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ISO 9001 2015 2008 Clause by Clause Matrix
ISO 9001 2015 2008 Clause by Clause Matrix
4.2 Understanding the needs and expectations No equivalent clause Organization’s interested parties include:
of interested parties Owner(s) – individuals, investment
Due to their effect or potential effect on the companies, corporate
organization’s ability to consistently provide ownership, stockholders
products and services that meet customer Employees
and applicable statutory and regulatory Regulators
requirements, the organization shall Customers
determine: Competitors
a) the interested parties that are relevant to Trade Associations
the quality management system; State and local business community
Owners
b) the requirements of these interested
Suppliers
parties that are relevant to the quality
management system. Neighbors
The organization shall monitor and review
information about these interested parties
and their relevant requirements.
5 Leadership
5.1 Leadership and commitment Top Management – new/now explicit
5.1.1 General 5.1 Management commitment commitments:
Top management shall demonstrate Top management shall provide evidence of Accountability for effectiveness
leadership and commitment with respect to its commitment to the development and Ensuring QMS achieves intended results
the quality management system by: implementation of the quality management Compatible with Strategic Direction of
a) taking accountability for the system and continually improving its organization
effectiveness of the quality effectiveness by Integration with business processes
management system; a) communicating to the organization the (interpreted in context of nature of
b) ensuring that the quality policy and importance of meeting customer as well organization – for profit; not for profit;
quality objectives are established for as statutory and regulatory private, public)
the quality management system and requirements,
b) establishing the quality policy,
are compatible with the context and
c) ensuring that quality objectives are
strategic direction of the organization;
established,
c) ensuring the integration of the quality d) conducting management reviews, and
management system requirements into e) ensuring the availability of resources.
the organization’s business processes;
d) promoting the use of the process
approach and risk-based thinking;
e) ensuring that the resources needed for
the quality management system are
available;
f) communicating the importance of
effective quality management and of
conforming to the quality management
system requirements;
g) ensuring that the quality management
system achieves its intended results;
h) engaging, directing and supporting
persons to contribute to the
effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management
roles to demonstrate their leadership
as it applies to their areas of
responsibility.
NOTE Reference to “business” in this
International Standard can be interpreted broadly
to mean those activities that are core to the
purposes of the organization’s existence, whether
the organization is public, private, for profit or not for
profit.
5.2 Policy
5.2.1 Developing the quality policy 5.3 Quality policy Policy ties to
Top management shall establish, implement Context of organization
and maintain a quality policy that: Top management shall ensure that the quality Strategic direction
a) is appropriate to the purpose and context policy
of the organization and supports its a)is appropriate to the purpose of the Review for continuing suitability was
strategic direction; organization, removed
b) provides a framework for setting quality b) includes a commitment to comply with
objectives; requirements and continually improve the Availability to interested parties added
effectiveness of the quality management
c) includes a commitment to satisfy
system,
applicable requirements;
c) provides a framework for establishing and
d) includes a commitment to continual reviewing quality objectives,
improvement of the quality management
d) is communicated and understood within the
system.
organization, and
5.2.2 Communicating the quality policy
e) is reviewed for continuing suitability.
The quality policy shall:
a) be available and be maintained as
documented information;
b) be communicated, understood and
applied within the organization;
c) be available to relevant interested
parties, as appropriate.
5.3 Organizational roles, responsibilities and
authorities 5.5.1 Responsibility and authority There is no longer a position of
Top management shall ensure that the Top management shall ensure that “management representative”
responsibilities and authorities for relevant responsibilities and authorities are defined There are now 5 responsibilities and
roles are assigned, communicated and and communicated within the organization. authorities that need to be assigned.
understood within the organization.
Top management shall assign the 5.5.2 Management representative
responsibility and authority for: Top management shall appoint a member
a) ensuring that the quality management of the organization's management who,
system conforms to the requirements of irrespective of other responsibilities, shall
this International Standard; have responsibility and authority that includes
b) ensuring that the processes are a) ensuring that processes needed for the
delivering their intended outputs; quality management system are
c) reporting on the performance of the established, implemented and
quality management system and on maintained,
opportunities for improvement (see 10.1), b) reporting to top management on the
in particular to top management; performance of the quality management
d) ensuring the promotion of customer system and any need for improvement,
focus throughout the organization; and
e) ensuring that the integrity of the quality c) ensuring the promotion of awareness of
management system is maintained customer requirements throughout the
organization.
when changes to the quality NOTE The responsibility of a management
management system are planned and representative can include liaison with external parties
implemented. on matters relating to the quality management system.
