Words Matter – ISO 9000:2015 QMS Vocabulary

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.

ISO 9000:2015 has replaced the 2000 version of the standard. This update coincided with and supported ISO 9001:2015.

For us medical device folks, it is also helpful since it supports (EN) ISO 13485:2006 published in March 2016. 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 know 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