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Transition change in ISO history

ISO 9001 : 2000 ISO 9001 : 2015


ISO ISO 9001 : Focused on ISO 9001 : 2008
9001:1987 Focused on managing &
1994 continual Only slight improving an
Focused on Still very rigid improvement, changes in organization. Risk lying at
manufacturi & focused on customer wording. No actual
ng & satisfaction, requirements were the heart of the
manufacturing standard (long term
documentati . leadership & added, removed or
on. process changed. success & customer
management. satisfaction.

Generally, ISO 9001:2015 highlighted :

 Risk-based standard
 New requirement in identifying risk and opportunities
 Focuses on planning (who are we & competitive environment)
 Change management
 Organizational knowledge (what are we learning previously)
 Participant of top management (leader of QMS)
 Disappearance of the term:
Document to Maintaining documented information
Record to Retaining documented information
ISO 9001 : 2008 ISO 9001 : 2015
4.1 Understanding the organization and its
context
 Completely new(not similar to any
clauses in 2008)
 Applied by asking question using
SWOT analysis
 External analysis (technologies,
competitor, environment)
 Internal analysis (what people
believe, values they bring to work,
culture)
4.2 Understanding the needs and
expectations of interested parties
 Completely new (not similar to any
clauses in 2008)
 Interested parties are anyone that
involved in company operation
 Example: customers, suppliers,
employees, owners, community,
schools & colleges, news media,
law enforcement.
 Communicate with them to identify
the parties and their expectations.
4.2.2 Quality manual 4.3 Determining the scope of the QMS
 The organization shall establish and  Similar to subclause 4.2.2 in ISO
maintain quality manual that 9001:2008, but more CRITICAL
includes the scope of QMS, the  SCOPE in previous ISO highlighted
documented procedures for the in single sentence, new ISO
QMS and a description of the SCOPE is an entire clauses.
interaction between the process of  Quality manual is no longer exist in
QMS. ISO 9001:2015.
 SCOPE of QMS must maintained
as documented information
(clauses 4.3 & defined the process
for QMS-clause 4.4)
4.1 QMS 4.4 Quality management system and its
 Implementation of QMS based on processes
quality policy and objectives.  Similar to clauses 4.1 in ISO 9001:
 Management shall plan and 2008, but more rigor implied.
communicate for both internal and  Inputs & outputs/ sequence &
external prospect of the interaction/ criteria & methods/
organization. resources/ authority & responsibility
/risk & opportunities/ evaluation/
improvement.
4.4.2 (No subclause)
 The organizational shall maintain
documented information to support
the operation of its processes
 The organizational shall retain
documented information to have
confidence that the processes are
being carried out as planned
5.1 Management Commitment 5.1 Leadership and commitment
 The organization shall communicate  Similar to clauses 5.1 in ISO 9001:
to meet the customer needs as well 2008, but new requirement added.
as statutory and regulatory  Previous ISO highlight 4 points, but
requirements. new ISO commit to these point.
 Establish the quality policy 1. Be accountable for the QMS
 Ensuring that quality objectives are 2. Make sure a quality policy &
established objectives are in place &
 Conducting management reviews consistent with the
 Ensuring the availability of organization’s strategy
resources 3. Advocate the process
approach & how risk affect
the business
4. Make sure that resources are
available for the functioning
QMS
5. Tell everybody how
important QMS is & why it’s
critical to conform to its
requirement
6. Make sure that the QMS
produces the expected
outcome
7. Show leadership in getting
employees involved in the
QMS
8. Encourage improvement
activities
9. Assist other managers in
showing QMS leadership