6 Planning
6.1 Actions to address risks and There is not a comparable clause in 2008
opportunities 5.4.2 Quality management system version; only the very general that planning
6.1.1 When planning for the quality planning of the QMS should meet the process
management system, the organization shall Top management shall ensure that approach requirements and quality
consider the issues referred to in 4.1 and the a) the planning of the quality management objectives
requirements referred to in 4.2 and determine system is carried out in order to meet the
the risks and opportunities that need to be requirements given in 4.1, as well as the This revision expects that the QMS
quality objectives, and addresses identified risks arising from the
addressed to:
b) the integrity of the quality management consideration of the context of the
a) give assurance that the quality system is maintained when changes to organization and the requirements of
management system can achieve its the quality management system are interested parties
intended result(s); planned and implemented.
b) enhance desirable effects; The context of the organization might lead to
c) prevent, or reduce, undesired effects; risks such as
d) achieve improvement. Product risks – FDA, DOT, EPA (examples
6.1.2 The organization shall plan: gas mileage requirements on vehicles;
a) actions to address these risks and product shipping risks-hazardous materials;
opportunities; vehicle lighting requirements; food and drug
b) how to: risks)
1) integrate and implement the actions
into its quality management system The requirements of interested parties may
processes (see 4.4); lead to risks identified during contract review
2) evaluate the effectiveness of these such as short delivery times or difficult
actions. product requirements or suppliers ability to
Actions taken to address risks and provide raw materials or components
opportunities shall be proportionate to the
potential impact on the conformity of products Most of our clients will identify risks during
and services. contract review and take actions such as
negotiating delivery dates or taking exception
NOTE 1 Options to address risks can include avoiding to product requirements or evaluating risks
risk, taking risk in order to pursue an opportunity, during design activities (especially design
eliminating the risk source, changing the likelihood or reviews, verification and validation) or
consequences, sharing the risk, or retaining risk by identifying risks when selecting and
informed decision. evaluating suppliers
NOTE 2 Opportunities can lead to the adoption of new
practices, launching new products, opening new markets,
addressing new clients, building partnerships, using new
technology and other desirable and viable possibilities to
address the organization’s or its customers’ needs.
7.1.2 People
The organization shall determine and provide
the persons necessary for the effective
implementation of its quality management
system and for the operation and control of
its processes.
7.1.3 Infrastructure 6.3 Infrastructure
The organization shall determine, provide The organization shall determine, provide
and maintain the infrastructure necessary for and maintain the infrastructure needed to
the operation of its processes and to achieve achieve conformity to product requirements.
conformity of products and services. Infrastructure includes, as applicable,
NOTE Infrastructure can include: a) buildings, workspace and associated
a) buildings and associated utilities; utilities,
b) equipment, including hardware and software; b) process equipment (both hardware and
c) transportation resources; software), and
d) information and communication technology. c) supporting services (such as transport,
communication or information systems).
7.1.4 Environment for the operation of
processes 6.4 Work environment
The organization shall determine, provide and The organization shall determine and manage
maintain the environment necessary for the the work environment needed to achieve Work environment as it applies to operation
operation of its processes and to achieve conformity to product requirements. of the processes as well as the product
conformity of products and services.
NOTE A suitable environment can be a NOTE The term “work environment” relates to
combination of human and physical factors, such as: those conditions under which work is performed
a) social (e.g. non-discriminatory, calm, non- including physical, environmental and other factors
confrontational); (such as noise, temperature, humidity, lighting or
b) psychological (e.g. stress-reducing, burnout weather).
prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise).
These factors can differ substantially depending on the
products and services provided.
7.3 Awareness
The organization shall ensure that persons 5.3 d Quality policy These awareness requirements were
doing work under the organization’s control 5.5.2 c dispersed in several clauses previously
are aware of: 6.2.2 d
a) the quality policy; Our clients should consider including
b) relevant quality objectives; questions related to these requirement in
c) their contribution to the effectiveness of their internal audits to help gage the
the quality management system, awareness of their personnel
including the benefits of improved
performance;
d) the implications of not conforming with
the quality management system
requirements.
8 Operation
8.1 Operational planning and control 7.1 Planning of product realization
The organization shall plan, implement and This planning clause now includes a change
control the processes (see 4.4) needed to The organization shall plan and develop the control requirement and a reference to clause 8.4
processes needed for product realization. for control of outsourced processes
meet the requirements for the provision of
products and services, and to implement the Planning of product realization shall be
actions determined in Clause 6, by: consistent with the requirements of the other
processes of the quality management system
a) determining the requirements for the (see 4.1).
products and services;
In planning product realization, the organization
b) establishing criteria for: shall determine the following, as appropriate:
1) the processes; a) quality objectives and requirements for the
2) the acceptance of products and product;
services; b) the need to establish processes and
c) determining the resources needed to documents, and to provide resources
achieve conformity to the product and specific to the product;
service requirements; c) required verification, validation,
d) implementing control of the processes in monitoring, measurement, inspection
accordance with the criteria; and test activities specific to the
e) determining and keeping documented product and the criteria for product
information to the extent necessary: acceptance;
1) to have confidence that the d) records needed to provide evidence that
processes have been carried out as planned; the realization processes and resulting
2) to demonstrate the conformity of product meet requirements (see 4.2.4).
products and services to their requirements. The output of this planning shall be in a form
NOTE “Keeping” implies both the maintaining and suitable for the organization's method of
the retaining of documented information. operations.
