QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 1

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Example of completed worksheet

This worksheet is used to identify the processes required for the Quality Management System. It is designed to ensure that all the requirements of
the ISO 9001:2015 standard are addressed and documented information available. In addition, the worksheet can be used as a training tool to help
interested parties, such as employees, customers, auditors, and registrar understand your QMS. .

PROCESS INPUTS – ISO 9001:2015 - FDIS PROCESS OUTPUTS DOCUMENTED RESPONSIBILITY Related /
Key Processes INFORMATION for Processes Interacting
for Processes Processes
Quality management systems - Requirements
1 Scope QMS-Manual QM-001 President
2 Normative references [
3 Terms and definitions Manual p.5
[

4 Context of the organization Context of the organization QMS-Section 4 ----- P-500

P-600
4.1 Understanding the organization and its context Organizational context P-400 President P-710
P-750
Context P-400 par 5.1 P-810
P-910
4.2 Understanding the needs and expectations of Needs and expectations P-400 par 5.2 P-930
interested parties P-1010
4.3 Determining the scope of the quality management Scope of the QMS P-400 par 5.4
system

4.4 Quality management system and its processes Process interactions P-400 par 5.5

4.4.1 The organization … Flow diagram FD-440-001

4.4.2 To the extent … QMS Process Identification, this F-440-001 Management Rep
form

Process support, confidence P-400, par 5.6

and documented information

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 2
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5 Leadership Leadership QMS-Section 5 ----- P-610

P-810
Leadership P-500 President P-930

5.1 Leadership and commitment Leadership and commitment P-500, par 5.1

5.1.1 General Business process map FD-510-001 ISO Committee

5.1.2 Customer focus Customer focus P-500, par 5.2

5.2 Policy Quality policy P-500, par 5.3 ISO Committee

5.2.1 Developing the quality policy Quality policy – attachment A-520-001

5.2.2 Communicating the quality policy Communication P-500, par 5.3.5 H R manager

5.3 Organizational roles, responsibilities and Roles, responsibility and P-500 par 5.4
authorities authority

Organization chart A-530-001

6 Planning Planning for the QMS QMS-Section-6 ----- P-400

P-750
Planning for the QMS P-600 Management Rep P-810

6.1 Actions to address risks and opportunities Risk management P-600, par. 5.3

6.1.1 When planning for the QMS… Planning the QMS P-600, par 5.1

6.1.2 The organization shall plan … Opportunity and risk P-600, par. 7.1

6.2 Quality objectives and planning to achieve them Quality objectives P-600, par. 5.4

6.3 Planning of changes Planning for changes P-600, par 5.5

P-750. par 5.5.5

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 3
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P-830, par 5.11

P-851, par 5.13

7 Support Support QMS-Section-7 ----- P-600

P-810
7.1 Resources Resource management P-710 Operations P-820
7.1.1 General P-710, par 5.1 manager P-840
P-851
7.1.2 People Personnel P-710, par 5.2 P-870
P-910
7.1.3 Infrastructure Infrastructure P-710, par 5.3

7.1.4 Environment for the operation of processes Environment P-710, par 5.3.1

7.1.5 Monitoring and measuring resources Control of monitoring and P-715 Quality assurance
measuring equipment manager

7.1.5.1 General General P-715, par 5.1

7.1.5.2 Measurement traceability Traceability P-715, par 5.2

7.1.6 Organizational knowledge Organizational knowledge, P-400, par 7.2

lessons learned and experience P-500, par 7.2
P-600, par 7.2
P-710, par 5.5
P-710, par 7.2
P-720, par 5.2.1

7.2 Competence Competence and awareness P-720 H. R. manager

Competence P-720, par.5.1.1

7.3 Awareness Awareness P-720, par.5.1.2

7.4 Communication Communication P-740 Management Rep

7.5 Documented information Control of documented P-750 Management Rep

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 4
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information

