[FULL CLIENT NAME ALL CAPS]
[Quality Manual Doc Title]
Revision
[Rev Number]
Issued
[Date of Issue]
Conforms to ISO 9001:2015
(c) [Copyright Year] [Full Client Name Reg Caps];
all rights reserved. This document may contain proprietary information and may
only be released to third parties with approval of management. Document is
uncontrolled unless otherwise marked; uncontrolled documents are not subject to
update notification.
TABLE OF CONTENTS
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Add welcome language here. This is the first thing a reader will see,
so it’s a good idea to add basic information about the company. If the intended
audience includes customers, you can add marketing language here, too.
Adding some photos of the facility or staff is a nice touch here, as
well.
This
manual is prepared for the purpose of defining the company’s interpretations of
the ISO 9001:2015 international standard, as well as to demonstrate how the
company complies with that standard.
This
manual presents “Notes” which are used to define how [Short Client Name] has
tailored its management system to suit its purposes. These are intended to
clarify implementation approaches and interpretations for concepts which are
not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.
Where
subordinate or supporting documentation is reference in this manual, these are
indicated by bold italics.
[Short Client Name] adopts the following
terms and definitions within its Quality Management System. Where no definition
is provided, the company typically adopts the definitions provided in ISO
9000: Quality Management – Fundamentals and Vocabulary. In some cases,
specific procedures or documentation may provide a different definition to be
used in the context of that document; in such cases, the definition will
supercede those provided for in this Quality Manual or ISO 9000.
Add additional terms as you see fit.
General
Terminology
[Short Client Name] –
[Full Client Name Reg Caps]
Document – written
information used to describe how an activity is done.
Record – captured evidence
of an activity having been done.
Risk-Based
Thinking Terminology
Risk – Negative effect of
uncertainty
Opportunity – Positive
effect of uncertainty
Uncertainty - A deficiency
of information related to understanding or knowledge of an event, its
consequence, or likelihood. (Not to be confused with measurement uncertainty.)
Nonconforming
Product Terminology
Rework: Efforts to bring
nonconforming product into conformance through additional operations that do not alter the original design
of the product.
Repair: Efforts to bring
nonconforming product into conformance through additional operations that alter
the original design of the product; this may be through the addition of
material no specified in the original design, or through altering pre-existing
design features.
Scrap: The discard of
nonconforming product in lieu of rework or repair.
[Short Client Name] has reviewed and
analyzed key aspects of itself and its stakeholders to determine the strategic
direction of the company. This requires understanding internal and external
issues that are of concern to [Short Client Name] and its interested parties
(per 4.2 below); the interested parties are identified per the document [Context
of the Org Proc. Title].
Such issues are monitored and updated as
appropriate, and discussed as part of management reviews.
The issues determined per 4.1 above are
identified through an analysis of risks facing [Short Client Name] and its
interested parties. “Interested parties” are those stakeholders who receive our
[Products or Services Plur.], or who may be impacted by them, or those parties
who may otherwise have a significant interest in our company. These parties are
identified per the document [Context of the Org Proc. Title].
This information is then used by senior
management to determine the company’s strategic direction. This is defined in
records of management review, and periodically updated as conditions and
situations change.
Based on
an analysis of the above issues of concern, interests of stakeholders, and in
consideration of its products and services, [Short Client Name] has determined
the scope of the management system as follows:
Add scope statement here. The scope statement must
include a description of your products and/or services. This is what will
appear on any resulting ISO 9001 certificate; you may consult with your
certification body for assistance.
(If more than one site)
The
quality system applies to all processes, activities, and employees of the
following locations within the company:
|
[Street Address]
[City] [STATEABBREV] [Zip]
[Phone]
|
Site 2 Address
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Site 3 Address
|
Site 4 Address
|
(If single site)
The
quality system applies to all processes, activities and employees within the
company. The facility is located at:
[Street
Address]
[City] [STATEABBREV] [Zip]
Phone:
[Phone]
Fax: [Fax]
Web: [Website]
(If exclusions)
The following clauses of ISO 9001 were
determined to be not applicable to [Short Client Name].
