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PT. CATUR DAYA SOLUSI1
Understanding of ISO 9001:2015
Sabar Kembaren
Date: 01 March 2017
2
Agenda
Why Change to ISO 9001:2015
How to build QMS
Quality Awareness
Understanding requirements and implementation
Summary
01
02
03
04
05
PT. CATUR DAYA SOLUSI3
INTRODUCTION
PT. CATUR DAYA SOLUSI4
5
• Why Change
to ISO
9001:2015
01
PT. CATUR DAYA SOLUSI6
• Decrease the emphasis on Documentation
• Increase the emphasis on Achieving Value for the Organization and
its customers
• Increase emphasis on Risk Management to achieve objectives
Reasons For The Changes (2)
Pre-Course
Discussion
PT. CATUR DAYA SOLUSI7
Future Relevance of ISO 9001:2008 (9001 WW Survey Result)
Pre-Course
Discussion
PT. CATUR DAYA SOLUSI8
World-wide Survey - Key User Inputs
• ISO 9001, as it is, must change to continue
be relevant
• Integrate with other MSS (EMS etc.)
• Provide one integral approach to the
management of the organization for
Leadership commitment & understanding,
strategic planning, management buy-in
• Need to work with ISO/CASCO and IAF to
ensure efficiency/effectiveness of audits and
address problems in certification audits
• Include tools and risk management
ISO InputFor Future
Pre-Course
Discussion
PT. CATUR DAYA SOLUSI9
Summary Changes (Based on ISO9001:2015)
• New revision process for ISO 9001:2015 already underway
• Major changes likely
• Update ISO 9001 to reflect modern business practices, changing business
environment etc, since last major revision
• Provide more emphasis on achieving product conformity
• Simplification of language
• Improve compatibility with other management system standards
• Validation projects will be undertaken with users
• Scheduled publication date is September 2015
• We will be working closely with IAF to define transition policy at the
appropriate time
PT. CATUR DAYA SOLUSI10
Competence The organization implementing a QMS would have to
identify the "competence" necessary for personnel doing work that
affects its quality performance, as well as ensuring that those
personnel are competent to do so. Competence would be defined as
the "ability to apply knowledge and skills to achieve intended results".
Documented Information The terms "document“ and "record" used in
ISO 9001: 2008 would both be replaced throughout the new
requirements by the phrase "documented information".
QMS ISO9001: 2015
PT. CATUR DAYA SOLUSI11
External Provision of Goods and Services An organisation would be
required to take a risk based approach to determine the type and extent of
controls appropriate to all types of external provider (whether it is by purchasing
from a supplier, for example, or through the outsourcing of processes and
functions, etc.) and all external provision of goods and services.
Exclusions There would no longer be any requirement to identify any QMS
requirements that could not be applied due to the nature of the organisations
business (clause 1.2 in ISO 9001: 2008). This is because a different approach
has been taken to the way in which the requirements of the revised version of
ISO 9001 have been stated, so there would no longer be any reasons for an
organization’s QMS not to be able to meet all the requirements of the future
standard.
QMS ISO9001: 2015
PT. CATUR DAYA SOLUSI12
Goods & Services Reference to "product" (as in ISO 9001 : 2008)
would be replaced by the phrase "goods and services".
lmprovement The term "continual improvement" would be changed to
just "improvement".
lnterested Parties An organization seeking to implement a QMS would
have to determine who are the "interested parties" relevant to its QMS,
as well as identifying what the requirements of those interested parties
are. An interested party (also referred to as a "stakeholder") would be
defined as any person or organization that can affect, be affected by, or
perceive themselves to be affected by a decision or activity of the
organization implementing the QMS.
QMS ISO9001: 2015
PT. CATUR DAYA SOLUSI13
Preventive Action There would no longer be a specific requirement
for "preventive action". This main reason given for this is that one of
the key purposes of a QMS is to act as a preventive tool anyway.
Process Approach There would be a specific requirement for
organizations to apply a process approach to their QMS as well as a
list of requirements identifying the essential elements of such an
approach.
QMS ISO9001: 2015
PT. CATUR DAYA SOLUSI14
Risks and Opportunities When planning for its QMS the organization
would have to identify the risks and opportunities that need to be
addressed to ensure that the QMS can achieve its intended outcome(s).
Having done this, the organization would have to plan actions to address
these risks and opportunities, integrate and implement them into its QMS
processes and evaluate the effectiveness of these actions.
