• Quality Management System
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Project management International standards
1
The ISO standards ISO 9000, a family of
standards for quality management
systems, and the ISO 10006:2003, for
Quality management systems and
guidelines for quality management in
projects.
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Biomedical engineering - Regulatory issues
1
The same standard (ISO EN 13486) is
usually applied for quality management
systems in US and worldwide.
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Audit - Quality audits
A system of quality audits may verify the
effectiveness of a quality management system
1
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Quality management - Mutually beneficial supplier relationships
1
These eight principles form the basis for the quality
management system standard ISO 9001:2008.
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Quality management - Quality improvement
Simple one is Process Approach,
which forms the basis of ISO
9001:2008 Quality Management
System standard, duly driven from the
'Eight principles of Quality
management', process approach
being one of them
1
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Quality management - Quality standards
1
The International Organization for
Standardization (ISO) created the
Quality Management System (QMS)
standards in 1987. They were the ISO
9000:1987 series of standards
comprising ISO 9001:1987, ISO
9002:1987 and ISO 9003:1987; which
were applicable in different types of
industries, based on the type of
activity or process: designing,
production or service delivery.
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Quality management - Quality standards
The Quality Management System
standards created by ISO are meant to
certify the processes and the system
of an organization, not the product or
service itself. ISO 9000 standards do
not certify the quality of the product or
service.
1
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ISO 22000 - ISO 22000 standard
1
ISO 22006 - Quality management systems
- Guidance on the application of ISO
9002:2000 for crop production.
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ISO 22000 - ISO 9001 vs ISO 22000
In comparison with ISO 9001, the
standard is a more procedural
orientated guidance than a principle
based one. Apart from that, ISO 22000
is an industrial-specific risk
management system for any type of
food processing and marketing, which
can be closely incorporated with the
quality management system of ISO
9001. The detailed similarities and
differences of the two standards can be
found elsewhere , , ,.
1
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ISO 14000 - Continual Improvement Process
1
The core requirement of a continual
improvement process (CIP) is
different from the one known from
quality management systems. CIP in
ISO 14001 has three dimensions
(Gastl, 2009):
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ISO/IEC 17025
1
Management requirements are primarily
related to the operation and effectiveness
of the quality management system within
the laboratory
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ISO/IEC 17025
1
A prerequisite for a laboratory to
become accredited is to have a
documented quality management
system
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Industrial engineering - History
Comprehensive quality management
system (TQM) developed in the forties
was gaining momentum after World War II
and was part of the recovery of Japan
after the war.
1
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ISO 9000
1
ISO 9000 deals with the fundamentals
of quality management systems,
including the eight management
principles on which the family of
standards is based
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ISO 9000 - Background
1
BSI has been certifying organizations
for their quality management systems
since 1978. Its first certification (FM
00001) is still extant and held by
Tarmac Limited, a successor to the
original company which held this
certificate. Today BSI claims to certify
organizations at nearly 70,000 sites
globally.
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ISO 9000 - Global adoption
1
Worldwide total of ISO 9001 - Quality
Management Systems - Requirements
certificates
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ISO 9000 - Contents of ISO 9001
The other two standards are
supplementary and contain deeper
information on how to sustain and improve
quality management systems; they are
therefore not used directly during third
party assessment
1
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ISO 9000 - Contents of ISO 9001
Section 4: Quality
Management System
1
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ISO 9000 - Certification
1
Although commonly referred to as
'ISO 9000' certification, the actual
standard to which an organization's
quality management system can be
certified is ISO 9001:2008
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ISO 9000 - 1987 version
1
ISO 9000:1987 had the same structure as
the UK Standard BS 5750, with three
'models' for quality management systems,
the selection of which was based on the
scope of activities of the organization:
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ISO 9000 - 2008 version
ISO 9001:2008 basically renarrates ISO
9001:2000. The 2008 version only introduced
clarifications to the existing requirements of
ISO 9001:2000 and some changes intended
to improve consistency with ISO 14001:2004.
There were no new requirements. For
example, in ISO 9001:2008, a quality
management system being upgraded just
needs to be checked to see if it is following
the clarifications introduced in the amended
version.
1
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ISO 9000 - 2008 version
ISO 9000:2005 "Quality
management systems.