·
List clause exclusions and rationale for each here.
(If
no exclusions)
The company claims no exclusions from the
ISO 9001 standard.
(Optional:
site exclusion table)
The following sites are excluded from the
company quality system at this time; in the future, these may be incorporated
into the company QMS, and this manual will be updated accordingly.
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Site 1 Address
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Site 2 Address
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Site 3 Address
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Site 4 Address
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4.4.1 Process Identification
[Short Client Name] has adopted a process
approach for its management system. By identifying the top-level processes
within the company, and then managing each of these discretely, this reduces
the potential for nonconforming [Products or Services Plur.] discovered during
final processes or after delivery. Instead, nonconformities and risks are
identified in real time, by actions taken within each of the top-level
processes.
Note: not all
activities are considered “processes” – the term “process” in this context
indicates the activity has been elevated to a higher level of control and
management oversight. The controls indicated herein are applicable only
to the top-level processes identified.
The following top-level processes have been
identified for [Short Client Name]:
·
List processes here
·
List processes here
Each process may be supported by other
activities, such as tasks or sub-processes. Monitoring and control of top level
processes ensures effective implementation and control of all subordinate tasks
or sub-processes.
Each top-level process has a
[Process Definition Doc Title] document which defines:
·
applicable inputs and outputs
·
process owner(s)
·
applicable responsibilities and authorities
·
applicable risks and opportunities
·
critical and supporting resources
·
criteria and methods employed to ensure the effectiveness of the process
·
quality objectives related to that process
The sequence of interaction of these
processes is illustrated in Appendix A.
Note: Appendix A
represents the typical sequence of processes, and may be altered
depending on customer or regulatory requirements at the job or contract level,
as needed.
4.4.2 Process Controls & Objectives
Each process has at least one objective
established for it; this is a statement of the intent of the process. Each
objective is then supported by at least one “metric” or key performance
indicator (KPI) which is then measured to determine the process’ ability to
meet the quality objective.
Note: some processes
have multiple objectives and multiple metrics. This is determined by the nature
of the process, it’s impact on [Products or Services Plur.], and associated
risks.
Note: Whereas ISO
9001 discusses process measurements and “quality objectives” as separate
concepts, [Short Client Name] combines them; i.e., quality objectives are used
to control the processes. Additional objectives for [Products or Services
Plur.] may be assigned, but these will also be used to measure process
effectiveness.
Throughout the year, metrics data is
measured and gathered by process owners or other assigned managers, in order to
present the data to [Senior Management Team Name]. The data is then analyzed by
[Senior Management Team Name] in order that [Senior Management Team Name] may
set goals and make adjustments for the purposes of long-term continual
improvement.
The specific quality objectives for each
process are defined in the applicable [Process Definition Doc Title].
Metrics, along with current standings and
goals for each objective, are recorded in records of management review.
When a process does not meet a goal, or an
unexpected problem is encountered with a
process, the corrective and preventive action process is implemented to
research and resolve the issue. In addition, opportunities for improvement are
sought and implemented, for the identified processes.
4.4.3 Outsourced Processes
Any process performed by a third party is
considered an “outsourced process” and must be controlled, as well. The
company’s outsourced processes, and the control methods implemented for each,
are defined in [Outsourced Processes Title].
The type
and extent of control to be applied to the outsourced process take into
consideration:
a)
the potential impact of the outsourced process on the company’s
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 purchasing
contract requirements.
[Senior Management Team Name] of [Short
Client Name] provides evidence of its leadership and commitment to the
development and implementation of the management system and continually
improving its effectiveness by:
a)
taking accountability of the effectiveness of the management system;
b)
ensuring that the Quality Policy and quality
objectives are established for the management system and are compatible with
the strategic direction and the context of the organization;
c)
ensuring the integration of the management system requirements into the organization’s other business processes, as
deemed appropriate (see note);
d)
promoting awareness of the process approach;
e)
ensuring that the resources needed for the management system are
available;
f)
communicating the importance of effective quality management and of
conforming to the management system requirements;
g)
ensuring that the management system achieves its intended results;
h)
engaging, directing and supporting persons to contribute to the
effectiveness of the management system;
i)
promoting continual improvement;
j)
supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility.