7.5.1 General General P-750, par 5.1

7.5.2 Creating and updating Creation, approval, distribution, P-750, par 5.2--5.7
and revisions

7.5.3 Control of documented Information Documented information P-750, par 5.1

required for the QMS and by
7.5.3.1 Documented information … ISO 9001 is controlled… P-750. par 5.1.2

7.5.3.2 For the control… Address distribution access, etc P-750. par 5.1.3

8 Operation Operation QMS-Section-8 ----- P-600

P-710
8.1 Operational planning and control Operational planning and P-810 Operations P-720
control manager P-740
P-750
Process flow diagram FD-810-001 P-870
P-910
8.2 Requirements for products and services Customer related processes P-820 P-912
P-930
8.2.1 Customer communication Communication P-820, par 5.2, 5.6 Sales Manager P-1020

8.2.2 Determining the requirements related to Determine requirements P-820, par 5.3
products and services

8.2.3 Review of requirements related to products and Review requirements P-820, par 5.4
services
8.2.3.1 The organization shall ensure… Ensure ability P-820, par 5.4.1

8.2.3.2 The organization shall retain… Documented information P-820, par 5.4.3

8.2.4 Changes to requirements for products and Changes P-820, par 5.5.6

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 5
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services

8.4 Control of externally provided processes, Control of external providers P-840 Materials manager
products and services
8.4.1 General Ensure conformity to P-840, par 5.2
requirements

8.4.2 Type and extent of control Controls P-840, par 5.4

8.4.3 Information for external providers Information P-840, par 5.7

8.5 Production and service provision Operations, production and FD-850-001 Management Rep
service – flow diagram

8.5.1 Control of production and service provision Control of production and P-851 Operations
service provision manager

8.5.2 Identification and traceability Identification and traceability P-852 Operations

manager
8.5.3 Property belonging to customers or external External property P-851, par 5.12
providers

8.5.4 Preservation Preservation P-854 Operations

Manager
8.5.5 Post-delivery activities Post delivery activities P-851, par 5.11

8.5.6 Control of changes Control of changes P-851, par 5.13

8.6 Release of products and services Release of products and P-851 par 5.9
services

8.7 Control of nonconforming outputs. Control of nonconforming P-870 Quality manager

outputs
8.7.1 The organization shall ensure outputs… Ensure identification and control P-870, par 5.2

8.7.2 The organization shall retain documented… Records of nonconformities P-870, par 5.4.3

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 6
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9 Performance evaluation Performance evaluation QMS-Section-9 ----- P-715

P-750
9.1 Monitoring, measurement, analysis and Monitoring, measurement, P-910 Quality manager P-810
evaluation analysis and evaluation P-820
P-830
9.1.1 General General P-910 par 5.1 to 5.5 P-840
P-1010
9.1.2 Customer satisfaction Customer satisfaction P-912 Sales manager P-1020

9.1.3 Analysis and evaluation Analysis and evaluation P-910 par 5.6

9.2 Internal audit Internal audits P-920 President

9.2.1 The organization shall conduct… Conduct audits P-920, par 5.1.1

9.2.2 The organization shall plan… Plan audits P-920, par 5.2

9.3 Management review Management review P-930 President

9.3.1 General General P-930, par 5.1

9.3.2 Management review inputs Inputs P-930, par 5.4

9.3.3 Management review outputs Outputs P-930, par 5.5

10 Improvement Improvement QMS-Section-10 ------- P-750

P-870
10.1 General Improvement P-1010 Quality manager P-910
P-912
10.2 Nonconformity and corrective action Nonconformity and corrective P-1020 Quality manager P-920
action P-930

10.2.1 When nonconformity occurs… Nonconformity… P-1020, par 5.2

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QMS - PROCESS IDENTIFICATION WORKSHEET - for ISO 9001:2015 QUALITY MANAGEMENT SYSTEM – Form F-440-001 7
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10.2.2 The organization shall retain… Documented information P-1020, par 5.4

10.3 Continual improvement Analysis of data for continual P-1010, par 5.4, 5.5
improvement

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