Fundamentals and vocabulary"
1
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ISO 9000 - Industry-specific interpretations
1
In 1998 QuEST Forum developed the TL
9000 Quality Management System to
meet the supply chain quality
requirements of the worldwide
telecommunications industry
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ISO 9000 - Industry-specific interpretations
ISO/TS 29001 is quality management
system requirements for the design,
development, production, installation, and
service of products for the petroleum,
petrochemical, and natural gas industries.
It is equivalent to API Spec Q1 without the
Monogram annex.
1
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ISO 9000 - Effectiveness
1
Does it help to implement an ISO 9001:2000compliant quality management system?
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ISO 9000 - Advantages
1
The quality principles in ISO 9000:2000
are also sound, according to Wade and
also to Barnes, who says that "ISO 9000
guidelines provide a comprehensive
model for quality management systems
that can make any company competitive."
Sroufe and Curkovic, (2008) found
benefits ranging from registration
required to remain part of a supply base,
better documentation, to cost benefits,
and improved involvement and
communication with management
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ISO 15189
ISO 15189 Medical laboratories —
Particular requirements for quality
and competence specifies the quality
management system requirements
particular to medical laboratories
1
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ISO 13485
ISO 13485 is an International
Organization for Standardization (ISO)
standard, published in 2003, that
represents the requirements for a
comprehensive quality management
system for the design and manufacture
of medical devices. This standard
supersedes earlier documents such as
EN 46001 and EN 46002 (both 1997), the
ISO 13485 published in 1996 and ISO
13488 (also 1996).
1
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ISO 13485
1
The preferred method to prove conformity
is the certification of the Quality
Management System according ISO 9001
and/or ISO 13485 and ISO 14971 by a
Notified Body
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ISO 10006
1
ISO 10006:2003, Quality management
systems - Guidelines for quality
management in projects, is an
international standard developed by
the International Organization for
Standardization.
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TickIT
1
Major objective was to provide industry
with a practical framework for the
management of software development
quality by developing more effective
quality management system certification
procedures. These involved:
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TickIT - The TickIT Guide
This describes the issues relating to
quality management system certification in
the software field from the viewpoint of the
customer who is initiating a development
project, and explains how the customer
can contribute to the quality of the
delivered products and services.
1
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TickIT - The TickIT Guide
This presents information and
guidance to software and software
service providing organizations,
including in house developers, on the
construction of their quality
management systems using the
TickIT procedures. This part also
indicates how organizations can
assess and improve the effectiveness
of their quality management systems.
1
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TickIT - The TickIT Guide
1
Part E: Software Quality Management System
Requirements – Standards Perspective
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TickIT - The TickIT Guide
1
Part F: Software Quality Management System
Requirements – Process Perspective
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TickIT - The TickIT Guide
This identifies and elaborates upon
the good practice required to provide
effective and continuous control of a
software quality management system.
It is organized around the basic
processes required for software
development, maintenance and
support and follows the structure set
out in ISO/IEC 12207:1995.
1
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Change control
Change control within quality
management systems (QMS) and
information technology (IT) systems
is a formal process used to ensure that
changes to a product or system are
introduced in a controlled and
coordinated manner.
1
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IBM Rational Team Concert - Overview
1
Rational Team Concert integrates with
several other products, including
Subversion, Git, and IBM Rational
ClearCase revision-control products, IBM
Rational ClearQuest and JIRA change
management products, IBM Rational
Quality Manager and HP Quality Center
quality management systems, and IBM
Rational Build Forge, Hudson, Jenkins,
CruiseControl, and Maven build and
process automation tools.
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Configuration management - Standards
1
ISO 10007:2003 Quality management systems Guidelines for configuration management
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Independent test organization - Affiliation of testing organizations
1
Many suppliers or vendors offer some
chemical testing, physical testing,
and software testing as a free service
to customers. It is common for
businesses to partner with reputable
suppliers: Many suppliers have
certified quality management
systems such as ISO 9000 or allow
customers to conduct technical and
quality audits. Data from testing is
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Software quality control
It is distinct from software quality
assurance which includes audits of the
quality management system against a
standard. Whereas software quality control
is a control of products, software quality
assurance is a control of processes.