Note: “business
processes” such as accounting, employee benefits management and legal
activities are out of scope of the QMS.
[Senior Management Team Name] of [Short
Client Name] adopts a customer-first approach which ensures that customer needs
and expectations are determined, converted into requirements and are met with
the aim of enhancing customer satisfaction.
This is accomplished
by assuring:
a)
customer and applicable statutory and regulatory requirements are
determined, understood and consistently met;
b)
the risks and opportunities that can affect conformity of products and
services and the ability to enhance customer satisfaction are determined and
addressed;
c)
the focus on enhancing customer satisfaction is maintained.
[Senior Management Team Name] has developed
the Quality Policy, defined in section 3.0 above, that governs day-to-day
operations to ensure quality.
The Quality Policy is released as a
standalone document as well, and is communicated and implemented throughout the
organization.
The Quality Policy of [Short Client Name]
is as follows:
Add
Quality Policy here.
[Senior
Management Team Name] has assigned responsibilities and authorities for all
relevant roles in the company. These are communicated through the combination
of the [Org Chart Title] and [Position Description Title]s.
In
addition, the following overall QMS responsibilities and authorities are
assigned as follows:
|
Responsibility
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Assigned
To
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Ensuring that the management system
conforms to applicable standards
|
[Senior Management
Team Name]
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Ensuring that the processes are delivering
their intended outputs
|
Applicable process
owner
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Reporting on the performance of the
management system and providing opportunities for improvement for the
management system
|
[Specific Title for
ISO MR]
|
|
Ensuring the promotion of customer focus
throughout the organization
|
[Senior Management
Team Name]
|
|
Ensuring that the integrity of the
management system is maintained when changes are planned and implemented
|
[Senior Management
Team Name]
|
The [ISO
MR Regular Title] has been assigned the role of [Specific Title for ISO MR]
when having a single point of contact to represent the [Short Client Name]
quality system is useful or required by customer or regulations. Other duties
of the [Specific Title for ISO MR] may be defined herein or within other
documented procedures.
Note: [Short
Client Name] deviates slightly from the approach towards risk and opportunity
presented in ISO 9001. Instead, [Short Client Name] views “uncertainty” as
neutral, but defines “risk” as a negative effect of uncertainty, and
“opportunity” as a positive effect of uncertainty. [Short Client Name] has
elected to manage risks and opportunities separately, except where they may
overlap. Formal risk management may not be utilized in all instances; instead,
the level of risk assessment, analysis, treatment and recordkeeping will be performed
to the level deemed appropriate for each circumstance or application.
[Short
Client Name] considers risks and opportunities when taking actions within the
management system, as well as when implementing or improving the management
system; likewise, these are considered relative to products and services. Risks
and opportunities are identified as part of the “Context of the Organization
Exercise” defined in [Context of the Org Proc. Title], as well as throughout
all other activities of the QMS.
Risks
and opportunities are managed in accordance with the document [Risk
Management Proc. Title]. This procedure defines how risks are managed
in order to minimize their likelihood and impact, and how opportunities are
managed to improve their likelihood and benefit.
As part
of the adoption of the process approach, [Short Client Name] utilizes its
process objectives, as discussed in 4.4 above, as the main quality objectives
for the QMS. These include overall product-related quality objectives;
additional product-related quality objectives may be defined in work
instructions or customer requirements.
The
process objectives have been developed in consideration that they:
a)
be consistent with the quality policy;
b)
be measurable;
c)
take into account applicable requirements;
d)
be relevant to conformity of products and services and to enhancement of
customer satisfaction;
e)
be monitored;
f)
be communicated;
g)
be updated as appropriate.
Process
quality objectives are defined in the minutes of management review per section
9.3 below.
The
planning of process quality objectives is defined in section 4.4. above.
Changes to the quality management system
and its processes are carried out in a planned manner per the procedure [Change
Mgmt Doc Title].
