• Are Tooling Design Records required by TS 16949
• Digital video camera system portable for production line and other monitoring?
• Long Term Risk of Building without full set of Released Drawings
• Design Review Participants - Medical Devices - Question
• First Article Inspection - Is FAI Design Verification?
• Anybody know about DFA (Design for Assembly) ?
• Design Verification & Design Outputs - FDA and 13485
• Engineering Design Review minutes as Verification & Validation Records
• Design Organization Manual - Seeking Example
• Design & Development Control Forms and Templates
• How to make risk analysis for design changes to existing devices
• Design and Development outputs - How Should I audit it? Clause 7.3.3
• Design: To claim exemption, or not to claim exemption (exclusion)
• Can Process Validation actually be Design Verification?
• Procedure for "Customer Acceptance of a design or process change"
• Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971.
• ISO 9001 Requirements for associated service - Design and develop software
• How to fill s/c and c/c in DFMEA (Design FMEA)?
• Are manufacturing processes/procedures considered Design Output-ISO 13485
• Clause 7.3 Design and Development - Verification and Validation
• Design and development inputs, how many records are maintained?
• Product Design Input as per TS 16949 clause 7.3.2.1
• Design and Development Audit checklist - What are design inputs and design outputs?
• TS 16949 Section 7.3 - We have no design activity
• Looking for help to give me some idea about my thesis project (Medical Device Design)
• What defines the need for the ISO9001 Design & Development process?
• ISO 9001 Certification for Landscape Gardening Company - can design be excluded?
• Customer-designated sources AS9100
• Design Input document example format/template needed
• Design and Development of a Service - Medical Department
• Design - Widget vs. Service - Exclusion? In Service operation design not addressed
• Product Design and Development - How do I know if Clause 7.3 applies?
• Designing a "part-specific" Receiving Gauge - Gauge first or job?
• Design an experiment to optimize the PCB solder reflow profile
• Plug Gauge design
• Basic format for Design and Development
• 6.2.2.1 Product Design Skills required for the personnel of Product Engineering
• Do I need to perform design verification
• Creating a system to capture Quality related issues for design department
• Construction Industry Design Procedure
• Design and Development vs. Production - ISO 9001 Clauses 7.3 vs. 7.5.1
• DFMEA (Design FMEA) for Trailers or any heavy vehicle design
• Design and Development Planning - AS9100B Clause 7.3.1
• Enhanced Design Review section - ISPE Commisioning and Qualification Guide
• Research vs. Design vs. Development in ISO 13485 - What is the difference?
• FDA QSR Inconsistency? Design Validation
• Design for Compact Wastewater Treatment Plant to Cater to a Healthcare Facility.
• What factors must be considered during gauge design?what are VG points ?
• Design Control and Process Validation Tools and Presentations (Medical Device) wanted
• Review of Design Dossier
• Design and Development Estimation and Offer - Sales vs. Engineers
• Design Input - Question on Specific Performance Criteria for Medical Devices
• Manufacturer control over third party design and manufacturing?
• Design Input class 3 device
• Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1?
• Is Prototyping Design Output or Design Verification?
• Looking for ISO 13485 Design Input and Output Files - Templates/Examples
• Design and Development - Verification & Validation (Cl 7.3.5 & 7.3.6)
• Preparing a Design Package for API 6A Valves for the Monogram audit
• Design and Development in a small Service Provider - ISO 9001 Clause 7.3
• Design Inputs not Quantitative - ISO 9001 Clause 7.3.2 requirement
• Exclusion of Design and Development Requirements (7.3 & sub-clauses) in TS16949?
• DRBFM (Design Review Based on Failure Mode) - Toyota method
• What results of a design review are documented in a DHF?
• Determining Legal& Statutory requirements while Auditing Design & Development process
• Design History File (DHF) Template Example for Consideration.
• Design Plan Template for Consideration
• Can an Electrical Design Engineer audit the work of a Mechanical Design Engineer?