5.2 Customer focus 5.1.2 Customer Focus


 Top management shall ensure that  Similar to clauses 5.2 in ISO 9001:
customer requirement are 2008, with addition of risk &
determined and met. opportunities.
 It was mentioned in ISO 9001:2008,
but expanded more in 2015 with
four points.
 Top management will make sure
that customer requirements and
applicable statutory and regulatory
requirements are determined and
met.
 Top management will make sure
that risks and opportunities affecting
products, services and customer
satisfaction are determined and
acted upon.
 Top management will make sure
that the organization focuses on
creating customer satisfaction.
5.3 Quality policy 5.2 Policy
 Quality policy must be appropriate  Similar to clauses 5.3 in ISO 9001:
to the purpose of the organization 2008, with some minor addition.
 Includes a commitment to comply  Quality policy is compulsory to any
with the requirement organization to be plan, implement
 Provide a framework to establish and control by the top management.
 Communicating and understood
within the organization
 Reviewed for continuing suitability
5.2.1 Establishing the quality policy
 It was stated in ISO 9001:2015 that
quality policy reflects the top
management vision and to guide
the action on their employees.
 These policy must:
 Fits the organization’s purpose,
environment and strategy.
 Gives direction for determining
quality objectives.
 Commits to meeting applicable
requirements.
 Commits to continually improving
the QMS.
5.2.2 Communicating the quality policy
 The quality policy must be
accessible and documented.
 The quality policy must be shared
openly, comprehended by
employees and utilized within the
organization
 Be accessible to interested parties.
5.3 Organizational Roles, Responsibilities
and Authorities
5.5.1 Responsibility and authority  Similar to subclauses 5.5.1 and
 Top management shall ensure that 5.5.2 in ISO 9001: 2008, the MQR
responsibilities and authorities are term is vanished, but responsibility
defined and communicated within
remain.
the organization.
 Responsibility for making sure that
5.5.2 Management representative (MQR) the QMS meets ISO 9001:2015’s
 Top management shall appoint a requirement
member of the organization that has  Responsibility for making sure that
a responsibility to ensuring the processes produce effective output
process needed for QMS are  Responsibility for reporting on the
established, implemented and QMS and improvement
maintained. Report to the top opportunities to top management
management on the performance of  Responsibility for driving a
the QMS and ensuring the customer focus throughout the
promotion of awareness of company
customer requirement.  Responsibility for ensuring that the
QMS stays effective when changes
occur
6.1 Action to Address Risks and
Opportunities
6.1.1 (No subclauses tittle)-inspired by
subclauses 8.5.3 and 5.4.2.
 Implement risk management
 Risk and opportunities arises
from brainstorming
 Comprises from clauses 4.1
and 4.2, including corrective
action(removed nonconformity)

6.1.2 (No subclauses tittle)-action to


address these risk and opportunities.
 Documented the listed risk and
opportunities
 Must understand how it
connects to other parts of the
standard
 Some clauses involved are
4.1,4.2, 10.2.1(e),9.1.3(e),
9.3.2(e), 5.1.1(d),5.1.2(d),
4.4.1(f).

5.4.1 Quality objectives 6.2 Quality Objectives and Planning to


 Top management shall ensure that Achieve them
quality objectives are established  Similar to subclauses 5.4.1 in ISO
and consistent with the quality 9001: 2008, with addition of plan to
policy.
achieve objectives.
 Company shall outline the plans to
achieved the objectives (resources
required, time frame of completion,
personnel involve, etc)

6.2.1 (No subclauses title)-outline


specific requirement for objective
 Established throughout the
organization
 Supporting the quality policy
 Objectives must be quantifiable
 Consider applicable requirements
 Be appropriate for effective
products, services and customer
satisfaction
 Be checked on a routine basis
 Be shared and discussed
 Be revised as often as needed
 Document your quality objectives

6.2.2 (No subclauses title)-plan to


achieve objective
 What will be done
 What resources will be required
 Who will be responsible
 When it will be completed
 How the results will be
evaluated
6.3 Planning of Changes
 Purpose of change and their
potential consequences
 The integrity of the quality
management system
 The availability of resources
 The allocation or reallocation of
responsibilities and authorities
6.1 Provision of resources 7.1 Resources
 The organization shall determine 7.1.1 General
and provide resources needed to  Similar to clauses 6.1 of ISO
implement and maintained the 9001:2008
QMS .  The organization shall consider
 To enhance customer satisfaction the capabilities & constraint on
by meeting customer requirements. existing internal resources / what
needs to be obtained from
external provider.
6.2 Human resources 7.1.2 People
 Personnel performing work affecting  Similar to clauses 6.2 of ISO
conformity to product requirements 9001:2008
shall be competent on the basis of  The organizational shall
appropriate training, education, determine and provide the
skills and experiences. personnel for effective
implementation, operation and
control of its processes.