[Short Client Name] determines and provides
the resources needed:
a)
to implement and maintain the management system and continually improve
its effectiveness
b)
to enhance customer satisfaction
by meeting customer requirements
Resource allocation is done with consideration
of the capability and constraints on existing internal resources, as well as
needs related to supplier expectations.
Resources and resource allocation are
assessed during management reviews.
Senior management ensures that it provides sufficient
staffing for the effective operation of the management system, as well its
identified processes.
[Short Client Name] determines, provides and
maintains the infrastructure needed to achieve conformity to product
requirements. Infrastructure includes,
as applicable:
a)
buildings, workspace and associated facilities;
b)
process equipment, hardware and software;
c)
supporting services such as transport;
d)
information and communication technology.
Equipment is validated per the procedure [Equipment
Validation Proc. Title] and maintained per the procedure [Preventive
Maintenance Proc. Title].
[Short Client
Name] provides a clean, safe and well-lit working environment. The [Senior Management Team Name] of [Short
Client Name] manages the work environment needed to achieve conformity to
product requirements. Specific
environmental requirements for products are determined during quality planning
and are documented in subordinate procedures, work instructions, or job
documentation. Where special work environments have been implemented, these
shall also be maintained per 6.3 above.
Human
factors are considered to the extent that they directly impact on the quality
of [Products or Services Plur.].
Note: Social,
psychological and safety aspects of the work environment are managed through
activities outside of the scope of the management system. Only work environment
aspects which can directly affect process efficiency or product and service
quality are managed through the management system.
Where equipment is used for critical
measurement activities, such as inspection and testing, these shall be subject
to control and either calibration or verification; see the procedure [Calibration
Proc. Title].
Note: Calibration
and measurement traceability is not employed for all measurement devices.
Instead, [Short Client Name] determines which devices will be subject to
calibration based on its processes, products and services, or in order to
comply with specifications or requirements. These decisions are also based on
the importance of a measurement, and considerations of risk.
[Short
Client Name] also determines the knowledge necessary for the operation of its
processes and to achieve conformity of products and services. This may include
knowledge and information obtained from:
a)
internal sources, such as lessons learned, feedback from subject matter
experts, and/or intellectual property;
b)
external sources such as standards, academia, conferences, and/or
information gathered from customers or suppliers.
This
knowledge shall be maintained, and made available to the extent necessary.
When
addressing changing needs and trends, [Short Client Name] shall consider its
current knowledge and determine how to acquire or access the necessary
additional knowledge.
Staff members performing work affecting
product quality are competent on the basis of appropriate education, training,
skills and experience. The documented procedure [Training Proc. Title] defines
these activities in detail.
Note: the
management system does not include other aspects of Human Resources management,
such as payroll, benefits, insurance, labor relations or disciplinary actions.
Training
and subsequent communication ensure that staff are aware of:
a)
the quality policy;
b)
relevant quality objectives;
c)
their contribution to the effectiveness of the management system,
including the benefits of improved performance;
d)
the implications of not conforming with the management system
requirements.
[Senior
Management Team Name] of [Short Client Name] ensures internal communication
takes place regarding the effectiveness of the management system. Internal
communication methods include (modify as appropriate):
a) use of corrective and preventive action
processes to report nonconformities or suggestions for improvement
b) use of the results of analysis of data
c) meetings (periodic, scheduled and/or unscheduled) to discuss aspects of
the QMS
d) use of the results of the internal audit process
e) regular company meetings with all employees
f) internal emails
g) memos to employees
h) [Short Client Name]’s “open door” policy which allows any employee
access to [Senior Management Team Name] for discussions on improving the
quality system
The management system documentation includes
both documents and records.
Note: the ISO
9001:2015 standard uses the term “documented information”; [Short Client Name]
does not use this term, but instead relies on the terms “document” and “record”
to avoid confusion. In this context the terms are defined by [Short Client
Name] as provided for in section 3.0 above. Documents and records undergo
different controls as defined herein.
