Awareness ISO 9001:2015

Quality Management System

By: Yusup
24 January 2019
Purpose

1. Increase the awareness of Quality Management System based on ISO

9001:2015.
2. Know & understand the ISO 9001:2015 requirements.
3. Know the related clause of ISO 9001:2015 with each department.
4. Know how implement the standard on each department.
5. Know the role, responsibilities & authorities of ISO 9001:2015
implementation at each department.

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Normative References
ISO 9001:2015 identifies only one document as “normatively
referenced” and “indispensable for its applications”:

ISO 9000:2015
Quality management systems
— Fundamentals and
vocabulary

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ISO 9000 Series
Three standards in the series:

ISO 9000 ISO 9001 ISO 9004

New Revisions released together in 2015 Currently under revision

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ISO 9000 Series
ISO 9000 ISO 9001 ISO 9004
Quality management Quality management Managing for the
systems—Fundamentals systems—Requirements sustained success of an
and vocabulary organization—
A quality management
approach
Essential background for Requirements aimed
the proper understanding primarily at giving Guidance for organizations
and implementation of confidence in the products that choose to progress
ISO 9001 and services beyond ISO 9001
an organization provides, requirements to address
thereby improving a broader range of topics
customer satisfaction that can lead to continual
improvement of the
organization's overall
performance

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ISO 9001:2015 Contents

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ISO 9001:2015 Contents

QMS PDCA Cycle

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ISO 9001:2015 Contents
4. Context of the organization
4.1 Understanding the organization and its context
• Shall determine the external & internal issues
• Shall monitor and review the external & internal issues
4.2 Understanding the needs and expectations of interested parties
• Shall determine the interested parties
• Shall determine the requirements of interested parties
4.3 Determining the scope management system
• Shall determine the scope of QMS
4.4 Management system and its processes
• Shall establish, implement, maintain and continually improve
QMS including the processes needed and their interactions.
• Shall maintain and retain the documented information.

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ISO 9001:2015 Contents

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ISO 9001:2015 Contents
5. Leadership
5.1 Leadership & commitment
• Shall demonstrate leadership & commitment
• Shall demonstrate leadership & commitment with respect
customer focus
5.2 Policy
• Establishing the quality policy
• Communicating the quality policy
5.3 Org. rules, responsibilities & authorities
• Shall ensure that the responsibilities & authorities are assigned,
communicated and understood.

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 ISO 9001:2015 Contents

Source : www.welchallyn.com

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ISO 9001:2015 Contents
6. Planning
6.1 Action to address risk & opportunities
• Shall determine the risk & opportunities
• Shall plan action to address the risk & opportunities.
6.2 Quality objectives
• Shall establish quality objectives
• Planning how to achieve quality objectives
6.3 Planning of changes
• The change of QMS shall be carried out in planned manner.
• Change shall consider (the purpose, integrity, availability of
resources, allocation or reallocation of responsibilities and
authorities.

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 ISO 9001:2015 Contents
Risk & opportunities
N Category Issue In/ R/ Risk/Opportunity Description P S PXI Proximity Action Plan PIC Last Current
O Issue Ext O Review Status
Date

1 Best Different eye level Int R High ratio defect at all 4 4 16 High QC Certification QIP - -
Quality QC inspection process

Unclear standard Int R Lost time 4 3 12 Medium Implement adidas QIP - -

problem solving quality standard
timeline

Probability Risk
(P) Matrix

Severity
(S) Trigger
Level

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ISO 9001:2015 Contents
7. Support
7.1 Resources
• Shall determine and provide the resources needed.
• Shall determine and provide the persons necessary.
• Shall determine, provide and maintain the infrastructure
necessary.
• Shall determine, provide and maintain the environment necessary.
• Shall determine, and provide the resource needed to ensure valid
and reliable results.
• Shall retain the evidences

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ISO 9001:2015 Contents
7. Support (Cont’d)
7.2 Competence
• Shall determine the necessary competence of person(s)
• Shall ensure that these person are competent on the basis of
appropriate education, training, or experience
• Shall evaluate the effectiveness
• Shall retain the evidence
7.3 Awareness
Shall ensure that persons doing work under the organization control are
aware of quality policy, quality objectives, contribution, the
implications of not conforming

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ISO 9001:2015 Contents
7. Support (Cont’d)
7.4 Communication
Shall determine the internal and external communications relevant to
QMS, including (on what it will communicate, when to communicate,
whit whom to communicate, how to communicate, who
communicates)
7.5 Documented information
• QMS shall include documented information
required by this standard.
• Documented information determined by the
organization as being necessary.
• Shall creating and updating, control of documented information

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ISO 9001:2015 Contents
8. Operation
8.1 Operation planning & control
• Shall plan, implement and control the process.
• The output of this planning shall be suitable for the operation.
8.2 Requirements for products & services
• Customer communication.
• Determining the requirements for products.
• Review of requirements for products.
• Changes to requirements for products.
8.3 Design & development of products &
services (excluded)

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ISO 9001:2015 Contents
8. Operation
8.4 Control of externally provided processes, products & services
• Shall ensure that externally provided process, product & services
conform to requirements.
• Shall determine the controls to be applied to externally provided
processes, product & services.
• Shall determine and apply criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external
providers based on their ability to provide processes or products
and services.
• Shall retain the evidence.
• Shall define the type and extent of control
• Shall ensure the adequacy of information for external providers

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ISO 9001:2015 Contents
8. Operation
8.5 Production & service provision
8.5.1 Control of production provision
8.5.2 Identification & traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

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ISO 9001:2015 Contents
8. Operation
8.6 Release of product & services
• Shall implement planned arrangements, at appropriate stages, to
verify that the product and service requirements have been meet.
• Release shall not proceed until the planned arrangements have
been satisfactorily completed.
• Shall retain the evidence

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ISO 9001:2015 Contents
8. Operation
8.7 Control of nonconforming outputs
8.7.1 Shall ensure that nonconforming outputs are identified and
controlled.
The organization shall deal with nonconforming outputs.
Conformity to the requirements shall be verified when
nonconforming outputs are corrected.
8.7.2 Shall retain the evidence that :
• Describes the nonconformity
• Describes the action taken
• Describes any concessions obtained
• Identifies the authority deciding the action in respect of
the nonconformity

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ISO 9001:2015 Contents
9. Performance evaluation
9.1 Monitoring, measurement, analysis & evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
• Shall conduct internal audits at planned intervals
• Shall retain the internal audit evidences
Note : See ISO 19011 for Guidance
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs

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ISO 9001:2015 Contents
10. Improvement
10.1 General
• Shall determine and select opportunities for improvement and
implement any necessary actions.
10.2 Nonconformity and corrective action
• When nonconformity occurs, including any arising from
complaints, shall react, evaluate, implement action, review,
update risk & opportunities, change QMS if necessary
• Corrective action shall be appropriate to the effects of the
nonconformities encountered.
• Shall retain the evidences

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ISO 9001:2015 Contents
10. Improvement
10.3 Continual improvement
• Shall continually improve the suitability, adequacy, and
effectiveness
• Shall consider the results of analysis and evaluation, and the
outputs from management review.

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THANK YOU