Employee Orientation to ISO 9001:2008 - Cray-Tek.craytek.com/crQuality/document/CraytekEmployee... · C raytek The Process Model Slide: 12 Unclassified ISO 9001:2008 Employee Orientation

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Employee Orientation to ISO 9001:2008

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Agenda • What is ISO 9000?

• How Does ISO Work?

• How Will ISO Affect You?

Slide: 2 Unclassified ISO 9001:2008 Employee Orientation Training

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What is ISO 9000?


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What is ISO 9000? • ISO 9000 IS primarily a management system standard

• These elements are good business practice

• ISO 9000 IS NOT…

• A certification for an organization’s products

• A detailed document telling you exactly how to operate. (It’s your organization.)


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What is ISO 9000? • Sections of the standard include:

– 4 Quality Management System

– 5 Management Responsibility

– 6 Resource Management

– 7 Product Realization

– 8 Measurement, Analysis and Improvement


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Key Benefits of ISO 9000 for an Organization • Improved operations

• Consistency of process

• Market expansion capability

• Improved intra-plant communication (if multiple locations)


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Key Benefits of ISO 9000 for Individuals • Your job is better defined

• Processes before and after are more consistent

• A defined method exists to report problems and get them resolved

• Strengthened company position to compete


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How does a company get ISO 9000 certified? • To become registered a company must first implement the

requirements of ISO 9000 – Evaluate your current quality system

– Add systems and processes to meet the requirements

– Document your processes as a Quality Manual, Procedures and Work Instructions

• Outside party comes in to review

• Ongoing audit surveillance structure


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How does it work?


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Process Definition


Inputs Transformation Output

• Methods • Materials • Machines • People • Environment • Measurement

• Change occurs • Result

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• An organization is a system of interlinked processes

• The standard is geared at managing and improving those processes

• Key processes – those that lead to products and services - must be identified


The Process Model

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The Process Model


Requirements

Management responsibility

Measurement, analysis,

improvement

Resource management

Product

realization

Input Output Product

Continual Improvement of the Quality Management System

Customers and other Interested

Parties

Customers and other Interested

Parties

Satisfaction

Figure 1 – Model of a process-based quality management system (Taken from ISO 9001:2008)

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Work Instructions Forms

*Documents needed by the organization to ensure the effective planning, operation and control of its processes

Quality Policy Quality Manual

Six Required Procedures: Control of Documents

Control of Records Control of Nonconforming Product

Internal Auditing Corrective Action Preventive Action

What Type of Documents

are required?

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How will ISO Impact You?


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• A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

• Conducted by people from your organization


What is an Internal Audit

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• Be available

• Be honest and open

• Identify process problems (Auditors are there to help the organization improve!)

• Help fix any discrepancies found


How do you participate in an internal audit?

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• To determine implementation effectiveness of the quality system.

• To determine conformance to specified contractual requirements.

• To provide a basis for improvement of your quality system.

• To meet regulatory requirements.

• To satisfy customer requirements.

• To achieve second or third party registration.


Why Audit?

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• Conducted by an independent company (Registrar) outside your organization

• Looking for evidence of compliance to the standard

• The outcome is becoming certified


What is a registration audit?

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• Same list as for the internal audit!

• Be available

• Be honest and open

• Identify process problems (Auditors are there to help the organization improve!)

• Help fix any discrepancies found


How do you participate in a registration audit?

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• The organization’s Quality Policy – What is it? (In your words) – How does your job relate to the Quality Policy?

• Explaining your job…

– What tasks are done – What paperwork or documents you use – How do decide what to work on – Related quality standards – How you were trained – Any tests you perform – What records you keep


How should YOU prepare for an audit?

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• Need to understand quality policy and how your job relates

• Work Instructions – how to find and how they relate

• Could be audited

• Possible changes in recordkeeping

• Possible changes in processes


Summary Review: How will you be impacted by ISO?

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• Everyone’s participation is needed for improvement

• Talk to your Management and Quality Manager to learn more


Closing

CRAYTEK ISO 9001 Employee Orientation Training

HAS COMPLETED THE CRAYTEK ISO 9001:2008 Employee Orientation Training

Supervisor’s Signature date

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