The output of this planning shall be suitable for NOTE 1 A document specifying the processes of the
the organization’s operations. quality management system (including the product
realization processes) and the resources to be applied to
The organization shall control planned
a specific product, project or contract can be referred to
changes and review the consequences of as a quality plan.
unintended changes, taking action to mitigate
any adverse effects, as necessary. NOTE 2 The organization may also apply the
The organization shall ensure that outsourced requirements given in 7.3 to the development of
processes are controlled (see 8.4). product realization processes.
8.2.4 Changes to requirements for Where product requirements are changed, the
products and services organization shall ensure that relevant
The organization shall ensure that relevant documents are amended and that relevant
documented information is amended, and that personnel are made aware of the changed
relevant persons are made aware of the requirements.
changed requirements, when the
requirements for products and services are NOTE In some situations, such as internet
changed. sales, a formal review is impractical for each
order. Instead the review can cover relevant
product information such as catalogues or
advertising material.
8.3 Design and development of products
and services 7.3 Design and development
8.3.1 General Clause introduction appears to require a
7.3.1 Design and development planning
The organization shall establish, implement design process
The organization shall plan and control the
and maintain a design and development
design and development of product. During
process that is appropriate to ensure the Sub-clauses for design review, design
the design and development planning, the
subsequent provision of products and verification and design validation were
organization shall determine
services. combined into a design control sub-clause
a) the design and development stages,
8.3.2 Design and development planning b) the review, verification and validation that
In determining the stages and controls for New explicit requirement to consider
are appropriate to each design and
design and development, the organization potential consequences of failure due to the
development stage, and
shall consider: nature of the products & services - an
c) the responsibilities and authorities for
aspect of risk identification in the design
a) the nature, duration and complexity of design and development.
process
the design and development activities;
b) the required process stages, including The organization shall manage the interfaces
applicable design and development between different groups involved in design
reviews; and development to ensure effective
c) the required design and development communication and clear assignment of
verification and validation activities; responsibility.
d) the responsibilities and authorities
Planning output shall be updated, as
involved in the design and development
appropriate, as the design and development
process;
progresses.
e) the internal and external resource
needs for the design and development of NOTE Design and development review, verification and
products and services; validation have distinct purposes. They can be
f) the need to control interfaces between conducted and recorded separately or in any
combination, as suitable for the product and the
persons involved in the design and
organization.
development process;
g) the need for involvement of customers
and users in the design and development
process;
h) the requirements for subsequent
provision of products and services;
i) the level of control expected for the
design and development process by
customers and other relevant interested
parties;
j) the documented information needed to
demonstrate that design and
development requirements have been
met.
8.3.3 Design and development Inputs 7.3.2 Design and development inputs
The organization shall determine the
Inputs relating to product requirements shall
requirements essential for the specific
be determined and records maintained (see
types of products and services to be
4.2.4). These inputs shall include
designed and developed. The organization
a) functional and performance requirements,
shall consider: b) applicable statutory and regulatory
a) functional and performance requirements,
requirements; c) where applicable, information derived from
b) information derived from previous previous similar designs, and
similar design and development d) other requirements essential for design
activities; and development.
c) statutory and regulatory requirements; The inputs shall be reviewed for adequacy.
d) standards or codes of practice that the Requirements shall be complete,
organization has committed to unambiguous and not in conflict with each
implement; other.
e) potential consequences of failure due to
the nature of the products and services.
Inputs shall be adequate for design and
development purposes, complete and
unambiguous. Conflicting design and
development inputs shall be resolved.
The organization shall retain documented
information on design and development
inputs.
8.3.4 Design and development controls 7.3.4 Design and development review
The organization shall apply controls to the At suitable stages, systematic reviews of
design and development process to ensure design and development shall be performed
that: in accordance with planned arrangements
a) the results to be achieved are defined; (see 7.3.1)
b) reviews are conducted to evaluate the a) to evaluate the ability of the results of
ability of the results of design and design and development to meet
development to meet requirements; requirements, and
c) verification activities are conducted to b) to identify any problems and propose
ensure that the design and development necessary actions.
outputs meet the input requirements; Participants in such reviews shall include
d) validation activities are conducted to representatives of functions concerned with
ensure that the resulting products and the design and development stage(s) being
services meet the requirements for the reviewed. Records of the results of the reviews
specified application or intended use; and any necessary actions shall be
e) any necessary actions are taken on maintained (see 4.2.4).
problems determined during the 7.3.5 Design and development verification
reviews, or verification and validation Verification shall be performed in accordance
activities; with planned arrangements (see 7.3.1) to
ensure that the design and development
f) documented information of these
outputs have met the design and development
activities is retained.
