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.pdf 4.1 - general requirements 4.2.3 - control of documents 4.2.4 - control of records 5 whys (problem solving method) 5s workplace organization methodology 6.2.2 - competence awareness and training 7.1 - planning of product realization 7.3 - design and development 7.5.2 - validation of processes 7.5.4 - customer property 7.6 - control of monitoring & measurement devices 8.2.2 - internal audits 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 211 - finished pharmaceuticals cgmp 21 cfr part 801 - labeling 21 cfr part 803 - medical device reporting 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2008 2016 2017 2020 accelerated life and stability testing acceptance criteria accessories (product) accuracy of a measurement device acronyms action plans active medical device adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace auditor aerospace manufacturer aerospace standards and regulations aerospace supplier(s) aiag (automotive industry action group) aiag manual(s) alarp (as low as reasonably possible) aluminum (general topics) amdd - asean medical device directive ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing ansi z1.4 - inspection by attributes anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) applicable clauses documents legal requirements etc. approvals apqp (advanced product quality planning) aql (acceptable quality level) article 12 as9100 - aerospace quality management systems as9100 revision d (2016) as9101 - aerospace qms audit requirements as9102 - aerospace first article inspection (fai) as9110 - aerospace maintenance quality systems asean (the association of southeast asian nations) asia asl (approved supplier list) aspects and impacts (environmental) asq (american society for quality) asq certifications assembly (general term) astm (american society for testing and materials) attribute data attribute data msa (measurement system analysis) audit checklist audit man-days audit nonconformances and findings audit observation auditor performance auditor qualification requirements and certifications auditor reporting auditors (general topics) audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia authority and responsibility authorized representative automated measurement gages automotive (general) automotive industry aviation sector aws (american welding society) banks (financial) barcodes batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning benchmarking bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing biological evaluations birthdays blood glucose blood glucose meters and test strips boeing boeing d6-51991 books brazil bribes brochures bs 25999 - business continuity (bc) business continuity business processes calculation formulas calibration (general topics) calibration (metrology) laboratories calibration data calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration software calibration standards and classes calibration verification calipers canada canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (measurement device) capability study (part dimensions from a process or machine) capacity analysis careers cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of conformance (c of c) certification audits certification bodies (cb) certifications (to a standard) cfda (china food and drugs administration) cgmp (current good manufacturing practices) change(s) (general) change control change management change request charts checklist or check sheet china chrysler classification(s) of parts or products class iii medical device class ii medical device class i medical device cleaning methods and processes cleanliness cleanrooms clinical evaluations and reports clinical trials and studies and investigations cloud computing cmdcas (canadian med device conformity assmnt system) cmk cmm (coordinate measuring machine) cnc machine shop cnc machining coatings color measurement combination devices and related rules combination drug-device products communications community discussions company name change company policies comparison comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance to a standard components computer viruses worms and related topics concessions configuration management construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) context of the organization contingency plans continuous improvement continuous process(es) contract manufacturing contract review and approval contracts and agreements (general) control charts (general) controlled documents control limits control of monitoring measurement & test equipment control plans conversion factors copyrights corrective action (ca) corrective action request (car) corrective action systems corrective action verification correlation study cost estimation cots (commercial off-the-shelf) counterfeit parts and products cpk (related to process capability) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment critical characteristics critical parts and components critical suppliers crossed gage r&r cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer documents customer feedback customer notification(s) customer owned property customer property customer requirements customer satisfaction customer specific requirements (csr) customer survey dashboard software for measureables data (general) data (import from and export to applications) data analysis databases data control data security date of manufacture datum (gd&t) dcma (defense contract management agency) deaths declaration of conformity defect rate defects and defectives definitions dental topics design and development design changes design control design exclusion design history file (dhf) design history record (dhr) design inputs and outputs design of experiments (doe) design validation design verification destructive tests and testing detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device master file device master record (dmr) dfmea (design fmea) diameter measurement dies differences (general) dimensional inspection dimensional measurement dimensions disaster preparedness and recovery disposable products distributors (distribution company) distributors (general) distributors (medical devices) dock audits dock to stock document content & structure document control document control (electronic) document control software documented procedures (requirements for) document identification and numbering document references document retention document review(s) and approval(s) document revisions and changes documents and documentation (general) documents of external origin dppm (defective parts per million) drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) easa (european aviation safety agency) easa part - 145 maintenance organisation approval education effectiveness efficiency egypt electrical safety electrocardiographs (general topics) electromagnetic compatibility electronic components parts assemblies and products electronic data (general) electronic documents forms and templates electronic format(s) electronic records electronic signatures and approvals elsmar elsmar cove tos and policies elsmar improvements (general) email (general) emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications ems (environmental management system) en 980 (ifu graphical symbols) en 10204 en 60601 - medical electrical equipment engineering engineering change notice (ecn) engineering change request (ecr) engineering changes engineering company engineering drawings en iso 13485:2012 environment (environmental related) equipment qualification and validation equivalent medical devices erp software esd (electrostatic discharge) essential