• Methods and Requirements for "Proof of Concept" Design - Class 2 Medical Device
• Measures of Medical Device Design Process
• Design Plan TEMPLATE
• When is a Design Review required? - ISO9001:2000 Clause 7.3
• Product Design vs. Manufacturing Process Design
• Design & Development Process - Graphic Design Work advice needed
• ISO 9001 Design & Development - 7.3.4 Review, 7.3.5 Verify, 7.3.6 Validate
• AS9100 Section Applicability for a Design Center's Technical Publications
• Design/Change Control Form Example and Advice
• Product Assurance Plan which Translates Design Goals into Design Requirements
• FDA - Reference to checking for "patent infringement" during Design Control process?
• Design Responsible - Determining if Organization is Design Responsible
• Customer Designated Special Characteristics - TS16949 Clause 7.2.1.1
• Medical Devices: Initial Design - Sterile or Non-sterile
• Design and Development Planning - Is It Sufficient and Practical or Not
• Sales Group Using Contract Manufacturer, Contract Designer for ISO 13485 Products
• TS16949 - section 7.3.3.2 - Design Output - Data for reliability
• Exclusion of Purchasing Process - Consumer Electronics Product Design House
• Design/Development Sample Size Needed to Qualify a Design Ploy
• Manufacturing Process Design Documentation - Inputs and Outputs
• Does TS Organization have to use the Design Information Checklist?
• Wine By Design - Does Development of a New Wine Qualify as Design?
• "Design" or "Design and Development" in and ISO9001:2000 system
• Is the Assembly of the Prototype after Designing considered a Production Process?
• Design Activities Schedule - ISO 9001 Audit Nonconformance 7.3 - Opinions?
• Method to assess / calculate a design wrt DFM/DFA - Seeking template
• How to Document the Design & Development and Resource Management Process in IT Firm?
• Multilevel Design in Minitab to conduct a DOE - 4 factors and each has 5 levels
• Design For Serviceability for Electronic Equipment
• Laboratory: Different Standard Designations for the Same Test Methods
• Manufacturing Process Design Output Data for Quality, Reliability, Maintainability
• Remote Location - Design Responsibility - TS 16949 Certification - Join the debate
• Design & Development (Commercialization) procedures needed
• Design Exclusion for AS9100B and not ISO 9001 - 7.3 Design conflicts
• Can you suggest meaningful KPI's for our Design and Development process?
• Need to design a test to measure inspection effectiveness
• Designing a scope for APQP
• Signatures Requirements for Design phase documents
• Slot-Machine Psychology, Design and Economics
• Design Verification - Design outputs not verified against customer requirements
• Response Surface Design - Repeats - Getting data into Minitab 15
• Product Samples related to Design And Development
• Everyday Design Enigmas
• Exclusion of Design and Development - Construction and Renovation of Premises
• Design Improvement, but not OEM or Design Responsible
• Class 1K & 10K cleanroom specification - Machine/equipment design for IC packaging
• ISO 6385:2004 - Ergonomic Principles in the Design of Work Systems
• Queries about Element no 5.5.1 and 7.5.2 - Designation of "Authority"
• AS9120 - Designed for aerospace suppliers known as "stockist distributors"
• Designated Customer Representative - TS 16949 - Section 5.5.2.1
• I want to know whether Development is a part of Design or not.
• Is more than one Design Control & New Product Release Procedure OK?
• Are we doing Design? We remanufacture engines for the aftermarket world
• ISO 9001-2000 quality management system design
• Medical Device Product Requirements Document (PRD) a "Design Review"?
• Design Validation of class 2 medical device - Vertebral Body Replacement
• "Product Design skills" Exclusions in TS16949 Clause 6.2.2.1
• Design of a Process - Standard Work with no Layout
• Designing a Test Part to Assess CMM Operator's Knowledge
• 7.3 Design and 7.4 Purchasing - Creating the procedure
• Design and Development Documentation and Records Requirements
• Monitoring of significant events by Design Organisations
• ISO9001 certification necessary for R&D? Design development facility
• Addressing ISO 9001 Section 7 in the Quality Manual when Design is Excluded
• Question on Clause 7 Design Related Exclusions
• Manufacturing process design inputs - Productivity, process capability, cost targets
• Control Of Production and Service Provision - Onsite /offshore design and development
• New product Design & Development for automotive requirements - Documents required
• Business Objectives of Design & Development
• What is “Design and Development” in Construction - Clause 7.3 ISO 9001
• Is detergents formulation included in design? ( clause 7)
• Design Input vs. Design Output - What constitutes Design Input?
