Introduction to Quality
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
Most headings have sub-headings e.g.
 Product realization
Planning of product realisation
Customer-related processes
Design and development
Purchasing
Production and service provision
Control of monitoring and measuring devices
WHAT IS QUALITY?
Quality has been defined as:
• “The totality of features and characteristics of a product or service which
bear on its ability to satisfy stated or implied needs.” ISO 8402:1994.
• The “degree to which a set of inherent characteristics fulfils requirements”
ISO 9001:2000
Quality has also been summed up by the phrase; FITNESS FOR
PURPOSE. Meaning the product or service is neither less nor more than
the customers given need.
Hence quality could also be thought of as:
Fitness for purpose, delivery of customer satisfaction,
Delivering an agreed service to an agreed standard,
or, … ?
Whether the quality of a service, or product, is appropriate depends on
the need(s) it is meant to fulfil. In meeting the need(s) of a service user
(‘customer’) you must include, not only what the service is required to do,
but also as appropriate; price, delivery, supporting service and un-stated
customer expectation/desires.
HOW DO WE ACHIEVE QUALITY?
Following a well publicised incident in the late 1980’s Radiotherapy
departments in the UK were given guidance from the Department of
Health to implement quality assurance systems based on the ‘QART’
report of May 1991 (itself based on BS5750/ISO9000). This was
followed by an ESTRO report in the late 1990’s making similar
recommendations based on ISO9000:1994. We have implemented
a quality management system since 1996, currently conforming to
the ISO 9001:2000 standard (originally ISO 9001:1994), which is
designed to allow us to deliver quality based on the eight quality
management principles:
and …
HOW DO WE ACHIEVE QUALITY? 2
and following the ‘Quality Cycle’:
Define Quality Objectives
Establish Process
Modify Process
Audit Process
Sometimes also referred to as the Plan – Do – Check – Act cycle.
This cycle has also been brought to the fore in the
Health Service as the plan/do/study/act cycle by
Service Improvement Teams; or the similar,
review/agree/implement/demonstrate model in
Clinical Governance.
HOW DO WE ACHIEVE QUALITY? 3
We have implemented a “Quality Management System”
(QMS), it is often referred to as a “Quality System”,
but it is probably best-understood if it is thought of as a
“Management System”.
It is also worth noting that we are ‘certified’ or ‘certificated’ to
ISO9001:2000, while it is our Certification Body (BSI) that is accredited.
In Clinical Oncology the system is lead by the Management Review
Meeting (all Clinical Oncologists, Heads of Staff Groups, Quality
Management Representatives & a couple of others) held twice a year
with feedback through Clinical Oncology Department meetings &
Radiotherapy meetings.
DOCUMENTATION
Documentation is essential to quality systems. It explains the
company’s policies & objectives, defines authority, and establishes
operational procedures and work instructions to help employees fulfil
their job responsibilities.
• ISO9001:2000 section 6 emphasises competence,
so documents only need be as detailed as required.
Documents can take any appropriate form,
e.g. written or diagram, and can be in any appropriate media, e.g. paper
or intranet.
• Note: Not all processes & procedures have to be documented;
especially if training, skills & expertise can be relied on.
DOCUMENTATION 2
QMS documentation is usually structured like a pyramid,
divided into tiers consisting of:
Quality Manual …
Procedures …
Work Instructions …
Records …
Expectations
• Staff must work to documented practice where it exists.
• Staff must be aware of Quality Policy & Objectives.
• Staff can expect to play a part in ‘quality’ audit.
• Staff can expect to be appropriately trained, and be provided
with suitable communication channels and appropriate
resources.
QUALITY CONTROL vs.
QUALITY ASSURANCE
 Quality Control aims to detect nonconformities – it focuses on the end
product.
Traditionally inspection processes are used at various points in the
production of a product or service to control, and assure, quality.
 Quality Assurance aims to prevent nonconformities – it focuses on
the process used to produce the end product.
Quality Assurance is all those planned and systematic actions
recommended to provide adequate confidence that a product or service
will satisfy given requirements for quality.
 Quality control and inspection are parts of quality assurance.
QUALITY ASSURANCE
ISO 9000 has always emphasised prevention methods, these avoid the
shortcomings of inspection processes and are effective as a quality
assurance system due to:
• Emphasis shifts from production to quality management.
Stress quality rather than quantity.
• Causes of problems are addressed.
Solve problems at the point that they occur.
• Quality responsibility is shared.
Responsibility for quality is shared at all levels.
• Teamwork is fostered.
Personnel through all areas work to find the causes of problems.
• The process continually improves.
The process is improved as problems are found and fixed.
QUALITY AUDITING
• A quality audit is a systematic and independent examination to
objectively determine whether quality activities and related results
comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve their objectives.
• Auditing is no more than the establishment of facts; it is not an
inquisition, rather it is aimed at helping error reduction / elimination,
compliance, verification and communication.
• Policies, systems, and procedures may be modified from this information
to ensure objectives are achieved, and where possible to improve them.
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
A procedure gives information on activities carried out, when & how
they are performed and the people that have direct responsibility for
them. While the Quality Manual is a company-level document,
procedures are an extension of the Quality Manual aimed at different
departments. They are activity-based, describing methods and
practices used to carry out various quality system activities spanning
functional or organization lines.
Procedures usually contain:
– The purpose and scope of an activity
– What is to be done and by whom
– When, where and how it will be done
– What materials, equipment and documents shall be used
– How it shall be controlled and recorded
Documented …
Level 2 – Procedures 2
Documented procedures do not need to be lengthy, and should be
easily understood. The ISO 9000:1994 standard said that a facility
need only have documented procedures and work instructions “where
the absence on same would adversely affect quality”, and “the range
and detail of the procedures that form part of the quality system
depend upon the complexity of the work, the methods used, and the
skills and training needed by personnel involved in carrying out the
activity”.
An effective procedure will reduce the amount of training needed for
new employees, as responsibilities are clearly defined. Ideally if a
procedure is well written, a new competent employee should be able
to perform the task simply by following the procedure.
Level 3 – Work Instructions
Work instructions provide more specific directions for performing an
activity listed under a procedure; they are likely to be used either
‘daily’ for critical activities, or less frequently when particular complex
activities are carried out. They may, if the order is critical, say step-bystep how to complete a specific task, or they may just tell the operator
what steps need to be followed, what equipment and resources are
required for a job, what precautionary measures need to be taken, and
so forth.
• Work instructions contain specifics; but should only exist where
necessary, and only be as detailed as required to assure clarity and
compliance.
• Particularly detailed instructions are most likely the domain of training
documents.
• Since work instructions are “how to” documents, they are likely to
change more frequently than something like the Quality Manual.
Level 4 – Records
Quality records are documents that furnish objective evidence that a
quality requirement has been fulfilled, or demonstrate that the quality
system is operating effectively.
• 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.