ISO 9001:2015 8.3 Design and Development (in Civil Engineering)

G

gavin.D

Hello everyone,

I'm hoping someone can offer some guidance on this one.

We're a civil engineering consultancy. Clients come to us looking for a design (requirements in an email or over the phone). They will usually send on some information such as ground information, drawings, lab data etc. We do a design based on this information and requirements. It always varies and you can never slap a design from one site onto another.

I'm wondering how you would approach the requirements for Clause 8.2-8.6 because it seems to me that we would have to produce a lot of records for every project we do (no matter how small) because every project is a new design.

We have a checking/sign off procedure to ensure work is checked before it goes out but very little apart from that. I'm trying to set up a QMS but minimise the records required while staying in compliance with the standard.

Thanks for taking the time to read this. I'm very interested in your recommendations.
 

Sidney Vianna

Post Responsibly
Leader
Admin
I'm wondering how you would approach the requirements for Clause 8.2-8.6 because it seems to me that we would have to produce a lot of records for every project we do (no matter how small) because every project is a new design.
One of the biggest mistakes people make is to think that ALL PROJECTS would have to be treated the same way. Commensuration and common sense have to be applied. If the design is simple, the reviews, verification, validation, etc...should also be simple and the records should reflect that. On the other hand, if the design is complex, multi-stage reviews, verifications, validations, etc. would be in order and the collection of records should also reflect the project complexity and records.
 
G

gavin.D

OK, I was under the impression that if we state a procedure, failure to follow it might be a non-conformance?
 

Sidney Vianna

Post Responsibly
Leader
Admin
The process and accompanying procedure should take into account the need for flexibility, depending on the size and complexity of the project. While you want the process to give you structure, you don't want it to be a straitjacket.
 

Colin

Quite Involved in Discussions
Sidney is correct (of course!), if you write your procedure to be very onerous, you have to 'feed the beast' each time. On the other hand, you could offer different options depending upon the size, complexity and don't forget, risks involved with the project.

As a simple example, years ago we had a procedure for managing consultancy projects which required full terms and conditions to be developed but that was for projects of more than 5 days work. For under 5 days a simple letter of intent was used otherwise we would use up too much time just preparing paperwork.
 
Thread starter Similar threads Forum Replies Date
C How to to become an ISO 9001:2015 consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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

Similar threads

Top Bottom