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AWARENESS TRAINING
ISO 9001:2015
SECTION A:
SECTION B:
SECTION C:
SECTION D:
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ISO
The International Organization
For Standardization
Headquarter- Located in Geneva,
Switzerland
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MEMBER OF ISO
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ISO
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Involving
Qualified
Representatives
Industry
Research Institutes
Government authorities
Consumer bodies
ISO 9001:1994
ISO 9001:2008
Note: ISO 9000 QMS is designed by ISO/ TC/ 176
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ISO 9000:
QUALITY
MANAGEMENT
SYSTEM
ISO 9001:2015
Quality Management System
Requirements
ISO 9004:2009
Quality Management System
Guidelines for Performance
Improvements
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IMPLEMENTATION OF
ISO STANDARD
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ISO/IEC 17011:2004
Accreditation
Body
ISO/IEC 17021:2006
EN 45012 or
ISO/IEC Guide 62
Certification
Body
ISO 9001:2015
Companies
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BVQI
MOODY INTERNATIONAL
DNV
LLOYDS
SGS YARSLEY
RWTUV
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ISO 9001:
2008
SECTION C: COMPARISON
BETWEEN ISO 9001: 2008 AND
ISO 9001: 2015
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2015
Exclusion is
mentioned
No specific reference to
exclusions
Preventive Action
Risk-based approach
Products
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ISO 9001:
2008
ISO 9001:
2008
2015
2015
Top management
commitment: policy,
objective, resources,
customer focus, MR,etc
Additional commitment
of top management
MR has to be
appointed by top
management
MR is not mentioned
Documented
procedure, record
Documented
information
Organizational
knowledge is not
mentioned
New: Organizational
knowledge
To maintain integrity
of QMS when
changes are planned
and implemented
More detailed
explanation on planning
of changes of QMS
Evaluation and
selection of suppliers
Risk-based approach to
control external provider,
products and services
Resources include
monitoring & measuring
device and organizational
knowledge
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DOCUMENTED INFORMATION
ISO 9001:
2008
1. Scope
2. Documented information to support operation
2015
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DOCUMENTED INFORMATION
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Customer Focus
Leadership
Engagement of
People
Relationship
Management
Evidencebased Decision
Making
Process
Approach
INTRODUCTION
Improvement
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Complexity
and
interaction of
processes
Competency
Objectives
Quality
Management
System
Size &
organisational
structure
Risks
Customers/
relevant
parties needs
Type of
products/
services
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PLAN
5.Leadership
5.1 Leadership and commitment
5.1.1. General
5.1.2. Customer focus
5.2 Policy
5.2.1 Developing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
7. Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
PLAN
6.Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
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Act
incorporate
improvement
as necessary
Input
9. Performance evaluation
Do Carry out
process
Check monitor/
measure process
performance
Output
DO
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CHECK &
ACT
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement
Establishment
Riskbased
thinking
Implementation
Maintenance
Continual
improvement
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Context of the
Organisation
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What is the
purpose of the
organisation?
Determine
internal and
external
issues
Monitoring
Review
information
about
external and
internal issues
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Internal
Values
Performance
Management structure
Staffing
Internal communication
External
Legal
Technology
Competition
Market
Cultural
Social and economic
environment
External Communication
EXAMPLE:
Determine
interested party
Determine their
requirements
Monitor and review
Owner,
Business
Partner
Employee
Society e/g:
competitor
Customer
Supplier
Banker
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Internal and
External Issues
Scope,
Exclusion &
Justification
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Resources
P1
P2
Requirements of
Interested
Parties
INPUT
Monitoring,
measuring &
evaluation method
P3
Responsibility
& Authority
Products and
Services
P4
S1
Performance
Indicator
S2
OUTPUT
S3
Risk, opportunity,
planning &
implementation
S4
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5 LEADERSHIP
Accountable for
effectiveness of QMS
Establishing quality
policy and objective in
line with strategic
direction and context
of organisation
Quality policy is
communicated,
understood and
applied
Integration of QMS in
business processes
Promoting awareness
of process approach
Communicating the
importance of effective
QMS and conforming
to its requirements
Promote continual
improvement
Support other
management roles to
demonstrate their
leadership
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5 LEADERSHIP
Enhancing customer
satisfaction
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5 LEADERSHIP
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1
Ensure QMS
conform to
ISO 9001
2
Ensure
process
deliver
intended
output
Report on the
performance
of QMS
Ensure
promotion of
customer
focus
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Ensure
integrity of
QMS after
change
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PLANNING OF QMS
Requirements of
Interested
Parties
Internal &
External Issues
RISKS &
OPPORTUNITIES
Integrate
in QMS
Implement
Evaluate
effectiveness
Continual
improvement
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QUALITY OBJECTIVE
Consistent with
quality policy
Measurable
In line with
applicable
requirements
Responsibility?
