Monday, July 6, 2009

Managing Quality

This first step in building a ISO 9000 Quality Management System is the creation of a "Quality Manual". This is a separate and distinct step from developing quality procedures. The purpose is to state in a concise and brief format, the policies and objectives of the company required to achieve a desired level of quality for the organization or division.

More than likely the input for the Quality Manual will come from your customers. It is the customer that drives the Quality Process. There requirements, needs, and future desires are the basis for implementing an ISO 9000 quality system in the first place.

At a minimum, the ISO 9000 Quality Manual is required to address each one of the paragraphs of the applicable ISO 9000 Series that the company plans to become registered against. ISO 9001:2008 is the focus of this manual. But, you may need to expand the scope to include EMS 14001, QS-9000, AS-9000, or other industry specific quality requirements.

Each area that is written should include, at a minimum, three parts: Scope, Policy and Responsibilities.

The Scope portion should simply state the purpose of the covered area.
The Policy portion should state the company policy regarding the applicable ISO clause.
The Responsibility portion should state who, in generic titles or positions, is responsible for the policy.

ISO 9000 does not require a specific format for the Quality Manual. A sample manual is provided in this guide for your use as a template to create your own Quality Manual. The Quality Manual Table of Contents is based on the ISO 9000 standard itself. This ensures that each required element is addressed and provides an excellent starting point for building your Quality System.

ISO 9000 Quality Manual Consist of:

Master List
Forward
Administration
Company Information
Quality Management System
Management Responsibility
Resources Management
Product Realization
Measure Analysis Improvement
Attachment

b. ISO 9000 Operating Procedure
The ISO 9000 Operating Procedure Template includes and integrates the top level ISO 9000 quality manual and the six required quality procedures, thus containing the most difficult part of the ISO 9000 documentation. The ISO 9000 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 9001 : 2008 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 9001 : 2008.

ISO 9000 Operating Procedures Consist Of:

Control of documents
Control of records
Internal Audit
Control of non-conformance product
Corrective Action
Preventive Action
Training
Purchasing

c. ISO 9000 Forms
ISO 9001 : 2008 does not require forms but ISO 9001 : 2008 requires to keep records. Our well-designed forms make it easy to record the necessary information. In addition, our well-designed forms guide the user through a business process (for example, our Corrective & Preventive Action Plan Form guides you through the entire corrective action process), ensuring not only that all data is recorded but that all steps have properly been executed.
All our ISO 9000 Forms:
can immediately be used without any or with only little modifications(if you really need to, you can easily edit and customize in Microsoft Wordor Excel).
are designed by experienced quality managers and ISO 9000 auditors so that all forms are fully compliant with ISO 9001 : 2008 requirements.
are professionally laid out so that they are really easy to use without separate instructions.

ISO 9000 Forms Consist Of :

Orientation Checklist
Training Calendar
Training Needs Analysis
Training Record
After Training Valuation Form
Training Request Form
Application Form
Leave Application Card
Meeting Attendance
Training Attendance List
Store Card
Order Tracking Form
Material Issue Record
Material Return Note
Document Issue Record
Request For Uncontrolled Document
Document Change Notice
Preventive Maintenance Record
Approved Supplier List
Selection / Evaluation of Supplier
Audit Schedule
Internal Audit Checklist
Corrective Action Report
Preventive Action Report
Outgoing Form
Corrective &Preventive Tracking List
Equipment Calibration Tracking List
Customer Semi-Product Inspection
Non Conformance Corrective Action Report
Record Master List
Customer Feed Back Form
Customer Satisfaction Evaluation
Customer Information List

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