1
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Quality (business)
Quality applied in these forms was
mainly developed by the procurement
directorates of NASA, the military and
nuclear industries from the 1960s and
this is why so much emphasis was
placed on Quality Assurance. The
original versions of Quality
Management System Standards
(eventually merged to ISO 9001) were
designed to contract manufacturers to
1
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Chartered Quality Institute - IRCA
1
consultants assisting organizations to develop and
implement quality management systems
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Software quality management - Links to IT methods
component „Quality in a project
environment”, which describes necessity
of double-checked and objective control of
created products. It proposes using 4
elements: quality management system,
function of quality control, planning quality
and quality controls.
1
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Software quality management - Links to IT methods
1
ISO 9000 – family of standards is related
to quality management systems and
designed to help organizations ensure that
they meet the needs of customers and
other stakeholders while meeting statutory
and regulatory requirements related to the
product.
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Quality assurance - Using contractors and/or consultants
Consultants and contractors will often
employ Quality Management Systems
(QMS), auditing and procedural
documentation writing CMMI, Six Sigma,
Measurement Systems Analysis (MSA),
Quality Function Deployment (QFD),
Failure Mode and Effects Analysis
(FMEA), and Advance Product Quality
Planning (APQP).
1
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Medical software - International Standards
The quality management system
requirements for manufacturing a
software medical device, as is the
case with any medical device, are
described in the QSR regulations of
the FDA and also in ISO 13485:2003.
1
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Hazard analysis and critical control points - Standards
The seven HACCP principles are
included in the international standard
ISO 22000 FSMS 2005. This standard is
a complete food safety and quality
management system incorporating the
elements of prerequisite
programmes(GMP & SSOP), HACCP
and the quality management system,
which together form an organization's
Total Quality Management system.
1
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Verification and validation
1
Verification and Validation are independent
procedures that are used together for
checking that a product, service, or system
meets requirements and specifications
and that it fulfills its intended purpose.
These are critical components of a quality
management system such as ISO 9000.
The words "verification" and "validation"
are sometimes preceded with
"Independent" (or IV&V), indicating that
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Humanitarian aid - Standards
1
develop and implement a
Humanitarian Quality
Management System
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Packaging - Package development considerations
An effective quality management
system and Verification and Validation
protocols are mandatory for some
types of packaging and recommended
for all.
1
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Quality management system
1
[ http://www.bizmanualz.com/blog/qualitymanagement-system-qms.html What is a
Quality Management System?],
Bizmanualz, Nov 18, 2013
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Quality management system - Quality management organizations and awards
1
(ISO 9000:2005 provides information the
fundamentals and vocabulary used in
quality management systems. ISO
9004:2009 provides guidance on quality
management approach for the sustained
success of an organization. Neither of
these standards can be used for
certification purposes as they provide
guidance, not requirements).
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McDonnell Douglas - 1980–1989
1
McDonnell Douglas then introduced a
major reorganization called the Total
Quality Management System (TQMS)
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Certified reference materials
Quality management systems
involving laboratory accreditation
under national and international
accreditation/certification
international_standard|standards
such as ISO 9000 and ISO/IEC 17025
require the use of Reference
Materials.
1
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Information technology governance
1
It has evolved from The Principles of
Scientific Management, Total Quality
Management and ISO 9001 Quality
Management Systems
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Occupational safety and health - International
ISO 9001 Quality Management
Systems and ISO 14001 Environmental
Management System can work in
tandem with BS OHSAS 18001/18002 to
complement each other and form a
better overall system
1
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Cold chain - Validation
1
A cold chain can be managed by a quality
management system. It should be
analyzed, measured, controlled,
documented, and Validation (drug
manufacture)|validated.
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Corrective and preventive action
To ensure that corrective and
preventive actions are effective, the
systematic investigation of the root
causes of failure is pivotal. CAPA is
part of the overall quality
management system (QMS).
1
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Corrective and preventive action - Concepts
Implementation of corrective and
preventive actions is the path towards
improvement and effectiveness of
Quality Management Systems
1
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IndosatM2 - History
** Achieved ISO 9001:2000
Certification of Quality Management
System
1
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OHSAS 18001 - How they work
1
Historically many organizations start with a
quality management system (ISO 9001)
and then add the environment
management requirements from ISO
14001
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Operations Management
1
In 1987 the International Organization for
Standardization (ISO), recognizing the
growing importance of quality, issued the
ISO 9000, a family of standards related to
quality management systems. There has
been some controversy thought regarding
the proper procedures to follow and the
amount of paperwork involved.