requirements checklist ethics ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization europe european authorized representative european council directive on medical devices european medical device regulations european union evidence evop (evolutionary operation of processes) examinations (course or certification tests) exclusions of clauses in a standard exemptions expiration date exports and exporting external document control external documents - prints standards etc. external processes faa (federal aviation administration) faa part 145 (certified repair station) fasteners (category - nuts bolts and others) fda (food and drug administration) fda guidance fda requirements feasibility analysis and review feedback firmware first article inspection (fai) first article inspection report (fair) fishbone diagram fixture(s) flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food packaging food safety ford motor company ford q1 formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum policies forum software (general) forum software instructions forum software questions forum suggestions (general) france fraud functional safety furnaces gadsl - global automotive declarable substance list gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gamma sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdp (good documentation practices) gdsn (global data synchronisation network) general motors (gm) germany glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmdn (global medical device nomenclature) gmdn codes gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gp-12 early production containment gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) guidance documents haccp (hazard analysis & critical control points) hardness tester harmonization of standards hazard analysis health (general) health canada health safety and environmental (hse) heat treatment height gages hibcc - health industry business communications council history holidays and related occasions home healthcare hospitals human error human factors human tissues and organs humidity (general) humidity control humor hypothesis test analysis iaf (international accreditation forum) iaqg (international aerospace quality group) iaqg 9100:2016 - aerospace quality management systems iatf (international automotive task force) iatf 16949:2016 identification (products and parts etc) identification and traceability (general) iec (international electrotechnical commission) iec 60335 - household electrical appliance safety iec 60601 - medical electrical equipment iec 60950 (information technology equipment - safety) iec 61010 - safety requirements for electrical equipment iec 61508 - functional safety of electronic controls iec 62304 - medical device software life cycle processes iec 62366 - medical device usability engineering iec 80002 - guidance on the application of iso 14971 imds (international material data system) implantable medical devices (imd) implementation (general) implementation of a standard in a company implementing a qms imports and importation improvement improvement plans and projects in-house laboratory incidents and incident reports incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) information technology (it) services infusion pumps and devices injection molding inks innovation inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records installation qualification (iq) instructions (general) instructions for use (ifu) integrated management systems interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal communications internal laboratory internet (general topics and news) interpretations iran irca (int'l register of certificated auditors) ishikawa diagram iso (int'l organization for standardization) iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11135 - medical device ethylene oxide sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 15197 - in vitro glucose monitoring systems iso 15223 - medical device label symbols iso 16269 - statistical interpretation of data iso 17025 - testing and calibration laboratories iso 19011 - quality (qms) and ems audits iso 22000 - food safety management systems iso 26000 - social responsibility iso 27000 series - information technology security iso 27001 - information security management system (isms) iso 31010 - risk assessment techniques iso 37001 - anti-bribery management systems iso 50001 - energy management systems israel italy itar (international traffic in arms regulations) itsm - it service management ivd (in vitro diagnostic) devices and reagens ivdd japan japan - ministry of health labour and welfare job descriptions job openings jobs (general) kaizen key performance indicators (kpi) key product or process characteristics (kpc) knowledge management korea labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) language issues language requirements lawsuits (general) layered process audit (lpa) layout inspection lead auditor course leadership leakage current lean lean manufacturing lean six sigma legacy products legal requirements level of concern (fda term) lithium ion batteries log books and log sheets low volume production machine shop maintenance malaysia management management review mandatory documents and procedures manufacturing processes marking (general such as labeling) material changes mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdds (medical device data system) mdr (medical device regulations) mdr (medical device reporting) mds (material declaration sheet) mdsap (medical device single audit program) measureables (also see metrics) measurement (general) measurement and monitoring and test devices measurement equipment verification measurement systems measurement techniques and procedures measurement uncertainty (mu) meddev - ec guidelines on medical devices medical device accessories medical device company or industry medical device electronics and electrical equipment medical device licensing medical device listing codes and classifications medical device parts and components medical device registration medical device reports including incident reporting medical devices medical devices (disposable) medical device safety medical device software medical device standards and regulations medical equipment (general) metal forming and stamping metrics (measurables such as for objectives) mhra (medical & healthcare regulatory agency) micrometers microsoft access .mdb database microsoft excel .xls .xlsx spreadsheet microsoft powerpoint .ppt .pps microsoft sharepoint software microsoft software minitab (statistical analysis software) mmc (maximum material condition - gd&t) mobile medical devices and applications (apps) molds and molding monitoring and measurement moop (means of operator protection) mop (means of protection) movies msa (measurement system analysis) msa manual msa study multimeters multiple business units multiple national or international locations multiple sites multiple standards in a company nadcap (nat'l aerospace & defense contractors accred. pgm) nested gage r&r new product introduction new products and new product requirements news nhs (uk national health service) nist (nat'l institute of standards & technology) non-destructive testing non-normal data distribution non-sterile medical devices nonconformance recurrence nonconformance report (ncr) nonconformances nonconformance system nonconforming material product or service notified bodies medical devices (nb-med) notified body oasis (online aerospace supplier information system) oasis database objective evidence objectives (quality environmental and other measureables) obl (own brand labeling) occurrence ranking (fmea) oem (original