The extent of the management system
documentation has been developed based on the following:
a)
The size of [Short Client Name]
b)
Complexity and interaction of the processes
c)
Risks and opportunities
d)
Competence of personnel
Documents
required for the management system are controlled in accordance with procedure [Control
of Documents Proc. Title]. The purpose of document control is to ensure
that staff have access to the latest, approved information, and to restrict the
use of obsolete information. All documented procedures are established,
documented, implemented and maintained.
A
documented procedure [Control of Records Proc. Title] has
been established to define the controls needed for the identification, storage,
retrieval, protection, retention time, and disposition of quality records. This procedure also defines the methods for
controlling records that are created by and/or retained by suppliers.
These
controls are applicable to those records which provide evidence of conformance
to requirements; this may be evidence of [Product or Service Sing.] requirements,
contractual requirements, procedural requirements, or statutory/regulatory
compliance. In addition, quality records include any records which provide
evidence of the effective operation of the management system.
[Short Client Name] plans and develops the
processes needed for realization of its [Products or Services Plur.]. Planning of [Product or Service Sing.] realization
is consistent with the requirements of the other processes of the management
system. Such planning considers the information related to the context of the
organization (see section 2.0 above), current resources and capabilities, as
well as [Product or Service Sing.] requirements.
Such planning is accomplished through:
a)
determining the requirements for the [Products or Services Plur.] ;
b)
establishing criteria for the processes and the acceptance of [Products or Services Plur.] ;
c)
determining the resources needed to achieve conformity to the [Product
or Service Sing.] requirements;
d)
implementing control of the processes in accordance with the criteria;
e)
determining, maintaining and retaining documented information to the
extent necessary to have confidence that the processes have been carried out as
planned and to demonstrate the conformity of [Products or Services Plur.] to their
requirements.
Changes to operational processes are done in
accordance with the document [Change Mgmt Doc Title].
Outsourced processes and the means by which
[Short Client Name] controls them are defined in the documented procedure [Outsourced
Processes Title].
[Short Client Name] has implemented
effective communication with customers in relation to:
a)
providing information relating to [Products or Services Plur.];
b)
handling enquiries, contracts or orders, including changes;
c)
obtaining customer feedback relating to products and services, including
customer complaints;
d)
handling or controlling customer property;
e)
establishing specific requirements for contingency actions, when
relevant.
During the intake of new business [Short
Client Name] captures:
a)
requirements specified by the customer, including the requirements for
delivery and post-delivery activities;
b)
requirements not stated by the customer but necessary for specified or
intended use, where known
c)
statutory and regulatory requirements related to [Products or Services
Plur.];
d)
any additional requirements determined by [Short Client Name].
These
activities are defined in greater detail in the procedure [Quoting and Orders Doc Title].
Once requirements are captured, [Short
Client Name] reviews the requirements prior to its commitment to supply the
[Product or Service Sing.] This review ensures that [Short Client Name] has the
capability and capacity to:
a)
meet all requirements specified by the customer, including requirements
for delivery and post-delivery activities;
b)
meet any requirements not stated by the customer, but which [Short
Client Name] knows as being necessary;
c)
meet all requirements determined necessary by [Short Client Name] itself;
d)
meet all related statutory and regulatory requirements;
e)
meet any contract or order requirements differing from those previously
expressed (i.e., from a previous [Short Client Name] quote).
These
activities are defined in greater detail in the procedure [Quoting and Orders Doc Title].
[Short
Client Name] updates all relevant requirements and documents when the
requirements are changed, and ensures that all appropriate staff are notified;
see the documented procedure [Change Mgmt Doc Title].
For new designs and for significant design
changes, [Short Client Name] ensures the translation of customer needs and
requirements into detailed design outputs. These address performance,
reliability, maintainability, testability, and safety issues, as well as
regulatory and statutory requirements.
This process ensures:
a)
Design planning is conducted
b)
Design inputs (requirements) are captured
c)
Design outputs are created under controlled conditions
d)
Design reviews, verification and validation are conducted
e)
Design changes are made in a controlled manner.
These activities are further defined in the
document [Design Procedure Doc Title].
