templates 1
S ISO 9001:2015 Internal Auditing Internal Auditing 8
H Auditing Santa's workshop General Auditing Discussions 0
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
F AS9100D Internal auditing requirements Internal Auditing 11
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4

Similar threads

Top Bottom