ISO 9001: 2008 Transition The current intention is that the transition
period for users of ISO 9001: 2008 to transfer to the new version of this
Standard would be three years , though this has still to be formally
ratified.
QMS ISO9001: 2015
15
• How to Build
QMS?
02
PT. CATUR DAYA SOLUSI16
Key terms and definitions
Management ?“Coordinated activities to direct and
control an organization”
Quality Management ?“Management with regard to
quality”
Quality Management System ?“Management system with regard
to quality”
PT. CATUR DAYA SOLUSI17
Key concepts (1): Process
With what?(resources)
Outputs? (what,to whom)
What results?(monitoring, measurements, performance indicators)
Inputs? (what, from whom)
How done?(criteria, methods/controlsdocumentation)
With who?(responsibilities,authorities)
PROCESS
PT. CATUR DAYA SOLUSI18
Key concepts (2): Process Approach
A Coherent System:
Understanding
requirements
Intended
results
Consistent,
predictable results
Meeting requirements
Customer satisfaction
Activities
understood
and managed as
interrelated
processes
Processes adding value
Processes providing effective performance
Improvements (through evaluation) of data/information
PDCA (process) methodology
(Interactions)
(Outputs)
(Inputs)
Process
PT. CATUR DAYA SOLUSI19
• Questions:
• Who is the owner of Process?
PT. CATUR DAYA SOLUSI20
2
0 Process Classification
Core Process/
Realization Process
Supporting Process
Interested
Parties
/Customers
Management
Process
Interested
Parties
/Customers
Monitoring, Measure,
Analysis
and Improvement Process
PT. CATUR DAYA SOLUSI21
Build your own Process for your organization
PT. CATUR DAYA SOLUSI22
•Supporting Process
- Documented Information Process (prev. Control
of document and records)
- Control of infrastructure
- Corrective and preventive maintenance
- Recruitment
- Training & Human Development
- Waste control
•Management & Planning
- Setup Policy, Objective and Target
- Business Risk Analysis/SWOT
- Management Review
Common Process explore from ISO-MS
MMA Process
- NC Corrective Action
- Internal Audit
- Customer Satisfaction Measurement
- Accident Investigation
Realization Process (Depend of Organization)
- Production
- In-Process Inspection
- Final Inspection
- Warehouse
- Complaint Handling
- Etc.
23
• Quality
• Awareness
03
PT. CATUR DAYA SOLUSI24
What is quality?
•Comply and Exceed expectation and need of customer and continuous improvement
William Edwards Deming (1900-1993)
•Quality mean Compliance with requirements Philip Bayard Crosby
(1926-2001):
•Quality mean Compliance with userJoseph Moses Juran
(1904 – 2008)
•Quality mean customer satisfactionKaoru Ishikawa (1915 – 1989)
• Degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)
ISO 9001
PT. CATUR DAYA SOLUSI25
Quality Management System Evolution
Non Quality Culture
Quality Inspection
Quality Control
Time
Q Performance
ZERO DEFECT
ZERO DEFECT CONTINUOSLY
ZERO DEFECT CONTINUOSLY &
CUSTOMERS SATISFCATIONQuality
Assurance
CUSTOMERS SATISFCATION CONSISTENTLYQUALITY
MANAGEMENT
(ISO 9001:2008)
ZERO DEFECT CONTINUOSLY &
INTERESTED PARTIES SATISFCATION
(ISO 9001:2015)
SUSTANAIBILITY
COMPLIANCE
PERFORMANC E
Copyright © 2013 BSI. All rights reserved. 26
PT. CATUR DAYA SOLUSI27
ISO 9000 Series evolution
ISO 9001 historical change
1st edition :
ISO 9001:1987
ISO 9002:1987
ISO 9003:1987
2nd edition :
ISO 9001:1994
ISO 9002:1994
ISO 9003:1994
3rd edition :
ISO 9001:2000
4th edition :
ISO 9001:2008BS 5750
Part 2:1979
5th edition :
ISO 9001:2015
28
• Understanding
Requirements
and
implementation
04
PT. CATUR DAYA SOLUSI29
PLAN DO CHECK ACT
4 Context of the organization
Understanding of the organization and its context
Expectations of interested parties
Scope of the QMS
Quality ManagementSystem
5 Leadership
Leadership andcommitment
Policy
Roles, responsibilities and authorities
6 Planning
Actions to address risk and opportunity
Quality objectivesand planning to achieve them
7 Support
Resources
Competence
Awareness
Communication
8 Operation
Operationalplanning and control
Determination of market needs and interactions with customers
Operational planning process
Control of externalprovision of goods and services
Development of goods and services
9 Performance Evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10 Improvement
Nonconformity and corrective action
Continual improvement
Documented information
Planning Changes
Production of goods and provision of services