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Product certification - Certification process
Some certification schemes, or the
product certifiers which operate those
Schemes, may require that the
product supplier operate a Quality
Management System registered to ISO
9000, or that the testing be performed
by a laboratory accredited to ISO
17025.ISO/IEC 17025:2005 The
decision to set these requirements is
most often made by the person or
1
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Specification - Process capability considerations
1
The process capability of materials and
products needs to be compatible with
the specified engineering tolerances.
Process controls must be in place and
an effective Quality management
system, such as Total Quality
Management, needs to keep actual
production within the desired
tolerances.
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Specification - Web service specification
1
Web services specifications are often under the
umbrella of a quality management system.
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Process management
improving the effectiveness of a quality
management system, to enhance
customer satisfaction by meeting customer
requirements. Source: clause 0.2 of ISO
9001:2000
1
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Auditing - Quality audits
A system of quality audits may verify the
effectiveness of a quality management system
1
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PMI Colleges - Standardization
1
The ISO 9001:2000 Certification is an
assurance to its students of quality
management system leading to effective
school governance and policies towards
relevant and quality learning. It also runs
parallel to the vision and mission of PMI
Colleges to be a center of excellence in
maritime and customs education in the
Philippines as well as in the Southeast
Asian region to be able to continuously
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PMI Colleges - Standardization
1
PMI Colleges’ quality management system
for its maritime education was previously
accredited and certified by Det Norske
Veritas (DNV).
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Gelatin - Safety concerns
1
All reputable gelatin manufacturers today
follow the Quality Management System
according to ISO 9001 to comply with all
required physical, chemical,
microbiological and technical production
and quality standards
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Iran Standard and Quality Inspection (ISQI) - History and development
1
ISQI was founded in 1989 with the goal
of improvement and establishing
Quality management systems in
producing and service companies
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TUBITAK Space Technologies Research Institute - Quality Policy
1
TÜBİTAK UZAY has the ISO 9001:2000
Quality Management System certificate
since 7 December 2000. Quality policy of
TÜBİTAK UZAY is determined in
accordance with its mission, vision and
range of activities.
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Boryspil International Airport - History
1
In 2002 Boryspil airport was certified under the ISO
9001 quality management system.
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Configuration management - Standards
1
* ISO 10007:2003 Quality management systems Guidelines for configuration management
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Advanced Card Systems - Awards and recognition
1
* 2007 ISO 9001:2000
standard certification
for quality management
systems
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AIDA/Web - History
1
In 2003 BiArt/ISO[ http://demo.nets.si/
Uvod] Quality management system was
built onto Aida's core document
management functionally (which now
forms the core of the Scribo CMS). In
2005 BiArt/BPM web-based Business
Process Management framework for
executing business processes according
to standard BPMN was built using
Aida/Web.
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Medical electronics - Regulatory issues
1
The same standard (ISO EN 13485) is
usually applied for quality management
systems in US and worldwide.
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Total productive maintenance - Total productive maintenance
1
One of the main objectives of TPM is to
increase the productivity of plant and
equipment with a modest investment in
maintenance Total quality
management|Total Quality management
(TQM) and Total Productive
Maintenance (TPM) are considered as
the key operational activities of the
quality management system
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Quality improvement
1
Simple one is Process Approach, which
forms the basis of ISO 9001:2008 Quality
Management System standard, duly
driven from the 'Eight principles of Quality
management', process approach being
one of them
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Quality improvement - Quality standards
The International Organization for
Standardization (International
Organization for Standardization|ISO)
created the Quality Management System
(QMS) standards in 1987. They were the
ISO 9000:1987 series of standards
comprising ISO 9001:1987, ISO
9002:1987 and ISO 9003:1987; which
were applicable in different types of
industries, based on the type of activity or
process: designing, production or service
delivery.
1
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ISO 10006
1
'ISO 10006:2003', Quality management
systems - Guidelines for quality
management in projects, is an
international standard developed by the
International Organization for
Standardization.
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Indian Statistical Institute
1
In addition, the Institute has a network of
units of Statistical Process
Control|Statistical Quality Control and
Operations Research at Vadodara,
Coimbatore, Hyderabad, India|Hyderabad,
Mumbai and Pune engaged in guiding the
industries, within and outside India, in
developing the most up–to–date quality
management systems and solving critical
problems of quality, reliability and
productivity.
