QS-9000 QUALITY SYSTEM REQUIREMENTS

Report
ISO 9001: 2008
AUDITING
Module 2 –
A Review of
ISO 9001:2008
Requirements
Note: Standards and the comments of this section will be
reviewed together. This is not an exact copy of the
standard.
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ISO 9001-2000 Review Module 2
ISO 9001:2000 Breakdown
0
Introduction
1
Scope
2
Normative
Reference
3
Terms and
Definitions
0.1 General
0.2 Process
Approach
0.3
Relationship
with ISO 9004
1.1 General
1.2
Application
0.4
Compatibility
with Other
Mgmt.
Systems
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ISO 9001-2000 Review Module 2
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ISO 9001:2000 Breakdown
4
Quality
Mgmt.
System
5
Mgmt.
Responsibility
6
Resource
Mgmt.
7
Product
Realization
4.1 General
Requirements
5.1 Mgmt
Commitment
6.1 Provision of
Resources
7.1 Planning of
Product Realization
4.2 Documentation
Requirements
5.2 Customer Focus
6.2 Human
Resources
7.2 CustomerRelated Processes
6.3 Infrastructure
7.3 Design And
Development
5.3 Quality Policy
5.4 Planning
5.5 Responsibility,
Authority &
Communication
6.4 Work
Environment
5.6 Mgmt. Review
7.4 Purchasing
8
Measurement,
Analysis, &
Improvement
8.1 General
8.2 Monitoring &
Measurement
8.3 Control of NonConforming Product
8.4 Analysis of Data
8.5 Improvement
7.5 Production &
Service Provision
7.6 Control of
Monitoring & Meas.
Devices
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O
Introduction
0.2 Process Approach (see Process Model in Section 3)
–
–
–
–
–
This standard promotes a process approach for development, implementation,
and improving system effectiveness, as well as enhancing customer satisfaction
by meeting customer requirements
Requires an organization to Determine and manage numerous linked activities.
An activity or set of activities using resources and managed to enable
transformation of input into outputs is considered a process
Identification and interactions of these processes as a system is considered the
‘process approach’ as it provides linkage between the individual processes and
the overall system and their combination
Emphasizes the importance of
a) Understanding and meeting of the requirements
b) The need to consider processes in terms of added value
c) Obtaining results of process performance and effectiveness
d) Continual improvement of processes based on objective
measurement
The model of a process-based QMS is shown in Figure 1, section 3
illustrates process linkages presented in clauses 4 to 8.
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O
Introduction
0.3 Relationship with ISO 9004
– ISO 9001 and ISO 9004 have been developed as a ‘consistent pair’
designed to complement one another, but can be used
independently; different scopes, but similar structure
– ISO 9001 specifies requirements to use for internal applications by
organizations, for certification or for contractual purposes, focusing
on QMS effectiveness in meeting customer requirements
– ISO 9004 provides guidance on a wider range of objectives of a
QMS than ISO 9001, particularly for continual improvement of the
organizations overall performance and efficiency as well as
effectiveness. It is designed to help an organization to move
beyond the requirements of ISO 9001 in pursuit of continual
improvement of performance, but is not for certification or
contractual purposes.
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1 Scope
1.2 Application
– All requirements of ISO 9001 are considered generic and are
intended to be applicable to all organization, regardless of type,
size and product
– Any requirements that cannot be applied due to the nature of an
organization and its product can be considered for exclusion
– Any exclusions made cannot be considered as conforming to the
standard unless they are limited to clause 7 where they do not
affect the ability or responsibility of the organization to provide
product that meets customer and applicable regulatory
requirements
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2
Normative Reference
Reference standard
ISO 9000: 2005 Quality Management Systems- Fundamentals and
vocabulary.
2008 version is not available.
ISO 9004: 2005 (2008 is not available)
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3
Terms & Definitions
 Terms and definitions are to be reviewed
 The terms to describe the supply chain:
2000 Standard:
SUPPLIER
ORGANIZATION
CUSTOMER
(Interested Parties)
1994 Standard:
SUBCONTRACTOR
SUPPLIER
CUSTOMER
Wherever the term “product” occurs, it can also mean “service”.
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ISO 9001:2008
The changes to the standard are in blue lettering.
Some word changes and notes added, no new requirements have
been added.
The changes are meant to help clarify the ISO requirements.
