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ISO 9001:2008 and ISO/TS 16949:2009 Quality Management Systems

ISO 9001:2008 and ISO/TS 16949:2009
 Quality Management Systems   
documentation development,
quality manual, procedures, flowcharts, templates
requirements checklist, instant download


About ISO 9001:2008
ISO standards are issued by the International Organization for Standardization (ISO) in Switzerland. The standards are developed with international participation of more than 100 countries. 

One of the most popular standards is the standard “ISO 9001 Quality Management Systems” that is used worldwide by manufacturing and service organizations. The latest revision of ISO 9001 is ISO 9001:2008.

The growing number of organizations with certified ISO 9001 quality management systems confirms the increasing popularity of ISO 9001. 

Based on the assurance that defined quality requirements are met, the organization with an ISO 9001quality management system has usually a competitive advantage over non-certified competitors.

Look at the Overview of an ISO 9001 Quality Management System

ISO 9001:2008 for Manufacturing

A quality system implemented by an organization should  meet two important objectives:
preserve and continuously improve the efficiency and effectiveness of the organization’s business activities, meet defined quality objectives for products and services, continuously achieve customer satisfaction
meet the requirements of the standard ISO 9001:2008

Proper documentation is an important part of an ISO 9001 Quality Management System.

The documentation specifically required by the standard are
 a quality manual that defines the organization’s quality management system
6 documented procedures for 
clause 4.2.3  - Control of Documents
clause 4.2.4 - Control of Records
clause 8.2.2 - Internal Audit
clause 8.3    - Control of  Nonconforming Product
clause 8.5.2 - Corrective Action
clause 8.5.3 - Preventive Action

In addition, many other documents such as procedures, control forms, etc. are needed to define quality objectives and processes, to document responsibilities and related activities, to describe product and service requirements, to create records of performed actions and compliance with requirements.

Appropriate information and guides for documentation development do assist with the development of the quality manual, procedures and other necessary documentation in order to meet the requirements of ISO 9001:2008. A detailed requirements checklist helps to identify any missing subject that must be addressed in order to meet  the requirements of ISO 9001:2008.

Using a Quality Management System Model
An easy way to get information about ISO 9001:2008, including the development of documentation such as the quality manual and procedures is to look at an ISO 9001 Information Tool and Quality Management System Model in an applied environment. Browsing through the model will give you a good understanding of the requirements of the standard ISO 9001. The model will also help you with the development of the quality manual, procedures, flowcharts and other documents and processes that are an important part of the implementation of an ISO 9001 Quality Management System. Keep always in mind that the standard specifies requirements that must be met by your organization. This includes records to provide evidence of compliance with the requirements of ISO 9001. 

Once you have looked through the ISO 9001 Information Tool and Quality Management System Model you will get a good idea of what would be involved with the implementation of ISO 9001 in your organization. Now you can make the decision to initiate the implementation process. The first steps are to inform all employees about the implementation of ISO 9001, followed by the development of documentation and the implementation of processes required by ISO 9001 and your organization's business activities.

For Chemicals Manufacturers and Distributors

About ISO/TS 16949:2009
ISO/TS 16949 is the international quality management system standard for manufacturers of automotive-parts and related services.
The standard ISO/TS 16949:2009, which is based on ISO 9001:2008, includes the requirements of ISO 9001:2008 plus additional requirements for the automotive parts industry. 
Free Download
Detailed Checklist of
ISO/TS 16949:2009 Requirements 

An increasing number of auto-parts manufacturers worldwide is implementing or upgrading to ISO/TS 16949:2009.

Organizations that have already implemented an ISO 9001 quality system and want also obtain certification for ISO/TS 16949:2009 just have to add the additional requirements of ISO/TS 16949 to their existing ISO 9001 Quality System..  

ISO/TS 16949:2009 Quality Management System


ISO/TS 16949:2009

One of the most time-consuming parts of the implementation process is the development of the necessary documentation. The standard specifically requires the development and maintenance of a quality manual and 7 documented procedures.

The minimum documentation used most commonly by an organization for the development and maintenance of an ISO/TS 16949 quality management system includes:
 a quality policy and quality objectives
 a quality manual
7 mandatory documented procedures for the clauses: 
4.2.3 Control of Documents
4.2.4 Control of Records Training
8.2.2 Internal Audit
8.3 Control of Nonconforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action
other documents that are necessary for the effective planning, operation and control of processes of the quality management system
records required by ISO/TS 16949:2009 to provide appropriate control and evidence of compliance with requirements of ISO/TS 16949 

An easy and effective method to get an overview and necessary information and tools for the implementation of an ISO/TS 16949:2009 quality management system is to use an ISO/TS 16949:2009 Quality Management System Model and Implementation Tool in an applied environment. 

This quality system model also contains detailed information of the requirements of the standard ISO/TS 16949 as well as guides and templates for the development of necessary documentation such as the quality manual, procedures, operating instructions, forms, flowcharts, etc.








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