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4.1 - general requirements 5s workplace organization methodology 7.5.2 - validation of processes 7.5.4 - customer property 7.6 - control of monitoring & measurement devices 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) 2016 2017 2018 2020 a2la (american association for laboratory accreditation) accelerated life and stability testing acceptance criteria accessories (product) accuracy of a measurement device acquisitions and mergers acronyms active medical device adverse event reporting aerospace (general) aerospace manufacturer 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) ansi y14.5 - dimensioning and tolerancing anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) apple (the company) 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 attribute data msa (measurement system analysis) audit checklist audit man-days audit nonconformances and findings 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 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 benchmarking bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing 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 standards and classes calibration verification calipers canada canada's sor 98-282 - complaint handling & problem reporting 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 cba (certified biomedical auditor) cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of analysis (c of a) 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 notice (document or form) charts checklist or check sheet china chinese (language) 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 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 cofepris (mexico's medical device and ivd oversight) combination devices and related rules combination drug-device products communications community discussions company divisional differences company name change company policies company vision or strategy comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance to a standard component manufacturers components computer viruses worms and related topics 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) contract manufacturing contract research organizations (cro) contract review and approval contracts and agreements (general) contract services control charts (general) controlled documents control limits control plans conversion factors copyrights corrective action (ca) corrective action request (car) corrective action systems 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 processes (general) crossed gage r&r cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer feedback customer notification(s) customer owned property customer property customer requirements customer satisfaction customer specific requirements (csr) customer survey 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 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) digital data dimensional inspection dimensions disaster preparedness and recovery disaster recovery distributors (distribution company) distributors (general) distributors (medical devices) dock audits dock to stock document classification 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) dose audit draft documents 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 ec certificate/certification education effectiveness efficiency electrical safety electrocardiographs (general topics) electronic components parts assemblies and products electronic data (general) electronic documents forms and templates 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 use and conservation engineering change request (ecr) engineering changes engineering drawings environment (environmental related) equipment qualification and validation equivalence studies equivalent medical devices erp software essential requirements checklist ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization european authorized representative european council directive on medical devices european medical device regulations european union european union medical device directives (mdd) european union regulations and standards 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) fda (food and drug administration) fda guidance fda requirements feasibility analysis and review feedback final inspection and/or testing financial (finance) departments 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 football ford motor company formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum software instructions forum software questions forum suggestions (general) france fraud functional requirements functional safety furls (fda's electronic registration and listing system) furnaces gadsl - global automotive declarable substance list gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdsn (global data synchronisation network) general motors (gm) germany glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmp (good manufacturing practices) goals (quality environmental and other measureables) gp-12 early production containment gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) gui (graphic user interface) guidance documents gum - measurement uncertainty document haccp (hazard analysis & critical control points) hardness tester harmonization of standards hazardous substances health (general) health canada health safety and environmental (hse) heat treatment height gages hibcc - health industry business communications council hipaa (health insurance portability and accountability act) history holidays and related occasions home healthcare hospitals human error 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 62366 - medical device usability engineering iec 62366-1:2015 medical device usability imds (international material data system) implantable medical devices (imd) implementation of a standard in a company implementing a qms imports and importation improvement improvement plans and projects incoming inspection (also see receiving inspection) india indian health ministry indonesia information security information technology (it) information technology (it) department infusion pumps and devices injection molding 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 intended use (medical devices) interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal communications internal laboratory international standards 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/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 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 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 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 layout inspection lead auditor(s) and related topics lead auditor course leadership leakage current lean lean six sigma legacy products legal requirements level of concern (fda term) liability insurance linkedin lithium ion batteries log books and log sheets low voltage directive 2006/95/ec machine shop maintenance malaysia management management review manufacturing (general term) manufacturing planning manufacturing processes marking (general such as labeling) material testing and test reports 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 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) medwatch (fda safety info & adverse event reporting system) metal forming and stamping metrics (measurables such as for objectives) mhra (medical & healthcare regulatory agency) microbial count micrometers microsoft excel .xls .xlsx spreadsheet microsoft powerpoint .ppt .pps microsoft sharepoint 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 multimeters multiple business units multiple national or international locations multiple sites multiple standards in a company music nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 nested gage r&r new products and new product requirements news nhs (uk national health service) nist (nat'l institute of standards & technology) 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) 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 osha (occupational safety and health admin) outsourced products and processes outsourcing ovens packaging (general) packaging labeling and related requirements packaging standards and specifications painting panama 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 pfh (probability of dangerous failure per hour) pfmea (process fmea) pharmaceuticals and pharmaceutical industry planning plastic injection molding plastic parts plastics pma (pre-market approval) pmda (japan) 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) 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 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 processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process performance process validation process verification and validation product audits product code production control production equipment production processes 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 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 recalls (general) receiving inspection record retention requirements records (evidence) and records control red (radio equipment directive) reference dimensions 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 compliance 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 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) rohs 2 directive root cause failure analysis routers (process) rpn (fmea risk priority number) rta (refuse to accept) guidance safety (general) safety requirements and regulations sample frequency 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) scales and balances scar (supplier corrective action request) scope (general term) 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 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 business qualification and certification small companies (small businesses) smed (single minute exchange of dies) software (general topics) software (off the shelf) software bugs 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 spanish 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 standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies 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 subcomponents and sub-assemblies subcontracted goods processes and services subcontracting and subcontractors supplier audits supplier control and monitoring supplier corrective & preventive action supplier data supplier evaluation/rating/approval supplier nonconformances supplier quality supplier quality engineer (sqe) supplier requirements suppliers (general topics) support processes surface finish measurement surgery products surgical products surveys (general) sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices symbols (general) taguchi designs and analysis tape measure targets (aka objectives) taxes and taxation technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing terminology testing (general testing topics) testing laboratories test methods and procedures and plans test reports thermocouples 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) tl 9000 tolerances (dimensional or other units) tools and tooling (general) top management 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 trade names training (general) training effectiveness training materials training needs training plan and training matrix training records training requirements training sources and resources transition (between standards or revisions to a standard) transition audits transition period transition training translations (languages) true position ts 16949 - automotive quality system standard ts 16949 4th edition turtle diagrams tus (temperature uniformity survey) uncertainty (aka mu - related to calibration) uncertainty budget (measurement) 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 values value stream mapping (vsm) variables data vda 5 - measurement system analysis vda 6.3 - process audit vda standards vdmax25 sterilization validation verification (general) verification of calibration version changes and change control veterinary medical devices virtual manufacturing vision measurement systems (electronic) visual inspection want to buy warranties (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding white papers who (world health organization) wifi wireless rf transmission wire work instructions (wi) youtube videos zero defects

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