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IT Governance
1
It has evolved from The Principles of
Scientific Management, Total Quality
Management and ISO 9001 Quality
Management Systems
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BSI Group - Management Systems Assessment and Certification
* ISO 13485 (Quality
management systems for
medical devices)
1
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BSI Group - Milestones
* BSI pioneered the development of
management systems standards: the first
of which was BS 5750, the original quality
management systems standard which
formed the template for the ISO 9000
series of quality standards, first published
in 1994.
1
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Production Part Approval Process - PPAP approval
1
1) The client's requirements have been
understood2) The product supplied meets
those requirements 3) The process
(including sub suppliers) is capable of
producing conforming product 4) The
production control plan and quality
management system will prevent nonconforming product reaching the client or
compromising the safety and reliability of
finished vehicles
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Quality audit
1
'Quality audit' is the process of systematic
examination of a quality system carried out
by an internal or external quality auditor or
an audit team. It is an important part of
organization's quality management system
and is a key element in the International
Organization for Standardization|ISO
quality system standard, ISO 9001.
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Quality audit
1
With the upgrade of the ISO9000 series
of standards from the 1994 to 2008
series, the focus of the audits has
shifted from purely procedural
adherence towards measurement of
the actual effectiveness of the Quality
Management System (QMS) and the
results that have been achieved
through the implementation of a QMS.
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List of International Organization for Standardization standards - ISO 5000 –
ISO 9999
* ISO 9000 Quality
management systems –
Fundamentals and
vocabulary
1
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List of International Organization for Standardization standards - ISO 5000 – ISO 9999
* ISO 9001 Quality
management systems –
Requirements
1
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List of International Organization for Standardization standards - ISO 10000 –
ISO 14999
1
* ISO 10005:2005 Quality
management systems –
Guidelines for quality plans
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List of International Organization for Standardization standards - ISO 10000 –
ISO 14999
1
* ISO 10006 Quality management systems –
Guidelines for quality management in projects
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List of International Organization for Standardization standards - ISO 10000 –
ISO 14999
1
* ISO 10007 Quality management systems –
Guidelines for configuration management
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List of International Organization for Standardization standards - ISO 10000 – ISO 14999
1
* ISO 13485:2003 Medical devices –
Quality management systems –
Requirements for regulatory purposes
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List of International Organization for Standardization standards - ISO 15000 – ISO 19999
1
* ISO/TS 16949 Quality management
systems – Particular requirements for
the application of ISO 9001:2008 for
automotive production and relevant
service part organizations
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ISO 9002
1
ISO 9000 deals with the fundamentals of
quality management systems, including
the eight management principles upon
which the family of standards is based
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ISO 9002 - Background
1
BSI has been certifying organizations for their
quality management systems since 1978
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ISO 9002 - Contents of ISO 9001
The other two standards are
supplementary and contain deeper
information on how to sustain and improve
quality management systems; they are
therefore not used directly during third
party assessment
1
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ISO 9002 - Contents of ISO 9001
1
** Section 4: Quality
Management System
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ISO 9002 - Certification
1
Although commonly referred to as ISO
9000 certification, the actual standard
to which an organization's quality
management system can be certified
is ISO 9001:2008
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ISO 9002 - 1987 version
1
ISO 9000:1987 had the same structure as
the UK Standard BS 5750, with three
models for quality management systems,
the selection of which was based on the
scope of activities of the organization:
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ISO 9002 - 2008 version
1
ISO 9001:2008 basically renarrates ISO
9001:2000. The 2008 version only
introduced clarifications to the existing
requirements of ISO 9001:2000 and some
changes intended to improve consistency
with ISO 14000|ISO 14001:2004. There
were no new requirements. For example,
in ISO 9001:2008, a quality management
system being upgraded just needs to be
checked to see if it is following the
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ISO 9002 - 2008 version
1
* ISO 9000:2005 Quality
management systems.
Fundamentals and
vocabulary
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ISO 9002 - Industry-specific interpretations
1
In 1998 QuEST Forum developed the
TL 9000 Quality Management System
to meet the supply chain quality
requirements of the worldwide
telecommunications industry
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ISO 9002 - Industry-specific interpretations
1
* 'ISO/TS 29001' is quality management
system requirements for the design,
development, production, installation, and
service of products for the petroleum,
petrochemical, and natural gas industries.