[Short Client Name] ensures that purchased [Product
or Service Sing.] conform to specified purchase requirements. The type and
extent of control applied to the supplier and the purchased products or
services are dependent on the effect on subsequent [Product or Service Sing.] realization
or the final product.
[Short Client Name] evaluates and selects
suppliers based on their ability to supply products and services in accordance
with the organization's requirements. Criteria for selection, evaluation and
re-evaluation are established.
Purchases are made via the release of formal
purchase orders and/or contracts which clearly describe what is being
purchased. Received products or services are then verified against requirements
to ensure satisfaction of requirements. Suppliers who do not providing
conforming products or services may be requested to conduct formal corrective
action.
These activities are further defined in the
documents [Purchasing Proc. Title] and [Receiving Proc. Title].
To control its provision of [Products or
Services Plur.], [Short Client Name] considers, as applicable, the following:
a)
the availability of documents or records that define the characteristics
of the [Products or Services Plur.] as well as the results to be achieved;
b)
the availability and use of suitable monitoring and measuring resources;
c)
the implementation of monitoring and measurement activities;
d)
the use of suitable infrastructure and environment;
e)
the appointment of competent persons, including any required qualifications;
f)
the validation and revalidation of special processes if applicable (see
below);
g)
the implementation of actions to prevent human error;
h)
the implementation of release, delivery and post-delivery activities.
If no
in-house special processes, but some done by suppliers:
At this time, [Short Client Name] does not
utilize any in-house “special processes” where the result of the process cannot
be verified by subsequent monitoring or measurement. Any such special processes are sent to outside
suppliers, and controlled and an outsourced process per [Outsourced Processes Title].
If
there are in-house special processes:
[Short Client Name] utilizes some “special
processes” where the result of the process cannot be verified by subsequent
monitoring or measurement. The special
processes in use and the methods of validation of each are defined in the
document [Special Process Doc Title].
Where appropriate, [Short Client Name]
identifies its [Product or Service Sing.] or other critical process outputs by
suitable means. Such identification includes the status of the [Product or
Service Sing.] with respect to monitoring and measurement requirements. Unless
otherwise indicated as nonconforming, pending inspection or disposition, or
some other similar identifier, all [Product or Service Sing.] shall be
considered conforming and suitable for use.
If
unique traceability is required by contract, regulatory, or other established
requirement, [Short Client Name] controls and records the unique identification
of the [Product or Service Sing.].
The
documented procedure [Identification & Traceability Proc. Title] defines
these methods in detail.
[Short Client Name] exercises care with
customer or supplier property while it is under the organization’s control or
being used by the organization. Upon
receipt, such property is identified, verified, protected and safeguarded. If any such property is lost, damaged or
otherwise found to be unsuitable for use, this is reported to the customer or
supplier and records maintained.
For
customer intellectual property, including customer furnished data used for
design, production and / or inspection, this is identified by customer and
maintained and preserved to prevent accidental loss, damage or inappropriate
use.
This
activity is defined in greater detail in the document [Customer Property Proc. Title].
[Short Client Name] preserves conformity of
product or other process outputs during internal processing and delivery. This preservation includes identification,
handling, packaging, storage, and protection. Preservation also applies to the
constituent parts of a product.
The documented procedure [Preservation
Proc. Title] defines the methods for preservation of product.
As
applicable, [Short Client Name] conducts the following activities which are
considered “post-delivery activities”:
·
Here
·
Here
·
Here
Post-delivery
activities are conducted in compliance with the management system defined
herein. In determining the extent of post-delivery activities that are
required, [Short Client Name] considers:
a)
statutory and regulatory requirements;
b)
the potential undesired consequences associated with its of [Products or
Services Plur.];
c)
the nature, use and intended lifetime of its of [Products or Services
Plur.];
d)
customer requirements;
e)
customer feedback.
[Short
Client Name] reviews and controls both planned and unplanned changes to
processes to the extent necessary to ensure continuing conformity with all requirements.
Process
change management is defined in the document [Change Mgmt Doc Title].
