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International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

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NIST's Engineering Statistics Handbook

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These are the TOP 1,000 MOST RECENTLY USED Thread Topic Tags (out of 6500+ tags)
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4.1 - general requirements 5 whys (problem solving method) 5s workplace organization methodology 7.5.4 - customer property 8.2.2 - internal audits 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 801 - labeling 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2016 2017 2020 a2la (american association for laboratory accreditation) aami (assn for the advancement of medical instrumentation) 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) aluminum alloy amdd - asean medical device directive ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) andons annex v/vii annex x anova (analysis of variance) 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) asl (approved supplier list) asq (american society for quality) asq certifications assembly (general term) astm (american society for testing and materials) attribute data 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 automotive (general) automotive industry aws (american welding society) barcodes barcoding (upca - upce - ean8 - ean 13 - qr code) batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning 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 bonus tolerance books brazil bribes brochures bs 25999 - business continuity (bc) business continuity 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 (measurement device) capability study (part dimensions from a process or machine) careers catheters 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) 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 chinese (language) 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 evaluations and reports clinical research 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 divisional differences 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 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 continuous improvement continuous process(es) contract manufacturing contract research organizations (cro) contract review and approval contracts and agreements (general) control charts (general) controlled documents control limits control of monitoring measurement & test equipment control of production equipment control plans copyrights corrective action (ca) corrective action request (car) corrective action systems corrective action verification 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 processes (general) critical suppliers crossed gage r&r customer approval customer communication customer complaints and customer found nonconformance customer documents customer feedback 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 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 control 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 dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement dies differences (general) 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 dod (department of defense) dppm (defective parts per million) drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) due date 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 60601 - medical electrical equipment energy sources engineering engineering change notice (ecn) 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 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 part 145 (certified repair station) fasteners (category - nuts bolts and others) fda (food and drug administration) fda guidance fda requirements feedback field service final inspection and/or testing firmware first article inspection (fai) 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 foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum software (general) forum software instructions forum suggestions (general) france fraud functional requirements functional safety furls (fda's electronic registration and listing system) 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) glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmdn (global medical device nomenclature) 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) guidance documents handling hardness tester harmonization of standards hazard analysis health canada hearing aids heat treatment height gages hibcc - health industry business communications council hipaa (health insurance portability and accountability act) histogram history holidays and related occasions home healthcare hospitals hospital use 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) 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) implantable medical devices (imd) implementation (general) implementation of a standard in a company implementing a qms imports and importation improvement improvement plans and projects incidents and incident reports incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) information technology (it) department information technology (it) services infusion pumps and devices injection molding inks innovation inputs (general) inspection (general) inspection methods and plans inspection records installation qualification (iq) 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/iec 15504 - software processes (spice) 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 19011 - quality (qms) and ems audits iso 22000 - food safety management systems 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 itar (international traffic in arms regulations) itsm - it service management ivd (in vitro diagnostic) devices and reagens ivdd ivdr (in vitro diagnostic regulations) 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) laboratory scope language issues language requirements lawsuits (general) layout inspection lead auditor course leadership lean lean manufacturing leed environmental building program legacy products legal requirements level of concern (fda term) lithium ion batteries load cells log books and log sheets lot numbering low voltage directive 2006/95/ec low volume production machine shop maintenance malaysia management management review mandatory documents and procedures manufacturing planning manufacturing processes marking (general such as labeling) material changes mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdd 98/79/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 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 data systems 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 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) medwatch (fda safety info & adverse event reporting system) metal forming and stamping metrics (measurables such as for objectives) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) microbial count micrometers microsoft excel .xls .xlsx spreadsheet microsoft powerpoint .ppt .pps microsoft sharepoint software microsoft software minitab (statistical analysis software) mmc (maximum material condition - gd&t) 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 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-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) 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) operator instructions opportunities for improvement (ofi) optical comparators organization organizational knowledge orthopedic implants osha (occupational safety and health admin) outputs (general) outsourced calibration outsourced products and processes outsourcing ovens packaging (general) packaging labeling and related requirements packaging standards and specifications pacs (picture archiving and communication) 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 philippines planning plastic injection molding plastics plating & coatings 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 review and approval ppk (related to process performance) ppm (parts per million) pre-clinical studies (medical devices) precision machining predicate devices and parts premarket approval 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 procedure format 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 product requirements product safety products and services professional certifications and degrees profile of a surface 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 control data 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 quotes (quotations for a service or product) 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 reference dimensions reference documents refurbishing registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard regulations and regulatory requirements regulatory affairs (ra) regulatory requirements relabeling (of products) reliability analysis and testing remanufacturing remote locations and sites repackaging repair and or overhaul replacement parts 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 rfid (radio frequency identification) ring gage 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 rpn (fmea risk priority number) russia safety (general) safety requirements and regulations samples (of a part product or service) 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 accreditation scope of certification (aka registration) scope of registration/certification changes scrap second party audit self declaration semiconductor manufacturing service company or industry service providers service provisions severity ranking (fmea) shelf life shipping (general) and shipping requirements shop travelers 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 bugs 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 spain spanish spc (statistical process control) special characteristics special processes specification details specifications (general term) spectrometer spectrophotometer sri lanka stability testing stainless steel standalone software standards (e.g. iso mdd ansi etc.) statistical analysis and studies statistical analysis tools statutory requirements stc (supplemental type certificate) sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage requirements and specifications strategic planning and objectives student questions 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) support processes surgery products surgical products surveillance audits sustainability symbolization for devices symbols (general) systems taguchi designs and analysis 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 texas thermocouples thickness meters 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 tracking (general) trade shows training (general) training effectiveness training materials training records training requirements training sources and resources transformer (electrical) transition (between standards or revisions to a standard) transition audits transition period transition training translations (languages) transportation (general) 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) uncontrolled documents 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 values 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 waste (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding wifi wireless rf transmission work environment work instructions (wi) x-bar charts x-ray device(s) youtube videos zero defects

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