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7/30/2019 Practical Guide to ISO 9001 Implementation
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ISO 9001:2008ISO 9001:2008
Practical Guidance toPractical Guidance to
By: Andy Hofmann, President
International Certification Services Inc.
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Presentation ObjectivesPresentation Objectives
Overview of ISO 9001:2008
Commitment Required by Organization
Keys to successful implementation
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ISO 9001:2008ISO 9001:2008
--
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Business Process FlowBusiness Process Flow
C
URe
C
U
SMeasurement,Anal sis,
Satisf
ManagementResponsibility
Resource
Quality Management System
Continual ImprovementContinuous
ImprovementCycle
A P
C D
ST
O
M
E
R
uiremen
ts
Input Productand/or ServiceRealization
O
M
E
R
Output
Improvement
a
ction
Quality Management System
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Structure of ISO 9001Structure of ISO 9001Based on a Plan-Do-Check-Act Business ProcessModel Organized into Five Major Clauses: 4.0 Quality Management System (general requirements,
documentation requirements, quality manual, control ofdocuments and records)
5.0 Management Responsibility (policy, objectives,planning, customer focus, QMS, management review)
6.0 Resource Management (human resources, facilities,work environment)
7.0 Product and/or Service Realization (contract, design,
purchasing, production, calibration)
8.0 Measurement, Analysis and Improvement(monitoring, audit, control of NC, continual improvement,customer satisfaction)
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Summary ofSummary of RequirementsRequirementsItems that your QMS must document: Policy
Control of Documents Control of Records
Internal Audits Nonconformance Control
Corrective Action Preventive Action Processes and Procedures required to control work
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ISO 9001:2008ISO 9001:2008
Imp ementat onImp ementat on omm tmentomm tment
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Implementation CommitmentImplementation Commitment Full support by Top Management
Implementation is planned, consistently communicatedand appropriate training provided
Regular review of progress - audit
Successes are identified and celebrated
Maximum use is made of existing methods
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Implementation CommitmentImplementation Commitment Establishment of organizational direction through policy
Setting of objectives and targets
Definition of metrics
Provision of resources and removal of road blocks
Assessment of customer risk
Consistent reinforcement of positives
Resources to resolve nonconformances
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Implementation CommitmentImplementation Commitment
Establishment of direction through policy
- Strategic framework for the organization
- Commitment to customer and stakeholders
-
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Implementation CommitmentImplementation Commitment
Setting of Objectives and Targets
- Linked to customer needs
- Measurable and Meaningful
- Risk Based
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Implementation CommitmentImplementation Commitment
Metrics
- Monitoring direct measurables- Monitoring of audits of processes
- Monitoring of customer indicators
- Action when different from plan
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Implementation CommitmentImplementation Commitment
Resources
- Adjustment where metrics indicate
- Recognition and removal of road blocksto improvement
-
- Review of Strategy for continued fit
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Implementation CommitmentImplementation Commitment
Assessment of Customer Risk
- Identification of key needs, past and future
- Review of delivery systems and personnel
- Optimization of resources to consistently deliver against
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ISO 9001:2008ISO 9001:2008Ke sKe s to Successto Success
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Keys to SuccessKeys to Success
Map your processes
Maximum use of existing systems Assign ownership of process steps
Identif sub- rocesses and
controls/procedures Obtain management direction for policy,
goals, targets and metrics
Training, Training, Training
React to measures
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Keys to SuccessKeys to Success
A time line for activities usually six to 18months
A focus point, someone responsible toencourage each stakeholder
egu ar s a us mee ngs w en orManagement
Regular communication on progress toeveryone
An external resource to assist withinterpretations
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Keys to SuccessKeys to Success
Have Fun
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Keys to SuccessKeys to Success
Quotation:
You do not have to do this;
Survival is not compulsory !
Dr. W. Edwards Deming