What is included in the Four Tiers of Documentation Pyramid?

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Documents to be included in 1.3 Material check in PPA report APQP and PPAP 4
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
D Should "Waste" be included as Output in SIPOC Chart? Process Maps, Process Mapping and Turtle Diagrams 8
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
R Parts included/not included in ECO/ECN Document Control Systems, Procedures, Forms and Templates 1
B IATF 16949 Clause 9.2.2.2 - Which QMS Processes are Included IATF 16949 - Automotive Quality Systems Standard 1
S Should Training Service providers be included in AVL? ISO 13485:2016 - Medical Device Quality Management Systems 7
Marc IAQG-OASIS - 9101:2016 Form 4: Cause Code Listing Now Included in Form AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Are Critical Business Processes Assets that need to be included in Asset Inventory? IEC 27001 - Information Security Management Systems (ISMS) 1
D What should be included in Management Review Meeting for ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
L Departmental Management Meetings -Topics which should be included IATF 16949 - Automotive Quality Systems Standard 4
W AS9102 Requirements - What information from the PO should be included in the FAIR? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4
K What is included in Raw Material and Component Specifications for Medical Devices? Other Medical Device Related Standards 3
S Samples for a Destructive Test included in a Lot Size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
R QMS System Upgrading - Should the HSE and Finance functions be included? Quality Manager and Management Related Issues 15
C Does every procedure need to be included within a policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included? CE Marking (Conformité Européene) / CB Scheme 5
T IEC 62366 included in 3rd ed IEC 60601? IEC 62366 - Medical Device Usability Engineering 1
K PPAP Cost - Cost of PPAP should be included in the quote? APQP and PPAP 5
Q Outsourced Process - Why certain "processes" are not included - ISO9001-2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H What should be included in a Machining Process FMEA? FMEA and Control Plans 8
T TS16949 Certification withdrawn - What should be included in a formal appeal request? IATF 16949 - Automotive Quality Systems Standard 3
B Checklist Contents - Do ISO clause references need to be included? Internal Auditing 4
J What should be included in the Design Change Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Should prices be included in customer related process ISO 13485:2016 - Medical Device Quality Management Systems 1
M Will a Business Plan be included in an ISO 9001 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
T Information System function MUST be included? Clause 6.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Equipment Error and Accuracy to be included in Uncertainty Calculations? Measurement Uncertainty (MU) 2
D How does "outsourcing" get included in the FMEA and Control Plan? FMEA and Control Plans 4
R Which information about predicate device should be included in 510k submission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
F Do Calibration Suppliers need to be included in the list of Approved Suppliers? IATF 16949 - Automotive Quality Systems Standard 12
S Master Validation Plan - What must be included in a "Master Validation Plan"? Qualification and Validation (including 21 CFR Part 11) 5
C MR Service Contract - What should be included ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Reference or recommendation of items to be included in the Business Plan IATF 16949 - Automotive Quality Systems Standard 3
B What key topic that is included in ISO9004 is excluded from ISO 9001 World News 2
J Quality Policy - should a brief description of the company & its product be included? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S What should be included in training documentation Training - Internal, External, Online and Distance Learning 19
B What other activities should be included in a Continuous Improvement process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Additional site to be included in TS Cert. (Common owners & some functions) IATF 16949 - Automotive Quality Systems Standard 5
T Internal Audit Yield %'s (Poll included) Internal Auditing 16
B Do we need a product to have a quality manual (FAA/EASA 145 included)? EASA and JAA Aviation Standards and Requirements 22
D Should QSRD codes be included in Documents Submitted to Regulatory Bodies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
H BS EN 13012:2001 for petrol pumps - Need to know if Vibration is included therein? Various Other Specifications, Standards, and related Requirements 1

Similar threads

Top Bottom