ISO 9001:2015 CLAUSE 7 SUPPORT

CLAUSE 7 SUPPORT
After addressing the context, commitment and planning, organizations will have to look at the
support needed to meet their goals and objectives. This includes resources, targeted internal and
external communications, as well as documented information that replaces previously used terms
such as documents, documentation and records. The organisation needs to supply competent
resource to deliver its goods and services. Again, nothing new here, awareness has been
strengthened so now everyone needs to know the implications of not conforming to the
management system requirements. The organisation needs to consider the need for both internal
and external communications relevant to the management system what, when and with whom
it will communicate. The final support requirement is going to generate a lot of heat but not
much light documented information. Gone are the terms documents, documentation and
records. However the requirements for the management of documented information are not new,
exceptional or excessive. One skeleton which is finally laid to rest is the idea that everyone needs
work instructions no matter how experienced or senior they are in the organisation. Auditing
awareness and communication should be easier; the requirements are crisper. The organization
needs to:

Determine and provide the resources needed for the establishment,

implementation,maintenance and continual improvement of the management system.

Determine the necessary competence of person(s) doing work under its control
that affects its discipline specic performance.

Ensure that these persons are competent on the basis of appropriate education, training,or
experience.

Where applicable, take actions to acquire the necessary competence, and evaluate
the effectiveness of the actions taken

Retain appropriate documented information as evidence of competence

Clause 7, Support, has five sub-clauses .

7. Support

7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the Operation of Processes

7.1.5 Monitoring and Measuring Resources

7.1.6 Organizational Knowledge

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Information

For purpose of this article only, I have rearrange clause 7 Support as

7. Support

7.1 Resources

7.1.1 General

7.1.3 Infrastructure

7.1.4 Environment for the Operation of Processes

7.1.5 Monitoring and Measuring Resources

7.1.2 People

7.2 Competence

7.3 Awareness

7.4 Communication

Clause 7.5 Documented Information is a separate article

Clause 7.1.6 Organizational Knowledge is a separate article.

7.1 Resource
In addition to clause 7.1, there are other references to resources throughout the standard, for
example:
4.4.d determine the resources needed for QMS processes and to ensure their availability
5.1.1.e top management ensure resources needed for QMS
are available
6.2.2.b The organization should determine what resources are needed to achieve quality
objectives
6.3.c The organization should consider availability of resources for planning any changes in
QMS
8.1.c the organization should determine any resources needed to achieve conformity to product
and
service
requirement.
8.3.2.e the organization should consider the internal and external resource needs for design and
development
of
product
and
services.
8.5.1.b the availability and use of suitable monitoring and measuring resources
9.3.2.d

management
review
of
adequacy
of
resources
9.3.3. management review of resource needs

7.1.1 General
The organization should determine and provide resources needed to establish, implement,
maintain, and continually improve the QMS. And should consider the capabilities of, and
constraints on, existing internal resources; and what needs to be obtained from external
providers.
This clause updates the ISO 9001:2008 clause 6.1 on Resources. It removes any mention of
resources for customer satisfaction. Customer satisfaction is mentioned at multiple clauses,
including 9.1.2. It adds consideration of internal resources and external providers. Additional
resource considerations are the capabilities of, and constraint on existing internal resources and
what needs to be obtained from external providers.

Top management has the responsibility to ensure the availability of resources to develop and
maintain your QMS. Clause 7.1 requires you to determine the nature and availability of such
resources. This is typically done through business and quality planning. Having adequate
resources is vital to ensure product conformity or satisfy customer requirements e.g. having
adequate personnel, materials and equipment to ensure timely production and delivery of
product. Use business planning (clause 5.1.1), quality management planning (clause 6.2.2) ,
planning for QMS processes (clause 4.4), and also during planning for any change in
QMS(clause 6.3) to identify and determine the nature of resource needs of QMS each process
and plan for its availability. The actual amount of resources needed may vary day to day and
over time. This is one reason why top management must review QMS performance
regularly(clause 9.3.3). While planning for your resources needed the organization must consider
what existing internal resources it has considering its capabilities and constraints and what needs
to be obtain by external providers. Consider developing performance indicators for each major
category of resources used, (e.g. machinery and equipment; human resources; facility and
environment; transport; communication systems; etc.) to determine the effective use of such
resources. This applies even in case the resources is being made available by external provider.
Where the resource planning process is performed off-site (e.g. at head-office), your QMS must
include the off-site processes within your QMS and ensure that such processes comply with ISO
9001 requirements. Evidence of the off-site facilitys compliance may include a copy of their
ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced
facility; etc.The expectation is to flow down to the off-site facility, the relevant ISO 9001
requirements that you would have to implement, had you carried out the process at your own
facility.