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4 Quality Management System
4.1 General Requirements
Organization establishes, documents, implements, maintains, and
continually improves QMS
– The organization shall;
a) determine the processes needed and their application
throughout the organization
b) Determine the sequence and interaction of processes
c) criteria and methods to ensure effective operation and
control
d) Ensure resource and information availability to support the
operation and monitoring of processes
e) Monitor, measure where applicable and analyze processes
f) Implement actions to obtain planned results and continual
improvement
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4 Quality Management System
4.1
General Requirements (continued)
– Where an organization chooses to outsource any process that affects
product conformity with requirements, the organization shall ensure control
over such processes. The type and extent of control to be applied to these
outsourced processes shall be defined within the quality management
system
NOTE 1: Processes needed for the QMS referred to in this slide should
include processes for management activities, provision of resources,
product realization and measurement, analysis and improvement.
NOTE 2: An outsourced process is a process that the organization needs for
the quality management system and which the organization chooses to
have performed by an external party.
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4 Quality Management System
 4.1 Continued:
NOTE 3: Ensuring control over outsourced processes does not
absolve the organization from its responsibility of conformity to
all customer, statutory and regulatory requirements. The type
and extent of control to be applied to the outsourced process
can be influenced by factors such as:
a.) the potential impact of the outsourced process on the
organizations capability to provide product that conforms to
requirements
b.) the degree to which the control for the process is shared
c.) the capability of achieving the necessary control through the
application of 7.4
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Explanation of 4.1
 Leading and operating an organization requires its successful
management in a systematic and visible manner; resulting from the
implementation and maintenance of a QMS that has been designed to
continually improve its performance.
 Organizations need to become customer-oriented by defining its
systems and processes and clearly communicating for effective
understanding, management and improvement.
 Performance is based on measures and data developed for the
effective and efficient operation and control of processes
 Examples of activities to create a customer-oriented process:
– Defining and promoting processes for organizational
performance toward continual improvement
– Acquiring and using process data regularly
– Using self assessments and management review to evaluate
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4 Quality Management System
4.2 Documentation Requirements
4.2.1 General
–
QMS documentation shall include;
a) Quality Policy and Quality Objectives
b) Quality Manual
c) Procedures and records required by ISO 9001: 2000
d) Documents and records shall be determined by the
organization to ensure effective planning, operation and
control of its processes
– Extent of QMS dependent on size of organization, type of
activities, complexity and interaction of the processes and the
competence of personnel
NOTE 1: “Documented Procedure” means that the procedure is
established, documented, implemented & maintained. A single
document may address the requirements of one or more procedures.
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4 Quality Management System
4.1 Note 1 continued; A requirement for a documented procedure
may be covered by more then one document.
NOTE 2: The extent of the QMS documentation can differ from one
organization to another due to:
a.) the size of the organization and type of activities
b.) the complexity of the processes and their interface
c.) the competence of personnel
NOTE 3: The documentation can be in any form or type of media
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4 Quality Management System
4.2.2 Quality Manual
–
The Quality Manual shall be established and maintained,
including;
• The scope of QMS, with details of and justifications for any
exclusions
– Permissible exclusions may be required where certain
functions are absent e.g. Design & Development,
Servicing, Customer Property, etc.
This is excluded only from Element 7 : Product
Realization.
• The documented procedures or reference to them
• A description of the interaction between the processes of QMS
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4 Quality Management System
4.2.3 Control of Documents
–
–
Documents required by the QMS shall be controlled. Records
shall be controlled per the requirements given in 4.2.4.
Documented procedures shall be established to define the
controls needed for the:
a) Approval for adequacy prior to issue,
b) Review, update and re-approve documents,
c) To ensure changes and the current revisions status of
documents are identified,
d) Ensure relevant versions of applicable documents are
available at points of use,
e) Documents remain legible and readily identifiable
f) Ensure that documents of external origin determined by the
organization to be necessary for the planning and operation
of the QMS are identified and their distribution controlled.
