ISO13485: TERMS AND DEFINITIONS Flashcards
ACTIVE MEDICAL DEVICE
ANY MEDICAL DEVICE RELYING FOR ITS FUNCTIONING ON A SOURCE OF ELECTRICAL ENERGY OR ANY SOURCE OF POWER OTHER THAN THAT DIRECTLY GENERATED BY THE HUMAN BODY OR GRAVITY.
ACTIVE IMPLANTABLE MEDICAL DEVICE
ANY ACTIVE MEDICAL DEVICE WHICH IS INTENDED TO BE TOTALLY OR PARTIALLY INTRODUCED, SURGICALLY OR MEDICALLY, INTO THE HUMAN BODY OR BY MEDICAL INTERVENTION INTO A NATURAL ORIFICE, AND WHICH IS INTENDED TO REMAIN AFFTER THE PROCEDURE
ADVISORY NOTICE
NOTICE ISSUE BY THE ORGANIZATION, SUBSEQUENT TO DELIVERY OF THE MEDICAL DEVICE, TO PROVIDE SUPPLEMENTARY INFORMATION AND/OR TO ADVISE WHAT ACTION SHOULD BE TAKEN IN
* THE USE OF A MEDICAL DEVICE
*THE MODIFICATION OF A MEDICAL DEVICE
*THE RETURN OF A MEDICAL DEVICE TO THE ORGANIZATION THAT SUPPLIED IT, OR
*THE DESTRUCTION OF A MEDICAL DEVICE
NOTE: ISSUE OF AN ADVISORY NOTICE MIGHT BE REQUIRED TO COMPLY WITH NATIONAL OR REGIONAL REGULUATIONS.
AUDIT
ANY STEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR OBTAINING AUDIT EVIDENCE AND EVALUATING IT OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AGREED CRITERIA ARE FULFILLED
AUDITEE/CLIENT
ORGANIZATION BEING AUDITED
AUDITOR
PERSON WITH THE COMPETENCE TO CONDUCT AN AUDIT
AUDIT CLIENT
ORGANIZATION OR PERSON REQUESTING AUDIT
AUDIT CONCLUSION
OUTCOME OF AN AUDIT PROVIDED BY THE AUDIT TEAM AFTER CONSIDERATION OF THE AUDIT OBJECTIVES; ALL AUDIT FINDINGS
AUDIT EVIDENCE
RECORDS, STATEMENT OF FACT OR OTHER INFORMATION WHICH ARE RELEVANT TO THE AUDIT CRITERIA AND VERIFIABLE
AUDIT FINDINGS
RESULTS OF THE EVALUATION OF THE COLLECTED AUDIT EVIDENCE AGAINST AUDIT CRITERIA
AUDIT PROGRAM
SET OF ONE OR MORE AUDITS PLANNED FOR SPECIFIC TIME FRAME AND DIRECTED TOWARDS A SPECIFIC PURPOSE
AUDITOR QUALIFICATIONS
COMBINATION OF INTERACTING PERSONAL ATTRIBUTES, EDUCATION/TRAINING, WORK AND AUDIT EXPERIENCE, AND AREAS OF COMPETENCE THAT ENABLE A PERSON TO BE APPOINTED AS AN AUDITOR.
AUDIT SCOPE
EXTENT AND BOUNDARIES OF AUDIT
AUDIT TEAM
ONE OR MORE AUDITORS CONDUCTION AN AUDIT
AUTHORIZED REPRESENTATIVE
NATURAL OR LEGAL PERSON ESTABLISHED WITHIN A COUNTRY OR JURISDICTION WHO HAS RECIEVED A WRITTEN MANDATE FROM THE MANUFACTURER TO ACT ON HIS BEHALF FOR SPECIFIED TASKS WITH REGARD TO THE LATTER’S OBLIGATIONS UNDER THAT COUNTRY OR JURISDICTION’S LEGISLATION
CAPABILITY
ABILITY OF AN ORGANIZATION, SYSTEM, OR PROCESS TO REALIZE A PRODUCT THAT WILL FULFILL THE REQUIREMENTS FOR THAT PRODUCT
CHARACTERISTIC
DISTINGUISHING FEATURE
CLINICAL EVALUATION
ASSESSMENT AND ANALYSIS OF CLINICAL DATA PERTAINING TO A MEDICAL DEVICE TO VERIFY THE CLINICAL SAFETY AND PERFORMANCE OF THE DEVICE WHEN USED AS INTENDED BY THE MANUFACTURER
COMPLAINT
WRITTEN, ELECTRONIC OR ORAL COMMUNICATION THAT ALLEGES DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, USABILITY, SAFETY OR PERFORMANCE OF A MEDICAL DEVICE THAT HAS BEEN RELEASED FROM THE ORGANIZATION’S CONTROL OR RELATED TO A SERVICE THAT AFFECTS THE PERFORMANCE OF SUCH MEDICAL DEVICES
CONFORMITY
THE FULFILMENT OF A REQUIREMENT
CONCESSION
PERMISSION TO USE OR RELEASE A PRODUCT THAT DOES NOT CONFORM TO SPECIFIED REQUIREMENTS
CONTINUAL IMPROVEMENT
RECURRING ACTIVITY DESIGNED TO INCREASE THE ABILITY OF THE ORGANIZATION TO FULFILL REQUIREMENTS
CORRECTION
ACTION TAKEN TO ELIMINATE THE CAUSE OF A DETECTED NONCONFORMITY OR OTHER UNDESIRABLE SITUATION
CRITERIA
SET OF POLICIES, PROCEDURES, OR REQUIREMENTS USED AS A REFERENCE
CUSTOMER
ORGANIZATION OR PERSON THAT RECEIVES A PRODUCT
CUSTOMER SATISFACTION
CUSTOMER’S PERFECPTION OF THE DEGREE TO WHICH ITS REQUIREMENTS HAVE BEEN FULFILLED
DELIVERY
THE ACT OR PROCESS OF DELIVERING PRODUCTS TO ANOTHER PARTY
DEPENDABILITY
COLLECTIVE TERM USED TO DESCRIBE THE AVAILABILITY PERFORMANCE AND ITS INFLUENCING FACTORS: RELIABILITY PERFORMANCE, MAINTAINABILITY PERFORMANCE, AND MAINTENANCE SUPPORT PERFORMANCE
DESIGN AND DEVELOPMENT
SET OF PROCESSES THAT TRANSFORMS REQUIREMENTS INTO SPECIFIED CHARACTERISTICS OR INTO THE SPECIFICATION OF A PRODUCT, PROCESS, OR SYSTEM
DISTRIBUTOR
NATURAL OR LEGAL PERSON IN THE SUPPLY CHAIN WHO, ON HIS OWN BEHALF, FUTHERS THE AVAILABILITY OF A MEDICAL DEVICE TO THE END USER
NOTE 1: MORE THAN ONE DISTRIBUTOR MAY BE INVOLVED IN THE SUPPLY CHAIN
NOTE 2:PERSONS IN THE SUPPLY CHAIN INVOLVED IN ACTIVITITIES SUCH AS STORAGE AND TRANSPORT ON BEHALF OF THE MANUFACTURER, IMPORTER OR DISTRIBUTOR, ARE NOT DISTRIBUTORS UNDER THIS DEFINITION
DOCUMENT
INFORMATION AND ITS SUPPORTING MEDIUM
EFFECTIVENESS
EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND PLANNED RESULTS ACHIEVED
EVIDENCE
QUALITATIVE OR QUANTITATIVE INFORMATION, RECORDS, OR STATEMENT OF FACT (RE: A PRODUCT, PROCESS, OR SERVICE) PERTAINING TO THE EXISTENCE AND IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM REQUIREMENT, WHICH IS BASED ON OBSERVATION, MEASUREMENT, OR TEST AND CAN BE VERIFIED
GRADE
CATEGORY OR RANK GIVEN TO THE DIFFERENT QUALITY REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING THE SAME FUNCTIONAL USE
GLP
GOOD LABORATORY PRACTICE
IMPLANTABLE MEDICAL DEVICE
MEDICAL DEVICE WHICH CAN ONLY BE REMOVED BY MEDICAL OR SURIGCAL INTERVENTION AND WHICH IS INTENDED TO:
- BE TOTALLY OR PARTIALLY INTRODUCED INTO THE HUMAN BODY OR A NATURAL ORIFICE, OR
- REPLACE AN EPITHELIAL SURFACE OR THE SURFACE OF THE EYE, AND
- REMAIN AFTER THE PROCEDURE FOR AT LEAST 30 DAYS
INDEPENDENCE
NOT UNDER THE DIRECT CONTROL OR AUTHORITY OF ANOTHER PERSON, OR GROUP. THE ABILITY TO ACT (DO WHAT IS REQUIRED, NECESSARY, OR RIGHT) WITHOUT INTERFERENCE OF PREJUDICE.
IMPORTER
NATURAL OR LEGAL PERSON IN THE SUPPLY CHAIN WHO IS THE FIRST IN A SUPPLY CHAIN TO MAKE A MEDICAL DEVICE, MANUFACTURED IN ANOTHER COUNTRY OR JURISDICTION WHERE IT IS TO BE MARKETED
INFRASTRUCTURE
(ORGANIZATION) SYSTEM OF FACILITIES, EQUIPMENT, AND SERVICES NEEDED FOR THE OPERATION OF AN ORGANIZATION
INFORMATION
MEANINGFUL DATA
INSPECTION
CONFORMITY EVALUATION BY OVSERVATION AND JUDGEMENT ACCOMPANIED AS APPROPRIATE BY MEASUREMENT, TESTING OR GAUGING
INTERESTED PARTY
PERSON OR GROUP HAVING AN INTEREST IN THE PERFORMANCE OR SUCCESS OF AN ORGANIZATION
INTERNAL AUDIT
A SYSTEMATIC AND INDEPENDANT EXAMINATION TO DETERMINE WHETHER ACTIVITIES AND RELATED RESULTS COMPLY WITH PLANNED ARRANGEMENTS AND WHETHER THESE ARRANGEMENTS ARE IMPLEMENTED EFFECTIVELY AND ARE SUITABLE TO ACHIEVE OBJECTIVES
IRCA
INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS, AN ORGANIZATIONLLY INDEPENDENT DIVISION OF THE INSTITUTE OF QUALITY ASSURANCE, UK. IRCA ADMINISTERS AND MANAGES AUDITOR REGISTRATION, INCLUDING TRAINING ORGANIZATIONS THAT PROVIDE AUDITOR TRAINING
1SO:9000:2005
QUALITY MANAGEMENT SYSTEMS-FUNDAMENTALS AND VOCABULARY
ISO:9004: 2009
MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION0 A QUALITY MANAGEMENT APPROACH
LABELING
LABEL, INSTRUCTIONS FOR USE, AND ANY OTHER INFORMATION THAT IS RELATED TO INDENTIFICATION, TECHNICAL DESCRIPTION, INTENDED PURPOSE AND PROPER USE OF THE MEDICAL DEVICE, BUT EXCLUDING SHIPPING DOCUMENTS
LIFE-CYCLE
ALL PHASES IN THE LIFE OF A MEDICAL DEVICE, FROM THE INITIAL CONCEPTION TO FINAL DECOMMISSIONING AND DISPOSAL
MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION
MANAGEMENT SYSTEM
SYSTEM TO ESTABLISH POLICY AND OBJECTIVES AND TO ACHIEVE THOSE OBJECTIVES
MANUFACTURER
NATURAL OR LEGAL PERSON WITH RESPONSIBILITY FOR DESIGN AND/OR MANUFACTURER OF A MEDICAL DEVICE WITH THE INTENTION OF MAKING THE MEDICAL DEVICE AVAILABLE FOR USE, UNDER HIS NAME:WHETHER OR NOT SUCH A MEDICAL DEVICE IS DESIGNED AND/OR MANUFACTURERS BY THAT PERSON HIMSELF OR ON HIS BEHALF BY ANOTHER PERSON(S).
MEDICAL DEVICE
INSTRUMENT, APPARATUS, IMPLEMENT, MACHINE, APPLIANCE, IMPLANT, REAGENT FOR IN VITRO USE, SOFTWARE, MATERIAL OR OTHER SIMILAR OR RELATED ARTICLE, INTENDED BY THE MFG TO BE USED, ALONE OR IN COMBINATION, FOR HUMAN BEINGS, FOR ONE OF MORE SPECIFIC MEDICAL PURPOSES OF:
- DIAGNOSIS, PREVENTION, MONITORING, TREATMENT OR ALLEVIATION OF DISEASE
- DIAGNOSIS, MONITORING, TREATMENT, ALLEVIATION OF OR COMPENSATION FOR AN INJURY
- INVESTIGATION, REPLACEMENT, MODIFICATION, OR SUPORT OF THE ANATOMY OR OF A PHYSIOLOGICAL PROCESS
- SUPPORTING OR SUSTAINING LIFE
- CONTROL OR SUSTAINING LIFE
- DISINFECTION OF MEDICAL DEVICES
- PROVIDING INFORMATION BY MEANS OF IN VITRO EXAMINATION OF SPECIMENS DERIVED FROM THE HUMAN BODY
MEDICAL DEVICE FAMILY
GROUP OF MEDICAL DEVICES MANUFACTURED BY OR FOR THE SAME ORGANIZATION AND HAVING THE SAME BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO SAFETY, INTENDED USE AND FUNCTION
NON-CONFORMITY
THE NON-FULFILMENT OF A REQUIREMENT
NON-COMPLIANCE
THE LACK OF ADHERENCE TO A QUALITY MANAGEMENT SYSTEM PROCESS OR PROCEDURE
OBJECTIVE EVIDENCE
DATA SUPPORTING THE EXISTENCE OR VERITY (TRUTH) OF SOMETHING
ORGANIZATION
GROUP OF PEOLE AND FACILITIES WITH AN ARRANGEMENT OF RESPONSIBILITIES, AUTHORITIES, AND RELATIONSHIPS
ORGANIZATIONAL STRUCTURE
ARRANGEMENT OF RESPONSIBILITIES, AUTHORITIES AND RELATIONSHIPS BETWEEN PEOPLE
PERFORMANCE EVALUATION
ASSESSMENT AND ANALYSIS OF DATA TO ESTABLISH OR VERIFY THE ABILITY OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE TO ACHIEVE ITS INTENDED USE
POST-MARKET SURVEILLANCE
SYSTEMATIC PROCESS TO COLLECT AND ANALYZE EXPERIENCE GAINED FROM MEDICAL DEVICES THAT HAVE BEEN PLACED ON THE MARKET
PREVENTIVE ACTION
ACTOIN TO ELIMINATE THE CAUSE OF A POTENTIAL NON-CONFORMITY OR OTHER UNDESIRABLE POTENTIAL SITUATION
PROCEDURE
SPECIFIED WAY TO CARRY OUT AN ACTIVITY OR PROCESS
PROCESS
SET OF INTERRELATED OR INTERACTIVE ACTIVITIES, WHICH TRANSFOR INPUTS INTO OUTPUTS
PRODUCT
RESULT OF A PROCESS NOTE: THERE ARE FOUR GENERIC PRODUCT CATEGORIES, AS FOLLOWS: 1-SERVICES (TRANSPORT) 2-SOFTWARE (COMPUTER PROGRAM) 3-HARDWARE (MECHANICAL PART) 4-PROCESSED MATERIAL (LUBRICANT)
PROCESS CAPABILITY
THE LIMITS OF INHERENT VARIABILITY WITHIN WHICH A PROCESS OPERATES AS GOVERNED BY PREVAILING CIRCUMSTANCES
PROJECT
UNIQUE PROCESS CONSISTING OF A SET OF COORDINATED AND CONTROLLED ACTIVITIES WITH START AND FINISH DATES, UNDERTAKEN TO ACHIEVE AN OBJECTIVE CONFORMING TO SPECIFIC REQUIREMENTS, INCLUDING THE CONSTRAINTS OF TIME, COST AND RESOURCES.
PURCHASED PRODUCT
PRODUCT PROVIDED BY A PARTY OUTSIDE THE ORGANIZATION’S QUALITY MANAGEMENT SYSTEM
QUALITY
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS
QUALIFIED AUDITOR
PERSON WHO HAS SUCCESSFULLY PASSED AN AUDITOR QUALIFICATION PROCESS
QUALITY ASSURANCE
PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING CONFIDENCE THAT THE QUALITY REQUIREMENTS WILL BE FULFILLED
QUALITY CHARACTERISTIC
INHERENT CHARACTERISTIC OF A PRODUCT, PROCESS OR SYSTEM RELATED TO A REQUIREMENT
QUALITY CONTROL
PART OF QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS
QUALITY IMPROVEMENT
PART OF QUALITY MANAGEMENT FOCUSED ON INCREASING THE ABILITY TO FULFILL QUALITY REQUIREMENTS
QUALITY MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY
QUALITY MANUAL
A DOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN ORGANIZATION
QUALITY OBJECTIVE
SOMETHING SOUGHT OR AIMED FOR, WITH RESPECT TO QUALITY
QUALITY PLAN
DOCUMENT SPECIFYING WHICH PROCEDURES AND ASSOCIATED RESOURCES SHALL BE APPLIED BY WHOME AND WHEN TO A SPECIFIED PROJECT, PRODUCT, PROCESS, OR CONTRACT
QUALITY PLANNING
PART OF THE QUALITY MANAGEMENT FOCUSED ON SETTING QUALITY OBJECTIVES AND SPECIFYING NECESSARY OPERATIONAL PROCESSES AND RELATED RESOURCES TO FULFILL THE QUALITY OBJECTIVES
QUALITY POLICY
OVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION RELATED TO QUALITY AS FORMALLY EXPRESSED BY TOP MANAGEMENT
QUALITY MANAGEMENT SYSTEM REVIEW
A FORMAL EVALUATION BY SENIOR MANAGEMENT OF THE STATUS AND ADEQUACY OF THE QUALITY MANAGEMENT SYSTEM IN RELATION TO QUALITY POLICY AND CURRENT BUSINESS OBJECTIVES AND GOALS RESULTING FROM CHANGING BUSINESS CIRCUMSTANCES
RECORD
DOCUMENT STATING RESULTS ACHIEVED OR PROVIDED EVIDENCE OF ACTIVITIES PERFORMED
RELIABILITY
THE ABILITY OF AN ITEM TO PERFORM A REQUIRED FUNCTION UNDER STATED CONDITIONS FOR A STATED PERIOD OF TIME
REQUIREMENT
NEED OR EXPECTION THAT IS STATED, GENERALLY IMPLIED OR OBLIGATORY
REGISTRATION BODY
AN IMPARTIAL BODY PROCESSING THE NECESSARY COMPETENCE TO OPERATE OA CERTIFICATION SYSTEM
REVIEW
ACTIVITY UNDERTAKEN TO DETERMINE THE SUITABILITY, ADEQUACY AND EFFECTIVENESS OF THE SUBJECT MATTER TO ACHIEVE ESTABLISHED OBJECTIVES
RISK
COMBINATION OF PROBABILITY OF OCCURRENCE OF HARM AND THE SEVERITY OF THAT HARM
RISK MANAGEMENT
SYSTEMATIC APPLICATION OF MANAGEMENT POLICIES, PROCEDURES AND PRACTICES TO THE TASKS OF ANALYSING, EVALUATING, CONTROLLING AND MONITORING RISK
STERIL BARRIER SYSTEM
MINIMUM PACKAGE THAT PREVENTS INGRESS OF MICROORGANISMZ AND ALLOWS ASEPTIC PRESENTATION OF THE PRODUCT AT THE POINT OF USE
STERILE MEDICAL DEVICE
MEDICAL DEVICE INTENDED TO MEET THE REQUIREMENTS OF STERILITY