7.1.3 Infrastructure
The organization should determine, provide, and maintain the infrastructure for the operation
of the processes to achieve conformity of products and services. Infrastructure may
include buildings and associated utilities; equipment including hardware and
software; transportation resource ; information and communication technology.
The only relevant requirement is that we must determine, provide and maintain that which is
necessary to make conforming products and services requirement. Compliance to this
requirement would require evidence that the organization has, determined, and then continues
to provide and maintain the required infrastructure. This need not be a document and
consensus among those interviewed will suffice. This also assumes there is consensus that the
infrastructure is reliable based on its maintenance.
Planning for the types of infrastructure resources needed for your business may include facility,
production equipment, IT equipment and software, laboratory, packaging, dies, molds, tooling,
jigs, fixtures, storage, transportation, communication, office, materials, labor, utilities and
supplies, etc. The key strategic business factors to be considered for infrastructure planning
include future needs, current availability and capacity, cushion for growth, contingency planning,
linkage to current and future product programs. This planning may be done through business
planning (clause 5.1.1), quality management planning (clause 6.2.2) , planning for QMS

processes (clause 4.4), and also during planning for any change in QMS(clause 6.3). The actual
deployment of such resources may be determined by each process owner. You are required to
maintain your infrastructure. Your planned preventive maintenance program should include
controls for schedule and timing, availability and training of personnel, types and scope of
maintenance, maintenance and competency/training records, tracking to maintenance objectives,
use, storage and control of spare parts, control of any maintenance outsourcing etc.
The notes identifies the types of infrastructure that might be considered:

Buildings and associated utilities Is the building and equipment suitable? For
example, if you are manufacturing metal stampings or storing metal products, a leaky roof,
non-enclosed travel paths between buildings, etc may not be suitable to ensure you can
consistently provide conforming products (if rust free is a requirement). Water treatment
services, beyond public water/sewer may be required to ensure regulatory compliance where
processes produce waste water unsuitable for discharge into the sewer, etc. This should be the
focus of consideration for buildings and associated utilities. Some auditors may inquire as to
contingency plans to ensure your infrastructure is maintained. Most organizations have at
least a basic contingency plan either for compliance or customer assurance.

Equipment including hardware and software This is pretty obvious that the
organization must have the proper equipment, however the addition of the hardware and
software wording has given pause to quite a few both in the 2008 version and in this one.
The intent is that the organization understand their equipment, but also maintain and upgrade
as appropriate, the related software. This may be specific to a piece of manufacturing
equipment within the building, a measuring system or device in the lab, or it may also be the
organizations ability to meet the customers needs with regard to communication (such as
being able to send/receive design files, programs for programmable machinery, etc). And the
expectation is that someone knows the status of these items and has a plan to maintain them.

Transportation Again, this is pretty obvious. If product must be maintained at a

certain temperature, for example, the proper fleet (either internal or by an external provider)
must be maintained. If a certain number of trips is required to provide just-in-time delivery, a
scheduling process must be maintained, etc. And there should be a contingency plan in the
event of service interruption.

