API Q1:10th edn Cl Applicability
Slide no.1
Q1:9th Q1:10
th Cl#
Cl#
9001Cl#
4.1.1
4.1.1
4.1
General QMS
MR
All HOD
4.1.2
4.1.2
5.2
Quality Policy
Top Mgt.
All Employee
4.1.3
4.1.3
6.2
Quality Objectives
Top Mgt
All HOD
4.1.4
4.1.4
4.3;4.4
QMS Planning
MR
All HOD
4.1.5
4.1.5
4.3;4.4
Communication –Internal/External
MR,HR, Sales
All HOD
4.2.1
4.2.1
5.1.1
General Management Responsibility
Top Mgt, MR
HR/ Production
4.2.2
4.2.2
5.3
Responsibility and Authority
HR
All HOD
4.2.3
4.2.3
5.3
Management Representative
Top Mgt, MR,HR
All HOD
4.3.1
4.3.1
7.1.1
Resources and Knowledge
HR
QC/Production
4.3.2
4.3.2
7.1.2
Human Resources
HR
QC/Production
4.3.3
4.3.3
7.1.3;7.1.
4
Work Environment
Production
Production,
Stores
QC Process
4.4.1
4.4.1
4.3;5.2;4.
4
General Documentation Requirements
MR
All QMS Doc User
4.4.2
4.4.2
Procedures
MR
All QMS Doc User
4.4.3
4.4.3
Control Of Internal Documents
MR
All QMS Doc User
7.5
Requirement
Prime auditee
Supporting
Auditee
API Q1:9th edn Cl Applicability
Slide no.2
Q1:9th Q1:10
th Cl#
Cl#
9001Cl#
4.4.4
4.4.4
7.5.3
Control and Use of External Documents
QC ,Engineering Head
External Doc
users
4.5
4.5
7.5.3
Control Of Records
MR
All QMS record
generator
5.1
5.1
8.2
Contract Review
Contract Review
QC/HR/Logistic
5.2
5.2
6.0
Planning
PPC, QC, Engineering
Production
5.3
5.3
4.1;6.1
Risk Management
MR
ALL HOD
5.4
5.4
8.3
Design
Design
QC/Prod
5.6.1
5.5.1
8.4
Purchasing Control
Purchase Head
Purchase Team
5.6.2
5.5.2
8.4.3
Purchasing Information
Purchase Head
Purchase Team
5.6.3
5.5.3
8.6
Verification of Purchased Product, Component or
Activities
QC
Purchase
5.7.1
5.6.1
8.5.1
General Product Realization
Production Head
Shop floor team
5.7.2
5.6.2
8.5.1
Quality Plan
Contract Review, QC
Head
Inspection Team
5.7.1.3
5.6.3
8.5.1
Process Control Documents
Production, QC
5.7.1.5
5.6.4
8.5.1
Validation Of Processes
Production, QC
5.7.3
5.6.5
8.5.2
Identification and Traceability
Production, QC
Requirement
Prime auditee
Supporting
Auditee
Stores/Logistic
API Q1:10th edn Cl Applicability
Slide no.3
Q1:9th
Cl#
Q1:10th
Cl#
5.7.5
5.6.7
8.5.4
Externally Owned Property
QC Head, Contract
Review
Stores
5.7.6
5.6.8
8.5.4
Preservation Of Product
Stores/Logistic
Production / QC
5.7.7
5.6.9
8.6
Inspection, Testing And Verification
QC Head
Inspection Team
5.7.8
5.6.10
7.1.3
Preventive Maintenance
Maintenance
Production,QC
5.9
5.7
8.6
Product Release
QC
Final QC/Product Release
Person
5.8
5.8
7.1.5
Testing, Measuring, Monitoring and Detection
Equipment
QC
Calibration Team
5.10
5.9
8.7;10.2
Control of Nonconforming Product
QC
Stores, Purchase,
Prod,Contract Review
5.11
5.10
6.3;8.5.6
Management of Change (MOC)
MR, HR, Purchase
All HOD
6.1
6.1
10.1;9.1.1
QMS Monitoring, Measurement, Analysis and
Improvement
MR
ALL HOD
6.2.1
6.2.1
9.1.2
Customer Satisfaction
Contract Review ,
QC
Who deal with Customer
6.2.2
6.2.2
9.2
Internal Audit
MR, Internal
Auditor
All HOD
6.3
6.3
9.1.3
Analysis Of Data
MR, HOD
Any Process Owner / HOD
6.4
6.4
10.0
Improvement
Top Mgt, MR
Any Process Owner/ HOD
6.4.2
6.4.2
10.2
Corrective Action
MR, QC, Contract
Review
Any Process Owner / HOD
9001Cl#
Prime
auditee
Requirement
Supporting
Auditee