Release of goods and services
Nonconforming goods and services
High Level Structure Process Flow – QMS ISO9001: 2015
TEN CLAUSES
PT. CATUR DAYA SOLUSI30
Context of the
Organization
1. Understanding the organization and its context
2. Understanding the needs and expectation of interested parties
3. Determining the scope of the quality management system
4. Quality management system (QMS)4Q:2008 : 4.1, 4.2.2, 5.2
“SO
LU
TIO
N F
OR
YO
UR
BU
SIN
ES
SCitizens
Customers
Distributors
Shareholders
Investors
Owners
Insurers
Government
Regulators
Recovery service suppliers
The Organization
Management
• Top Management
• Those accountable for Quality policy and implementation
Those who implement and maintain the QMS
• Those who maintain QMS and risk procedures
Other Staff
Contractors
Competitors
Media
Commentators
Trade groups
Neighbors
Pressure groups
Emergency services
Other response agencies
Transport services
Staff dependents
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 QMS4.4. QMS and its Processes
PT. CATUR DAYA SOLUSI32
There will be many people, entities, and organizations which will be either
interested in or have an impact on, the environmental performance of the
organization and its activities.
It is important to consider who is affected or involved in the environmental
related activity
Understanding the needs and expectations of
interested parties
Organization
Employees
Competitors
Supply Chain
Government
Non-
governmental
organisationsCommunities
Customers
Owners and
Financial
Community
Company
Decision
MakersRecruitment and
retention
Access to
capital
Changing
markets
Informed
decisions
Social
license to
operate
Reputational
Risk
Regulatory
Constraints
Input Costs
Competitive
advantage
PT. CATUR DAYA SOLUSI33
Understanding the needs and expectations
of interested parties
What are the stakeholder’s needs and expectations?
An organization is expected to gain a general (i.e. high-level, not detailed)
understanding of the expressed needs and expectations of those internal and
external interested parties that have been determined by the organization to
be relevant
Which ones become obligations?
Some interested party are mandatory because they have been incorporated
into laws, regulations, permits and licenses by governmental or even court
decision.
The organization may decide to voluntarily agree to or adopt other
requirements of interested parties
PT. CATUR DAYA SOLUSI34
Determining the scope
The scope is - physical boundaries and organizational boundaries
It is not permissible to exclude activities, products and services from the
control of the EMS if included within the identified scope
When determining the scope, the organisation shall considered:
• External and internal issues
• Compliance obligations
• Organizational units, functions and physical boundaries
• Activities, products and services
• Authority and ability to exercise control and influence
A scope statement must be documented and made available to
interested parties
PT. CATUR DAYA SOLUSI35
Leadership
1.Leadership and Commitment
2.Policy
3.Organizational role, responsibility and authoritirs5Q:2008 : 5.1, 5.3, 5.5
PT. CATUR DAYA SOLUSI36
5. Leadership
5.1. Leadership and commitment
Leadership and commitment for the quality management
system
Customer focus
5.2. Policy
5.3. Organizational roles,
responsibilities and authorities
PT. CATUR DAYA SOLUSI37
5.2 Policy
provides a framework for setting objectives
appropriate to the purpose
and context of the organization
communicated, understood and applied within the
organization
available to interested parties
maintained as documented information
Top management shall establish, implement and maintain an environmental policy
includes a commitment to fulfil
its compliance obligations
includes a commitment
to continual improvement
PT. CATUR DAYA SOLUSI38
5.3 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant
roles are assigned and communicated within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the management system conforms to the requirements of this
International Standard;
b) reporting on the performance of the management system, including
environmental performance, to top management
b) ensuring that the processes are delivering their intended outputs;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained
when changes to the quality management system are planned and
implemented.