g) Prevent unintended use of obsolete documents & apply
suitable identification to them if they are retained for any
purpose
17
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4 Quality Management System
4.2.4 Control of Records
Records shall be established and maintained to provide evidence of
conformity to requirements and of the effective operation of the QMS
shall be controlled
Records shall remain legible, readily identifiable, and retrievable
Records shall be established to define the controls needed for the:
• Identification,
• Storage,
• Protection,
• Retrieval,
• Retention Time, and
• Disposition of Records
Documented procedure is required
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5 Management Responsibility
5.1 Management Commitment
Top Management shall provide evidence of its commitment to the
development and implementation of the QMS and continually
improving its effectiveness by;
a) Communicating to the organization the importance of
meeting customer as well as statutory and regulatory
requirements,
b) Establishing the Quality Policy,
c) Ensuring quality objectives are established,
d) Conducting Management Reviews, and
e) Ensuring the availability of resources
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Explanation of 5.1
Management should consider:
– Establishing vision, mission, policies, and strategy consistent with
the organization’s purpose
– Leading by example to develop trust
– Communicating direction, objectives and values to all
– Participating in improvement projects and programs
– Obtaining feedback from all stakeholders
– Identify processes that provide added value and the support
processes that influence the effectiveness and efficiency of the
realization processes
– Create an environment to build involvement and development of
people
– Provide the structure and resources to support the goals and plans
– Determine the measures for performance to gage success
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5 MANAGEMENT RESPONSIBILITY
 5.2 Customer Focus
– Top management shall ensure customer needs and expectations
are determined and met with the aim of enhancing customer
satisfaction
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Explanation of 5.2








Determine the interested parties
• Customers, end users
• People within the organization
• Owners, bankers, investors, public sector/community, unions
• Suppliers, partners
• Society affected by the organization or its products
Understand the needs and expectations of the customer (internal and
external)
Translate needs into requirements
Identify and assess competition and market opportunities
Identify resources and develop programs to maintain them
Determine the potential benefits of supplier partnerships
Consider relationships with suppliers
Understand and apply statutory and regulatory requirements
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5 Management Responsibility
5.3 Quality Policy
–
Top management shall ensure that the Quality Policy:
a) Is appropriate to the purpose of the organization,
b) Includes commitment to comply with requirements and
continually improve the effectiveness of the QMS,
c) Provides a framework for establishing and reviewing quality
objectives,
d) Is communicated and understood within the organization,
and
e) Is reviewed for continuing suitability.
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5 Management Responsibility
5.4 Planning
5.4.1 Quality Objectives
– Top management shall ensure that quality objectives, including
those needed to meet requirements for product (see 7.1a) are
established at relevant functions and levels within the organization.
These quality objectives shall be measurable and consistent with
the Quality Policy.
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5 Management Responsibility
5.4.2 Quality Management System Planning
– Top Management shall ensure that
a. the planning for the QMS is carried out to meet the requirement
given in 4.1 as well as quality objectives, and
b. Integrity of system is maintained when changes are planned and
implemented to the QMS
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5 Management Responsibility
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
–
Top management shall ensure that the responsibilities and
authorities are defined and communicated within the organization.
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5 Management Responsibility
5.5.2
–
Management Representative
Top management appoints a member of the organizations
management who shall have responsibility & authority that
includes:
a) Ensuring processes for QMS are established, implemented
and maintained,
b) Reporting to top management on performance on QMS and
any need for improvement, and
c) Ensuring the promotion of awareness of customer
requirements throughout the organization
Note: The responsibility of the management representative can
include liaison with external parties on matters relating to the
QMS
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5 Management Responsibility
5.5.3
–
Internal Communication
Top management shall ensure that appropriate communication
processes are established within the organization and that
communication takes place regarding the effectiveness of the
QMS.
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Explanation of 5.5.3



Define and communicate the responsibility and authority for maintaining
the system
Appoint Management Representative and provide appropriate authority
Define and implement the process to communicate the policies,
requirements, objectives, and accomplishments
– Meetings, recognition programs, postings, surveys, etc.
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5 Management Responsibility
5.6 Management Review
5.6.1 General
– Top management shall review the organization’s QMS, at planned
intervals, to ensure its continuing suitability, adequacy and
effectiveness
– Management Review shall include assessing opportunities for
improvement and the need for changes to the QMS, including the
Quality Policy and Quality Objectives.
– Records from Management Reviews shall be maintained (see
4.2.4).
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5 Management Responsibility
5.6.2
–
a.
b.
c.
d.
e.
f.
g.