It is equivalent to API Spec Q1 without the
Monogram annex.
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ISO 9002 - Effectiveness
1
#Does it help to implement an ISO 9001:2000compliant quality management system?
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ISO 9002 - Advantages
1
Journal of Operations Management,
Volume 26, Issue 4, July 2008, Pages
503-520 The quality principles in ISO
9000:2000 are also sound, according to
Wade and Barnes, who says that ISO
9000 guidelines provide a
comprehensive model for quality
management systems that can make
any company competitive
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Indian Institute of Technology - Technical and cultural festivals
1
Shaastra holds the distinction of being
the first student-managed event in the
world to implement a formal Quality
Management System, earning ISO
9001:2000 certification
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ISO 50001
1
The system is modeled after the ISO 9001
Quality Management System and the ISO
14001 Environmental Management System
(EMS). Eccleston describes the
procedural details of the ISO Energy
Management System (EnMS) and
compares its procedures with those of the
ISO 14001 EMS.Eccleston C., March F.,
and Cohen T., Inside Energy: The
Handbook for Implementing an ISO 50001
Energy Management Systems, CRC Press
Inc. 300 pages (2011).
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ISO 50001 - Structure
1
The structure of ISO 50001 is designed
according to other ISO management
system standards, in particular ISO
9001 (Quality Management Systems)
and ISO 14001 (Environmental
Management Systems). Since all three
management systems are based on the
PDCA cycle, ISO 50001 can be
integrated easily to these systems.
http://www.iso.org/iso/home/standards/
management-standards/iso50001.htm
viewed 24 October 2012.
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Farm assurance
1
In the United Kingdom and Australia,
the major farm assurance
programmes are based on a quality
management system for food safety
that originated with the US space
agency NASA, known as Hazard
Analysis and Critical Control Points
(HACCP)
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Calibration - Quality
Quality management systems call for an
effective metrology system which includes
formal, periodic, and documented calibration
of all measuring instruments. ISO 9000ISO
9001: Quality management systems —
Requirements (2008), section 7.6. and ISO
17025ISO 17025: General requirements for
the competence of testing and calibration
laboratories (2005), section 5. standards
require that these traceable actions are to a
high level and set out how they can be
quantified.
1
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Measurement Systems Analysis
MSA is an important element of Six Sigma
methodology and of other quality management
systems.
1
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Measurement Systems Analysis - Factors affecting measurement systems
* Management: training programs,
metrology system, support of people,
support of quality management system,
etc.
1
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Project development - International standards
1
* The ISO standards ISO 9000, a family of
standards for quality management
systems, and the ISO 10006:2003, for
Quality management systems and
guidelines for quality management in
projects.
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Clinical Quality Management System
1
A 'Clinical Quality Management
System (CQMS)' allows an entire
practice staff to take part in
increasing the quality of care
delivered to their patients
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Quality system
1
[ http://www.bizmanualz.com/blog/qualitymanagement-system-qms.html What is a
Quality Management System?],
Bizmanualz, Nov 18, 2013
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Quality management framework
1
Based on the iTQM (integrated total
quality management system) which
shows that research into this field is
“about how to design a top-down
orchestrated serviced oriented
architecture to integrate TQM element
cores into a whole system supported
by advanced information technology,
data mining, service policies, forced
training and governance” (WANG
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AS9100
'AS9100' is a widely adopted and
standardized quality management system
for the aerospace industry.
1
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ISO 9001:2000
1
ISO 9000 deals with the fundamentals of
quality management systems, including
the eight management principles upon
which the family of standards is based
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ISO 9001:2000 - Background
1
BSI has been certifying organizations for their
quality management systems since 1978
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ISO 9001:2000 - Industry-specific interpretations
1
In 1998 QuEST Forum developed the TL
9000 Quality Management System to meet
the supply chain quality requirements of
the worldwide telecommunications
industry
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Indian Institute of Technology Roorkee - Student activities
1
Students conduct two fests every year,
Cognizance (Technical festival) and
Thomso (Cultural festival).
Cognizance, India's second largest
technical festival is 9001:2008
certified and operates a quality
management system in organizing its
events.
