ISO
9001:2015 QMS Awareness – Operation – General Information, Operational Planning
and Control, Requirements for Products and Services
===========
Clause 8 of ISO
9001:2015 QMS standard deals with support requirements.
Operation = An organized
activity that carried out by many people in the organization doing many tasks
Operation is the action
of functioning of the organization to achieve its objectives.
Operation = Operational
planning + Operational control + Customer communication + Determining, review
of and changes to requirements for products and services + Design and
development activities (including planning, inputs, controls, outputs and changes)
+ Control of externally provided processes, products and services (including
type and extent of controls, information for external providers) + Production
and service provision (including control, identification, traceability,
external providers’ property, preservation, post-delivery activities, control
of changes) + Release of products and services + Control of nonconforming
outputs.
Requirements for operation
Requirements for support are mentioned in clause
8 of ISO 9001:2015 QMS standard. The
relevant sub-clauses of Clause 8 of the standard are as under:
8 Support
8.1 Operational planning and control
8.2 Requirements for
products and services
8.2.1 Customer
communication
8.2.2 Determining the requirements
for products and services
8.2.3 Review of the
requirements for products and services
8.2.4 Changes to
requirements for products and services
8.3 Design and
development of products and services
8.3.1 General
8.3.2 Design and
development planning
8.3.3 Design and
development inputs
8.3.4 Design and
development control
8.3.5 Design and
development outputs
8.3.6 Design and
development changes
8.4 Control of
externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of
control
8.4.3 Information for
external providers
8.5 Production and
service provision
8.5.1 Control of
production and service provision
8.5.2 Identification and
traceability
8.5.3 Property belonging
to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery
activities
8.5.6 Control of changes
8.6 Release of products
and services
8.7 Control of
nonconforming outputs
Operational Planning and
Control
The organization needs
to plan, implement and control – Processes (please refer to the requirements
mentioned in clause 4.4).
The organization needs
to implement – Actions determined in planning (Please refer to the requirements
mentioned in clause 6).
The organization needs
to determine – (i) Requirements for products / services, (ii) Resource needs,
(iii) Documented information to retain and maintain to the extent necessary.
The organization needs
to establish – (i) Criteria for processes, and (ii) Criteria for acceptance of
products / services.
The organization needs
to implement – Control as per established criteria.
The organization needs
to control – (i) Planned changes, and (ii) Outsourced processes.
Outsourced processes =
Processes done by others (people / organization)
The organization needs
to review – Consequences of unintended changes.
Unintended = Not planned
as a goal
The organization needs
to take – Necessary action to mitigate (to make less severe) any adverse
effects.
The organization needs to
maintain documented information – As determined
The organization needs
to retain documented information – As determined
We find that
requirements for operational planning and control in ISO 9001:2015 QMS standard
focuses on operational planning and control that requires the organization to
plan, implement, and control the processes to meet its quality management
system (QMS) requirements. A few real-life examples are mentioned below:
1. Production Scheduling – A manufacturing
organization is involved in production activities and is required to plan and
control its production activities effectively. The organization may use techniques
like production scheduling, capacity planning, resource allocation etc to
ensure its production processes in a coordinated manner, which will help in
meeting customer requirements, optimizing resources and minimizing delays in
production.
2. If an organization relies on external suppliers,
then the organization needs to carefully select and evaluate its suppliers.
3. When implementing change to processes, products or
services, the organization must have effective control measures in place. By
effective change management, the organization can minimize potential risks to
its processes, maintain product / service as per requirements, and ensure a
smooth change to processes, products or services.
4. Operational planning and control must have risk-based
thinking. The organization should identify and assess potential risks to their
processes, products and services. The organization can develop mitigation
strategies, implement controls and regularly monitor and review risk levels.
5. By maintaining and retaining adequate documented
information, the organization can have proper operational planning and control.
Documented procedures provide clear instructions about the activities to be
carried out, including control measures, responsibilities, and process flow.
Requirements for
Products and Services
The organization needs
to communicate with customers – (i) Providing information on product / service,
(ii) Handling enquiries, (iii) With regard to contracts / orders, (iv) With
regard to changes, (v) with regard to obtaining customer feedback / customer
complaints, (vi) With regard to handling / controlling customer property, (vii)
For establishing specific contingency action requirements, when relevant.
A few real-life examples
of customer communication that involve providing information, handling
enquiries, handling feedback and handling customer property are mentioned
below:
1. Providing Product / Service Information and
Specifications – Customer communication involves providing detailed information
about the features of the product / service, its specifications, usage
guidelines, and any applicable warranties. This will help the customer to make
an informed decision and will ensure the customer has a clear understanding of
the product / service s/he is considering.
2. Handling Enquiries and Requests – Customer
communication also involves promptly addressing inquiries and requests from
customers. This include responding to queries about product / service availability,
pricing, delivery options, technical support etc. Timely and accurate response
demonstrates better customer service and helps build customer trust and
customer satisfaction.
3. Resolving Customer Complaints – In situations
where a customer raises a complaints and / or expresses dissatisfaction,
effective customer communication plays a crucial role in building customer
trust and customer satisfaction. Here the customer communication involves
actively listening to the customer’s concerns, empathizing with the customer
situation, and working toward a resolution. Keeping the customer informed
throughout the complaint resolution process will help manage expectations of
the customer and also demonstrate a commitment to the customer satisfaction.
4. Collecting Customer Feedback – Collecting customer
feedback is an essential part of customer communication. There are various
methods for collecting customer feedback that may include survey, feedback
form, or online platform to collect customer opinions and experiences. Customer
feedback provides valuable insights for improvement and helps the organization
identify areas for improvement.
5. Handling Customer Property – There may be
situations where customer property is entrusted to the organization for various
purposes. A repair service may handle customer’s device. In such a case,
effective customer communication involves providing clear information to the
customer how customer’s property will be handled, stored, protected and
applicable terms and conditions, if any.
6. Order Tracking / Updating Status – Organizations
dealing with product delivery or providing service, customer communication
includes providing updates on order status, tracking information and expected
delivery time.
7. Service Renewal Reminder – Customer communication
also involves informing customers about the service renewal, maintenance
schedules etc. Sending timely reminder builds trust and relationship of the
organization with the customer
The organization needs to
ensure – (i) Defining product / service requirements (including legal and
others considered necessary, and (ii) Organization’s ability to meet product /
service requirements.
The organization needs
to review (before commitment to supply the product / service to a customer) –
(i) Customer requirements, (ii) Requirements for delivery, (iii) Requirements
for post-delivery activities, (iv) Requirements not stated by the customer, but
necessary for the specified / intended use, when known, (v) Requirements
specified by the organization, (vi) Applicable legal requirements, and (vii)
Changed contract / order requirements.
Legal requirements =
Statutory requirements + Regulatory requirements
The organization needs
to resolve – Changed contract / order requirements.
The organization needs
to ensure – (i) Amendment of changed requirements in relevant documented
information, (ii) Providing information of changed requirements to relevant
persons, and (iii) Organization’s ability to meet changed requirements.
The organization needs
to confirm (before acceptance) – Customer requirements, if customer does not
provide documented information.
The organization needs
to retain documented information (records) – (i) Review results, and (ii) New
requirements for product / service.
It should be noted that
where a formal review is impractical for each other, for example online sales,
the review will cover product information / catalogue.
Think of
the following Questions
(1)
What activities are involved in the operational
planning and control?
(2)
How can you improve customer communication in
your organization?
(3)
What
documented information you may need to maintain for operational activities?
(4)
What documented information you may need to
retain for operational activities?
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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