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 System” 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.
A
quality system implemented by an organization
should meet two important objectives:
h
preserve
and improve the efficiency and effectiveness of
the organization’s operating activities, meet
defined quality objectives for products and
services as well as customer satisfaction
h
meet
the requirements of the standard ISO 9001:2008
An
important part of an ISO 9001 Quality Management System
is the required documentation.
The
documentation specifically required by the standard are
h
a
quality manual that defines the organization’s
quality management system
h
6
documented procedures
In
addition, many other documents such as operating
procedures, control forms, etc.are needed in order to define responsibilities,
processes and activities, to document product and
service descriptions and requirements, mandatory quality
objectives and to document results.
Appropriate information and tools 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 comply with the requirements of ISO 9001:2008.
Using a Quality Management System Model An
easy way to get answers to most questions about ISO
9001:2008, including the development of the quality
manual and procedures is to look at an Information
Tool and Quality 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 later with the
development of the quality manual, procedures,
flowcharts and other documents and processes that are an
important part of the implementation process. 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 Information
Tool and Quality 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 the quality manual, procedures and other required
documentation.
About
ISO/TS 16949:2009
ISO/TS 16949 is the international quality management system standard for manufacturers of automotive-parts.
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.
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.
The
most time-consuming part 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 and maintenance of
an ISO/TS 16949 quality management system includes:
h
a
quality policy and quality objectives
h
a
quality manual
h
7
mandatory documented procedures for the
clauses:
4.2.3 Control of Documents
4.2.4 Control of Records
6.2.2.2 Training
8.2.2 Internal Audit
8.3 Control of Nonconforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action
h
other
documents that are necessary for the
effective planning, operation and
control of processes of the quality
management system
h
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 of an
ISO/TS 16949:2009 quality management system is to look
at an ISO/TS
16949:2009 Quality Management System Model in an
applied environment. This quality system model also
contains detailed information about the requirements of
the standard as well as tools for the development of
documentation such as the quality manual, procedures,
forms, templates, flowcharts, etc.
Software
Engineering Standards
The implementation of software engineering standards and
the compliance with the standard’s requirements can
often be very time consuming. Using available
checklists, guides and templates will save time and
money, and assists in meeting the requirements of the
applicable standards.
Useful
tools for software development and compliance with
specific international standards Guides,
checklists and templates for software engineering standards and specifications do
assist with the fundamental software development to meet
the requirements of applicable standards. This
includes software development and maintenance,
configuration management, documentation development,
project management, quality assurance, verification and
validation of standard requirements, case tools,
languages and notations, metrics, privacy, process
improvement, reliability, safety, security, software
reuse, and vocabulary standards.
Using available tools such as checklists,
templates and guides for the development of software
that meets the requirements of applicable standards
saves time and assists that requirements are
met.
For FDA
related standards and Medical Device Firms:
*
IEC 62304:2006 Medical Device Software – Software Life Cycle Processes... see
more information
*
IEC
60601-1-4: Medical Electrical Equipment Part 1: General
Requirements for Safety.Part 4. - Programmable Electrical Medical Systems... see
more information
*
ISO/IEC 12207: 2008 System and software engineering -
Software life cycle processes ... see
more information
*
ANSI/UL 1998-2004 Standard for Software in Programmable
Components ... see
more information
*
FDA Document “General Principles of Software
Validation” Final Guidance for Industry and FDA
staff’ ... see
more information
*
FDA Document “Guidance for Industry, FDA Reviewers and
Compliance on Off-The-Shelf Software Use in Medical
Devices” ... see
more information
*
ANSI/AAMI/ISO 13485:2003 Medical
devices - Quality management systems-
Requirements for regulatory purposes ... see
more information
*
90003:2004 Software
engineering: Guidelines for the application of
ISO 9001:2000 to computer software ... see
more information
*
FDA Document “Guidance for the Content of Pre-market
Submissions for Software Contained in Medical Devices
... see
more information
Templates,
checklists and guides for software documentation
development and compliance with software
engineering standards
* Set of Templates for Software
Configuration Management Documents - Version 5.0.
Compliance with IEC 62304, ISO/IEC 15288, ISO/IEC 12207
... more
information
*Template
for a Software Maintenance Plan (ISO/IEC 12207, ISO/IEC
14764... more
information
* Template for a Software Documentation
Management Plan ... more
information
* Template for a System Documentation Management
Plan, includes ISO/IEC 15288, System Life Cycle
Processes (2002), Section 5.4.8 ... more
information
*
FDA 21 CFR Part 11 Electronic Records; Electronic
Signatures ... more
information
*
ISO/IEC 90003:2004
Supplier Assessment Checklist for the evaluation of
software regarding compliance with the standard ISO/IEC
90003:2004 ...more
information
*
ISO/IEC 27002:2005 information technology – security
techniques -- Code of practice for information security
management
...more
information
*
ISO/IEC 20000-1:2005 Information technology
–Service management –Part 1: Specification
... more
information
*
ISO/IEC 15288:2008-Systems and software
engineering-System life cycle processes
... more
information
* Guide to Software Engineering Standards and
Specifications -Part I
Software Development and Maintenance Standards ... more
information
* Guide to Software Engineering Standards and
Specifications -Part II
Software Development Supporting Process Standards -
(Configuration Management, Documentation, Project
Management, Quality Assurance, and Verification and
Validation Standards) ... more
information
* Guide to Software Engineering Standards and
Specifications Part III
Software Engineering Tools and Techniques Standards -
(Case Tools, Languages and Notations, Metrics, Privacy,
Process Improvement, Reliability, Safety, Security,
Software Reuse, and Vocabulary Standards) ... more
information