6.3 Infrastructure 7.1.3 Infrastructure


 The organization shall determine,  Similar to clauses 6.3 of ISO
provide and maintain the 9001:2008
infrastructure needed to achieved  Identify needed infrastructure
conformity to product requirement. and make it available
 Maintain infrastructure
 Preventive and predictive
maintenance

6.4 Work environment 7.1.4 Environment for the operation of


 The organization shall determine processes
and manage the work environment  Similar to clauses 6.4 of ISO
needed to achieve conformity to 9001:2008, and consider ;
product requirement.  Temperature and humidity
 Relates to the condition which work  Safety hazards
is performed including physical  Lighting, noise, vibration
environment.  Housekeeping
 Personal hygiene and behavior

7.1.5 Monitoring and measuring


resources
7.6 Control of monitoring and measuring 7.1.5.1 General
equipment  Similar to clauses 7.6 of ISO
 The organization shall determine
9001:2008, but with less
the monitoring and measurement to
be undertaken and the monitoring emphasis on calibration
and measuring equipment needed  Activities including calibration,
to provide evidence of conformity. verification, preventive
maintenance, breakdown
maintenance and repair, etc.
 Implied process on product,
process, environment and
measuring instruments.

7.1.5.2 Measurement traceability


 All the measuring equipment
shall be calibrated or verified at
specified intervals and the
process shall be retained as
documented information
 Identified to determine their
status
 Control from adjustment or
damage that would invalidate the
calibration status.

7.1.6 Organizational knowledge


 Completely new. No similarity
from previous version.
 The organization shall determine
the knowledge necessary for the
operation and this knowledge
shall be maintained and be made
available necessarily.
 Organizational knowledge is
generally gained by experience
based on internal and external
sources.

6.2 Human resources 7.2 Competence


 Divided into competence, training  Similar to clause 6.2 in ISO 9001 :
and awareness. 2008
 The organization shall determine  The word ‘training’ isn’t in the title of
the necessary competence for this clause because competencies
personnel doing work, applied, is define as a mix of education,
evaluate and maintain appropriate training, skills and experiences.
records of education, training, skills  Personnel involved are top
and experience. management, salaried personnel,
hourly personnel, supervisor and
managers, recent hires and etc.
 All competency program shall be
retained documented information.

6.2 Human resources 7.3 Awareness


 Divided into competence, training  Similar to clause 6.2 in ISO
and awareness. 9001:2008, with some minor
 The organization shall determine additions.
the necessary competence for  The organization shall ensure that
personnel doing work, applied, the employees are aware of the
evaluate and maintain appropriate quality policy, relevant quality
records of education, training, skills objectives, their contribution and the
and experience. implication of not conforming.
5.5.3 Internal communication 7.4 Communication
 Top management shall ensure that  Similar to clause 5.5.3 in ISO
appropriate communication 9001:2008, with new planning
processes are established within requirements.
the organization regarding the  The organization shall determine
QMS. the internal and external
communication relevant to the QMS

4.2.3 Control of documents 7.5 Documented information


 Document required by the QMS  Similar to clause 4.2.3 & 4.2.4 in
shall be controlled. ISO 9001:2008, with some minor
4.2.4 Control of records additions.
 Records shall remain legible,  Records the related documentation
readily identifiable and retrievable. plan and implementation.

