UK QMS Requirements

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Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 25
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 7
B IATF 16949 Supplier QMS Requirements IATF 16949 - Automotive Quality Systems Standard 3
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
D How to add AS9145 requirements to my existing AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T IATF 16949 Quality Management System (QMS) Scope Requirements IATF 16949 - Automotive Quality Systems Standard 18
Marc IAQG 9100:2016 - QMS Requirements for Aviation, Space and Defense AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Buckyb Boeing QMS Requirements for Tier 2 Distributors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
J Requirements for Review and Approval of QMS Documents Document Control Systems, Procedures, Forms and Templates 14
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
T QMS & CE Mark requirements for an EU Market Distributor/Trader CE Marking (Conformité Européene) / CB Scheme 7
D Auditor Requirement to 'Map' TS 16949 Requirements against our QMS IATF 16949 - Automotive Quality Systems Standard 27
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
M AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
J QMS Planning Requirements - What are the 5 clauses involved? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
J What's the meaning of word "map" (Map these requirements with your implemented QMS)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
K How can I revise my QMS documents to meet requirements of ISO 9001: 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Requirements for Implementing an ISO 9001:2008 Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q QMS General Formula - Satisfying the Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
Hershal Accreditation to ISO 17025:2005 meets ISO 9001:2008 QMS requirements ISO 17025 related Discussions 5
J Software for tracking QMS training - Database to track training requirements Quality Tools, Improvement and Analysis 2
P QMS-requirements should be excluded from the customer specific requirements Customer and Company Specific Requirements 13
T How to implement Customer Requirements into your QMS under TS IATF 16949 - Automotive Quality Systems Standard 1
1 Should I be concerned about Sarbanes-Oxley requirements affecting my ISO9001:2000 QMS Various Other Specifications, Standards, and related Requirements 6
D Heavy Truck QMS Requirements Customer and Company Specific Requirements 1
Gman2 ISO 9001:2000 - Requirements for Control of the QMS Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist ISO 13485:2016 - Medical Device Quality Management Systems 26
T Errors & Omissions in Creating QMS Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T QMS Compliance Department KPIs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
A E-signatures for QMS? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
B QMS On-Boarding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Scalable QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E Visual Management Boards & QMS ISO 13485:2016 - Medical Device Quality Management Systems 8

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