Siemens Healthcare Integrated Management System (Or the journey to it)

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Siemens Healthcare Integrated Management
System(Or the journey to it)
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Mike DallengerProcess Improvement
ManagerSiemens Healthcare 10 YearsMajor Areas
Of Work Quality Management Environmental
Management Process Management Process
Improvement
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Company Profile
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Historically ImagingApprox 12 Years Ago Managed
Services7 Years Ago PETNETMore Recently
DiagnosticsComplete Healthcare Workflow!
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Imaging
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Managed Services
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PETNET
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Diagnostics
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BACKGROUND
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Increasingly Complex World Existing
Business in-vivo (within living)
imaging radio active pharmaceuticals Recent
Acquisitions in-vitro (within glass)
fluids Customer Requirements Traditionally
QMS EHS added
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Increasingly Complex World Existing
Business independent 9001, 14001,
18001 Recent Acquisitions UK Business part of
European wide 9001
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Increasingly Complex Siemens WorldHeavily
Regulated IndustryUK - Medicines and Healthcare
products Regulatory Agency (MHRA)Similar
organisations in every country Different
requirementsGENERAL TERMS ALL PRODUCTS NEED
TO BE APPROVED BEFORE BEING SOLD IN ANY
COUNTRY!
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Siemens History Compliance Risk
AdverseCountry Sold Unapproved
ProductInternal Regulation Enhanced Series
of documents Expert audit teams Audit every
country Needed to address business
acquisitions, existing management systems and
recently introduced internal regulations!
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Brand ProtectionEffective Management E
conomic Downturn
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Approach
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Publically Available Specification - PAS
99 Appropriate Management Systems For
Healthcare this is Quality Regulatory Health
and Safety Environment Process Business
Continuity
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Management System Plan Do Check - Act

• Framework for managing and improving an
  organization's policies, procedures and
  processes.

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Elements of our IMS
R
Regulatory
Q
Quality
H
HS
E
Environment
P
Process
Business Continuity
B
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Common Requirements
Common Requirements a) Policy b) Planning c)
Implementation and Operation d) Performance
Assessment e) Improvement f) Management Review
Common Requirements Integrated Management System
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IMS Manual
PAS 992006 identifies six requirements common to
all systems a) Policy b) Planning c)
Implementation and Operation d) Performance
Assessment e) Improvement f) Management
Review These are defined in IMS manual.
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Policies, Objectives and Programmes
Quality Regulatory Affairs Health
Safety Environmental Process Management
Business Continuity
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Documentation Approach Black and Blue
2.2 Environmental policy Top management shall
define the organization's environmental policy
and ensure that, within the defined scope of its
environmental management system, it a) is
appropriate to the nature, scale and
environmental impacts of its activities, products
and services, b) includes a commitment to
continual improvement and prevention of
pollution, c) includes a commitment to comply
with applicable legal requirements and with other
requirements to which the organization subscribes
which relate to its environmental aspects, d)
provides the framework for setting and reviewing
environmental objectives and targets, e) is
documented, implemented and maintained, f) is
communicated to all persons working for or on
behalf of the organization, and g) is available
to the public. Healthcare has developed an
environmental policy. It is reviewed on an annual
basis and authorized by the Managing Director. It
contains the required commitments and it is
supported by a number of environmental objectives.
These objectives are also reviewed on an annual
basis by being presented to the directors of the
business for discussion and agreement. This
information is recorded within the document
05/01/05/005 Siemens Healthcare -
Integrated Management System Policies, Objectives
and Programmes It is also deployed via the
Healthcare intranet site for employees and on the
Healthcare internet site for external use (e.g.
members of the public).
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Key IMS Processes
Management System Manuals for each area of our
IMS. Supported by the following key IMS
processes. 05/01/05/006 - Document
Control 05/01/05/014 - Corrective and
Preventative Action 05/01/05/015 - Control of
Quality Records 05/01/05/016 - Management Systems
Audit and Assessment 05/01/05/017 - Control of
non Conforming Product These five key processes
deployed across the whole of our IMS
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Documentation Approach Audit and Training
New sections added for Audit and
Training Rationale Wanted the arrangements to
be thought through at the time of document
preparation/maintenance, i.e. What and how
will we audit Who and how will training be
delivered
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Benefits
Challenged The Organisation New
Requirements All management systems
refreshed Consolidated Approaches Policy Prog
rammes Objectives Management Review
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Benefits
All management systems looked the same A
FIRST! Defined Ownership No increase in
management system headcount Extra 250 staff and
new business activities! Documentation
Requirement plus Healthcare approaches Increased
Transparency Facilitated Support Common
Approach
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Benefits External Audits
Pas 99 Audits 3 year integrated audit
plan Reduced number of audit days despite
extra 250 staff despite additional business
complexity Auditors that operate across all
management systems
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EXPERIENCE
Healthcare Expert Audits Very forensic Document
ed Approaches Documented Records Coroners
Court? Pas 99 Audits 3 year integrated audit
plan Integrated Policies, programmes and
objectives Updated annually with management
review
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Achievements?
Successful PAS 99 surveillance audits More
Challenging Auditors Integrated
Approach Appropriate Levels Of
Review Successful Healthcare Expert
audit Global Finalists Siemens QT AWARD
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Summary
It was time for revolution, not evolution Fresh
start Facilitated top down approach
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Questions