Review Input
Includes
audit results,
customer feedback,
process performance, product conformity,
status of preventive and corrective actions,
follow-up actions from previous reviews;
changes that could affect the QMS;
improvement recommendations
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5 Management Responsibility
5.6.3
–
Review Output
The output from the Management Review shall include any
decisions and actions related to:
a) Improvement of the effectiveness of the QMS and its
processes,
b) Improvement of product related to customer requirements,
and
c) Resource needs.
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Explanation of 5.6




Management Review should be developed as a tool to go beyond the
requirements and provide a constant opportunity to make the system
more efficient and effective
A platform to exchange input, ideas, discuss and evaluate the system
and the business in an open format
Frequency is determined by the needs of the organization
Use the output from Reviews as a springboard toward improvement
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6 Resource Management
6.1 Provision of Resources
– The organization shall determine and provide the resources
needed to:
a) implement, maintain and continually improve the
effectiveness of the quality management system
b) To enhance customer satisfaction by meeting
customer requirements
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Explanation of 6.1 Provision of Resources


Identify resources and make available to process performers
– People
– Infrastructure
– Work environment
– Information
– Suppliers
– Partners
– Natural resources
– Financial
Consider what is needed to improve the organization
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6 Resource Management
6.2 Human Resources
6.2.1 General
Personnel performing work affecting conformity to product
requirements shall be competent on the basis of appropriate
education, training, skills and experience.
NOTE; conformity to product requirements can be affected directly or
indirectly by personnel performing any task within the QMS.
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6 Resource Management
6.2.2 Competence, Training & Awareness
– The organization shall:
a) determine the necessary competence for personnel performing
work affecting product quality,
b) where applicable provide training or take other actions to
achieve the necessary competence
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to the
achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and
experience (see 4.2.4)
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6 Resource Management
6.3 Infrastructure
– The organization shall determine, provide and maintain the
infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable;
a. Buildings, workspace and associated utilities
b. Process equipment (both hardware and software), and
c. Support services (such as transport and communication or
information systems)
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6 Resource Management
6.4 Work Environment
– Determine and manage the work environment needed to achieve
conformity to product requirements
NOTE: the term work environment relates to those conditions under
which work is performed including physical, environment and other
factors (such as noise, temperature, humidity, lighting or weather)
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Explanation of 6.4
Ensure environment has a positive influence on the people:








Open doors, creative thinking, positive attitude
Safety rules and guidance
Ergonomics
Workplace location
Social interaction
Facility
Utilities
Physical environment
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7 Product Realization
7.1 Planning of Product Realization
-- The organization shall plan and develop the processes needed for
product realization. Planning of product realization shall be consistent
with the requirements of the other processes of the QMS (see 4.1)
-- In planning product realization, the organization shall determine the
following, as appropriate:
a) Quality objectives and requirements for the product;
b) The need to establish processes and documents and to provide
resources specific to the product;
c) Required verification, validation, monitoring, measurements,
inspection, and test activities specific to the product and the
criteria for product acceptance;
d) Records needed to provide evidence that the realization
processes and resulting product meet requirements (see 4.2.4)
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7 Product Realization
7.1 Planning of Product Realization
--The output of this planning shall be in a form suitable for the
organization’s method of operations.
NOTE 1: A document specifying the processes of the QMS (including
product realization processes) and the resources to be applied to a
specific product, project or contract, can be referred to as the quality
plan.
NOTE 2: The organization may also apply the requirements given in 7.3 to
the development of product realization processes.
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Explanation of 7.1






Driven by the need for continual improvement
Define the outputs of core processes as well as the necessary inputs
and activities required for efficient and effective achievement
Define the interrelationships of processes
Consider verification and validation activities
Procedures should document processes necessary to support effective
and efficient system operation
Process should considered performers for skills, safety, coordination of
processes, review of process performance and potential for innovation
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7 Product Realization
7.2 Customer Related Processes
7.2.1 Determination of Requirements Related to the Product
--The organization shall determine
a. Requirements specified by customer including delivery and
post-delivery activities,
b. Requirements not stated by the customer but necessary for the
specified or intended use where known and,
c. Statutory and regulatory requirements applicable to the
product, and
d. Any additional requirements considered necessary by the
organization
NOTE: Post delivery activities include, for example, actions under
warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as
recycling or final disposition.