8.1 Operational planning and control


 Similar to clause 7.1 in ISO
9001:2008
 The organization shall plan,
implement and control the process.
 Start with determining the
requirements for the products and
services
 establishing criteria for process and
the acceptance
 determining the resources needed
to achieve conformity to the product
and service requirements
 implementing control of the
processes in accordance with the
criteria
 determining, maintaining and
retaining documented information

8.2 Requirement for products and services


8.2.1 Customer communication
 Similar to clause 7.2.3 in ISO
9001:2008
 Communication with the customer
by providing information relating to
products and services, handling
enquires, obtaining customer
feedback, controlling customer
property and establish specific
requirement.
8.2.2 Determining the requirements for
products and services
 Similar to clause 7.2.1 in ISO
9001:2008
 The requirements for the products
and services are defined the
organization can meet the claims
for the products and services it
offers.

8.2.3 Review of the requirements for


products and services
 Similar to clause 7.2.2 in ISO
9001:2008
 The organization shall ensure that it
has the ability to meet the
requirements for products and
services to be offered to customers.

8.3 Design and development of products


and services
8.3.1 General
 Similar to clause 7.3 in ISO 9001:
2008
 The organization shall ensure that it
has the ability to meet the
requirements for products and
services to be offered to customers.
8.3.2 Design and development planning
 The organization shall consider the
nature of the design process, the
required process stage,
responsibilities and etc.
8.3.3 Design and development inputs
 The organization shall determine
the requirements essential for the
specific types of products and
services to be designed and
developed
8.3.4 Design and development control
 Control shall be applied to ensures
that the results to be achieved are
defined, verification and validation
are conducted and retained
documented information.
8.3.5 Design and developments output
 All the input requirement are met
and observed the subsequent
process to evaluate the output and
all the design and development
outputs are retained.
8.3.6 Design and development changes
 The organization shall identify,
review and control changes made
during, or subsequent to, the design
and development of products and
services, to the extent necessary to
ensure that there is no adverse
impact on conformity to
requirements.
8.4 Control of externally provided
processes, products and services
8.4.1 General
 Similar to clause 7.4.1 in ISO 9001:
2008
 The organization shall ensure that
externally provided processes,
products and services conform to
requirements.

8.4.2 Type and extent of control


 Similar to clause 7.4.1 & 7.4.3 in
ISO 9001: 2008
 The organization shall ensure that
externally provided processes,
products and services do not
adversely affect the organization’s
ability to consistently deliver
conforming products and services
to its customers.

8.4.3 Information for external providers


 Similar to clause 7.4.2 in ISO 9001:
2008
 The organization shall ensure the
adequacy of requirements prior to
their communication to the
external provider.
8.5 Production and service provision

8.5.1 Control of production and service


provision
 Similar to clause 7.5.1 & 7.5.2 in
ISO 9001: 2008
 The organization shall implement
production and service provision
under controlled conditions.

8.5.3 Property belonging to customers or


external provider
 Similar to clause 7.5.4 in ISO 9001:
2008, with addition supplier
property

8.5.4 Preservation
 Similar to clause 7.5.1 & 7.2.1 in
ISO 9001: 2008

8.6 Release of product and services


 Similar to clause 8.2.4 in ISO 9001:
2008

8.7 Control of nonconforming outputs


 Similar to clause 8.3 in ISO 9001:
2008

9 Performance Evaluation
9.1 Monitoring, measurement, analysis
8.1 The organization shall plan and and evaluation
implement the monitoring, analysis and 9.1.1 General
improvement processes needed  Similar to clause 8.1 in ISO
a) to demonstrate conformity to 9001:2008
product requirements.  The implementation steps start
b) to ensure conformity of the quality with determine what needs to be
management system, and monitored and measured.
c) to continually improve the  Then, start identify the methods
effectiveness of the quality for monitoring, measurement,
management system. analysis and evaluation.
d) This shall include determination of  Determined when will the
applicable methods, including monitoring and measurement be
statistical techniques. performed and when the results
can be analyzed and evaluated.
 Next, performance and
effectiveness of QMS are
evaluate and retain documented
8.2.1 Customer satisfaction information.
 As one of the measurements of the 9.1.2 Customer satisfaction
performance of the quality  Similar to clause 8.2.1 in ISO
management system, the 9001:2008
organization shall monitor  Can be observe from customer
information relating to customer surveys and feedback on
perception as to whether the delivered product and services,
organization has met. meeting with customers, market
share analysis, warranty claims
and dealer reports.

