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AWARENESS TRAINING
ISO 9001:2015

SECTION A:

ISO 9000 BACKGROUND

SECTION B:

MODELS OF ISO 9000 & ITS


CERTIFICATION

SECTION C:

COMPARISON: ISO 9001: 2008 AND


ISO 9001:2015

SECTION D:

ISO 9001:2015 ELEMENT


DESCRIPTION

SQC CONSULTING GROUP

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ISO
The International Organization
For Standardization
Headquarter- Located in Geneva,
Switzerland

Word derived from Greek ISOS


Meaning EQUAL

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MEMBER OF ISO

To promote the development of


standardization and related activities in
the world with a view to facilitating the
international exchange of goods services.

To develop cooperation in the spheres of


intellectual, scientific, technological and
economic activity.

Is a worldwide federation of national


standard bodies from more than 157
countries, one from each country.
Representative from Malaysia - Department
of Standards Malaysia (Standards Malaysia).
Since 1969, Malaysia became the member of
ISO.

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ISO

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REVISION OF ISO 9001 STANDARDS


ISO 9001 International Standards are revised at least every 5
years
ISO/ TC 176 established in 1976

ISO TECHNICAL COMMITTEE


ISO 9001:1987

Involving
Qualified
Representatives

Industry
Research Institutes
Government authorities
Consumer bodies

ISO 9001:1994

ISO 9001: 2000

ISO 9001:2008
Note: ISO 9000 QMS is designed by ISO/ TC/ 176

ISO 9001: 2015


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ISO 9000 SERIES


ISO 9000:2005
Quality Management System
Fundamental and Vocabulary

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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ACCREDITATION BODY &


CERTIFICATION BODY
International
Accreditation
Forum (IAF)

Say / write what you do:


(Mission, responsibilities, goals, process steps, processes or
work descriptions, etc.)
Do what you say / wrote:
(Perform to the point to obtain desired results, document and
implement processes and record the results.)

ISO/IEC 17011:2004

e.g. Pacific Accreditation Cooperation(PAC),


Europe Accreditation Cooperation(EA),
Inter-American Accreditation
Cooperation
ISO/IEC Guide 61
(IAAC)

Accreditation
Body
ISO/IEC 17021:2006

EN 45012 or
ISO/IEC Guide 62

Certification
Body

Prove it, show evidences & records:


(Show the documented processes and recorded results.)

e.g. Standards Malaysia (Msia), UKAS,


JAB, DAR, SCC...

ISO 9001:2015

Companies

e.g. BM TRADA(MALAYSIA) S/B [UK],


SIRIM QAS S/B [MSIA],
TUV NORD [GERMAN],
BSI [UK],
LLOYDS [UK],
PSB [SPORE]...

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An impartial body, government or non-government, processing the


necessary competence and reliability to operate a certification system and
in which those with an interest in the process of certification are
represented without any single interest predominating.

Responsibility for accrediting Certification Bodies to perform assessments


and award certifications against the International Standard.
United Kingdom Accreditation Service (UKAS)
Department of Standards Malaysia (DSM)
Joint Accreditation System of Australia and New Zealand
(JAS-ANZ)
National Institute of Metrology, Standardization & Industrial Quality,
Brazil (INMETRO)
Standards Council of Canada (SCC)
Hong Kong Laboratory Accreditation Scheme (HOKLAS)
The Japan Accreditation Board for Conformity Assessment (JAB)

LOCAL Certification Body:


Sirim QAS Sdn Bhd
NON-LOCAL Certification Body Operate in Msia:
BM TRADA

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

Products and services

New: Understanding the


Organisation and its Context,
needs and expectations of
Interested Parties

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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

New: Actions to address


risks and opportunities

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 are human


resources,
infrastructure, work
environment

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

3. Documented information to prove processes are carried out as planned


4. Quality Policy
5. Quality objective

New sub-clause for


post delivery activities

6. Documented information of fitness of purpose of monitoring and


measuring equipment
7. Documented information of evidence of competence
8. Documented information to show conformity of products/ services
9. Results of review of requirements, any new or changed requirements for
products/ services

10. Documented information (Design meets requirements)

New sub-clause for release of


products and services

11. Documented information resulting from design and development


process
12. Design and development changes
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DOCUMENTED INFORMATION

13. Evaluation, monitoring and re-evaluation of external provider


14. Documented information that defined the characteristics products and
services
15. Documented information necessary to maintain traceability (if
traceability is required)