When it will be
completed?
Resources?
Relevant to product/
service conformity &
customer
satisfaction
Be monitored
Be communicated to
What will be
done?
Achieve
Quality
Objective
How to
evaluate the
results?
Be updated as
appropriate
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Purpose of change
and potential
consequences
Integrity of quality
management
system
Planning
for Changes
6.3 Planning of Changes
Availability of
resources
Responsibilities &
authorities
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7.1 Resources
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People
Infrastructure
Environment for
operation of
processes
Monitoring &
measuring
resources
7 SUPPORT
Organizational
Knowledge
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Determine the
necessary
competence
Quality
Policy
Ensure competence
(education, training,
experience)
7.2
Competence
Quality
Objective
Retain documented
evidence of
competence
7.3
Awareness
Contribution
to QMS
Implication
of nonconformity
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ISO 9001:
2015
WHAT
WHEN
WHO
Identification
& Description
HOW
Necessary
for effective
QMS
Format &
Media
Review &
Approval
Distribution,
access,
retrieval & use
Storage &
preservation
Control of
changes
Retention &
Disposition
Control of
external
documented
information
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8 OPERATION
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Products/
services
information
Handling of
customer
property
8.2.1
Customer
Communication
Enquiries,
contracts/
orders &
changes
8 OPERATION
Customers
views and
perceptions,
complaints
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Contingency
action (when
relevant)
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8.2.2 Determination of
Requirements Related to Products
and Services
8.2.3 Review of Requirements
Related to Products and Services
8.4 Control of
Externally
Provided
Products &
Services
8.7 Control of
Nonconforming
Process
Outputs, &
Services
Products
8.3.2
8.3.3
8.3.4
8.3.5
Design &
Development
Planning
Design &
Development
Inputs
Design &
Development
Control
Design &
Development
Outputs
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Internal &
external
resources
Statutory,
regulatory
requirements
Potential
consequences of
failure
Requirement
of products/
services
Design &
Development
Inputs
Level of control
expected by
customer/
interested parties
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Clearly
defined
results
Review of
design &
development
Design &
Development
Control
Meet requirements
Design &
Development
Outputs
Validation
Verification
Review,
control &
identify
changes
Design &
Development
Changes
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Control of Externally
Provided Products & Services
Products/
services
conformity
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Products/
services
provided
directly to
customer
Outsource
Retain
documented
information
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Approval of
products/
services,
methods,
processes/
equipment
Products/
services/
processes
Documented
info of
Product/
Service
Characteristi
c
Competence
Information
for external
provider
Verification
activities at
external
providers
premises
Documented
info on
activities
Product/
service
release,
delivery, post
delivery
Validation &
periodic Revalidation
Controlled
Conditions
Competence
Interaction
with QMS
Monitoring &
Measuring
Activities
Control &
monitoring
of the
external
providers
performance
Suitable M &
M resources
Suitable
infrastructure
&
Environment
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Process Output
Results of any activities which are ready for delivery
to the organisations customer or internal customer
(e/g: Products, services, intermediate parts,
components, etc)
Inclusive of external
providers properties
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Material, components,
tools and equipment,
customer premises,
intellectual property,
personal data
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Statutory &
regulatory
requirements
8.5.5
Product
and
services
risks
Post
Delivery
Activities
Retain
documented
Review and information of
control
review,
unplanned authorization &
changes
necessary
Unplanned
action
Customer
feedback
changes in
production and
service provision
Nature,
use &
lifetime of
products/
services
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Segregation, containment,
return or suspension
Correction
Plan arrangement
for verification
Implement
8.7 Nonconforming
Process Outputs,
Products, Services
Retain evidence of
conformity &
documented info
of person
authorized release
Correction
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Verification
Retain
documented
information
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WHAT?
METHOD?
WHEN
WHEN
MONITOR
ANALYSE &
&
EVALUATE?
MEASURE?
9 PERFORMANCE EVALUATION
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Select auditor
Carry out audit and report audit
results to management
Take correction and corrective action
Retain documented information
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Status of action
from previous
MR
1
Effectiveness of
action taken to
address risk &
opportunities
9.3
Management
Review
New potential
opportunities
Changes in
internal and
external issues
Information on
quality
performance
M & M results
Audit results
Customer satisfaction
10 IMPROVEMENT
Adequacy of resources
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React to NC (take
action / deal with
consequence)
Implement action
Retain documented
information (nature of
NC, action and results)
Make changes to
QMS
Review
effectiveness of CA
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Improve
processes
Improve
products
and
services
Improve QMS
results
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Thank You
SQC CONSULTING GROUP
Tel: 03-7955 2633
Fax: 03-7954 1833
Website: www.sqc.com.my
SQC CONSULTING GROUP
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