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7 Product Realization
7.2.2 Review of Requirements Related to the Product
–
Organization shall review the requirements related to the product.
This review shall be conducted prior to the organization’s
commitment to supply a product to the customer (e.g. submission
of tenders, acceptance of contracts or orders, acceptance of
changes to contracts or orders) and shall ensure that:
a) Product requirements are defined,
b) Contract or order requirements differing from those
previously expressed are resolved, and
c) Organization has the ability to meet the defined requirements
Records of the results of the review and actions arising from the
review shall be maintained. (4.2.4)
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7 Product Realization
7.2.2 Review of Requirements Related to the Product (cont.)
– Records of the Review and actions arising from the review shall be
maintained
– Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed by the
organization before acceptance
– Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that relevant
personnel are made aware of the changed requirements.
NOTE: In some situations, such as internet sales, a formal review is
impractical for each order. Instead the review can cover relevant
product information such as catalogues or advertising material.
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7 Product Realization
7.2.3 Customer Communication
– Determine and implement effective arrangements for customer
communication in relation to:
a) Product information
b) Enquiries, contracts or order handling (including
amendments)
c) Customer feedback, including complaints
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Explanation of 7.2



Define the mutually acceptable processes to communicate efficiently
and effectively with all interested parties
Implement and maintain processes to ensure the understanding of
needs and expectations as well as translating requirements for the
organization
Understand the impact of the processes before initiating action; assure
its mutual acceptability
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7 Product Realization
7.3 Design and Development
7.3.1 Design and Development Planning
-- The organization shall plan and control the design and
development of product.
--During the design and development planning, the organization
shall determine
a) The design and development stages,
b) The review, verification and validation that are appropriate to
each design and development stage, and
c) The responsibilities and authorities for design and
development.
--The organization shall manage the interfaces between different
groups involved in design and development to ensure effective
communication and clear assignment of responsibility.
--Planning output shall be updated, as appropriate, as the design
and development progresses.
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7 Product Realization
7.3.1 continued:
NOTE: Design and development review, verification and validation
have distinct purposes. They can be conducted and recorded
separately or in any combination, as suitable for the product and
the organization.
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7 Product Realization
7.3.2 Design/Development Inputs
–
Inputs relating to product requirements shall be determined and
records maintained (see 4.2.4). These inputs shall include:
a) Functional and performance requirements,
b) Applicable statutory and regulatory requirements,
c) Where applicable, information derived from previous designs,
and
d) Other requirements essential for design and development.
--
The inputs shall be reviewed for adequacy. Requirements shall
be complete, unambiguous and not in conflict with each other.
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7 Product Realization
7.3.3 Design/Development Outputs
–
–
Outputs shall be provided in a form suitable for verification
against the design and development input and shall be approved
prior to release
Design and Development Outputs shall:
a) Meet input requirements for design and development
b) Provide appropriate information for production and service
provision
c) Contain or reference product acceptance criteria
d) Specify product characteristics essential to safe and proper
use
NOTE: Information for production and service provision can
include details for the preservation of product.
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7 Product Realization
7.3.4 Design/Development Review
-- At suitable stages, systematic reviews of design and development
shall be performed in accordance with planned arrangements (see
7.3.1) to:
a) Evaluate the ability of results of design and development to
meet requirements, and
b) Identify any problems and propose necessary actions
-- Participants in such reviews shall include representatives of
functions concerned with the design and development stage(s)
being reviewed. Records of the results of the reviews and any
necessary actions shall be maintained (see 4.2.4)
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7 Product Realization
7.3.5 Design/Development Verification
–
–
Verification shall be performed in accordance with planned
arrangements (see 7.3.1) to ensure design and development
outputs have satisfied the design and development input
requirements
Records of the results of the verification and any necessary
actions shall be maintained ( see 4.2.4)
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7 Product Realization
7.3.6 Design/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 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)
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7 Product Realization
7.3.7 Control of Design/Development Changes
–
–
–
–
Design and development changes shall be identified and records
maintained
Changes shall be reviewed, verified, validated (as appropriate),
and approved before implementation
Review of design and development changes shall include
evaluation of the effect of the changes on constituent parts and
product already delivered.
