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Deployment of ISO-9001 and TS-16949 Policies, Procedures

The understanding of Quality Management Systems for an organization is critical in today’s business environment. These systems include elements for corporations to insure that their entire enterprises are being managed though the application of industry agreed to operational management standards. These systems included but are not limited to product development systems, quality management systems and environmental health and safety management systems.  I have learned from both failure and success in the development and implementation of these systems. I have experience in both the rapid deployment of these systems and as part of a team developing and modifying these procedures and polices in organizations.  Although the following outlines of these specifics are very generic and brief they serve as a good baseline for the level of activities that are required to become ISO-9000 or TS-16949 compliant.

ISO 9001:

Normative References

Terms and Definitions

Quality Management System

General Requirements

Documentation Requirements

General

Quality Manual

Control of Documents

Control of Records

Management Responsibility

Management Commitment

Customer Focus

Quality Policy

 

 

Planning

Quality Objectives

Quality Management System Planning

Responsibility, Authority and Communication

Responsibility and Authority

Management Representative

Internal Communication

Management Review

General

Review Input

Review Output

Resource Management

Provision of Resources

Human Resources

General

Competence, Awareness and Training

Infrastructure

Work Environment

 

 

 

 

 

Product Realization

Planning of Product Realization

Customer Related Processes

Determination of Requirements Relating to Product

Review Requirements Related to Product

Customer Communication

Design and Development

Design and Development Planning

Design and Development Inputs

Design and Development Outputs

Design and Development Review

Design and Development Verification

Design and Development Validation

Control of Design and Development Changes

Purchasing

Purchasing Process

Purchasing Information

Verification of Purchased Product

Production and Service Provision

Control of Production and Service Provision

Validation of Processes for Product and Service provision

Identification and trace ability

 

Customer Property

Preservation of Product

Control of Measuring and Monitoring Devices

Measurement Analysis and Improvement

General

Monitoring and Measurement

Customer Satisfaction

Internal Audit

Monitoring and Measurement of Processes

Monitoring and Measurement of Product

Control of non conforming product

Analysis of data

Improvement

Continual improvement

Corrective Action

Preventative Action

TS-16949:

The following is a list of the standard TS-16949 policies and procedures. They are a supplement to ISO9000 procedures specific for the automotive industry. Many of these polices and  procedures match up with current auto industry quality management systems standards such as QS-9000, but require much more involvement from management and more focus on processes within organizations. In addition the TS-16949 standard adds approximately (39) new elements that require new polices and procedures to be written that are above and beyond current automotive industry specific QS-9000 requirements.

 

 

 

EXAMPLE OF STANDARD TS 16949 OPERATIONAL PROCEDURES AND POLICES

QUALITY MANAGEMENT SYSTEM

    • Customer Oriented Processes
    • Documentation and Records

MANAGEMENT RESPONSIBILITY

    • Management Commitment
    • Customer Focus
    • Quality Policy
    • Quality System Planning
    • Organization and Communication
    • Management Review

RESOURCE MANAGEMENT

    • Provision of Resources
    • Human Resources and Training
    • Infrastructure
    • Work Environment

 

PRODUCT REALIZATION

    • Planning of Product Realization
    • Customer-related Processes
    • Design Control
    • Purchasing
    • Operations
    • Measuring and Monitoring Equipment

MEASUREMENT, ANALYSIS AND IMPROVEMENT

    • Planning of Monitoring and Measurement
    • Monitoring and Measurement
    • Control of Nonconforming Product
    • Analysis of Data
    • Continual Improvement

 

SUMMARY OF SPECIFIC TS-19649 ELEMENTS

§         Quality System Documentation

§         Control of Documents

§         Control of Quality Records

§         Management Review

§         Training and Awareness

§         Quality Planning

§         Change Control

§         Order Processing for Catalog Products

§         Engineering Change Request

§         Product Design

§         Design of Manufacturing Processes

§         Production Part Approval

§         Subcontractor Part Approval

§         Supplier Evaluation

§         Purchasing

§         Verification of Purchased Product

§         Production Control

§         Production Work Order

§         Work Orders

§         Control Plans

§         Work Instructions

§         Product Identification and Trace ability

§         Product Handling and Preservation

§         Storage and Inventory

§         Packaging, Labeling and Shipping

§         Equipment Maintenance

§         Production Tooling Management

§         Customer Property

§         Measuring and Monitoring Equipment

§         Measurement System Analysis

§         Laboratory Control

§         Customer Satisfaction

§         Internal Quality Audits

§         Audit Nonconformity Report

§         Monitoring and Measurement of Processes

§         Monitoring and Measurement of Product

§         Control of Nonconforming Product

§         Product Nonconformity Report

§         Analysis of Data

§         Continual Improvement

§         Quality Objectives Project Sheet

§         Customer Feedback and Complaints

§         Corrective and Preventive Action

§         Corrective/Preventive Action Request