Quality Policy

When crafting your Quality Policy, think about these items.

• The eight principles of the ISO 9001 standard
• Continuous improvement
• Product requirements
• Quality objectives
• How do you continuously improve?
• What are your quality principles?
• Quality strategies
• Does it align with your corporate mission?
• Customer satisfaction
• Supplier relationships

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Representative

The management representative ensures the adequacy of the quality management systems. The management representative is the main contact for the ISO auditor.

Your QA manual may separate individual clauses to a specific person. For example Design and development may be the responsibility of the Research Engineering Manager.

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Key Elements

I recommend you go through each section of the Main and Key Elements. For each section in the QA Manual, provide a summary and document the supporting procedure. If there is no supporting procedure than address that section fully in the QA Manual.

If you would like to review a completed ISO 9001 Quality Manual, sign up for QA Solutions e-zine. You will be immediately able to download the manual.

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Process Interaction Chart

A process interaction chart shows the inputs and outputs between your managment systems.

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Quality Objectives Must Be

• measurable
• Relate to your business products
• documented
• reviewed
• tracked

Quality Objectives Documentation

Your quality objective documentation should

• Tell specifically what you are measuring
• State how you collect the data.
• The frequency of the measurement
• Provide targeted goals
• State who is responsible for gathering the data
• State how they are recorded.
• State when they are reviewed

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Quality Objective examples

Examples of Quality Objectives:

• Percent yield for a product
• Cycle time for a product.
• CpK for a given process characteristic
• CpK for a product characteristic
• Number of product returns
• Product returns parts per million.
• Corrective action cycle time
• Number of open corrective actions
• Number of audit action items.
• Sales Volume
• Net profit
• inventory turns
• Number of key customers.
• installation time
• Number of preventive actions
• Quality Costs.
• Number of supplier rejects
• Key supplier lead times
• Number of data entry errors
• Rework costs.
• Defect costs.
• Number of processes out of control

Determining Objectives

Select quality assurance metrics based on your business needs. The metrics need to make sense to your organization.

When determining metrics, select metrics that are global to the entire operation. Then select metrics that support those global metrics. Break the metrics down by department, process, organization function or product.

All employees should be able to identify the metrics. All employees should know how their work affect the metrics.

Make metric targets reasonable and challenging. Management provides the plans to achieve the targets. During the quality management review, review the metrics and document the plans to achieve the targets.

Some companies put the quality objectives within the quality assurance manual. I do not recommend this. Your customers do not need to see your quality objectives. In most cases these are confidential.