QMS
Common
PT. CATUR DAYA SOLUSI39
Planning
1.Actions to address risk and
opportunities
2.QMS Objectives and planning to
achived them
3.Planning Change6Q:2008 : 4.1, 5.4.1, 5.4.2, 6.4,
7.1, 7.2, 7.3, 7.4, 7.5
PT. CATUR DAYA SOLUSI40
Clause 6: Planning
Plan actions to address risks and opportunities
Determine risks and opportunities
4.1
9.2
6.1
6.1
Issues
6.1. Actions to address risks and opportunities6.2. Quality objectives and planning to achieve them6.3. Planning of changes
PT. CATUR DAYA SOLUSI41
Control It
Share orTransfer It
Diversify orAvoid It
RiskManagement
ProcessLevel
ActivityLevel
Entity Level
RiskMonitoring
Identification
Measurement
Prioritization
RiskAssessment
Risk Analysis
PT. CATUR DAYA SOLUSI42
Risk assessment tools
Likelihood of loss
Severity of loss
Slight Moderate Extreme
Very unlikely Very low risk Very low risk High risk
Unlikely Very low risk Medium risk Very high risk
Likely Low risk High risk Very high risk
Very likely Low risk Very high risk Very high risk
Simple risk estimator
Copyright © 2013 BSI. All rights reserved.
Organization
objectives
progressing
Current
Situation
OBJECTIVE AND EFFORT OF THE WHOLE
INSTITUTION
Future
Situation
Risk Analysis
Vision
Mission
Performance
indicators
Risk A
Objectives A
Risk B
Objectives B
Risk C
Objectives C
PT. CATUR DAYA SOLUSI44
• Planning/implementing QMS changes (6.3),
• Controlling operational changes, planned and unintentional (8.1)
• Addressing unplanned changes affecting products & services (8.5.6)
• See also 7.1.6 Organizational knowledge - for addressing changing needs
and trends, with respect to knowledge
6.3. ‘Planning of Changes’
PT. CATUR DAYA SOLUSI45
Support
1.Resources
2.Competence
3.Awareness
4.Communication
5.Documented information7Q:2008 : 4.2, 5.5.1, 5.5.3, 6.1, 6.2, 6.3, 7.2.3
PT. CATUR DAYA SOLUSI46
7.1 Resources
Human resources - specialized skills and knowledge
Natural resources
Infrastructure - organization’s buildings, equipment,
underground tanks and drainage system
Technology and financial resources.
PT. CATUR DAYA SOLUSI47
7.1.6 Organizational knowledge
The organization shall determine the knowledge necessary for the operation of its
processes and to achieve conformity of products and services.
This knowledge shall be maintained and be made available to the extent
necessary.
When addressing changing needs and trends, the organization shall consider its
current knowledge and determine how to acquire or access any necessary
additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by
experience. It is information that is used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from
failures and successful projects; capturing and sharing undocumented knowledge and experience; the
results of improvements in processes, products and services);
b) external sources ( e.g. standards; academia; conferences; gathering knowledge from customers or
external providers).
PT. CATUR DAYA SOLUSI48
7. 2 Competency
The organization shall:
a) determine the necessary competence of person(s) doing work under
its control that affects its environmental performance and its ability to
fulfil its compliance obligations; person(s) doing work under its
control that affects the performance and effectiveness of the QMS
b) ensure that these persons are competent on the basis of appropriate
education, training or experience;
c) determine training needs associated with quality management
system;
d) where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken.
PT. CATUR DAYA SOLUSI49
7.3 Awareness
The organization shall ensure that persons doing work under the organization’s
control are aware of:
a) the quality policy;
b) their contribution to the effectiveness of the environmental management
system, including the benefits of enhanced quality performance; effectiveness
of QMS,
d) the implications of not conforming with the quality management system
requirements, including not fulfilling the organization’s compliance obligations
PT. CATUR DAYA SOLUSI50
Interaction
Job roles-Competency-Training-Promotion
Standard of
Competency
Level
Competency
Level
Measurement
Gap of
Competency
analysis
Training Need
Analysis
Company
Business
Planning
Training
Execution
Training
Effectiveness
Evaluation
Suggestion
from
Department
Training
Plan
Job Roles,
Responsibility
and Authority
Promotion &
Career
developmentImpact, Risk &
Opportunity
evaluation
result
Applicable
Legal
Organization
Structure
PT. CATUR DAYA SOLUSI51
7.4 Communication
Internal communication and
External communication
Equal treatment
Decide on communicating significant aspects
externally
Consistent and reliable communications
The organization shall determine the internal and external communications
relevant to the IMS management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
PT. CATUR DAYA SOLUSI52
7.5 Documented information
Focus on the implementation of the quality management
system and on quality performance, not on a complex
documented information control system.
Documented information does not require manual, and
may be integrated with other information management
systems implemented by the organization.
Documented information can include:
paper
electronic documents maintained on computers and
remote servers.
