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4.1 - general requirements 5s workplace organization methodology 7.5.2 - validation of processes 7.5.4 - customer property 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 801 - labeling 21 cfr part 803 - medical device reporting 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 2016 2017 aami (assn for the advancement of medical instrumentation) accelerated life and stability testing acceptance criteria accessories (product) accuracy of a measurement device acquisitions and mergers acronyms active medical device adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace manufacturer aerospace standards and regulations 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) annex v/vii annex x anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) api q2 - oil and gas industry service suppliers applicable clauses documents legal requirements etc. approvals approved suppliers 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 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 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 autoclaves automated measurement gages automotive (general) automotive industry barcoding (upca - upce - ean8 - ean 13 - qr code) 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 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 verification calipers canada canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (part dimensions from a process or machine) careers catheters cba (certified biomedical auditor) cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of conformance (c of c) certificates (general) certification audits certification bodies (cb) certification process certifications (to a standard) cfda (china food and drugs administration) change(s) (general) change control change management 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 cleanroom validation clinical data management (cdm) clinical evaluations and reports clinical trials and studies and investigations cloud computing clsi (clinical and laboratory standards institute) cmdcas (canadian med device conformity assmnt system) cmk cmm (coordinate measuring machine) cnc machine shop cnc machining coatings cofepris (mexico's medical device and ivd oversight) 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 (general) compliance to a standard component manufacturers components concessions construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) context of the organization contingency plans continual improvement (also see continuous improvement) continuous improvement continuous process(es) contract audits and contract auditing contract manufacturing contractors (goods and services providers) contract review and approval contracts and agreements (general) control charts (general) controlled documents control limits control methods control plans controls copyrights corrective action (ca) corrective action request (car) corrective action systems corrosion cots (commercial off-the-shelf) counterfeiting control counterfeit parts and products cpk (related to process capability) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment creepage distance critical characteristics critical parts and components critical suppliers cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer documents 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 collection and/or entry data control data integrity data security date of manufacture datum (gd&t) dcma (defense contract management agency) deaths declaration of conformity 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 destructive tests and testing detection controls detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device identification number (din) device master file device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement differences (general) dimensional inspection dimensional measurement dimensions displays (video monitors) disposable products distribution centers distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits 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) dod (department of defense) drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) easa (european aviation safety agency) easa part - 145 maintenance organisation approval ec certificate/certification education effectiveness efficiency electrical safety electromagnetic compatibility electronic components parts assemblies and products electronic data (general) electronic documents forms and templates electronic records electronic signatures and approvals elsmar 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 60601 - medical electrical equipment endoscopic equipment engineering 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 ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization europe european medical device regulations european union european union regulations and standards evidence evop (evolutionary operation of processes) examinations (course or certification tests) exclusions of clauses in a standard exclusions of product lines in registration to a standard exemptions expiration date exports and exporting external communications external document control external documents - prints standards etc. external processes faa (federal aviation administration) failure modes fasteners (category - nuts bolts and others) fda (food and drug administration) fda guidance fda requirements feasibility analysis and review final inspection and/or testing financial (finance) departments first article inspection (fai) first article inspection report (fair) fishbone diagram fixture(s) florida flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food packaging food safety football ford motor company ford q1 foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum software instructions forum software problems forum software questions forum suggestions (general) france fraud functional requirements functional safety furls (fda's electronic registration and listing system) gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdpr (eu general data protection regulation) general motors (gm) germany glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) gui (graphic user interface) guidance documents haccp (hazard analysis & critical control points) hardness tester harmonization of standards health (general) health canada health safety and environmental (hse) hearing aids heat treatment height gages hibcc - health industry business communications council high level structure (hls) hipaa (health insurance portability and accountability act) history holidays and related occasions home healthcare hospitals human factors human tissues and organs humidity (general) humidity control humor hurricanes 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 62133 - secondary cells and batteries safety requirements iec 62304 - medical device software life cycle processes iec 80002 - guidance on the application of iso 14971 imdrf (international medical devices regulators forum) imds (international material data system) immunity tests implantable medical devices (imd) implementation of a standard in a company imports and importation improvement improvement plans and projects in-house laboratory incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) information technology (it) department injection molding inks 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 laboratory internet (general topics and news) interpretations investigational use only (iuo) iran irca (int'l register of certificated auditors) ishikawa diagram isms (information security management system) 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 15378 - primary packaging materials for medicinal products iso 16269 - statistical interpretation of data iso 17025 - testing and calibration laboratories 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 isolation israel ivd (in vitro diagnostic) devices and reagens ivdr (in vitro diagnostic regulations) japan japan - ministry of health labour and welfare job openings jobs (general) 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) laboratory