ISO 9001:2015 QMS Awareness – Support
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Clause 7 of ISO 9001:2015 QMS standard deals
with support requirements.
Support = Help = Assistance
Support in relation to a quality management
system is to provide assistance or help in implementation of the quality management
system of an organization by providing adequate resources, competence,
awareness, communication and documented information (documents and records). The
term "support" in this context refers to the resources and
infrastructure needed to establish, implement, maintain, and continually
improve the Quality Management System (QMS) of an organization.
The support requirements outlined in Clause 7
of the standard include the provision of resources such as people,
infrastructure, and equipment, as well as ensuring that personnel are competent
and aware of the quality management system requirements. This clause also
addresses the need for effective communication and the availability of
documented information to support the quality management system.
Overall, support requirements are critical to
the success of a quality management system. By providing adequate resources,
competence, awareness, communication, and documented information, an organization
can ensure that its quality management system is effective and continually
improving.
Requirements for support
Requirements for support are mentioned in clause
7 of ISO 9001:2015 QMS standard. The
relevant sub-clauses of Clause 7 of the standard are as under:
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for 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
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
Resources
Resource = A stock or supply of money,
materials, staff (people) and other assets that can be drawn on by a person or
organization in order to function or operate effectively.
Resource in ISO 9001:2015 QMS standard refers
to people, infrastructure, environment, monitoring and measuring resources (=
monitoring and measuring equipment) and organizational knowledge, necessary for
the effective implementation and operation of the organization’s quality
management system and control of organization’s processes, so that product /
service conformity is achieved.
The organization needs to consider – (i)
Capabilities of existing internal resources, (ii) Constraints on existing
internal resources, and (iii) What will be obtained or available from external providers.
The organization needs to determine – Resources,
needed for the establishment, implementation, maintenance and continual
improvement of the quality management system, that include (i) People, (ii)
Infrastructure, (iii) Environment, (iv) Monitoring and measuring resources, and
(v) Organizational knowledge.
The organization needs to provide – Determined resources,
needed for the establishment, implementation, maintenance and continual
improvement of the quality management system, that include (i) People, (ii)
Infrastructure, (iii) Environment, (iv) Monitoring and measuring resources.
The organization needs to identify and
safeguard – Monitoring and measuring resources.
The organization needs to ensure – Suitability
of monitoring and measuring resources.
The organization needs to maintain – (i)
Infrastructure, (ii) Environment for the operation of processes, and (iii)
Continuing fitness of monitoring and measuring resources.
The organization needs to carry out calibration
/ verification of monitoring and measuring resources – At specified intervals or
prior to use against measurable standards (applicable when measurement
traceability is required or the organization considers necessary).
The organization needs to determine at the time
when the measuring equipment found to be unfit – Whether the validity of
previous measurement results adversely affected?
The organization needs to take appropriate
action – If the validity of previous measurement results adversely affected.
The organization needs to maintain and make
available – Determined knowledge.
When addressing changing needs and trends, the
organization needs to (i) Consider current knowledge maintained and available in
the organization, and (ii) Determine ways to acquire or access any necessary
additional knowledge and required updates.
It is necessary to understand the term ‘organizational
knowledge’ or ‘knowledge’ used above. The term ‘organizational knowledge’ or
‘knowledge’ refers to the knowledge specific to the organization, which gained
by experience the people of the organization. This knowledge is used and shared
to achieve the organization’s objectives. Sources of knowledge can be – (i)
Internal, such as intellectual property (copyrights, patents, design etc.),
knowledge gained from experience, lessons learned from failed projects and
successful projects, captured and shared knowledge and experience (documented
and undocumented), results of improvement initiatives in processes, products
and services. (ii) External, such as standards, book, literature, publication, academia,
conference, customer, external provider etc.
The organization needs to retain documented
information (records) as evidence of – (i) Fitness of monitoring and measuring resources,
(ii) Basis used for calibration / verification when there is no measurement
standard available or exist.
While implementing the requirements of the
standard, following should be clearly understood:
(i)
Infrastructure can be land, building,
associated utilities (electricity, water), equipment, machinery, hardware,
software, transportation resources (two / three / four-wheeler, etc.),
information, communication technology etc.
(ii)
A suitable environment for the operation of processes
can be a combination of human, psychological and physical factors. Human
factors may be social (such as, non-discriminatory, calm, non-confrontational),
psychological (that reduces stress, prevention from fire / burn, emotional
protection) and physical (such as, temperature, heat, light, airflow, hygiene,
noise etc.).
Non-discriminatory
= Not making an unfair or prejudicial distinction between people
Calm and
non-confrontational = That tends to deal with situations calmly and
diplomatically, not aggressive or hostile
(iii)
Monitoring and measuring resources are needed
to ensure valid and reliable results when monitoring and measuring is used to
verify product / service conformity to requirements.
Competence
Competence = The fact of having the ability or
skill that is needed for doing something
Competence is the ability or skill to do
something successfully or efficiently. Competence means that a person or an
organization has the ability to do something well. The person or the
organization is capable of performing a task or job effectively. Competence can
be described as the combination of training, skills, experience and knowledge
that the person has and his ability to apply them to perform a task or job
safely. Other factors, such as attitude and physical ability of the person, can
also affect the person’s competence. Competence is ability to apply knowledge
(available collection of information and meaningful data) and skills to achieve
intended results.
The organization needs to determine necessary
competence of persons doing the work related to the quality management system of
the organization.
The organization needs to ensure – Persons are
competent. Basis – Appropriate education / training / experience.
The organization needs to take action to acquire
necessary competence, where applicable.