SECTION D: ISO 9001: 2015


ELEMENTS

16. Documented information describing the results of review of changes in


provision of products/ services, personnel authorising the change, and any
necessary actions
17. Documented information providing traceability to the person authorising
release of products/ services
18. Action taken on nonconforming process outputs, products and services,
including concessions, person who made the decision
19. Monitoring and measuring activities
20. Documented information as evidence of implementation of audit
program and audit results
21. Results of management review
22. Nature of nonconformities, actions and results of corrective action

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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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ISO 9001: 2015


Introduction
1.Scope
2.Normative references
3.Terms and definitions

ISO 9001: 2015

PLAN

4.Context of the organization


4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality Management System and its processes

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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ISO 9001: 2015


8. Operation

Act
incorporate
improvement
as necessary

Input

9. Performance evaluation

8.5 Production and service provision


8.5.1 Control of production and
service provision
8.5.2 Identification and
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
8.6 Release of products and services
8.7 Control of nonconforming
outputs

Plan the process


(depends on RISK)

Do Carry out
process

Check monitor/
measure process
performance

Output

Interaction with other process

Interaction with other process

8.1 Operational planning and control


8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements
related to products and services
8.2.3 Review of requirements related to
products and services
8.2.4 Changes to requirements for
products and services
8.3 Design and development or products and
services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided products and
services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers

ISO 9001: 2015

DO

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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
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs

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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4.1 Understanding the


Organisation and its
Context (External & Internal
Issues)

4.2 Understanding the


Needs and Expectations
of Interested Parties

Context of the
Organisation

4 CONTEXT OF THE ORGANISATION

4.3 Determining the


Scope of Quality
Management System

4.4 Quality Management


System and its Processes

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4.1 Understanding the Organisation and


its Context

What is the
purpose of the
organisation?

Determine
internal and
external
issues

Monitoring

Review
information
about
external and
internal issues

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4.1 Understanding the Organisation and its


Context

Internal

Values
Performance
Management structure
Staffing
Internal communication

4.2 Understanding the Needs and Expectations


of Interested Parties

Who are the interested parties?

External

Person/ organization that can affect, be affected by, or


perceive themselves to be affected by a decision or activity

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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4.3 Determining the Scope of QMS

4.4 Quality Management System and its


Processes

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

Sequence & Interaction


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5.1.1 Leadership and Commitment for QMS

5.1 Leadership & Commitment

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

Resources for QMS are


available

Communicating the
importance of effective
QMS and conforming
to its requirements

Engage, direct and


support persons to
contribute to QMS

QMS achieves its


intended results

Promote continual
improvement

Support other
management roles to
demonstrate their
leadership
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5.1.2 Customer Focus


Determine customer ,
statutory, regulatory
requirements

Determine and address


risks and opportunities
that can affect conformity
of product/ services

5.2 Quality Policy


Consistently provide
products/ services that
meet customer, legal
requirements

5 LEADERSHIP

Enhancing customer
satisfaction

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Appropriate to purpose and context of


organisation

Framework for setting and reviewing


quality objectives

Include commitment to satisfy


applicable requirements and continual
improvement to QMS

Available as documented information

Communicated, understood and


applied

Available to interested party

5.3 Organisational Roles, Responsibilities and


Authorities

5 LEADERSHIP

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ROLES, RESPONSIBILITIES & AUTHORITIES

1
Ensure QMS
conform to
ISO 9001

2
Ensure
process
deliver
intended
output

Report on the
performance
of QMS

Ensure
promotion of
customer
focus

5
Ensure
integrity of
QMS after
change

6.1 Action to Address Risks and Opportunities

6 PLANNING FOR THE QMS

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PLANNING OF QMS

Requirements of
Interested
Parties

Internal &
External Issues

RISKS &
OPPORTUNITIES

6.2 Quality Objective and Planning to Achieve them

6 PLANNING FOR THE QMS


Plan
action

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

6 PLANNING FOR THE QMS

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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To ensure customer and statutory,


regulatory requirements are met

Building & associated utilities


Equipment (hardware & software)
Transportation
Information & communication
technology

To achieve conformity of products and


services
Physical, social, psychological,
environmental
Maintain documented information (fitness
for purpose)
If traceability required, verified/ calibrated,
identified (status), safeguarded