Records of the results of the review of changes any necessary
actions shall be maintained (see 4.2.4)
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7 Product Realization
7.4 Purchasing
7.4.1 Purchasing Process
–
–
Ensure purchased product conforms to specified requirements—
type and extent of control applied shall be dependent on the
effect of the purchased product on subsequent product realization
or the final product
Suppliers shall be evaluated and selected based on their ability to
supply to the organization’s requirements;
a) Criteria for selection, evaluation and re-evaluation must be
established
b) Records of this evaluation shall be maintained (4.2.4)
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7 Product Realization
7.4.2 Purchasing Information
–
Information shall describe the product to be purchased including
(as appropriate):
a) Approval requirements for product, procedures, processes,
equipment
b) Qualification requirements of personnel
c) Quality management system requirements
Specified purchase requirements shall be ensured for adequacy
prior to communication to supplier
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7 Product Realization
7.4.3 Verification of Purchased Product
–
–
The organization shall establish and implement the inspection or
other activities necessary for ensuring that purchased product
meets specified purchase requirements.
Where the organization or its customer intends to perform
verification at the supplier’s premises, the organization shall state
the intended verification arrangements and method of product
release in the purchasing information.
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7 Product Realization
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
–
Provisions for production and service shall be carried out under
controlled conditions including:
a) Availability of information describing product characteristics
b) Availability of work instructions as necessary
c) Use of suitable equipment
d) Availability and use of monitoring and measuring equipment
e) Implementation of monitoring and measurement
f) Implementation of product release, delivery, and postdelivery activities
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7 Product Realization
7.5.2 Validation of Processes for Production and
Service Provision
–
–
–
Any processes for production and service provision where the
resulting output cannot be verified by subsequent monitoring
or measurement and as a consequence deficiencies become
apparent only after product is in use or the service has been
delivered
Demonstrate that the processes have the ability to achieve
the desired results
Establish arrangements for these processes including:
a) Defined criteria for review and approval of processes
b) Equipment approval and personnel qualification
c) Use of specific methods and procedures
d) Record requirement (4.2.4)
e) Revalidation
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7 Product Realization
7.5.3 Identification and Traceability
–
Where appropriate, the organization shall identify product by suitable
means throughout product realization
– The organization shall identify product status with respect to
monitoring and measuring requirements
– Where traceability is a requirement, the organization shall control and
record unique identification of the product and maintain records
(4.2.4)
NOTE: In some industry sectors, configuration management is a means
by which identification and traceability are maintained.
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7 Product Realization
7.5.4 Customer Property
–
–
Exercise care and identify, verify, protect and safeguard customer
property for use or incorporation into product while under control of
organization
Damaged, lost or unsuitable for use. The organization shall report to
the customer and records of occurrence are maintained (4.2.4)
Note: Customer property can include intellectual property. And personal
data
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7 Product Realization
7.5.5 Preservation of Product
–
The organization shall preserve the product during internal
processing and delivery to the intended destination in order to
maintain conformity to requirements. As applicable, preservation shall
include identification, handling, storage and protection. Preservation
shall also apply to the constituent parts of a product.
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Explanation of 7.5
Go beyond realization to achieve both compliance to requirements and
provide benefit to interested parties by:
– Training employees
– Communicating and recording information
– Reducing waste
– Developing suppliers
– Improving infrastructure and environment
– Monitor processes and prevent problems
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7 Product Realization
7.6 Control of Monitoring and Measuring Equipment
–
–
The organization shall determine the monitoring and
measurement to be taken and the monitoring and measuring
equipment needed to provide evidence of conformity of product
to determined requirements (see 7.2.1).
The organization shall establish processes to ensure that
monitoring and measurement can be carried out and are carried
out in a manner that is consistent with the monitoring and
measurement requirements.
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7 Product Realization
7.6 Control of Monitoring and Measuring Devices
–
Where necessary to ensure valid results, measuring equipment
shall:
a)
b)
c)
d)
e)
Be calibrated or verified or both at specified intervals, or prior to
use, against measurement standards traceable to international
or national measurement standards; where no such standards
exist, the basis used for calibration or verification shall be
recorded; (4.2.4)
Be adjusted or re-adjusted as necessary;
Have identification in order to determine its calibration status;
Be safeguarded from adjustments that would invalidate the
measurement result;
Be protected from damage and deterioration during handling,
maintenance and storage.