The organization needs to evaluate effectiveness
of the actions taken.
The organization needs to retain documented
information (records) of competence evidence.
Clarification – Actions to improve competence
in the organization can be – (i) Providing training to people, (ii) mentoring
(guidance) of people, (iii) Reassignment of people, (iv) Hiring / contracting
competent people etc.
Awareness
Awareness is the knowledge that something
exists or understanding of the subject matter.
The organization needs to ensure – People know
and understand – (i) Quality policy of the organization, (ii) Quality
objectives established by the organization, (iii) People’s contribution to the
organization’s quality management system effectiveness, (iv) Benefits of
improved performance, (v) Implications of not meeting the quality management
system requirements.
One may have following questions:
(i)
Why people should know quality policy of the
organization?
(ii)
Why people should know the established quality
objectives?
(iii)
What are the benefits of improved performance?
(iv)
If quality management system requirements are
not met, what are the implications?
Please consider following answers to above
questions:
(i)
The quality policy of an organization is a
statement of organization’s commitment to quality and it provides a framework for
setting quality objectives. When people within the organization know and
understand the quality policy of the organization, they can align their work according
to the direction set by the quality policy. Understanding the quality policy of
the organization helps to create a culture of quality within the organization,
which is helpful for the successful implementation and maintenance of the
quality management system.
(ii)
Quality objectives are established at relevant
functions, levels and processes needed for the quality management system.
Quality objectives are specific, measurable, and time-bound targets that an
organization sets for itself to achieve. When people within the organization
know and understand the established quality objectives, they can align their
work with these objectives, and ensure that their efforts contribute to achieve
them. This helps to ensure that people in the organization is working towards
achieving established goals, which is needed for the successful implementation
and maintenance of the quality management system.
(iii)
Improved performance in an organization leads
to a range of benefits for the organization, including customer satisfaction,
improved product and service quality, increased productivity, increased
efficiency, reduced costs, and improved competitiveness. These benefits ultimately
lead the organization to its increased profitability and long-term success.
(iv)
If quality management system requirements are
not met in an organization, the organization may experience a range of negative
consequences that may include bad product, bad service, customer complaints, lost
business, decreased productivity, increased costs, potential legal and
regulatory consequences etc. Not meeting quality management system requirements
can damage an organization’s reputation that can have long-term consequences
for its success. Therefore, it is required that the organization ensures that
it meets all quality management system requirements to avoid the negative
consequences mentioned above.
Communication
Communication
=The act of imparting, sharing or exchanging information, ideas or feelings
Communication
is imparting, sharing or exchanging of information by speaking, writing or
using some other medium.
The
organization needs to determine – Internal communication and external
communication that include – (i) Contents (what) to communicate, (ii) Timing
(when) to communicate, (iii) People / Organizations / Parties (whom) to
communicate, (iv) Methods / means (how) to communicate, (v) Person / authority
/ organization (who) to communicate.
Documented
Information
Documented
information = Information contained in a medium / format
Documented
information is the meaningful data and facts about something, which can be in
any format and media and from any source. Retaining documented information serves
as an evidence of conformity, nonconformity or results achieved.
Annex A
of ISO 9001:2015 QMS standard provides clarification that an organization can
choose to use terms which suit their operations, for example, using ‘records’,
‘documentation’ or ‘protocols’ rather than ‘documented information’.
The terms
‘documentation’, ‘quality manual’, ‘documented procedures’, ‘records’ used in
ISO 9001:2008 QMS standard are replaced and used by the term ‘documented
information’ in ISO 9001:2015 QMS standard.
ISO
9001:2015 QMS standard requires to either maintain or retain documented
information in some of its clauses. Documented information may be (i) As
required by ISO 9001:2015 QMS standard, and (ii) As determined by the
organization.
The
organization needs to ascertain – (i) What documented information required by
ISO 9001:2015 QMS standard, and (ii) What documented information determined by
the organization.
For
creating and updating a documented information, the organization needs to ensure
appropriately – (i) Identification, (ii) Description, (iii) Format, (iv) Media,
and (v) Review and approval for suitability and adequacy.
For
controlling documented information, the organization needs to – (i) Ensure – Availability
for use, suitability for use adequately protected, (ii) Address – As applicable
– Distribution, access, retrieval, use, storage, preservation, preservation of legibility,
version (change) control, (iii) Identify, determine and control – External
origin documented information, (iv) Protect the documented information retained
as evidence of conformity – From unintended alteration.
Protected
= Remained adequately confidential, proper use, sincere, truthful
Access =
Permission to view, or the permission and authority to view and change
It should
be noted that documented information required for the quality management system
of one organization may differ from another organization due to size, type,
products / services, processes, processes complexity, processes interaction,
competence of persons.
Additional
Reading Suggested – A Concise Guide on Creating and Updating Documented Information
(eBook)
Think of the
following Questions
(1)
What support needed for the quality management
system?
(2)
Why support needed for the quality management
system?
(3)
What do you understand by the terms ‘maintaining
documented information’ and ‘retaining documented information’?
(4)
What are the requirements of ISO 9001:2015 QMS
standard for support of the quality management system?
Best wishes,
Keshav Ram Singhal
Please have your comments /
reaction.
To train your employees with ISO
9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN:
B093YFFY7Z), which is available worldwide at Amazon. Please
search this Training Handbook in Amazon Website of your country.
You may also supply your employees
following eBooks - (i) A Concise Guide on Creating and Updating Documented Information
(eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/
(ii) Applying Risk-based Thinking in an Organization Implementing ISO
9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/
Thanks.
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