scope language issues language requirements laser measurement equipment laser micrometer lawsuits (general) layout inspection lead auditor course leadership leakage current lean lean manufacturing lean six sigma legacy products legal requirements level of concern (fda term) liability insurance lithium ion batteries low voltage directive 2006/95/ec machine shop maintenance malaysia management management review mandatory documents and procedures manufacturing (general term) manufacturing planning manufacturing processes marketing (general) marking (general such as labeling) material changes mathematical equations matrix mdd (medical device directive) mdd 93/42/eec 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 resolution and tolerances 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 file medical device licensing medical device listing codes and classifications medical device parts and components medical device registration medical device repair and servicing 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) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) micrometers microsoft excel .xls .xlsx spreadsheet 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 mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study multiple business units multiple national or international locations multiple sites multiple standards in a company music nace codes nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 nadcap ac7114 nested gage r&r 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 objectives (quality environmental and other measureables) obl (own brand labeling) occupational health and safety (oh&s) 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 organization organizational knowledge osha (occupational safety and health admin) outputs (general) outsourced calibration outsourced products and processes outsourced software outsourcing ovens over the counter (see otc) packaging (general) packaging labeling and related requirements packaging standards and specifications painting paper documents and records particulates pcb (printed circuit board) pems (programmable electrical medical system) peppol (pan-european public procurement online) performance measureables performance qualification (pq) personal health information pfd (probability of failure on demand) pfmea (process fmea) pharmaceuticals and pharmaceutical industry planning plastic injection molding plastic parts plastics plating & coatings pmda (japan) poka yoke policies and policy statements policy documents post delivery activities post market clinical follow up post market surveillance ppap (production part approval process) ppk (related to process performance) ppm (parts per million) pre-clinical studies (medical devices) pre-control chart predicate devices and parts premarket approval premarket notification premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts 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 production control production processes product limits product requirements product safety products and services professional certifications and degrees prototypes and prototype testing psw (part submission warrant) purchase orders purchasing purchasing controls qms (quality management system) qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department 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 quotes (quotations for a service or product) radius measurement raw materials raw material suppliers reach (ec 1907/2006) recalls (general) receiving inspection recertification (to a standard) record retention requirements records (evidence) and records control reference documents refurbishing registrar audits registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard regrind material regulations and regulatory requirements regulatory affairs (ra) regulatory compliance regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing remote locations and sites repackaging repair and or overhaul reports (general) required documents required procedures requirements and specifications research and development (r&d) research use only (ruo) device or software resistance (electrical) resources response time responsibilities returned products and/or parts revalidation of a process or product revision control revisions to a document or standard rework rework and repair procedures ring gage risk based compliance risk based thinking (rbt) risk management and analysis risk register robotics rohs (restriction of hazardous substances) root cause failure analysis routers (process) rpn (fmea risk priority number) rta (refuse to accept) guidance safety (general) safety requirements and regulations salt spray testing sample frequency samples and sampling plans sample size sampling plans for attribute data sampling plans for variables data sanctioned interpretations sap erp (enterprise resource planning) saudi arabia scales and balances scar (supplier corrective action request) scope (general term) scope of accreditation scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit self certification serial numbers service company or industry service exclusions 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) small business qualification and certification 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) sorting out nonconforming material or goods south africa spc (statistical process control) special characteristics special processes specification details specifications (general term) spectrometer spectrophotometer sri lanka stability testing stainless steel stamps (e.g. inked document control stamps) standalone software standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies statistical analysis tools statutory requirements sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage (general) storage requirements and specifications strategic planning and objectives student questions sub-supplier 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 data supplier development supplier evaluation/rating/approval supplier nonconformances supplier quality supplier requirements suppliers (general topics) support processes surface finish measurement surgery products surgical products surveys (general) sustainability symbolization for devices symbols (general) systems taguchi designs and analysis tape measure technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing terminology 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 plug gages and set plugs thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) titanium tl 9000 tolerances (dimensional or other units) tools and tooling (general) top management torque torque wrench or tool touch current (tc) toyota tpm - total productive maintenance traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products tracking (general) training (general) training effectiveness training materials training plan and training matrix training records training requirements training sources and resources transformer (electrical) transition (between standards or revisions to a standard) transition audits transition matrix transition period transition training translations (languages) transportation (general) travel true position ts 16949 - automotive quality system standard ts 16949 4th edition turtle diagrams uncertainty (aka mu - related to calibration) uncertainty budget (measurement) uncontrolled documents unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management usability of a product user manuals validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing variables data vda 5 - measurement system analysis vda 6.3 - process audit vda standards verification (general) verification of calibration version changes and change control veterinary medical devices virtual manufacturing vision measurement systems (electronic) visual inspection volkswagen want to buy warranties (general) water (general) webinar websites weee (waste electrical and electronic equipment) weekend random topics welding wire work environment work instructions (wi) x-ray device(s) youtube videos

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