Understanding of ISO 9001:2015
Agenda
Why Change to ISO 9001:2015
How to build QMS
Quality Awareness
Understanding requirements and implementation
Summary
01
02
03
04
•
Why Change
to ISO
9001:2015
• 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)Future Relevance of ISO 9001:2008
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 Input
For Future
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
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".
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
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.
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.
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.
•
How to Build
QMS?
Key terms and definitions
Management ?
“Coordinated activities to direct and
control an organization
”
Quality Management ?
“Management with regard to
quality
”
Quality Management System ?
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)
•
Questions:
2
0
Process Classification
Core Process/ Realization Process
Supporting Process
Interested Parties /Customers
Management Process
Interested Parties /Customers
Monitoring, Measure, Analysis
•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
•
Quality
•
Awareness
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 user
Joseph Moses Juran
(1904
–
2008)
•Quality mean customer satisfaction
Kaoru Ishikawa
(1915
–
1989)
• Degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)
Quality Management System Evolution
Quality Inspection
Quality Control
Q Performance
ZERO DEFECT
ZERO DEFECT CONTINUOSLY
ZERO DEFECT CONTINUOSLY & CUSTOMERS SATISFCATION
Quality Assurance
CUSTOMERS SATISFCATION CONSISTENTLY
QUALITY MANAGEMENT (ISO 9001:2008)
ZERO DEFECT CONTINUOSLY & INTERESTED PARTIES SATISFCATION
(ISO 9001:2015)
SUSTANAIBILITY
COMPLIANCE
ISO 9000 Series evolution
ISO 9001 historical change
1stedition :
ISO 9001:1987 ISO 9002:1987 ISO 9003:1987
2ndedition :
ISO 9001:1994 ISO 9002:1994 ISO 9003:1994
3rdedition :
ISO 9001:2000
4thedition :
ISO 9001:2008
BS 5750 Part 2:1979
5thedition :
•
Understanding
Requirements
and
implementation
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 Management System 5 Leadership Leadership and commitment Policy Roles, responsibilities and authorities 6 Planning Actions to address risk and opportunity
Quality objectives and planning to achieve them 7 Support Resources Competence Awareness Communication 8 Operation Operational planning and control Determination of market needs and interactions with customers
Operational planning process
Control of external provision 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
High Level Structure Process Flow – QMS ISO9001: 2015
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)
4
“SO LU TI O N F O R Y O U R B U S IN E S S Citizens Customers Distributors Shareholders Investors Owners Insurers Government Regulators Recovery service 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
4.1. Understanding the organization and its
context
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 GovernmentNon-governmental Communities
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.
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
Leadership
1.Leadership and Commitment 2.Policy
3.Organizational role, responsibility and authoritirs
5
5. Leadership
5.1. Leadership and commitment
Leadership and commitment for the quality management
system
Customer focus
5.2. Policy
5.3. Organizational roles,
5.2 Policy
provides a framework for setting objectives
appropriate to the purpose and context of the organization
communicated, understood
and applied within the documented informationmaintained as
Top management shall establish, implement and maintain an environmental policy
includes a commitment to fulfil its compliance obligations includes a commitment
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.
Planning
1.Actions to address risk and opportunities
2.QMS Objectives and planning to achived them
3.Planning Change
6
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 opportunities
Control It
Share or Transfer It
Risk
Management
Process Level
Activity Level
Risk Monitoring
Identification
Measurement
Risk
Assessment
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
Organization objectives progressing
Current Situation
OBJECTIVE AND EFFORT OF THE WHOLE
INSTITUTION
Future Situation
Risk Analysis
Vision
Mission
Risk A Objectives A
Risk B Objectives B
• 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
Support
1.Resources 2.Competence 3.Awareness 4.Communication
5.Documented information
7
7.1 Resources
Human resources - specialized skills and knowledge Natural resources
Infrastructure - organization’s buildings, equipment, underground tanks and drainage system
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
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
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
Interaction
Job roles-Competency-Training-Promotion
Standard of Competency Level Competency Level Measurement Gap of Competency analysis Training Need Analysis Company Business Planning Training Effectiveness Suggestion from Department Training Job Roles, Responsibility and Authority Promotion & Careerdevelopment Impact, Risk & Opportunity
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;
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
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
8
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
Performance
Evaluation
1.Monitoring, measurement, analysis and evaluation
2.Internal Audit
3.Management Review
9
Performance evaluation
Determine monitoring required Global performance indicators Performance indicators specific to an activity or piece ofequipment
Compliance obligations
Commitment confirmation
and authority to Objectives
“SO LU TI O N F O R Y O U R B U S IN E S S
INTERNAL 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
Management review
Involve Top Management
• Determine if QMS is
• Continuingly Suitable
• Adequate
• Effective
• Determine if QMS needs to be CHANGED
NEED:
“SO LU TI O N F O R Y O U R B U S IN E S S
MANAGEMENT REVIEW
Previous actions/ status External/ internal issues N/C’s, corrective actions Monitoring/ Measurement Audit results Customer satisfaction External providers Adequacy of resources CONSIDER: REVIEW QMS performance Opportunities (C.I)Changes to QMS
Resource needs
WHAT NEEDS TO CHANGE?
Improvement
1.Nonconformity and corrective action 2.Continual Improvement
10
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
•
Summary
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
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