equipment manufacturer) off the shelf (ots) equipment or parts or software ohsas 18000 & 18001 & 18002 online internet training courses and universities operational planning operational qualification (oq) opportunities for improvement (ofi) optical comparators organizational knowledge orthopedic implants osha (occupational safety and health admin) outsourced calibration outsourced products and processes outsourcing ovens packaging (general) packaging labeling and related requirements packaging standards and specifications painting paper documents and records particulates pcb (printed circuit board) pear (process effectiveness assessment report) pems (programmable electrical medical system) peppol (pan-european public procurement online) performance measureables performance qualification (pq) personal health information pfmea (process fmea) pharmaceuticals and pharmaceutical industry planning plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) pmda (japan) policies and policy statements policy documents post market clinical follow up post market surveillance powder coat paint ppap (production part approval process) ppap manual ppk (related to process performance) ppm (parts per million) pre-clinical studies (medical devices) predicate devices and parts premarket approval premarket notification premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts printers and printing equipment prints (drawings or blueprints) privacy private label products problem solving procedure examples procedures (general) process approach process audits process capability process changes and change notifications process controls and control plans process design and development process documentation processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process performance process validation process variation process verification and validation product audits product code production production processes product requirements product safety products and services professional certifications and degrees project management proprietary information prototypes and prototype testing psw (part submission warrant) purchase orders purchasing purchasing controls qms (quality management system) qs-9000 qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality magazine quality management systems quality management system software quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quality systems quality tools raw materials raw material suppliers reach (ec 1907/2006) reach certification reach rohs recalls (general) receiving inspection recertification (to a standard) record retention requirements records (evidence) and records control red (radio equipment directive) reference documents refurbishing registrar audits registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard regulations and regulatory requirements regulatory affairs (ra) regulatory affairs certification (rac) regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing remanufacturing remote locations and sites repackaging repair and or overhaul reportable event reporting (medical devices) reports (general) required documents required procedures requirements and specifications research and development (r&d) research use only (ruo) device or software resistance (electrical) resources responsibilities revalidation of a process or product revision control revisions to a document or standard rework rfid (radio frequency identification) ring gage risk based compliance risk based thinking (rbt) risk management and analysis risk management file (rmf) risk register robotics rohs (restriction of hazardous substances) rohs 2 directive root cause failure analysis routers (process) rpn (fmea risk priority number) russia safety (general) safety requirements and regulations samples and sampling plans sample size sampling plans for attribute data sampling plans for variables data sap erp (enterprise resource planning) saudi arabia scales and balances scar (supplier corrective action request) scope (general term) scope of certification (aka registration) scrap second party audit semiconductor manufacturing service company or industry service providers service provisions severity ranking (fmea) sheet metal shelf life shipping (general) and shipping requirements signatures single fault condition single use devices (sud) six sigma (general) six sigma black belt small companies (small businesses) smed (single minute exchange of dies) software (general topics) software (off the shelf) software development life cycle (sdlc) software medical devices software tools (for qa statistics doc control etc.) software validation soldering sole source supplier sop (standard operating procedure) south africa spc (statistical process control) special characteristics special processes specification details specifications (general term) spectrophotometer sri lanka stability testing stainless steel stamps (e.g. inked document control stamps) standalone software standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies statistical analysis tools statutory requirements stc (supplemental type certificate) sterile medical devices sterile packaging sterility and sterilization techniques sterilization validation storage requirements and specifications student questions subcomponents and sub-assemblies subcontracted goods processes and services subcontracting and subcontractors substantial equivalence supplier audits supplier control and monitoring supplier corrective & preventive action supplier development supplier evaluation/rating/approval supplier nonconformances supplier quality supplier quality engineer (sqe) supplier requirements suppliers (general topics) supplier selection qualification and approval support processes surface roughness surgery products surgical products sustainability symbolization for devices symbols (general) systems taguchi designs and analysis tape measure taper gages taxes and taxation technical documentation technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing test equipment testing (general testing topics) testing laboratories test methods and procedures and plans test reports thermocouples thermometers and thermostats third party audits and auditing thread inspection gages thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) titanium tl 9000 tolerances (dimensional or other units) tolerances (process) tools and tooling (general) top management torque torque wrench or tool toyota tpm - total productive maintenance tqm (total quality management) traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products trade shows training (general) training effectiveness training materials training plan and training matrix training records training requirements training sources and resources transition audits transition matrix transition period transition training translations (languages) travel true position ts 16949 - automotive quality system standard turtle diagrams tus (temperature uniformity survey) ultrasonic testing uncertainty (aka mu - related to calibration) uncertainty budget (measurement) unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management usability of a product validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing value stream mapping (vsm) variables data vda 6.3 - process audit vda standards verification (general) verification of calibration veterinary medical devices vision measurement systems (electronic) visual inspection volkswagen want to buy warranties (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding who (world health organization) wire work environment work instructions (wi) x-bar charts x-ray device(s) youtube videos

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