Siemens Healthcare

Integrated Management System

(Or the journey to it)

Mike Dallenger

Process Improvement Manager

Siemens Healthcare 10 Years

Major Areas Of Work

Quality ManagementEnvironmental ManagementProcess ManagementProcess 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 Businessin-vivo (within living) – imagingradio active pharmaceuticals

Recent Acquisitionsin-vitro (within glass) – fluids

Customer RequirementsTraditionally QMSEH&S added

Increasingly Complex World

Existing Businessindependent 9001, 14001, 18001

Recent AcquisitionsUK Business part of European wide 9001

Increasingly Complex Siemens World

Heavily Regulated IndustryUK - Medicines and Healthcare products Regulatory Agency (MHRA)

Similar organisations in every countryDifferent 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 documentsExpert 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:

QualityRegulatoryHealth and SafetyEnvironmentProcessBusiness Continuity

Management System – Plan – Do – Check - Act

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

Elements of our IMS

R

Q

H

E

P

B

Regulatory

Quality

H&S

Environment

Process

Business Continuity

Common Requirements

Common Requirements = Integrated Management System

Common Requirements

a) Policy

b) Planning

c) Implementation and Operation

d) Performance Assessment

e) Improvement

f) Management Review

IMS Manual

PAS 99:2006 identifies six requirements common to all systems:

a) Policyb) Planningc) Implementation and Operationd) Performance Assessmente) Improvementf) 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 policyTop management shall define the organization's environmental policy and ensure that, within the definedscope of its environmental management system, ita) 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 towhich 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, andg) is available to the public.

Healthcare has developed an environmental policy. It is reviewed on an annual basis and authorized by theManaging Director. It contains the required commitments and it is supported by a number of environmentalobjectives. These objectives are also reviewed on an annual basis by being presented to the directors ofthe business for discussion and agreement.

This information is recorded within the document 05/01/05/005 Siemens Healthcare - IntegratedManagement System Policies, Objectives and Programmes It is also deployed via the Healthcare intranetsite 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 approachesIncreased TransparencyFacilitated 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