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ISO 9001 Lecture

The document discusses ISO 9001, an international standard for quality management systems. It specifies the requirements for a QMS. The standard was updated in 2015. Organizations use it to demonstrate their ability to consistently meet customer and regulatory requirements by focusing on meeting customer needs and exceeding expectations. It also promotes continual improvement.

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Kevo Young
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42 views9 pages

ISO 9001 Lecture

The document discusses ISO 9001, an international standard for quality management systems. It specifies the requirements for a QMS. The standard was updated in 2015. Organizations use it to demonstrate their ability to consistently meet customer and regulatory requirements by focusing on meeting customer needs and exceeding expectations. It also promotes continual improvement.

Uploaded by

Kevo Young
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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ISO 9001:2015

• ISO stands for the International


Organization for Standardization).
• ISO 9001 is defined as the international
standard that specifies requirements for a
quality management system (QMS).
• The standard was updated in 2015, and it is
referred to as ISO 9001:2015.
Cont
• Organizations use the standard to demonstrate
the ability to consistently provide products and
services that meet customer and regulatory
requirements
• the primary focus of the ISO 9001 standard is
to meet customer requirements and strive to
exceed customer expectations.
Cont.
• A Quality Management System based on ISO
9001: Defines how an organization can meet
the requirements of its customers and other
stakeholders.
• Promotes the idea of continual improvement.
What are the ISO 9001
requirements?
• The structure of the ISO 9001:2015 standard is
split into 10 sections (clauses). The first three
are introductory, while the last seven contain
the requirements for the Quality Management
System against which a company can be
certified.
Benefits of ISO
• Ensures that products and services are safe,
reliable and of good quality.
• For business, they are strategic tools that
reduce costs by minimizing waste and errors
and increasing productivity.
Standard operating procedures (SOPs)
• Definition: SOP is the set of step by step
written instructions intended to document how
to perform routinely.
• They are the back bone of organization
performance .
Importance of SOPs
• Describe how to perform routine activities
• Provides a training aid
• Guide & standardize working procedures
• Ensure quality & integrity of data
generated/information captured
• Provide an auditing tool
• Ensures Consistency
Internal Audit - Self- Evaluation
Reasons to perform™
• Value added to Management -What value will
it achieve for the organization?
• Conformance to Internal Procedures-Often a
visual of a task or a review of documentation
™ Compliance to Regulations/Standards-check
the type of monitoring or documentation audit
• Effectiveness of Corrective Actions-monitor,
measure and analyze
Sops in theatre.
• The sop in theatre :Peri-operative management of
patients in KNH theatres.
• the work instruction are given as clauses for
example at the Receiving Area (RA)
• Clause 2.0 the RA Nurse shall establish rapport
with the patient, the primary nurse, and the porter
and where applicable the guardian/parent.
• The (RA) nurse shall receive report from the ward
nurse handing over the patient at the receiving
area of theatre.

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