ISO 9001 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 9001:2015.
The growing number of organizations with certified ISO
9001 quality management systems confirms the increasing
popularity of ISO 9001.
Based on the assurance that quality requirements
are met, the organization with an ISO 9001 quality
management system has usually a competitive advantage
over non-certified competitors.
quality system implemented by an organization
should meet two important objectives:
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
the requirements of the standard ISO 9001:2015
setup and compliance with requirements and
procedures are an important part of an ISO 9001 Quality Management System.
Once you have looked through the ISO
9001:2015 Requirements Checklist you will see what would be involved with the implementation
or upgrade to ISO 9001:2015 in your organization. Now you can
start and prepare the implementation process. The
first steps are to inform employees about the
implementation or upgrade of ISO 9001:2015, followed by the development
of documentation and the implementation of processes
required by ISO 9001:2015.
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
increasing number of auto-parts manufacturers worldwide
is implementing or upgrading to ISO/TS 16949:2009.
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..
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
minimum documentation used most commonly by an
organization for the development and maintenance of
an ISO/TS 16949 quality management system includes:
quality policy and quality objectives
mandatory documented procedures for the
4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audit
8.3 Control of Nonconforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action
documents that are necessary for the
effective planning, operation and
control of processes of the quality
required by ISO/TS 16949:2009 to provide
appropriate control and evidence of
compliance with requirements of ISO/TS
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
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.