Information and communication technology Customer requirements often specify

their preferred method of communication and order processing, and the organization must be
able to meet their criteria (ie electronic purchase orders & acknowledgements, advance ship
notices, electronic billing, etc)

7.1.4 Environment for the Operation of Processes

The organization should determine, provide, and maintain environment necessary for the
operation of processes and to achieve conformity of products and services. A Suitable

environment for operation of processes can be a combination of human and physical factors
such as social (for e.g. non-discriminatory, calm, non-confrontational etc), psychological (for
e.g. stress reducing, burnout prevention, emotional protective), physical (for example,
temperature, heat, humidity,light, airflow,hygiene, noise). These factors can differ depending
on type of product and service provided by the organization
The organization shall determine, provide and maintain the environment necessary for the
operation of its processes and to achieve conformity of its goods and services. The NOTE
adds, physical, social, psychological, environmental and other factors (such as temperature,
humidity, ergonomics, and cleanliness).The clause NOTE adds social and psychological
environments, adds factors of ergonomics and cleanliness, and drops the examples of noise,
lighting, and weather from the ISO 9001:2008 standard. Environment for operation of process is
Work Environment which includes controls for ergonomics, personnel safety and facility
conditions that are conducive to achieving product quality. Some of the factors to consider in
determining and managing the work environment include ergonomics (worker movement;
fatigue; manual effort and loads, etc), workplace location, heat, light, humidity, airflow, noise,
vibration, hygiene, cleanliness, pollution, adequate facilities (lockers, lunchroom, cafeteria,
washrooms etc); health and safety regulations; cleanliness of premises; etc. the extent to which
the above environmental factors may apply to any organization will vary based on size, risk and
other considerations. The ISO 9001:2015 also wants the organization to look into social issues
such as non discriminatory environment, and also a clam and non confrontational environment.
psychological Issues such as stress-reducing, burnout prevention and emotionally protective etc.
should also be not ignored by the organization. The focus should be employee safety, welfare and
product conformity. Performance indicators to measure the effectiveness of processes that
determine and control the effective use of infrastructure may include equipment maintenance
uptime / downtime; productivity equipment and workforce; accident and safety incidents; nonvalue added use of floor space; excessive handling and storage; number of instances specific
resources were not available or delayed; Though there is no need for a documented information
requirement, social and psychological surveys can be shown as objective evidence in these areas.

7.1.5 Monitoring and Measuring Resources

7.1.5.1 General
The organization should determine and provide the resources needed for valid and reliable
monitoring and measuring results ,where monitoring or measuring is used for evidence of
conformity of products and services to specified requirements. The organization should ensure
that the resources provided are suitable for type of monitoring and measurement activities
being undertaken and are maintained to ensure continued fitness for their purpose. The
Organization should retain appropriate documented information as evidence of fitness for
purpose of monitoring and measurement resources.