NOTE Design and development reviews, verification input requirements. Records of the results of
and validation have distinct purposes. They can be the verification and any necessary actions shall
conducted separately or in any combination, as is suitable be maintained (see 4.2.4).
for the products and services of the organization. 7.3.6 Design and development validation
Design and development validation shall be
performed in accordance with planned
arrangements (see 7.3.1) to ensure that the
resulting product is capable of meeting the
requirements for the specified application or
intended use, where known. Wherever
practicable, validation shall be completed
prior to the delivery or implementation of
the product. Records of the results of
validation and any necessary actions shall
be maintained (see 4.2.4).
8.3.5 Design and development outputs 7.3.3 Design and development outputs
The organization shall ensure that design and The outputs of design and development
development outputs: shall be in a form suitable for verification
a) meet the input requirements; against the design and development input
b) are adequate for the subsequent and shall be approved prior to release.
processes for the provision of products
and services; Design and development outputs shall
c) include or reference monitoring and a) meet the input requirements for design and
measuring requirements, as appropriate, development,
and acceptance criteria; b) provide appropriate information for
d) specify the characteristics of the purchasing, production and service
products and services that are essential provision,
for their intended purpose and their safe c) contain or reference product acceptance
and proper provision. criteria, and
The organization shall retain documented d) specify the characteristics of the product that
information on design and development are essential for its safe and proper use.
outputs. NOTE Information for production and service
provision can include details for the preservation
of product.
8.3.6 Design and development changes 7.3.7 Control of design and development
The organization shall identify, review and changes
control changes made during, or subsequent Design and development changes shall be
to, the design and development of products identified and records maintained. The
and services, to the extent necessary to changes shall be reviewed, verified and
ensure that there is no adverse impact on validated, as appropriate, and approved before
conformity to requirements. implementation. The review of design and
The organization shall retain documented development changes shall include evaluation
information on: of the effect of the changes on constituent
a) design and development changes; parts and product already delivered. Records
of the results of the review of changes and
b) the results of reviews;
any necessary actions shall be maintained
c) the authorization of the changes; (see 4.2.4).
d) the actions taken to prevent adverse
impacts.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and 8.2.3 Monitoring and measurement of
evaluation processes
9.1.1 General The organization shall apply suitable
The organization shall determine: methods for monitoring and, where
a) what needs to be monitored and applicable, measurement of the quality
measured; management system processes. These
b) the methods for monitoring, measurement, methods shall demonstrate the ability of
analysis and evaluation needed to ensure the processes to achieve planned results.
valid results; When planned results are not achieved,
c) when the monitoring and measuring shall correction and corrective action shall be
be performed; taken, as appropriate.
d) when the results from monitoring
and measurement shall be analysed NOTE When determining suitable methods, it
and evaluated. is advisable that the organization consider the
The organization shall evaluate the type and extent of monitoring or measurement
performance and the effectiveness of the appropriate to each of its processes in relation
quality management system. The organization to their impact on the conformity to product
shall retain appropriate documented requirements and on the effectiveness of the
information as evidence of the results. quality management system.
8.2.1 Customer satisfaction
9.1.2 Customer satisfaction As one of the measurements of the
The organization shall monitor customers’ performance of the quality management
perceptions of the degree to which their system, the organization shall monitor
needs and expectations have been fulfilled. information relating to customer
The organization shall determine the methods perception as to whether the organization
for obtaining, monitoring and reviewing this has met customer requirements. The
information. methods for obtaining and using this
NOTE Examples of monitoring customer information shall be determined.
perceptions can include customer surveys,
customer feedback on delivered products and NOTE Monitoring customer perception can
services, meetings with customers, market- include obtaining input from sources such as
share analysis, compliments, warranty claims customer satisfaction surveys, customer data
and dealer reports.
on delivered product quality, user opinion
surveys, lost business analysis, compliments,
warranty claims and dealer reports.
10 Improvement 8 Improvement
10.1 General 8.5.1 Continual improvement
The organization shall determine and select The organization shall continually improve Now need to select specific opportunities for
opportunities for improvement and implement the effectiveness of the quality management improvement and take actions
any necessary actions to meet customer system through the use of the quality
requirements and enhance customer policy, quality objectives, audit results,
satisfaction. analysis of data, corrective and preventive
actions and management review.
These shall include:
a) improving products and services to
meet requirements as well as to
address future needs and expectations;
b) correcting, preventing or reducing
undesired effects;
c) improving the performance and
effectiveness of the quality management
system.
NOTE Examples of improvement
can include correction, corrective
action, continual improvement,
breakthrough change, innovation and re-
organization.