SBS - The best value in QMS software

ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP?

duff999

Involved In Discussions
#1
Hi All,

We are establishing our QMS and have questions regarding design verification and validation. Do most folks create a separate SOP regarding section 7.3.6 Design and Development Verification or is it part of the the Design and Development SOP capturing the entire process. I broke out a separate document regarding process validation but wasn't sure how to handle design V&V.

Thanks,
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#4
It depends how detailed and long your procedures are and general preference. I keep my procedures light and prefer to keep the number to minimum so I usually write a single procedure for D&D. I've worked for companies that had more than 20 procedures and work instructions for the D&D process alone.
There are no requirements or expectation as to the number of procedures, as long as it works for you.
 
Thread starter Similar threads Forum Replies Date
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
R Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Complaint Handling Responsibilities for a Design Partner - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
J ISO 13485 System Design for an R&D Center ISO 13485:2016 - Medical Device Quality Management Systems 2
S Audit checklist for "Design Controls" per ISO 13485 wanted Internal Auditing 3
K ISO 13485 and DHF (Design History File) requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
E ISO 9001 vs ISO 13485 or both? A QMS for a Design and Development Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 13485 Section 7.3 Design & Development Exclusions ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
J ISO 13485 Requirements - Design Exclusion - Predicate Products Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 8
A We Design and Develop - All of our Manufacturing is Outsourced - ISO 13485 Question ISO 13485:2016 - Medical Device Quality Management Systems 18
Q ISO 13485 Design Control Procedure for Virtual Manufacturer wanted ISO 13485:2016 - Medical Device Quality Management Systems 8
P Quality formats - ISO 13485 Design and development related records and formats ISO 13485:2016 - Medical Device Quality Management Systems 7
B Are manufacturing processes/procedures considered Design Output-ISO 13485 Design and Development of Products and Processes 10
D Research vs. Design vs. Development in ISO 13485 - What is the difference? Design and Development of Products and Processes 4
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
Q Exclusion of Design and Development Controls - ISO 13485 Section 1.2 Design and Development of Products and Processes 6
L Looking for ISO 13485 Design Input and Output Files - Templates/Examples Design and Development of Products and Processes 2
R Design Validation and Clinical Evaluations to meet ISO 13485 requirements Design and Development of Products and Processes 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 13
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2

Similar threads

Top Bottom