7.1.5.2 Measurement Traceability

Where measurement traceability is a requirement(statutory or regulatory or customer or
relevant interested party expectation) or considered by the organization to be an essential part
of providing confidence in the validity of measurement results, measuring instruments must
be verified or calibrated at specified intervals or prior to use against measurement standards
traceable to international or national measurement standards. The organization must retain
the basis used for calibration or verification as documented information if no such standard
exists as a documented information. Measuring instruments must be identified in order to
determine their calibration status; It must be safeguarded from adjustments, damage, or
deterioration that would invalidate calibration status and subsequent measurement results.
The organization should determine if validity of previous measurement results has been
adversely affected when an instrument is found to be defective during its planned verification
or calibration, or during its use, and take appropriate corrective action as necessary.
This clause is specifically about monitoring product and service for conformity. This clause
replaces old clause 7.6 on Control of Monitoring and Measuring Equipment and is one of the
structural changes in the 2015 revision. the use of the term equipment has been changed to
resources. It needs evidence of the fitness for purpose of the resources. Humans may carry out
the activity without equipment. Calibrated equipment now termed instruments. Monitoring
and measuring the quality system has a whole clause (9 Performance Evaluation) dedicated to it.
This clause is sticking only with monitoring and measuring devices and equipment used to
monitor the product (or service). So, the organization must ensure they have identified and put
in place the appropriate resources including (7.1.2 People, 7.1.3 Infrastructure, 7.1.4
Environment) and now 7.1.5 Monitoring and measuring resources.
Requirements for what needs to be measured and the acceptance criteria may come from the
customer, regulatory, industry and your own organization. Product realization planning must
determine the following what specific product and process characteristics needs to be monitored
and measured, the criteria for product acceptance, the type of Monitoring and Measurement
Device needed, frequency i.e. at what stages of realization to do it, sample size, etc. You must
then determine what Monitoring and Measurement Device is appropriate for each measuring or
monitoring requirement. Consideration must be given to the measurement capability (precision)
of the Monitoring and Measurement Device which may have to be several times greater than the
tolerance criteria for product measurement. This would depend on the industry you are in and
the criticality of end use for the product for e.g. the precision requirements for ball bearings may
be much greater than say for cutting cloth to make a shirt. Personnel using Monitoring and
Measurement Devices must have competence and training in the use of Monitoring and
Measurement Devices in terms of their function, range and precision of measurement,
reliability, use and maintenance.Monitoring and Measurement Devices may include
measurement and testing tools, equipment, hardware and software. They may be owned by your
organization, your employees or the customer. Monitoring and Measurement Devices may be
used to verify product as well as to measure process conformity for e.g. a temperature controller
on an oven. Besides Monitoring and Measurement Devices used for product conformity, you
may need to calibrate and control certain Monitoring and Measurement Devices used in related
and peripheral processes such as production equipment, tooling, maintenance, etc. To ensure

valid measurement and monitoring results, Monitoring and Measurement Devices must be
controlled. A process is required, to control the identification of monitoring measurement,
selection, purchase, status, identification, calibration, verification, adjustment or re- adjustment,
use, handling, maintenance and storage, training, handling of nonconforming Monitoring and
Measurement Devices, etc. You must keep appropriate records to demonstrate effective
operation and control of your Monitoring and Measurement Device processes. These records
must include calibration and verification records traceable to national, international or other
benchmark used for calibration.
All Monitoring and Measurement Devices used for product verification must be capable of
being calibrated, verified or both. Calibration is setting or correcting an Monitoring and
Measurement Device, usually by adjusting it to match or conform to a dependably known and
traceable standard for e.g. adjusting a micrometer or caliper to conform to master blocks
traceable to national standards. Verification is confirming that the Monitoring and Measurement
Device is meeting or performing to acceptable national measurement standards and does not
involve any correction or adjustment for e.g. verifying a ruler or tape measure against a
calibrated ruler that has been calibrated to a national standard. A ruler or tape measure is
generally not capable of being calibrated and when it gets out of calibration its use must be
discontinued. There are Monitoring and Measurement Devices that are capable of being both
calibrated and verified for e.g. a CMM- coordinate measuring machine and may require both to
be done in specific situations based on frequency of use and criticality of measurement. This
requirement also applies to the use of computer software whose capability and calibration status
must be established prior to initial use and reconfirmed (verified) at defined intervals.
You must define the frequency and method of calibration for each type and level i.e. whether
used in shop floor, laboratory or standard of Monitoring and Measurement Device. Your
calibration records must identify what standard you used for calibration and show traceability of
the standards you use at your facility to national or international standards. In rare circumstances,
national or international standards may not exist for calibrating a specific Monitoring and
Measurement Device. In such situations consider using industry, manufacturer or even your own
organizational standard to validate the accuracy and reliability of your Monitoring and
Measurement Device. Consult with your customer if the contractual circumstances require it.
Your quality plan must define the measurement and monitoring required and the type of
Monitoring and Measurement Device needed for it, including the frequency of measurement and
acceptance criteria. Depending on the risk and precision and reliability of measurements needed,
you might consider doing statistical studies on Monitoring and Measurement Devices referenced
in your quality plans. Ensure that personnel performing such statistical studies are trained and
competent to do so. A multitude of software tools are available to manage and control
Monitoring and Measurement Devices. There are many acceptable methods to identify
Monitoring and Measurement Devices and their calibration status. The methods you select must
consider the manufacturers recommendations, frequency of use, environment the Monitoring and
Measurement Device is used in, risk in misuse or incorrect tool being used, etc. Where an
Monitoring and Measurement Device is found to be out of calibration, you must take appropriate
correction action to contain and re-verify the product affected, to the extent practical. This is in
addition to containing, repair and recalibration of the defective Monitoring and Measurement
Device. Customer or internal engineering changes may result in a change in product

