Siemens Healthcare
Integrated Management System
(Or the journey to it)
Mike Dallenger
Process Improvement Manager
Siemens Healthcare 10 Years
Major Areas Of Work
Quality Management
Environmental Management
Process Management
Process Improvement
Company Profile
Historically Imaging
Approx 12 Years Ago Managed Services
7 Years Ago PETNET
More Recently Diagnostics
Complete Healthcare Workflow!
Imaging
Managed Services
PETNET
Diagnostics
BACKGROUND
Increasingly Complex World
Existing Business
in-vivo (within living) – imaging
radio active pharmaceuticals
Recent Acquisitions
in-vitro (within glass) – fluids
Customer Requirements
Traditionally QMS
EH&S added
Increasingly Complex World
Existing Business
independent 9001, 14001, 18001
Recent Acquisitions
UK Business part of European wide 9001
Increasingly Complex Siemens World
Heavily Regulated Industry
UK - Medicines and Healthcare products Regulatory Agency
(MHRA)
Similar organisations in every country
Different requirements
GENERAL TERMS – ALL PRODUCTS NEED TO BE
APPROVED BEFORE BEING SOLD IN ANY COUNTRY!
Siemens History = Compliance Risk Adverse
Country Sold Unapproved Product
Internal Regulation “Enhanced”
Series of documents
Expert audit teams
Audit every country
Needed to address business acquisitions, existing
management systems and recently introduced internal
regulations!
Brand Protection
Effective Management
Economic Downturn
Approach
Publically Available Specification - PAS 99
Appropriate Management Systems
For Healthcare this is:
Quality
Regulatory
Health and Safety
Environment
Process
Business Continuity
Management System – Plan – Do – Check - Act
Framework for managing and improving an organization's policies, procedures and
processes.
Elements of our IMS
R
Regulatory
Q
Quality
H
H&S
E
Environment
P
Process
B
Business
Continuity
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
IMS Manual
PAS 99:2006 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.
Policies, Objectives and Programmes
Quality
Regulatory Affairs
Health & Safety
Environmental
Process Management
Business Continuity
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).
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
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
Benefits
Challenged The Organisation – New Requirements
All management systems “refreshed”
Consolidated Approaches
Policy
Programmes
Objectives
Management Review
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
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
EXPERIENCE
Healthcare Expert Audits
Very forensic
Documented Approaches
Documented Records
Coroner’s Court?
Pas 99 Audits
3 year integrated audit plan
Integrated Policies, programmes and objectives
Updated annually with management review
Achievements?
Successful PAS 99 surveillance audits
More Challenging Auditors
Integrated Approach
Appropriate Levels Of Review
Successful “Healthcare Expert” audit
Global Finalists Siemens QT AWARD
Summary
It was time for revolution, not evolution
Fresh start
Facilitated top down approach
Questions