ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company)

T

theadeth

Registered
Hi! Covers :bigwave:our company was ISO 9001:2008 certified [FONT=&quot]under the provision of PCB Repair/Rework, PCB Assembly and Repair of Power supplies, 7.3 Design was excluded because there is no design and development of products within the organizations. Design and development services we provide was executed at the customer site as per their requirements.Currently we are in transition to ISO 9001:2015 and still confused if 8.3 Design and development of products and services are still not applicable to our company.


Please help.....[/FONT]
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

theadeth said:
Hi! Covers :bigwave:our company was ISO 9001:2008 certified [FONT=&quot]under the provision of PCB Repair/Rework, PCB Assembly and Repair of Power supplies, 7.3 Design was excluded because there is no design and development of products within the organizations. Design and development services we provide was executed at the customer site as per their requirements.Currently we are in transition to ISO 9001:2015 and still confused if 8.3 Design and development of products and services are still not applicable to our company.


Please help.....[/FONT]
Click to expand...

My suggestion is the following:

You now will need to include Design and Development, even thought it appears that most of your D&D is at the customer's facility, if I understand your question correctly.
 
J

joburum

Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

If everything is done per customer requirements and you are not designing anything yourself then it should be labeled not applicable.
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

joburum said:
If everything is done per customer requirements and you are not designing anything yourself then it should be labeled not applicable.
Click to expand...

If I was reading his question correctly, they do D&D at the Customer's Facility. It is not Customer D&D. Even though they do the D&D to the Customer's requirements they still have D&D which will need to be stated.

So, we agree to disagree.
 
howste

howste

Thaumaturge
Trusted Information Resource
Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

It sounds like you aren't designing product. I think you are designing rework and repair services unless these are developed by the customer with your people working to their requirements.
 
T

theadeth

Registered
Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

:thanx: CouryFerguson, joburum and howste for the replies.
For further explanation our design group was on customer site everyday. Their main function was pcb layouting from existing schematics and pcb's, reverse engineering base from old pcb's to provide schematics.
That`s why until now Im still confused if 8.3 D&D still not applicable on our organization.
 
H

harry

Trusted Information Resource
Re: ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Compa

From your description, your team is at the customers site to participate in the design process by providing design inputs. Therefore you can exclude D&D in your QMS.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Computerized System Validation in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Experience Records - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Integrating ISO 9001:2015 audits with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 13
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 9
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 9001:2015 Document Revison History ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Preservation of Raw Materials in ISO 9001:2015 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Assignment on the link between Quality Gurus & ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
S ISO 9001:2015 Project Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Recertification Audit Timing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 9001:2015 Is a Project Evaluation form necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna ISO 9001 News ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Management Review ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
J Process capability analysis in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Use an iso 9001/2015 form for api q1 systeme Oil and Gas Industry Standards and Regulations 5
Q Which Kapt standard assignment ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Quality Awareness 7.3 ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Quality Management-ISO 9001:2015 General Auditing Discussions 1
G ISO 9001-2015 How to co-relate Clause 4.2 & Clause 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
B ISO 9001:2015 vs ISO 13485:2016 Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 9
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 8
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
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
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom