Words Matter - ISO 9000:2015 Quality Management System Vocabulary
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sam@lazzara.net
sam@lazzara.net
ISO 9000:2015 has replaced the 2000 version of the standard. This update has been timed to coincide with and support the ISO 9001:2015 published in September 2015. For us medical device folks, it is also helpful since it supports (EN) ISO 13485:2006 published in March 2016.
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the "small words" mean. ISO's small word glossary is here.
For example, did you know that "COMPLY" means a person or organization meet specified standards, whereas "CONFORM" means an ITEM meet specified requirements? And according to ISO 9000:2015, an ITEM is an OBJECT, and an OBJECT is anything perceivable or conceivable (also known as an ENTITY). And examples of ITEMs are product, service, process, person, organization, system, and resource.
To understand the difference between COMPLY and CONFORM you need to learn the difference between "standards" and "requirements".
ISO's home page says:
A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. We published over 19000 International Standards that can be purchased from the ISO store or from our members.
Ok, so there's really no difference between COMPLY and CONFORM, according to ISO.
Hats off to the 162 national members of ISO for driving us insane!
Here is a quick comparison between the ISO 9000 old and new version:
ISO 9000:2005 Term
|
EN ISO 9000:2015 Term
|
Remarks
|
ACTIVITY
|
New term
|
|
ASSOCIATION
|
New term
|
|
AUDIT CLIENT
|
AUDIT CLIENT
|
No change
|
AUDIT CONCLUSION
|
AUDIT CONCLUSION
|
Removed mention of audit team
|
AUDIT CRITERIA
|
AUDIT CRITERIA
|
Expanded/clarified
|
AUDIT EVIDENCE
|
AUDIT EVIDENCE
|
No change
|
AUDIT FINDINGS
|
AUDIT FINDINGS
|
No change
|
AUDIT GUIDE
|
New term
|
|
AUDIT OBSERVER
|
New term
|
|
AUDIT PLAN
|
AUDIT PLAN
|
No change
|
AUDIT PROGRAMME
|
AUDIT PROGRAMME
|
No change
|
AUDIT SCOPE
|
AUDIT SCOPE
|
No change
|
AUDIT TEAM
|
AUDIT TEAM
|
No change
|
AUDIT TECHNICAL EXPERT
|
New term
|
|
AUDIT
|
AUDIT
|
Changed “audit evidence” to “objective evidence
|
AUDITEE
|
AUDITEE
|
No change
|
AUDITOR
|
AUDITOR
|
Removed mention of personal attributes and competence
|
CAPABILITY
|
CAPABILITY
|
Updated to apply new “object” term
|
CHANGE CONTROL
|
New term
|
|
CHARACTERISTIC
|
CHARACTERISTIC
|
No change
|
COMPETENCE ACQUISITION
|
New term
|
|
COMPETENCE
|
COMPETENCE
|
Expanded/clarified
|
COMPLAINT
|
New term
|
|
CONCESSION
|
CONCESSION
|
Changed “product” to “product or service”
|
CONFIGURATION AUTHORITY
|
New term
|
|
CONFIGURATION BASELINE
|
New term
|
|
CONFIGURATION CONTROL BOARD
|
New term
|
|
CONFIGURATION MANAGEMENT
|
New term
|
|
CONFIGURATION OBJECT
|
New term
|
|
CONFIGURATION STATUS ACCOUNTING
|
New term
|
|
CONFIGURATION
|
New term
|
|
CONFORMITY
|
CONFORMITY
|
No change
|
CONTEXT OF THE ORGANIZATION
|
New term
|
|
CONTINUAL IMPROVEMENT
|
CONTINUAL IMPROVEMENT
|
Changed “increase the ability to fulfill
requirements” to “enhance performance” (applies new “performance” term)
|
CONTRACT
|
CONTRACT
|
No change
|
CORRECTION
|
CORRECTION
|
No change
|
CORRECTIVE ACTION
|
CORRECTIVE ACTION
|
Narrowed to only apply to nonconformities
Expanded to add “prevent recurrence”
|
CUSTOMER SATISFACTION CODE OF CONDUCT
|
New term
|
|
CUSTOMER SATISFACTION
|
CUSTOMER SATISFACTION
|
No change
|
CUSTOMER SERVICE
|
New term
|
|
CUSTOMER
|
CUSTOMER
|
Expanded/clarified
Changed “product” to “product or service”
|
DATA
|
New term
|
|
DEFECT
|
DEFECT
|
Changed “Non-fufilment of a requirement” to
“Nonconformity”
|
DEPENDABILITY
|
DEPENDABILITY
|
Updated to apply new “performance” term
|
DESIGN AND DEVELOPMENT
|
DESIGN AND DEVELOPMENT
|
Updated to apply new “object” term
|
DETERMINATION
|
New term
|
|
DEVIATION PERMIT
|
DEVIATION PERMIT
|
Changed “product” to “product or service”
|
DISPOSITIONING AUTHORITY
|
New term
|
|
DISPUTE RESOLUTION PROCESS
|
New term
|
|
DISPUTE RESOLVER
|
New term
|
|
DISPUTE
|
New term
|
|
DISUPUTE RESOLUTION PROCESS (DRP) PROVIDER
|
New term
|
|
DOCUMENT
|
DOCUMENT
|
Clarified
|
DOCUMENTED INFORMATION
|
New term
|
|
EFFECTIVENESS
|
EFFECTIVENESS
|
No change
|
EFFICIENCY
|
EFFICIENCY
|
No change
|
ENGAGEMENT
|
New term
|
|
ENTITY: See OBJECT.
|
New term
|
|
EXTERNAL PROVIDER
|
New term
|
|
FEEDBACK
|
New term
|
|
GRADE
|
GRADE
|
Updated to apply new “object” term
|
HUMAN FACTOR
|
New term
|
|
IMPROVEMENT
|
New term
|
|
INFORMATION SYSTEM
|
New term
|
|
INFORMATION
|
INFORMATION
|
No change
|
INFRASTRUCTURE
|
INFRASTRUCTURE
|
No change
|
INNOVATION
|
New term
|
|
INSPECTION
|
INSPECTION
|
Clarified
|
INTERESTED PARTY
|
INTERESTED PARTY
|
Expanded/clarified
|
INVOLVEMENT
|
New term
|
|
ITEM: See OBJECT.
|
New term
|
|
MANAGEMENT SYSTEM
|
MANAGEMENT SYSTEM
|
Expanded/clarified
|
MANAGEMENT
|
MANAGEMENT
|
No change
|
MEASUREMENT MANAGEMENT SYSTEM
|
MEASUREMENT MANAGEMENT SYSTEM
|
No change
|
MEASUREMENT PROCESS
|
MEASUREMENT PROCESS
|
No change
|
MEASUREMENT
|
New term
|
|
MEASURING EQUIPMENT
|
MEASURING EQUIPMENT
|
No change
|
METROLOGICAL CHARACTERISTIC
|
METROLOGICAL CHARACTERISTIC
|
Clarified
|
METROLOGICAL CONFIRMATION
|
METROLOGICAL CONFIRMATION
|
No change
|
METROLOGICAL FUNCTION
|
METROLOGICAL FUNCTION
|
Function changed to “Functional unit”
|
MISSION
|
New term
|
|
MONITORING
|
New term
|
|
NONCONFORMITY
|
NONCONFORMITY
|
No change
|
OBJECT
|
New term
|
|
OBJECTIVE EVIDENCE
|
OBJECTIVE EVIDENCE
|
No change
|
OBJECTIVE
|
New term
|
|
ORGANIZATION
|
ORGANIZATION
|
Expanded/clarified
Added purpose “to achieve objectives”
|
ORGANIZATIONAL STRUCTURE
|
Retired
|
|
OUTPUT
|
New term
|
|
OUTSOURCE
|
New term
|
|
PERFORMANCE
|
New term
|
|
POLICY
|
New term
|
|
PREVENTIVE ACTION
|
PREVENTIVE ACTION
|
No change
|
PROCEDURE
|
PROCEDURE
|
No change
|
PROCESS
|
PROCESS
|
Clarified
|
PRODUCT CONFIGURATION INFORMATION
|
New term
|
|
PRODUCT: Result of a process.