• Design Control - Outsourced Process Requirements
• Can we Exclude Design and Development clause in “Industrial Design” Company?
• Thoughts on the Design and Development group?
• Free Warehouse Layout & Planning Guide and Facilities & Workplace Design guide
• 7.3.2.2 - Process Design in Remanufacturing - Registration Finding for no DFMEA
• Design and Development - Defect Prevention Plan
• Looking for Unique forum for Design and Development
• Exclusion of Design and Development Controls - ISO 13485 Section 1.2
• Design and Development in a small company
• Designing a Mil-Std-105 or ANSI/ASQ Z1.4 Sampling Plan
• Severity Reduction by Product or Process Design Change? Seeking Good Example
• Quality Plan - Necessary for any Order? Mature Processes & Not Design Responsible
• Design vs. Repair / Refurbishment Modifications - ISO 9001 Design Exclusions
• Design & Development - Exclusion of 7.3 - We Manufacture to Customer Prints
• Design and Development Activities Flow - Please Critique
• Design and Development Measureables - ISO9001:2000 Clause 7.3
• Manufacturing Lessons Learned - New product from Design into Manufacturing
• Remote Design Center Locations on ISO 9001 Certificate
• Project Management QMS - Manufacturing and Designing of Special Purposed Machines
• Outsourced Design with Internal Design Change
• Outsourced Processes & Process Design - Interpretation of the "Outsourced Processes"
• EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development
• Company doesn’t design product - Exclusion of clause 7.3
• Design Control - paperwork takes longer than the complete design project!
• Manufacturing Process Design Output - Method of rapid NC detection & feedback
• Confusion regarding design responsibility - What can arguably be excluded?
• Outsourcing Design Work to Sister Facilities - How to best go about doing this
• 6.2.2.1 Product Design Skill - Doubts - No product design responsibility
• Design and development skills - No responsibility for product design and development
• DME (design margin evaluation) vs. DFMEA
• Evidence for manufacturing process design output data
• Hard to change factors in DOE (Split Plot Designs) - Injection molded parts
• Does someone have a checklist for design input items for medical devices?
• Design Process Not Compliant - What clause though?
• Design Validation & Process Validation Requirements - Automotive Electronics
• Required skills for Automotive R&D Electronic / Electrical design validation
• Test plan of Design Validation Plan and Report (DVP & R)
• Design Verification Sample Size - What philosophies are out there
• Design/Development Output & Verification - ISO 9001 7.3.3 Design & Development Output
• Permissible Exclusions in Section 7 - Design control requirements - No design
• Warehouse Design Layout - FDA Regulated Medical Manufacturer
• Product Development Program - Design, develop, approve and manufacture new products
• What to review in Proprietary Designs? TS 16949 Clause 7.1.4
• Design and Development of Pharmaceutical Formulations
• What Qualifies as Design/Development - ISO 9001 - Service support company
• An Early Brush with Design of Experiments
• AAR M-1003 - No design exclusions permitted
• How to Comply with ISO 9001 Clause 7.3.1 Design and Development planning
• Document Review Audit Findings - Design and Process Approach
• Interpreting "Design" and development - AS9100B Section 7.3
• Design Validation and Clinical Evaluations to meet ISO 13485 requirements
• ISO 9001:2000 Design and Developement
• As R+D (research and design) facility only, do we need TS16949?
• 7.3.4.1 Design and Development Monitoring - Monitor/analyize the defined measurements
• Design DOE with restrictions - Best shape of a speed vs. time curve - Injection mould
• AS9100 - Would like to know if I can exclude the design
• ISO/TS 16949:2002 - 6.2.2.1 Product Design Skills - Tools and techniques needed
• Looking for a example of a final design summary
• Manufacturing process design validation - What aspects are validated?
• ISO 9001:2000 clause 7.3 Design & Development Exclusion - Collagen casing for sausage

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