Documents
are changed in accordance with procedure [Control of Documents Proc. Title].
Acceptance
criteria for [Products or Services Plur.] are defined in appropriate
subordinate documentation. Reviews, inspections and tests are conducted at
appropriate stages to verify that the requirements have been met. This is done
before [Products or Services Plur.] are released or services are delivered.
Each
process utilizes different methods for measuring and releasing [Products or
Services Plur.]. These methods are defined in [Process Definition Doc Title]s.
[Short
Client Name] ensures that [Products or Services Plur.] or other process outputs
that do not conform to their requirements are identified and controlled to
prevent their unintended use or delivery.
The
controls for such nonconformances are defined in [Control of NCP Proc. Title] and [Control
of Nonconforming Service Proc Title]. ß delete
whichever do not apply.
[Short Client Name] has determined which
aspects of its quality management system must be monitored and measured, as
well as the methods to utilize and records to maintain, within this [Quality
Manual Doc Title] and subordinate documentation.
Monitoring and measurement of the
processes, as defined in 4.4 above, ensure that the [Senior Management Team
Name] evaluates the performance and effectiveness of the quality management
system itself.
As one
of the measurements of the performance of the management system, [Short Client
Name] monitors information relating to customer perception as to whether the
organization has met customer requirements. The methods for obtaining and using
this information include:
·
EDIT LIST AS NEEDED
·
recording customer complaints
·
product rejections or returns
·
repeat orders for product
·
changing volume of orders for product
·
trends in on-time delivery
·
obtain customer scorecards from certain customers
·
submittal of customer satisfaction surveys
The
corrective and preventive action system shall be used to develop and implement
plans for customer satisfaction improvement that address deficiencies
identified by these evaluations, and assess the effectiveness of the results.
[Short Client Name] analyzes and evaluates the
data and information arising from monitoring and measurement in order to evaluate:
a)
conformity of [Products or Services Plur.];
b)
the degree of customer satisfaction;
c)
the performance and effectiveness of the quality management system;
d)
if planning has been implemented effectively;
e)
the effectiveness of actions taken to address risks and opportunities;
f)
the performance of external providers;
g)
the need for improvements to the quality management system.
Statistical techniques used may be defined
in appropriate documented procedures; in all cases, the methods are based on
established standards or are otherwise determined to be statistically valid.
[Short Client Name] conducts internal audits
at planned intervals to determine whether the management system conforms to
contractual and regulatory requirements,
to the requirements of ISO 9001, and to management system requirements.
Audits also seek to ensure that the management system has been effectively
implemented and is maintained.
These activities are defined in the document
[Internal
Auditing Proc. Title].
The [Senior Management Team Name] reviews
the management system, at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness. The review includes assessing
opportunities for improvement, and the need for changes to the management
system, including the Quality Policy and quality
objectives.
Management review frequency, agenda
(inputs), outputs, required members, actions taken and other review
requirements are defined in the documented procedure [Management Review Proc. Title].
Records from management reviews are
maintained.
[Short Client Name] uses the management
system to improve its processes, products and services. Such improvements aim
to address the needs and expectations of customers as well as other interested
parties, to the extent possible.
Improvement shall be driven by an analysis
of data related to:
The results of analysis shall be used to
evaluate:
h)
conformity of products and services;
i)
the degree of customer satisfaction;
j)
the performance and effectiveness of the management system;
k)
the effectiveness of planning;
l)
the effectiveness of actions taken to address risks and opportunities;
m) the performance of external
providers;
n)
other improvements to the management system.
[Short Client Name] takes corrective action
to eliminate the cause of nonconformity in order to prevent recurrence. Likewise, the company takes preventive action
to eliminate the causes of potential nonconformities in order to prevent their
occurrence.
These activities are done through the use
of the formal Corrective Action ([CAR Form Abbreviation]) system, and
are defined in the document [Corrective Preventive Action Proc. Title].
Through the process effectiveness reviews,
done as part of Management Review, [Short Client Name] works to continually
improve the suitability, adequacy and effectiveness of the quality management
system. This includes seeking opportunities for improvement.
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