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7 Product Realization
7.6 Control of Monitoring and Measuring Devices (cont.)
–
The organization shall assess and record the validity of previous
measuring results when the equipment is found not to conform to
requirements. The organization shall take appropriate action on
the equipment and any product affected. Records of the results
of the calibration and verification shall be maintained (see 4.2.4).
– When used in the monitoring and measuring of specified
requirements, the ability of computer software to satisfy the
intended application shall be confirmed. This shall be undertaken
prior to initial use and reconfirmed as necessary. (see ISO
10012-1 and ISO 10012-2 for guidance)
Note: Conformation of the ability of computer software to satisfy the
intended application would typically include the verification and
configuration management to maintain its suitability for use.
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8 Measurement, Analysis &
Improvement
8.1 General
–
–
Processes for monitoring, measurement, analysis and improvement
shall be planned and implemented to:
a) Demonstrate conformity to product requirements
b) Ensure conformity of QMS
c) Continually improve QMS effectiveness
Includes determining applicable methods (including statistical
techniques) and the extent of their use
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8 Measurement, Analysis &
Improvement
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
–
As one of the measurements of the performance of the QMS, the
organization shall monitor information relating to customer perception as
to whether the organization has met customer requirements. The
methods for obtaining and using this information shall be determined.
Note: Monitoring customer perception can include obtaining input from
sources such as customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost business analysis,
compliments, warranty claims and dealer reports.
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8 Measurement, Analysis &
Improvement
8.2.2 Internal Audit
–
–
–
–
The organization shall conduct internal audits at planned intervals to
determine whether the QMS
a) Conforms to the planned arrangements (see 7.1), to the
requirements of ISO9001 and to the QMS requirements of the
organization, and
b) Is effectively implemented and maintained
Audit programs shall be planned, taking into consideration the status
and importance of the processes and the areas to be audited as well
as previous audit results
Audit criteria, scope, frequency and methods shall be defined.
The selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process. Auditors shall not
audit their own work.
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8 Measurement, Analysis &
Improvement
8.2.2 Internal Audit (cont.)
–
–
Responsibilities and requirements for planning and conducting
audits, and for reporting results and maintaining records (see 4.2.4)
shall be defined in documented procedure
Management responsible for the area being audited shall ensure
that actions are taken without undue delay to eliminate detected
nonconformities and their causes. Follow-up activities shall include
the verification of actions taken and reporting of verification results
–
NOTE: See ISO 19011 for guidance
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8 Measurement, Analysis &
Improvement
8.2.3 Monitoring and Measurement of Processes
–
The organization shall apply suitable methods for monitoring and,
where applicable, measurement of the QMS processes. These
methods shall demonstrate the ability of the processes to achieve
planned results.
– When planned results are not achieved, correction and corrective
actions shall be taken, as appropriate, to ensure conformity of the
product
Note: When determining suitable methods, it is advisable that the
organization consider the type and extent of monitoring and
measurement appropriate to each of its processes. In relation to
their impact on the conformity to the product requirements and on
the effectiveness of the quality management system.
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8 Measurement, Analysis &
Improvement
8.2.4 Monitoring and Measurement of Product
The organization shall monitor and measure characteristics of the
product to verify that product requirements have been met. This
shall be carried out at appropriate stages of the product
realization process in accordance with planned arrangements.
(see 7.1) Evidence of conformity with acceptance criteria shall be
maintained.
Records shall indicate the person (s) authorizing release of the
product for delivery to the customer. (see 4.2.4)
The release of the product and delivery of the service to the customer
shall not proceed until the planned arrangements (see 7.1) have
been satisfactorily completed, unless otherwise approved by a
relevant authority and where applicable, by the customer.
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8 Measurement, Analysis &
Improvement
8.3 Control of Nonconforming Product
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–
–
The organization shall ensure that product which does not conform
to product requirements is identified and controlled to prevent its
unintended use or delivery
Controls and related responsibilities and authorities for dealing with
nonconforming product shall be defined in a documented procedure
Where applicable the organization shall deal with Nonconforming by
one or more of the following ways:
a) Taking action to eliminate the detected nonconformity;
b) Authorizing use, release or acceptance under concession by a
relevant authority and, where applicable, by the customer;
c) Taking action to preclude its original intended use or application
d) By taking action appropriate to the effects, or potential effects,
of the nonconformity when nonconforming product is detected
after delivery or use has started.