Determine & maintain knowledge


Internal (lesson learnt from failure,
experience)
External (Standards, conferences, )
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Determine the
necessary
competence

Quality
Policy

Ensure competence
(education, training,
experience)

7.2
Competence

Take action to acquire


competence (training,
mentoring, etc) and
evaluate effectiveness

Quality
Objective

Retain documented
evidence of
competence

7.3
Awareness

Contribution
to QMS

Implication
of nonconformity
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7.5 Documented Information


7.5.2 Creating & Updating
Control of Documented Information

ISO 9001:
2015

WHAT

WHEN

WHO

Identification
& Description

HOW
Necessary
for effective
QMS

7.4 Communication (Internal & External)


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Format &
Media
Review &
Approval

Distribution,
access,
retrieval & use

Storage &
preservation

Control of
changes

Retention &
Disposition

Control of
external
documented
information
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8.1 Operational Planning & Control

8 OPERATION

Determine requirements of product/ service


Establish criteria for the processes and acceptance of products/
services
Determine resources needed

Implement control of the process against criteria

Retain documented information (evidence that processes are


carried out as planned and evidence of conformity)

Control planned changes & review consequences of


unintended changes, take action to mitigate adverse effects
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Products/
services
information

Handling of
customer
property

8.2 Determination of Requirements for Products


and Services

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

8.3 Design and development of


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

8.5 Production and Service


Provision

8.3.6 Design & Development Changes

8.6 Release of Product and Services


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Design & Development Planning


Standards/
Codes of
Practice

Nature, duration & complexity


Requirements of process stage

Internal &
external
resources

Statutory,
regulatory
requirements

Verification & validation

Potential
consequences of
failure

Responsibilities & Authorities


Control of interfaces

Requirement
of products/
services

Involvement of customer/ user groups

Design &
Development
Inputs

Level of control
expected by
customer/
interested parties

Documented information (Design meets requirements)


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Clearly
defined
results

Review of
design &
development

Design &
Development
Control

Fit for intended purpose

Meet requirements

Design &
Development
Outputs

Validation

Adequate for subsequent


process

Monitoring & measuring


requirements, acceptance
criteria

Verification

Retain documented information

Review,
control &
identify
changes
Design &
Development
Changes

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Control of Externally
Provided Products & Services

and development changes

Products/
services
conformity

Retain documented information on design

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Products/ services from external provide


incorporate into organization products/
services

Establish criteria for


evaluation, selection,
monitoring of
performance, reevaluation
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Products/
services
provided
directly to
customer

Outsource

Retain
documented
information

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8.5 Production and Service Provision

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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8.5.2 Identification & Traceability

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8.5.3 Property Belonging to Customers or


External Providers
8.5.4 Preservation

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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8.6 Release of Products and Services

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

Informing the Customer

Correction

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Obtaining authorization for use as is


, release, continuation or reprovision, acceptance under
concession

Verification

Retain
documented
information
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Monitoring, Measurement, Analysis &


Evaluation

WHAT?

METHOD?

WHEN
WHEN
MONITOR
ANALYSE &
&
EVALUATE?
MEASURE?

RETAIN DOCUMENTED INFORMATION AS


EVIDENCE OF RESULTS

9 PERFORMANCE EVALUATION

Evaluate quality performance and effectiveness of QMS


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9.2 Internal Audit

9.1.3 ANALYSIS AND EVALUATION

Audit program (quality objectives, importance


of process, customer feedback, changes, results
of audit) , audit criteria, scope

Output of analysis and evaluation


1

Demonstrate conformity to product and service requirements

Access and enhance customer satisfaction

Ensure conformity and effectiveness of quality management system

Demonstrate that planning has been successfully implemented

Assess the performance of processes

Assess the performance of external provider(s)

Determine the need or opportunities for improvements

Input to management review

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

OUTPUT: Continual improvement opportunities,


any need for changes and resource needs

Non-conformity and corrective


action

M & M results

Audit results

Customer satisfaction

Issues concerning external


provider, interested parties

10 IMPROVEMENT

Adequacy of resources

Process performance and


conformity of product and
service
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React to NC (take
action / deal with
consequence)

Evaluate need for


action (review,
determine cause,
determine similar NC)

Implement action

Retain documented
information (nature of
NC, action and results)

Make changes to
QMS

Review
effectiveness of CA

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Output of analysis and evaluation, outputs


from management review

10.2 Nonconformity and Corrective Action

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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