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Software reliability - Definitions
1
There are many different definitions of
quality. For some it is the capability of a
software product to conform to
requirements. (ISO/IEC
9001,International Organization for
Standardization, ISO/IEC 9001: Quality
management systems -- Requirements,
1999. commented by International
Organization for Standardization,
ISO/IEC 24765: Systems and software
engineering — Vocabulary, 2010.) while
for others it can be synonymous with
customer value (Highsmith, 2002) or
even defect level.
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Rajendra S. Pawar - Biography
Crosby|Phil Crosby's
Complete Quality
Management System in
NIIT
1
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Shaastra
1
Shaastra is entirely student managed
and holds the distinction of being the
first such event in the world to be ISO
9001:2000 certified for implementing
a Quality Management System.
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Saarang - Organisation
1
The Cores, 24 in total, lead the various
departments of Finance, Publicity,
Sponsorship, Events, Design,
Hospitality, Facilities and
Requirements, Security and QMS
(Quality Management
System).http://sudhishkamath.com/201
1/01/18/saarang-2011-better-thanbefore/ They are assisted by the coordinators(around 200 in number) who
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Higher education accreditation - Germany
1
These agencies accredit programs of
study for Bachelor and Master
degrees and quality management
systems (system accreditation) from
state or state recognized Higher
Education institutions in Germany
and abroad.Accreditation Council,
[http://www.akkreditierungsrat.de/in
dex.php?id=9L=1 Accreditation of
Programs] AKAST only accredit
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Metrology - Metrological traceability
Traceability, accuracy and
precision|accuracy, precision,
systematic bias, evaluation of
measurement uncertainty are critical
parts of a quality management
system.
1
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Cosmetics - International
ISO 22716 provides a comprehensive
approach for a quality management
system for those engaged in the
manufacturing, packaging, testing,
storage, and transportation of cosmetic
end products. The standard deals with all
aspects of the supply chain, from the early
delivery of raw materials and components
until the shipment of the final product to
the
1
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Cosmetics - International
The standard is based on other quality
management systems, ensuring smooth
integration with such systems as ISO 9001
or the British Retail Consortium (BRC)
standard for consumer products
1
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Hazard Analysis and Critical Control Points - Standards
The seven HACCP principles are
included in the international standard
ISO 22000 FSMS 2005. This standard is
a complete food safety and quality ISO
22000 FSMS 2005 management system
incorporating the elements of
prerequisite programmes(GMP
SSOP), HACCP and the quality
management system, which together
form an organization's Total Quality
1
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Hospital accreditation - International schemes
DNV Healthcare is a Norwegian-US
health care accrediting organisation
providing a quality management
system constructed in accordance
with ISO 9001 and approved by the U.S.
Centers for Medicare and Medicaid
Services (CMS).
1
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Tolerance (engineering) - Considerations when setting tolerances
The process capability of systems,
materials, and products needs to be
compatible with the specified engineering
tolerances. Process controls must be in
place and an effective Quality
management system, such as Total
Quality Management, needs to keep
actual production within the desired
tolerances. A process capability index is
used to indicate the relationship between
tolerances and actual measured
production.
1
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Gold Coast, Queensland - Utilities
Gold Coast Water has also been
recognised for its world leading HACCP
water quality management system by the
World Health Organisation which
published Gold Coast Water's system as a
good model for managing water quality
and safety from catchment to tap. The
Gold Coast desalination project|Gold
Coast desalination plant, which opened in
February 2009, has the capacity to supply
up to 133 megalitres of desalinated water
per day.
1
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Bureau of Indian Standards - Management System Certification
* Quality Management System
Certification Scheme IS/ISO 9001
1
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Bureau of Indian Standards - Management System Certification
* Service Quality
Management System
Certification Scheme
IS 15700
1
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ISO 21500
ISO also designed this standard to
align with other, related standards such
as ISO 10006:2003, Quality
management systems − Guidelines for
quality management in projects, ISO
10007:2003, Quality management
systems − Guidelines for configuration
management, ISO 31000:2009, Risk
management – Principles and
guidelines
1
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Crown Paints
1
More than 1,250 employees work for
Crown Paints, which has its
headquarters in Darwen in Lancashire.
Its manufacturing sites in Darwen and
Hull operate to ISO 9001 quality
management system and ISO 14001
environmental management system.
