5.2 Personnel Use competent staff Use competent staff Supervise as necessary Supervise as necessary Document qualifications and training Document qualifications and training Maintain documented training program Maintain documented training program Define responsibilities and authorities Define responsibilities and authorities Applies also to contracted workers Applies also to contracted workers
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5.2 Personnel l Use competent staff l Supervise as necessary l Document qualifications and training l Maintain documented training program l Define responsibilities.
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5.2 Personnel5.2 Personnel
Use competent staffUse competent staff
Supervise as necessarySupervise as necessary
Document qualifications and trainingDocument qualifications and training
Maintain documented training programMaintain documented training program
Define responsibilities and authoritiesDefine responsibilities and authorities
Applies also to contracted workersApplies also to contracted workers
Use competent staffUse competent staff
Supervise as necessarySupervise as necessary
Document qualifications and trainingDocument qualifications and training
Maintain documented training programMaintain documented training program
Define responsibilities and authoritiesDefine responsibilities and authorities
Applies also to contracted workersApplies also to contracted workers
Quality Manager (title irrelevantQuality Manager (title irrelevant))may have other dutiesmay have other dutiesdirect access to top managementdirect access to top management
““defined responsibility and authority for defined responsibility and authority for ensuring that the quality system is ensuring that the quality system is
implemented and followed at all times”implemented and followed at all times”
Quality Manager (title irrelevantQuality Manager (title irrelevant))may have other dutiesmay have other dutiesdirect access to top managementdirect access to top management
““defined responsibility and authority for defined responsibility and authority for ensuring that the quality system is ensuring that the quality system is
implemented and followed at all times”implemented and followed at all times”
4.4 Contract Review4.4 Contract Review
Requirements for any testingRequirements for any testing documenteddocumentedunderstoodunderstood
and and resourcesresources for implementing quality for implementing quality
management”management”
Why Document the System?Why Document the System?
For system to functionFor system to function
Define responsibilities and authoritiesDefine responsibilities and authoritieswho does whatwho does what
Ensure compliance with standard(s)Ensure compliance with standard(s)
For system to functionFor system to function
Define responsibilities and authoritiesDefine responsibilities and authoritieswho does whatwho does what
Ensure compliance with standard(s)Ensure compliance with standard(s)
What is Required?What is Required?
CommunicatedCommunicated
AvailableAvailable
UnderstoodUnderstood
ImplementedImplemented
Easily updatedEasily updated
CommunicatedCommunicated
AvailableAvailable
UnderstoodUnderstood
ImplementedImplemented
Easily updatedEasily updated
Verbal InstructionsVerbal Instructions
Often:Often:Not heardNot heard
MisunderstoodMisunderstood
Quickly forgottenQuickly forgotten
IgnoredIgnored
Often:Often:Not heardNot heard
MisunderstoodMisunderstood
Quickly forgottenQuickly forgotten
IgnoredIgnored
What is Required?What is Required?
A quality manualA quality manual
A quality policyA quality policy
Document key areas of activityDocument key areas of activity
A quality manualA quality manual
A quality policyA quality policy
Document key areas of activityDocument key areas of activity
A Typical Documentation Structure
A Typical Documentation Structure
Quality ManualQuality Manual
ProceduresProcedures
Work InstructionsWork Instructions
FormsForms
RecordsRecords
Quality ManualQuality Manual
ProceduresProcedures
Work InstructionsWork Instructions
FormsForms
RecordsRecords
Document DesignDocument Design
Work Work InstructionsInstructions
ProcedureProcedure Manual(s) Manual(s)
QualityQualityManualManual
IncreasingIncreasingIncreasingIncreasing
DetailDetailDetailDetail
Definition of SystemDefinition of System
(Company Policy &(Company Policy &
System Outline)System Outline)
Description of the ProcessesDescription of the Processes
(Defines how the Policy is carried(Defines how the Policy is carried
out in individual work Processes)out in individual work Processes)
Instructions for Individual Instructions for Individual Job FunctionsJob Functions(Defines how specific tasks that are referenced in that are referenced in
procedures are carried out)procedures are carried out)
Work FunctionsWork FunctionsWork FunctionsWork Functions
What is a Quality Manual?What is a Quality Manual?
ISO/IEC Guide 25ISO/IEC Guide 25
““A document stating the quality policy, A document stating the quality policy,
quality system and quality practices of an quality system and quality practices of an
organisation”organisation”
ISO/IEC Guide 25ISO/IEC Guide 25
““A document stating the quality policy, A document stating the quality policy,
quality system and quality practices of an quality system and quality practices of an
organisation”organisation”
Required in Quality ManualRequired in Quality Manual
Quality policyQuality policy Structure of documentationStructure of documentation Cross reference supporting documentsCross reference supporting documents Include or refer to:Include or refer to:
systems, instructionssystems, instructionsresponsibilities and authoritiesresponsibilities and authorities
Quality policyQuality policy Structure of documentationStructure of documentation Cross reference supporting documentsCross reference supporting documents Include or refer to:Include or refer to:
systems, instructionssystems, instructionsresponsibilities and authoritiesresponsibilities and authorities
Quality PolicyQuality Policy
ConciseConcise
Overall objectivesOverall objectives
Authorised by chief executiveAuthorised by chief executive
Commitment to good practiceCommitment to good practice
Commitment to Standard(s)Commitment to Standard(s)
Staff must familiarise and useStaff must familiarise and use
ConciseConcise
Overall objectivesOverall objectives
Authorised by chief executiveAuthorised by chief executive
Commitment to good practiceCommitment to good practice
Commitment to Standard(s)Commitment to Standard(s)
Staff must familiarise and useStaff must familiarise and use
Must Document:Must Document:
Scope of activitiesScope of activities
Document control and reviewDocument control and review
Creates documentation structureCreates documentation structure Creates numbering systemCreates numbering system Decides formats and stylesDecides formats and styles Writes Quality ManualWrites Quality Manual Writes some other documentsWrites some other documents
e.g. document controle.g. document controlhow to write a documenthow to write a document
Creates documentation structureCreates documentation structure Creates numbering systemCreates numbering system Decides formats and stylesDecides formats and styles Writes Quality ManualWrites Quality Manual Writes some other documentsWrites some other documents
e.g. document controle.g. document controlhow to write a documenthow to write a document
Quality ManagerQuality Manager
Keeps overview of documentationKeeps overview of documentation
Makes system workMakes system workdocumentationdocumentation
document reviewdocument review
document controldocument control
Keeps overview of documentationKeeps overview of documentation
Makes system workMakes system workdocumentationdocumentation