Developing
and implementing ISO 9001:2015 QMS – 11 – Establishing and Developing Quality
Policy and Quality Objectives, and Creating and Updating Documented Information
=========
In the
previous write-up, it is mentioned that in the initial status survey, it should
also be found out whether required documented information are created, updated
and maintained / retained as per the requirements of ISO 9001:2015 QMS
standard. In case of any gap determined with regard to documented information
should be noted for further action of implementation.
In this connection,
ISO 9001:2015 QMS standard requires:
(i)
To
develop a quality policy
(ii)
To
establish quality objectives at relevant functions, levels and processes
(iii)
To
create, update, control and retain documented information
The
standard also requires to maintain documented information to support operation of
its processes and retain them to have confidence that the processes are carried
out as planned.
ISO
9001:2015 QMS standard requires to maintain following documented information:
-
Scope of
the organization’s quality management system (4.3)
-
Information
to support the operation of organization’s processes (4.4.2)
-
Quality
policy (5.2)
-
Quality objectives
(6.2.1)
-
Operational
planning and control (8.1)
-
Documented
information that defines the characteristics of the products and services to be
produced / provided, activities to be performed, and the results to be achieved
(8.5.1)
-
In
addition to the above, the organization should determine documented information
(to maintain) as being necessary for the effectiveness of the organization’s
quality management system (7.5.1)
ISO
9001:2015 QMS standard also requires to retain following documented
information:
-
Processes
carried out as planned (4.4.2)
-
Monitoring
and measuring resources – evidence of fitness, and basis used for calibration
and verification, where no international or national measurement standard
exists (7.1.5)
-
Evidence
of competence (7.2)
-
Operational
planning and control (8.1)
-
Results
of the review of requirements, including any new or changed requirements, for
products and services, and where requirements for products and services are
changed, amendment of relevant documented information (8.2.3)
-
Confirmation
that design and development requirements are met (8.3.2)
-
Design
and development inputs (8.3.3)
-
Design
and development controls activities (8.3.4)
-
Design
and development outputs (8.3.5)
-
Design
and development changes, results of reviews, authorization of changes, and
actions taken to prevent adverse impacts (8.3.6)
-
Evaluation,
selection, monitoring of performance, and re-evaluation activities of external
providers and any necessary actions (8.4.1)
-
Necessary
information to maintain traceability (8.5.2)
-
Information
regarding property belonging to customer or external provider is lost, damaged
or otherwise found to be unsuitable for use and reporting to the customer or external
provider (8.5.3)
-
Results
of the reviews of changes, personnel authorizing the changes, and any necessary
action (8.5.6)
-
Evidence
of product / service conformity with the accepted criteria (8.6)
-
Traceability
to the person(s) authorizing release of products and services for delivering to
the customer (8.6)
-
Release
of product / service including evidence of conformity with acceptance criteria,
information that describes nonconformity, actions taken, any concession
obtained, and that identifies the authority deciding the action (8.7.2)
-
Evidence
of results in monitoring, measurement, analysis and evaluation (9.1.1)
-
Evidence
of the implementation of the internal audit programme, and internal audit
results (9.2)
-
Evidence
of the results of management review (9.3)
-
Evidence
of nature of nonconformities and subsequent actions, and results of any
corrective action (10.2)
-
In
addition to the above, the organization should determine documented information
(to retain) as being necessary for the effectiveness of the organization’s
quality management system (7.5.1)
It is
better, in the beginning, to formulate the organization’s quality policy and
quality objectives in line with vision, mission and long-term business goals of
the organization. Quality objectives need to be established at relevant
functions, levels and processes needed for the quality management system.
Therefore,
the members of the task force may be assigned the following work:
-
Defining
the scope of the organization’s quality management system
-
Formulating
organization’s quality policy
-
Formulating
quality objectives
-
Determining
documented information to maintain
-
Determining
documented information to retain
We need
to understand the meaning of two terms that looks similar but having different
meaning. (1) Documented Information Retained – Documented Information Retained
are records that serve as evidence of past activities, decisions, and events.
They show what happened and are kept for historical, legal, regulatory, or
knowledge preservation purposes. (2) Documented Information Maintained –
Documented Information Maintained are documents that provide guidance,
procedure, work instructions, and other relevant information that are actively
used to support ongoing processes and operations.
The task
force should take the following decision with regard to the documented
information other than mentioned in the above Para:
-
Who will
create or update the documented information?
-
Who will
control the documented information?
It should
be ensured that the documented information, created and updated, should be
reviewed and approved for adequacy. Documented information pertaining to a
particular activity or process should be developed / created by persons
involved in respective activity or process with the help of task force members.
For example, documented information pertaining to operational planning and
control should be developed / created by persons involved in operations. It
will ensure ownership of documentation and will be easy to understand. There is
also a need of regular review of documented information, which is essential to
ensure its accuracy and relevance. The task force convenor may be assigned the responsibility
of reviewing documented information from time to time. The top management
should approve the documents for adequacy before issue. These steps look
appropriate to ensure the effectiveness of the organization’s quality
management system documentation.
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/
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