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8 Measurement, Analysis &
Improvement
8.3 Control of Nonconforming Product
–
–
Records of the nature of nonconformity and any subsequent actions
taken shall be maintained (4.2.4)
Nonconforming product corrections shall be subject to re-verification to
demonstrate conformity to requirements
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8 Measurement, Analysis &
Improvement
8.4 Analysis of Data
–
–
–
Determine, collect and analyze appropriate data to demonstrate
suitability and effectiveness of QMS and the opportunities to
improve it
Includes data generated as result of monitoring and measurement
and from other relevant sources
Analysis shall provide information relating to:
a) Customer satisfaction
b) Conformity to product requirements (see 8.2.4)
c) Product and process characteristics and trends including
opportunities for preventive action. ( see 8.2.3 & 8.2.4)
d) Suppliers (see 7.4)
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8 Measurement, Analysis &
Improvement
8.5 Improvement
8.5.1 Continual Improvement
–
Effectiveness of QMS shall be continually improved through use of
the Quality Policy, quality objectives, audit results, data analysis,
corrective and preventive actions, and management review.
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8 Measurement, Analysis &
Improvement
8.5.2 Corrective Action
–
–
Action shall be taken to eliminate the causes of nonconformities in
order to prevent recurrence and shall be appropriate to the effects of
the nonconformities encountered
Procedure shall be documented to define requirements for:
a) Reviewing nonconformities (including customer complaints)
b) Determining causes of nonconformities
c) Evaluating a need for action to avoid recurrence
d) Determining and implementing action needed
e) Recording results of actions taken (4.2.4)
f) Reviewing the effectiveness of corrective actions taken
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8 Measurement, Analysis &
Improvement
8.5.3 Preventive Action
–
–
Action shall be determined to eliminate the causes of potential
nonconformities in order to prevent occurrence. Preventive actions
shall be appropriate to the effects of the potential problems
Procedure shall be established to define requirements for:
a) Determining potential nonconformities and their causes
b) Evaluating need for action to prevent occurrence of
nonconformities
c) Determining and implementing action needed
d) Records of results for actions taken (see 4.2.4)
e) Reviewing the effectiveness of preventive action taken
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ISO 9001-2000 Review Module 2
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Quiz
1. The difference between Corrective actions and Preventive
actions is :
a. Corrective actions are short term and Preventive actions are
long term
b. Corrective actions are for correction of the problem and
preventive actions are to prevent the reoccurrence
c. Corrective actions are for problems occurred and preventive
actions for potential problem solving.
d. None of the above
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Quiz
2. The Continual Improvement process should consider :
a.
b.
c.
d.
Quality Objectives
Corrective and preventive actions
Management Review
All of the above
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ISO 9001-2000 Review Module 2
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Quiz
3. Which one of the following clauses addresses product
inspection on the production floor?
a.
b.
c.
d.
7.5.1
7.5.3
7.5.4
8.2.4
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ISO 9001-2000 Review Module 2
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Quiz
4. Which clause addresses Customer satisfaction?
a.
b.
c.
d.
8.2.1
7.5.4
7.5.1
7.2.2
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Quiz
5. Which clause addresses Human resources?
a.
b.
c.
d.
6.2
5.1
6.3
8.5
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Quiz
6. Which of the following is a requirement of ISO 9001:2000?
a.
b.
c.
d.
Business Plan communication
Management Meetings for quality objectives
Employee meetings
Communications methods
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Quiz
6. Which of the following is required to identify the competency of
employees?
a.
b.
c.
d.
Education and Training
Skills needed for the job
Experience against the requirement
All of the above
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Quiz
7. Which one of the following is not a requirement to review in
Management review meetings?
a.
b.
c.
d.
Preventive actions
Changes in Quality objectives
Employee performance reviews
Continual improvement logs
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ISO 9001-2000 Review Module 2
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Quiz
8. The Contract review process must address all of the following
requirements except:
a.
b.
c.
d.
Regulatory requirements
Customer specific requirements
Future years contracts
None of the above
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ISO 9001-2000 Review Module 2
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Quiz
9. What does it mean when you see (4,2,4)?
a. The document is controlled
b. The form must be completed
c. A record is required
d. All the above
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ISO 9001-2000 Review Module 2
90
Quiz
10. Which of the following does not require a Record?
a. Maintenance breakdown time
b. Inspection results
c. Management review minutes
d. Design review minutes
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