measurement, requirements and/or the Monitoring and Measurement Device to be used. These
changes would normally be reflected in your quality plan. If you use external calibration
services, you are still expected to impose the specific control requirements of this clause to the
external
organization.
Performance indicators such as the monthly trends in the number of out of calibration
Monitoring and Measurement Devices, or the number of Monitoring and Measurement Devices
past their calibration due date, number of Monitoring and Measurement Devices being used and
not controlled, reduction in untrained personnel found using Monitoring and Measurement
Devices, etc. Use these indicators to tighten and improve the effectiveness of your Monitoring
and Measurement Device process. You could use a product quality plan, documented procedure
or other combination of specific practices, procedures, documents and methods. Look at the risks
related to your product, processes and resources in determining the extent of documented
controls you need to have.
The organization should ensure that the resources provided are suitable for the specific type of
monitoring and measurement activities being undertaken. The organization should have the right
instruments and equipment on hand and they must be capable of determining good from
bad. The word suitable provides the expectation that the instruments be accurate, reliable
and precise enough to make appropriate judgments about product (and services). This includes
the very common disciplines of calibration, reproducibility & reliability studies, etc to ensure the
instruments used to measure product (and service) are suitable. They should be maintained to
ensure their continued fitness for their purpose. Once the organization have selected and
confirmed the appropriate monitoring and measuring devices, they must have a surveillance
program to ensure their continued suitability. The organization should retain appropriate
documented information as evidence of fitness for purpose of monitoring and measurement
resources. There should be documented records of these activities. Where measurement
traceability is a statutory or regulatory requirement a customer or relevant interested party
expectation or considered by the organization to be an essential part of providing confidence in
the validity of measurement results, measuring instruments must be verified or calibrated 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 retained as documented information. There must be a generally accepted
calibration program which should always include traceable standards and a schedule for
verification/calibration. The use of traceable standards is required because simply having
something to measure your devices by does not necessarily ensure an adequate calibration
program. For example, using old worn gauge blocks, pins, hardness standards, etc is not a best
practice. Your standards (in addition to your instruments) should be maintained and traceable to
an international standard to ensure the validity of your monitoring and measuring program. The
devices must be identified in order to determine their calibration status; This is the simplest
thing to do a simple calibration sticker will suffice. Keep in mind that it is NOT required that
stickers be on every device, but why not do it? If each instrument has its own unique serial
number and is properly identified and can be cross-referenced to its calibration status, that meets
compliance requirements. However, auditors just feel a better warm and fuzzy feeling if there is
a sticker including last calibrated or next calibrated. And even if you do have a database or
master list of instruments which tells you the status of each instrument, a quick glance at the
instrument itself doesnt hurt to ensure your instruments are maintained 100% of the time. The