|
PRODUCT
|
Expanded/clarified
|
PROGRESS EVALUATION
|
New term
|
|
PROJECT MANAGEMENT PLAN
|
New term
|
|
PROJECT MANAGEMENT
|
New term
|
|
PROJECT
|
PROJECT
|
No change
|
PROVIDER
|
New term
|
|
QUALIFICATION PROCESS
|
Retired
|
|
QUALITY ASSURANCE
|
QUALITY ASSURANCE
|
No change
|
QUALITY CHARACTERISTIC
|
QUALITY CHARACTERISTIC
|
Updated to apply new “object” term
|
QUALITY CONTROL
|
QUALITY CONTROL
|
No change
|
QUALITY IMPROVEMENT
|
QUALITY IMPROVEMENT
|
No change
|
QUALITY MANAGEMENT SYSTEM CONSULTANT
|
New term
|
|
QUALITY MANAGEMENT SYSTEM REALIZATION
|
New term
|
|
QUALITY MANAGEMENT SYSTEM
|
QUALITY MANAGEMENT SYSTEM
|
Clarified
|
QUALITY MANAGEMENT
|
QUALITY MANAGEMENT
|
Simplified
|
QUALITY MANUAL
|
QUALITY MANUAL
|
Changed Document to Specification which means
“Document stating requirements”
|
QUALITY OBJECTIVE
|
QUALITY OBJECTIVE
|
Updated to refer to “Objective” term
|
QUALITY PLAN
|
QUALITY PLAN
|
Changed Document to Specification
Updated to apply new “object” term
|
QUALITY PLANNING
|
QUALITY PLANNING
|
Changed “fulfil” to “achieve”
|
QUALITY POLICY
|
QUALITY POLICY
|
Updated to apply new “Policy” term
|
QUALITY REQUIREMENT
|
New term
|
|
QUALITY
|
QUALITY
|
Updated to apply new “object” term
|
RECORD
|
RECORD
|
No change
|
REGRADE
|
REGRADE
|
Changed “product” to “product or service”
|
REGULATORY REQUIREMENT
|
New term
|
|
RELEASE
|
RELEASE
|
Clarification
|
REPAIR
|
REPAIR
|
Changed “product” to “product or service”
|
REQUIREMENT
|
REQUIREMENT
|
No change
|
REVIEW
|
REVIEW
|
Updated to apply new “object” term
|
REWORK
|
REWORK
|
Changed “product” to “product or service”
|
RISK
|
New term (differs from ISO 14971)
|
|
SCRAP
|
SCRAP
|
Changed “product” to “product or service”
|
SERVICE
|
New term
|
|
SPECIFICATION
|
SPECIFICATION
|
No change
|
STAKEHOLDER: See INTERESTED PARTY.
|
New term
|
|
STATUTORY REQUIREMENT
|
New term
|
|
STRATEGY
|
New term
|
|
SUCCESS
|
New term
|
|
SUPPLIER
|
SUPPLIER: See PROVIDER.
|
Changed “product” to “product or service”
|
SUSTAINED SUCCESS
|
New term
|
|
SYSTEM
|
SYSTEM
|
No change
|
TEST
|
TEST.
|
Expanded/clarified
|
TOP MANAGEMENT
|
TOP MANAGEMENT
|
No change
|
TRACEABILITY
|
TRACEABILITY
|
Updated to apply new “object” term
|
VALIDATION
|
VALIDATION
|
No change
|
VERIFICATION
|
VERIFICATION
|
No change
|
VISION
|
New term
|
|
WORK ENVIRONMENT
|
WORK ENVIRONMENT
|
No change
|
