Performance Excellent Plan in a Service Organization

L

Laxmi Priya

#1
Hi

My friend is running a consultancy and in need of some kind of lead regarding design of performance excellence plan for a service organization.

Please give me some practical case study of a service organization which implemented QMS and achieved performance excellence.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Performance of high shear mixer (or rapid mixing granulator Qualification and Validation (including 21 CFR Part 11) 4
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
B Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted] Training - Internal, External, Online and Distance Learning 2
F 5520A High Performance Multi-Product Calibrators General Measurement Device and Calibration Topics 0
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
M Performance Standard for Balloon Trocars Other Medical Device Related Standards 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
qualprod Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 2
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
B Essential Performance of a Cone Beam Computed Tomography Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D IEC 60601-1 - Essential performance doesn't make sense IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
M Product Performance Claims Other Medical Device Related Standards 4
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2
M FDA News USFDA – Safety and Performance Based Pathway Guidance Medical Device and FDA Regulations and Standards News 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
Ed Panek Do standards have performance reviews? General Information Resources 2
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
S Package performance testing for non-sterile Hydrogels US Food and Drug Administration (FDA) 1
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
D IEC 60601-1 - Performance limits for essential performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Marc Definition GSPR - General Safety and Performance Requirements Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
A Users won't return devices from pre-CE performance evaluation study EU Medical Device Regulations 3
D Essential performance, accompanying documents....confused IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
qualprod Identification of Training Needs = People Performance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8

Similar threads

Top Bottom