devices must be safeguarded from adjustments, damage or deterioration that would invalidate the
calibration status and subsequent measurement results. Safeguarding from damage and
deterioration is the simplest of these three. Obviously protective cases, protective films, filters,
etc keep an instrument in its tip top condition. Regular maintenance helps too removable of
dust, atomized grease, etc. Safeguarding from adjustments is a little more difficult, but can be
easily achieved by removing adjustment tools from general use, using seals on access panels,
etc. Most auditors are reasonable with regard to this, however, if someone wanted to make an
adjustment to an instrument, there are many ways to work around the safeguards. It is unlikely
to happen, and between calibration checks can add an additional assurance that instruments are
safeguarded against adjustments.The organization should determine if the validity of previous
measurement results has been adversely affected when an instrument is found to be defective
during its planned verification or calibration, or during its use, and take appropriate corrective
action as necessary. The addition of intermittent checks (between calibration checks) helps to
mitigate the impact should an instrument be found to be out of calibration. For example, if a
micrometer is calibrated monthly and on todays monthly check it is found to be out of
calibration, every measurement it has taken for the past 30 days must be validated. This can
require isolation of product, product recall, etc in the absence of any other evidence of
compliance. Between calibration checks help to detect adjustments, errors, etc. ISO9001:2008
used to include a reference to the ability of computer software to satisfy the intended
application shall be confirmed. This was an attempt to ensure that dependence on software be
confirmed (rather than simply taking a computers word for it). The idea was to prove out
software and use common sense before turning it over. For example, implementing the use of a
coordinate measuring machine requires a great deal of validation. A poorly programmed
measuring routine can result in a software rejecting good parts due to measurement or
calculation errors. This section was intended to prevent that. However, the language was not
clear and was often met with blank stares by those who were asked to demonstrate compliance in
this area. So the specific reference to software was removed. The use of the word suitable in
the beginning of this section applies to all monitoring and measuring equipment (including
software), so the removal of it has little or no real effect.

7.1.2 People
The organization should determine and provide the persons necessary for the effective
implementation of its QMS and also for operation and control of its processes.

7.2 Competence
The organization must determine the necessary competence of person(s) doing work under its
control that affects the performance and effectiveness of its QMS; It must ensure that ensure
that these persons are competent on the basis of appropriate education, training, or
experience and where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken; It must retain documented information as
evidence of competence. Applicable actions can include, for example, training, mentoring, or
reassignment of currently employed persons; or hiring or contracting of competent

persons. Competence is defined in the section on terms as the ability to apply knowledge
and skills to achieve intended results. Demonstrated competence is sometimes referred to as
qualification.

7.3 Awareness
Persons doing work under the organizations control must be aware of the quality
policy; relevant quality objectives; their contribution to effectiveness of the QMS, including
benefits of improved quality performance; and the implications of not conforming with
system requirements.
This clause requires to determine what is needed/necessary. Ensure persons are competent to
meet those needs. Where there are gaps, fill the gaps. And maintain records. Top management is
responsible for ensuring the availability of resources which includes HR. Clause 5.3 requires top
management to define the organization roles and its responsibilities and authorities. Clause 7.1.2
required that adequate Human Resources be determined and provided. And here in clause 7.2
the specific requirements for controlling HR are defined. In clause 7.3 awareness needed by the
personnel working under its control are defined. Planning for HR process controls must include
determining competency criteria, skills evaluation, identification of training needs, types of
training, provision of training, how training effectiveness is evaluated, methods to communicate
awareness of the importance of quality requirements and meeting quality objectives, to all
employees. Although training may end up being the best solution, dont overlook other actions,
such as, changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully
trained and competent people. Criteria for competency must be developed based on appropriate
education, skills, training and experience for activities, tasks, functions and processes. The level
and detail of such qualifications, skills, training and experience will depend upon the complexity
of product, process, technology and customer and regulatory requirements. It is up to your
organization to determine the necessary criteria for the various functions and activities affecting
product and QMS based on these factors. A Skills Matrix is a useful tool used by organizations
to determine and manage the competency levels required by different activities and functions. An
organization may create a comprehensive training program that is fully integrated with the
quality management system. It should begins with the identification of processes. Then the
processes are described and that becomes the basis of the training program ensuring the
persons performing the work understand the processes and are competent to perform them. And
as persons are chosen and assigned to processes, they are evaluated based on their previous
education and experience versus the requirements of the process, and where gaps are identified,
they are provided with additional training.
Organizations undergo significant changes through growth or decline, acquisitions, new
technology and new products and processes, Also, many organizations are now outsourcing their
production labor to save on payroll costs and benefits. Labor related nonconformities can easily
arise in such cases. Planning for your HR process must ensure that contract and agency personnel
performing work affecting product quality have adequate competency and training. Appropriate
records must be kept of such training.

