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.