8.1 The organization shall plan and 9.1.3 Analysis and evaluation
implement the monitoring, analysis and  Similar to clause 8.1 in ISO
improvement processes needed 9001:2008
a) to demonstrate conformity to  It is closely related to subclauses
product requirements. 9.1.1
b) to ensure conformity of the quality  Some sources need to be
management system, and analyzed including conformity of
c) to continually improve the products and services, customer
effectiveness of the quality satisfaction, effectiveness of
management system. QMS, effectiveness of planning,
d) This shall include determination of action on risk and opportunities,
applicable methods, including performance of suppliers and
statistical techniques. subcontractors and need for
improvements to the QMS.

8.1 The organization shall plan and 9.2 Internal Audit


implement the monitoring, analysis and  Similar to clause 8.1 in ISO
improvement processes needed 9001:2008
a) to demonstrate conformity to
product requirements.
9.2.1 The organization shall conduct
b) to ensure conformity of the quality
internal audit at planned intervals to
management system, and
determined whether the QMS are:
c) to continually improve the
 Conforms to organization’s own
effectiveness of the quality
requirement for its QMS
management system.
 Effectively implemented and
d) This shall include determination of
maintained.
applicable methods, including
statistical techniques.
9.2.2 The organization shall plan,
establish, implement and maintain
audit program. Define the audit criteria
and scope for each audit. Select
auditors and conduct audits, ensure
that the results of the audit are reported
and take appropriate correction and
corrective action without delay.

5.6 Management review 9.3 Management Review


 Top management shall review  Similar to clause 5.6 in ISO
the organization’s quality 9001:2008, additional
management system, at planned requirement related to inputs
intervals, to ensure its continuing
 Including in management review
suitability, adequacy and
input and output to ensure
effectiveness.
continuing suitability, adequacy,
effectiveness and alignment with
the organization’s goal.
8.3 Control of nonconforming product 10 Improvement
 The organization shall ensure that 10.1 General
product which does not conform to  Similar to clauses 8.3 and
product requirements is 8.5.1 in ISO 9001:2008
identified and controlled to prevent  Including improving products
its unintended use or delivery. and services, correcting,
8.5.1 Continual improvement preventing or reducing
 The organization shall continually undesired effects. Also
improve the effectiveness of the improve QMS.
quality management system  Comprises of clauses 9.1.1,
through the use of the quality policy, 9.1.3, 9.3, 10.1 & 6.1.
quality objectives, audit results,
analysis of data, corrective
and preventive actions.

8.3 Control of nonconforming product 10.2 Nonconformity and Corrective Action


 The organization shall ensure that  Similar to 8.3 and 8.5.2 in ISO
product which does not conform to 9001:2008.
product requirements is
identified and controlled to prevent 10.2.1 When nonconformity occurs, the
its unintended use or delivery. organization shall:
 React to nonconformity
8.5.2 Corrective action  Evaluate the action needed
 The organization shall take action to  Implement any action needed
eliminate the causes of  Review the effectiveness
nonconformities in order to prevent  Update risk & opportunities
recurrence. determined during planning
 Corrective actions shall be  Make necessary change
appropriate to the effects of the
nonconformities encountered. 10..2.2 The organization shall retain
documented information as evidence
 To identify the potential cause of
problems
 Measure the results of any
corrective action

8.5.1 Continual improvement 10.3 Continual improvement


 The organization shall improve the  Similar to subclauses 8.5.1 in ISO
effectiveness of the QMS through 9001:2008
quality policy, objectives, audit  Examine the results of analysis and
results, corrective and preventive evaluation (subclauses 9.1.3 &
action. clauses 9.3).

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