Quality awareness must be focused on meeting customer and regulatory requirements and
Quality objective.The organization must also promote awareness of its quality policy. The
process to promote quality awareness may include the use of methods such as cross-functional
teams, involvement in quality planning, quality circles, improvement suggestions, product
workshops, zero defect programs, product review checklist etc. QMS personnel must be
motivated to achieve the organizations quality objectives. The process to motivate employees
may include the use of methods such as employee recognition awards, ongoing training
programs, performance reviews, employee surveys, poster campaigns etc,. You must determine
and keep appropriate records of education, training, skills and experience. These records must
demonstrate the effective operation of HR process controls. Performance indicators to measure
the effectiveness of the HR process in determining competency and training needs of the
workforce, could include employee turnover, employee complaints, number of instances
unqualified personnel were found performing QMS activity, number of instances competency
criteria were not met and number of instances no training or competency records maintained; etc.

7.4 Communication
The organization should determine the internal and external communications relevant to the
QMS, including: on what it will communicate; when to communicate; with whom to
communicate; how to communicate.
Communications is a complex and difficult activity. Poor communication leads to chaos, poor
performance, poor morale and other bad things. Good communication can foster a sense of
community, teamwork and a clear sense of purpose and direction.The organization must decide
what, when, with whom and how we will communicate both internally and externally. Problems
may arise due to incomplete, ambiguous or inaccurate information being transmitted;
transmission to the wrong person, too late or at the wrong time; use of inappropriate or unreliable
media, etc. Communication problems are probably the most common cause of QMS
nonconformities. Tracking some of the more serious communication issues could serve as useful
performance indicators to determine and improve communication process effectiveness. Clause
4.4 control of processes requires you to determine the sequence and interaction of QMS
processes. Each process requires inputs to flow from one process and outputs to flow to another
process. There is a continuous (communication) flow regarding tangible (materials and product)
and intangible (information) inputs and outputs taking place within your organization.
Top management must plan for internal and external communication methods and resources at
the high level using the business planning process and deploy these methods though the
information technology, logistic and HR processes.Each process owner must identify the
methods of communication such as computer, documents, telephone, meetings, directives,
visual, etc,used and determine whether these methods are appropriate and are they effective for
the purpose intended? (do they prevent non-conformities from arising due to the reasons
mentioned above?). Process owners should provide feedback on communications effectiveness to
the processes providing and controlling such resources. Communication by the MR on the
effectiveness of the QMS must not only take place at the top management level but also at
appropriate levels within the organization. If everyone is responsible for quality, then all process

owners as well as their personnel are entitled to receive periodic feedback on their areas of
responsibility.

Example: Communications
ENTITY

Customer

WHAT

WHEN

Product/
service agreement

Quality
policy

Delivery

Audits

Improvement
s

Suppliers

HOW/ HOW
OFTEN

Contract
initiation
renewal or
amendment

After
changes to
policies or
processes

Service
reviews

Internet

Contract

WHO

Contract
Marketing
Manager/customer
executive

Risks

Contract
agreement

Quality
Policy

Contract
amendments

Quality
policy

Applicable
legislation and
regulatory
requirements

Contract
initiation and
renewal

After
changes to
policies or
processes

Service
Review

At
induction and
refresher
training

Awareness
training

News
letters

Staff

After
changes to
policies or

Company/t

Purchasing Manager/
Purchasing executive

HR Manager/ Team
leader

ENTITY

WHAT

WHEN

Customer
requirements
Customer
satisfaction

All
applicable policies
and processes

processes

Regulators

Shareholders

Applicable
legislation and
regulatory
requirements
Changes in
legislation and
regulation

At
contract start
and refresher
training
After
changes to
policies or
processes

After
taking on new
work

Contract
initiation and
renewal

corporate
governance
Results

WHO

eam meetings

HOW/ HOW
OFTEN

After
changes to
policies or
processes

Intranet

Notice
boards

Awareness
training

Company/t
eam meetings

legal advisor /HR

Manager

Intranet
Notice
boards

Newsletter
s

Intranet

Annual
report

Example: Communications

CEO/GM