SUBCONTRACTOR
AN INDIVIDUAL OR ORGANIZATION GIVEN WORK THAT FORMS PART OF THE SUPPLIES CONTRACT WITH THE PURCHASER
SPECIFICATION
DOCUMENT STATING REQUIREMENTS
SUPPLIER
ORGANIZATION OR PERSON THAT PROVIDED A PRODUCT TO ANOTHER
SUPPLIER EVALUATION
AUDIT OR MEASUREMENT OF A SUPPLIER’S PERFORMANCE, CARRIED OUT AFTER ORDERS HAVE BEEN PLACED.
SYSTEM
SET OF INTERRELATED OR INTERACTING ELEMENTS
TEST
DETERMINATION OF ONE OR MORE CHARACTERISTICS ACCORDING TO A PROCEDURE
TOP MANAGEMENT
PERSON OR GROUP OF PEOPLE WHO DIRECT AND CONTROL AN ORGANIZATION
TOTAL QUALITY CONTROL
TOTAL QUALITY CONTROL IS AN INTEGRATED APPROACH TO PROMOTING CONTINUOUS IMPROVEMENT THROUGH THE APPLICATION OF MODERN TOOLS AND TECHNIQUES
TOTAL QUALITY MANAGEMENT
TOTAL QUALITY MANAGEMENT IS AN ORGANIZATON-WIDE APPROACH TO CHANGING ATTITUDE AND BEHAVIOUR, WHICH CONTINUOUSLY IMPROVES THE HEALTH OF A BUSINESS ENTITY
TRACEABILITY
ABILITY TO TRACE THE HISTORY, APPLICATION, OR LOCATION OF THAT WHICH IS UNDER CONSIDERATION
VALIDATION
CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE, THAT THE REQUIREMENTS FOR A SPECIFIC INTENDED USE OR APPLICATION HAVE BEEN FULFILLED
VERIFICATION
CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE, THAT THE REQUIREMENTS HAVE BEEN FULFILLED
WORK ENVIRONMENT
SET OF CONDITIONS UNDER WHICH WORK IS PERFORMED
WORK INSTRUCTIONS
STEPS FOR PRODUCING THE PRODUCT OR DELIVERING THE SERVICE, EXAMPLES INCLUDE TEMPLATES, PHOTOGRAPHS, AND WRITTEN INSTRUCTIONS.
ISO 9000 SERIES STANDARDS
A set of international standards on quality management and quality assurance developed to help organizations effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific to any particular industry, product or service. The standards were developed by the International Organization for Standardization (ISO) (see listing). The standards underwent major revision in 2000 and now include ISO 9000:2005 (definitions), ISO 9001:2008 (requirements), ISO 9004:2009 (continuous improvement) and ISO 9001: 2015 (risk management).
ISO 9001
ISO 9001:A voluntary quality management system standard developed by the International Organization for Standardization (ISO). First released in 1987 and one of several documents in the ISO 9000 family.
ISO 26000:
ISO 26000:An international standard developed by the International Organization for Standardization (ISO) to help organizations effectively assess and address those social responsibilities that are relevant and significant to their mission and vision; operations and processes; customers, employees, communities and other stakeholders; and environmental impact.
