Quality formats - ISO 13485 Design and development related records and formats

Elsmar Forum Sponsor

Stijloor

Leader
Super Moderator
#5
I have not yet got proper feedback for my thread.
Let me help you a little bit. Maybe you could provide us with some more specifics about your organization, and why this information you're looking for is important for you. A "nice" post usually tends to get more responses.

Stijloor.
 
P

ppppp

#6
I want this information for preparing design and development documentation for ISO 13485 which I'm preparing for my organisation. So I need sample formats.
 

Stijloor

Leader
Super Moderator
#7
I want this information for preparing design and development documentation for ISO 13485 which I'm preparing for my organisation. So I need sample formats.
Help us with information and specifics about your products, etc. More relevant information will get you reponses. You may want to look around here, and note how other Participants have worded their requests for information.

Stijloor, Forum Moderator.
 

Al Rosen

Leader
Super Moderator
#8
I want this information for preparing design and development documentation for ISO 13485 which I'm preparing for my organisation. So I need sample formats.
A D&D record could be as simple as an entry in an engineering notebook and as complex as a 100 page test report.
 
Thread starter Similar threads Forum Replies Date
V Qualification & Management Of Contract Quality Control Lab - Formats & Templates US Food and Drug Administration (FDA) 0
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
ScottK Opening for Manager, Supplier Quality Engineering on my team- Orangeburg, NY - On-site Job Openings, Consulting and Employment Opportunities 0
S Quality and Technology Roadmaps Misc. Quality Assurance and Business Systems Related Topics 0
T Organization and personnel problems with quality Other Medical Device and Orthopedic Related Topics 3
M Is On-Time Delivery a Quality Objective? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
E Where can i get latest toyota and honda Supplier Quality Assurance Manual (SQAM) Customer and Company Specific Requirements 3
C Quality keynote speakers Consultants and Consulting 6
M AS9100 examples of procedures, quality manual, etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
K Size of Quality Department ISO 13485:2016 - Medical Device Quality Management Systems 11
A Quality and Safety in one. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N What quality training do you suggest? Manufacturing and Related Processes 14
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
Sidney Vianna Interesting Discussion Accreditation Matters: Our Role in The Quality Infrastructure ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
R Quality System Software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Is there any value in monthly quality reporting? Manufacturing and Related Processes 8
R Authorities of Quality Manager IATF 16949 - Automotive Quality Systems Standard 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
C Supplier Audit - Looking for a quality audit checklist General Auditing Discussions 3
A How would a candidate for Quality Systems Manager role answer questions in a med device manufacturing org ISO 13485:2016 - Medical Device Quality Management Systems 11
F EU MDR Quality Plan template CE Marking (Conformité Européene) / CB Scheme 3
M Quality Manager and Production Manager Advice Quality Manager and Management Related Issues 19
T What is a Quality Management System? Manufacturing and Related Processes 20
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
W Posting Non-Quality System instructions on the Production Floor Manufacturing and Related Processes 13
CaliperJim Cost of Quality calculation Quality Tools, Improvement and Analysis 4
Cats Clause Certified Quality Systems Ltd (CQS) accredited by International Accreditation Board Registrars and Notified Bodies 4
T Quality toolbox decision tree Quality Tools, Improvement and Analysis 5
Sidney Vianna A young Steve Jobs take on Quality, Marketing & Business Processes. Coffee Break and Water Cooler Discussions 0
hogheavenfarm Free Quality Professional Books Buy, Sell or Trade - NO Commercial Advertisements 11
T Stellantis supplier quality manual Supplier Quality Assurance and other Supplier Issues 5
lyobovnik Work From Home Exception for Quality Managers? Quality Manager and Management Related Issues 19
T Accreditations as part of 9001 - Quality checks on your company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
M Who is performing quality control? IATF 16949 - Automotive Quality Systems Standard 2
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
T ISO quality system software such as MQ1 (which is what we currently use) Document Control Systems, Procedures, Forms and Templates 9
M Quality 'Engagement' Effort Misc. Quality Assurance and Business Systems Related Topics 5
Q Quality role Human Factors and Ergonomics in Engineering 2
bobdoering Is your quality department having a "No Chili" day? Funny Stuff - Jokes and Humour 2
E Compressed air quality in ME equipment (used in OR) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
A API Q1 9th Edition Surveillance Audit - Quality Policy Oil and Gas Industry Standards and Regulations 2
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
Q Quality Awareness 7.3 ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Quality Engineering Long Term Career Advice Career and Occupation Discussions 6
M Quality Management-ISO 9001:2015 General Auditing Discussions 1

Similar threads

Top Bottom