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Awareness - Programme - ISO 9001 PDF
Awareness - Programme - ISO 9001 PDF
ISO 9001:2015
AWARENESS
COURSE AGENDA
Standardisationand
Standardisation andCompetency
CompetencyAssured
Assured
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COURSE OBJECTIVES
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BACKGROUND
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BACKGROUND
MAJOR MINOR
CHANGE CHANGE
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Standardisationand
Standardisation andCompetency
CompetencyAssured
Assured
What’s new?
Used of HLS
Leadership
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Leadership
(5)
Improvement
(10) Planning
(6)
Performance
Evaluation
Support
(9)
(7)
Operations
(8)
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PDCA CYCLE
Quality Management System (4)
ORGANIZATION
& ITS CONTEXT
(4)
SUPPORT &
OPERATION
(7,8)
PLAN DO CUSTOMER
SATISFACTION
CUSTOMER PERFORMANCE
RESULTS OF
REQUIREMENTS PLANNING LEADERSHIP EVALUATION
(9) QMS
(6) (5)
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9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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CLAUSE 1 :
SCOPE
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Clause 4:
Context of the
organisation
positive
Issues
negative
Conditions for
consideration
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Organization
External Issues:
(PESTLE):
Political Intended
Economic Outcomes
Social Internal Issues: of the QMS
Technology (FITCOW)
Legal - Financial - Competency
Environment - Infrastructure - Operation
- Technology - Work Environment
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Monitor and review
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Customers
(Requirements)
regulatory
Suppliers
requirements
Regulators
NGOs
Investors
Employees Monitor and
review
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Establish
9001
The requirements of interested parties
Maintain
Activities, products and services
Continually
Scope shall be maintained as documented
improve
information
Maintain
4.4.2 Retain
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4.4.2
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PROCESS APPROACH
Plan the Process –
(Extent of Planning
ACT – depends on RISK)
Incorporate
improvements
as necessary
PROCESS
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Clause 5:
Leadership
Promote improvement
Support other relevant management roles to Standardisationand
Standardisation andCompetency
CompetencyAssured
Assured
demonstrate their leadership 38
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MAINTAIN documented
information
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Clause 6:
Planning
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Culture
Technique
Plan
Act Organization Do
Check
Principles for Risk management Risk management
risk management framework process(es))
(Clause 3) (Clause 4) (Clause 5)
Issue
Current
Categorization Treatment Recommended Status
Process Risk Effect Risk Probability Severity Risk
& Internal/ Category Action
Control
External
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MAINTAIN documented
information Standardisationand
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Clause 7:
Support
7.1 Resources
Organizational knowledge
Environment for operation
7.2 Competence
Monitoring and
7.1 Resources measuring resources
People Infrastructure
Support
7.5 Documented
7.4 Communication 7.3 Awareness
Information
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7.1 Resources
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7.1.2 People
7.1.2 People
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7.1.3 Infrastructure
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RETAIN documented
information
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7.2 Competence
• Shall determine the necessary competence of person(s)
doing work under its control that affects its QMS
performance.
• Ensure these persons are competence on the basis of
appropriate education, training or experience.
• Take action to acquire the necessary competence and
evaluate the effectiveness.
• Retain appropriate documented information as evidence
of competence.
RETAIN documented
information Standardisation and Competency Assured
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7.3 Awareness
Awareness:
• The Quality policy
• The relevant quality objective
• Their contribution to the effectiveness of QMS,
including the benefits of improved performance
• The implication of not conforming with QMS
requirements
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7.4 Communication
WHAT to HOW to
communicate? communicate?
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Clause 8:
Operation
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RETAIN documented
information
Vendor
Supplier
Information Type and
for External Criteria extent of
Associate provider control
(8.4.3) (8.4.2)
Outsource
Evaluate, select,
monitor and
reevaluate (8.4.1) Documented information RETAIN documented
information
Information for external providers are now Standardisationand
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more detailed and explicit
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RETAIN documented
information
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RETAIN documented
information
8.5.4 Preservation
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Clause 9:
Performance Evaluation
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• Shall analyse and evaluate appropriate data and information arising from
monitoring, measurement and other sources.
• The result of analysis shall be used to evaluate:
• Conformity of product and services
• The degree of customer satisfaction
• The performance and effectiveness of the QMS
• If planning has been implemented effectively
• The effectiveness of actions taken to address risks and opportunities
• The performance of external providers
• The need for improvements to the quality management system
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RETAIN documented
information
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Responsibilities
Frequency Reporting
Retain Reported to
Correction and relevant
documented
Corrective action management
Information
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RETAIN documented
information
Clause 10:
Improvement
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10 Improvement
10.1 General
The organization shall determine and select opportunities
for improvement and implement necessary actions to meet
customer requirements and enhance customer satisfaction.
These shall include, :
• Improving products and services to meet requirements,
including address future needs and opportunities
• Correcting, preventing or reducing undesired effects
• Improving the performance and effective of quality
management system
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Shall consider the outputs of the analysis and evaluation and the
output from management review, to determine if there are
needs or opportunities that shall be addressed as part of
continual improvement.
THANK YOU
SIRIM STS SDN BHD
SIRIM Complex
1 Persiaran Dato’ Menteri , Section 2
40700 Shah Alam, Selangor
E-mail: sirimsts@sirim.my
Tel: 03 5544 6278/6276
Fax: 03 5544 6290
sirimsts@sirim.my
www.sirimsts.my
www.facebook.com/SIRIM.STS
twitter.com/SIRIMSTS
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