PT. CATUR DAYA SOLUSI53
Operation
1. Operational Planning and Control
2. Determination of market needs and interactions with customers
3. Operational planning process
4. Control of external provision of goods and services
5. Development of goods and services
6. Production of goods and provision of services
7. Release of goods and services
8. Nonconforming goods and services
9.
8Q : 6.4, 7.1, 7,3, 7.5.1, 7.5.2,
8.2, 8.3
PT. CATUR DAYA SOLUSI54
Operational Planning and Controls
Operational Planning and Controls should:
1. Plan, implement and control the processes (see 4.4) needed to meet
the requirements for the provision of products and services (QMS)
2. To implement the actions identified in 6.1 and 6.2, by:
– — establishing operating criteria for the process(es);
– — implementing control of the process(es), in accordance with the
operating criteria.
3. The organization shall control planned changes and review the
consequences of unintended changes, taking action to mitigate any
adverse effects, as necessary.
• The organization shall ensure that outsourced processes are
controlled or influenced. The type and extent of control or influence to
be applied to the process(es) shall be defined within the environmental
management system.
PT. CATUR DAYA SOLUSI55
Performance
Evaluation
1.Monitoring, measurement, analysis and
evaluation
2.Internal Audit
3.Management Review9Q: 2008 : 5.6, 8.2, 8.3, 8.4
PT. CATUR DAYA SOLUSI56
Performance evaluation
Determine
monitoring
required
Global performance
indicators
Performance
indicators specific to
an activity or piece of
equipment
Compliance
obligations
Commitment
confirmation
and authority to
act
Objectives
Evaluated
performance
Non-conformity
management
Results analysis
and performance
evaluation
Conformity
evaluation to
operational
requirements
“SO
LU
TIO
N F
OR
YO
UR
BU
SIN
ES
SINTERNAL AUDITS
Confirm:
QMS confirms to the requirements of the standard
QMS Properly implemented and maintained
QMS Effectiveness
Provide information to management
Identify opportunities for improvement
!!! Selection of auditors and conduct of audits shall ensure
objectivity and impartiality
PT. CATUR DAYA SOLUSI58
Management review
Involve Top Management
• Determine if QMS is
• Continuingly Suitable
• Adequate
• Effective
• Determine if QMS needs to be CHANGED
NEED:
- Management Review Schedule
- Documented Minutes
“SO
LU
TIO
N F
OR
YO
UR
BU
SIN
ES
SMANAGEMENT REVIEW
Previous actions/status
External/internal issues
N/C’s,corrective actions
Monitoring/Measurement
Audit results
Customer satisfaction
External providers
Adequacy ofresources
CONSIDER:
REVIEW
QMS performance
Risks andopportunities
Continual improvement (C.I)
Opportunities (C.I)
Changes to QMS
Resource needs
Doc. Information
WHAT NEEDSTO CHANGE?
! !
Communication
PT. CATUR DAYA SOLUSI60
Improvement
1.Nonconformity and corrective action
2.Continual Improvement10Q : 8.5.1, 8.5.2, 8.5.3
PT. CATUR DAYA SOLUSI61
Improvement: Nonconformity and
corrective action
PT. CATUR DAYA SOLUSI62
Nonconformity and corrective actions
“React” to the non-conformity:
Actions to control it
Deal with the “consequences
Eliminate the cause
Review
Determining their cause
Other similar nonconformities do or potentially could exist
Implement actions
Review the effectiveness
Changes if necessary to the QMS
63
• Summary
05
PT. CATUR DAYA SOLUSI64
Summary• Building process of organization based on organization needed
• New management system standard based on HLS
• Context organization to sustainability of organization
• Leadership engagement
• Planning including risk and opportunity and in aligned with objective, target
and program
• Support process deeper in organizational knowledge management,
managing of work environment, awareness, communication, and
documented information
• Operation: control all aspect influence quality to meet quality by clearly
determined requirement of process, proper operational control,
preservation and after services)
• Performance evaluation on QMS including quality performance,
achievement of target, management performance
• Improvement including control of NC
PT. CATUR DAYA SOLUSI65
Any Questions?
PT. CATUR DAYA SOLUSI66
TERIMA KASIH
PT. CATUR DAYA SOLUSIHead Office:
The CEO Building Level.12Jl. TB Simatupang No. 18c Jakarta 12430
Operasional Office:Kawasan Citragrand Blok R3 No 30, Jl. Alternatif Cibubur Km 3
Telp.021-84300011