Management Systems
This training is to:
Provide a basic understanding of quality
management systems (QMS) as applied
in Clinical Oncology.
ESSENTIAL VOCABULARY
To understand the ISO9000 standard, there are certain
terms you should become familiar with.
• Supplier – An organization that provides a ‘product’ (a product can be a
service!); e.g. the treatment radiographers supply a treatment service.
• Customer – The recipient of a product; e.g. the treatment radiographers
are customers of the treatment planning service.
• Product – The result of a process.
• Process – A set of interrelated, or interacting, activities that transform
inputs into outputs. Procedures form part of Processes. e.g. the patient
journey through clinical evaluation.
• Procedure – A specified way to carry out an activity or process.
• Audit – The systematic, independent and documented process for
obtaining evidence and evaluating it objectively to determine the extent to
which specified criteria are fulfilled.
ESSENTIAL VOCABULARY 2
• Nonconformity – The non-fulfilment of a requirement of the system.
(Alternatively: non-conformance)
The department Quality Management Representatives (QMRs) usually
decide whether a reported ‘observation’ is a nonconformity.
• Corrective action – Action to eliminate the cause of a detected
nonconformity.
• Preventive action – Action to eliminate the cause of a potential
nonconformity, or other undesirable situation.
• Nonconformity/Corrective Action Report (NCAR) – A document
recording information about nonconformities and their corrective actions.
• Issue Report - A document recording information about a treatment
“issue” and its resolution.
• Opportunity for Improvement – A recorded suggestion, observation or
non-treatment “issue”. Can lead to Corrective or Preventive actions.
• Deviation permit – permission to depart from a specified requirement
(sometimes also referred to as a concession; strictly a concession is a
permit to release nonconforming product).
INTRODUCTION TO ISO 9000
For those that may remember:
Under the 1994 standard there were three models in the series:
ISO 9001, 9002, and 9003; and each model had a slightly different
scope.
Now:
Under the 2000 revision of the standard there is now only ISO9001 with
8 sections, and an organization must examine its activities and
document any relevant exclusions from (section 7 of) the standard that
applies to their quality management system. ISO9004 is published as
guidelines for performance improvement.
Remember:
ISO 9000 is intended to be relevant to all types of organizations.
Whether manufacturing industries as diverse as medical equipment,
pharmaceuticals, or paper pulp, or service industries such as medicine,
banking, or transportation, the ISO 9001 quality system model is
applicable to all products and services.
ISO 9001:2000
and …
HOW DO WE ACHIEVE QUALITY? 2
Quality Manual …
Procedures …
Work Instructions …
Records …
Expectations
Remember:
* It is an audit of the process, not the people carrying it out.
* It is not a test!
Level 1 – Quality Manual
The Quality Manual usually states the company’s quality policy and
describes the organization’s quality system.
• The quality manual should be brief, concise and not weighted down
with details.
• Specific “how-to” procedural matters should be located in other
supporting documents, such as procedures and work instructions.
Level 2 - Procedures
Documented …
Level 2 – Procedures 2
• Quality records should be easy to read (watch your writing), dated &
clean (don’t place your cup on them), and easily identified & retrieved
(not in a locked filing cabinet, in a disused toilet, in the basement
without a light). See QAP 1.3.