Crown Paints holds the Investors in
People standard, which in July 2013
was upgraded to the Gold award.
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Food packaging - Regulations
1
Food packaging considerations may
include: use of Hazard analysis and
critical control points, Verification and
validation protocols, Good
manufacturing practices, use of an
effective Quality management
system, Track and trace systems, and
requirements for label content
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ISO 1750 - ISO 10000 – ISO 14999
1
* ISO 10006:2003 Quality management systems –
Guidelines for quality management in projects
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ISO 1750 - ISO 10000 – ISO 14999
1
* ISO/TR 10013:2001
Guidelines for quality
management system
documentation
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ISO 1750 - ISO 10000 – ISO 14999
* ISO 10019:2005 Guidelines for the
selection of quality management system
consultants and use of their services
1
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ISO 1750 - ISO 15000 – ISO 19999
1
** ISO/IEC TS 17021-3:2013 Conformity
assessment -- Requirements for bodies
providing audit and certification of
management systems -- Part 3:
Competence requirements for auditing and
certification of quality management
systems
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Patient Management Software - History
1
In order to obtain a medical device licence,
manufacturers must hold a quality
management system (QMS) certificate
issued by an accredited registrar showing
that the QMS is compliant with ISO 13485:
2003 Medical devices – Quality
management systems – requirements for
regulatory purposes
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Test method - Content of a test method
Quality management systems usually
require full documentation of the
procedures used in a test. The document
for a test method might include:
1
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Reusable packaging - Industrial shipping containers
Bulk foods, chemicals, and
pharmaceuticals are often shipped in
reusable and returnable containers.
These need to be carefully inspected,
cleaned and sanitized as part of the
reuse cycle. An effective Quality
Management System is necessary.
1
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METRiQ
'METRiQ' is a trademarked linguistic
quality management system developed by
[http://www.fxtrans.com ForeignExchange
Translations, Inc.] of Newton,
Massachusetts. It makes use of a Webbased tool programmed to provide
objective measurement of all tasks in a
translation project workflow.
1
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Manufacturing test requirement design specification
'Manufacturing test requirement design
specification' ('MTRD') is a document which
specifies how testing is to be implemented on
a new or modified manufactured product.
The specification includes which tests will be
applied to different build processes, the
percentage of coverage for each stage of
those build process, and how data on errors
and problems will be gathered and
processed. It would be expected to refer
heavily to the organisation's Quality
Management System (QMS).
1
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ISO/TS 16949
The 'International Organization for
Standardization|ISO/TS16949' is an ISO
technical specification aimed at the
development of a quality management
system that provides for continual
improvement, emphasizing
wikt:defect|defect prevention and the
reduction of variation and waste in the
supply chain. It is based on the ISO 9001
standard and the first edition was
1
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ISO/TS 16949
It was prepared by the International
Automotive Task Force (IATF) and the
Technical Committee of ISO. It harmonizes
the country-specific regulations of quality
Management systems.
1
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ISO/TS 16949
1
About 30 percent of the more than 100
existing automobile manufacturers
affiliate the requirements of the norm
but especially the large Asian
manufacturers have differentiated,
own requirements for the quality
management systems of their
corporate group and their suppliers.
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ISO/TS 16949 - Historical background
1
Many suppliers were asked by the car
manufacturers (OEMs) to build and
certify their quality management
system according to the rules and
regulations of their own country
organizations, such as:
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ISO/TS 16949 - Contents of the specification
* Chapter 4: Quality Management System
(general requirements, control of documents
and records)
1
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ISO/TS 16949 - Contents of the specification
1
It looks at the business processes in a
process environment in which there
are interactions and interfaces that
need to be recognized, mapped and
controlled by the quality management
system
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ISO/TS 16949 - Contents of the specification
A key requirement of ISO / TS
16949:2009 is the fulfillment of
customer-specific requirements, set up
by the automotive manufacturer in
addition to the quality management
system of their suppliers. This may
have decisively contributed to the
worldwide recognition of the TS by
many manufacturers.
1
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Acceptance sampling - History
More recently, quality assurance
broadened the scope beyond final
inspection to include all aspects of
manufacturing. Broader quality
management systems include
methodologies such as statistical
process control, HACCP, six sigma, and
ISO 9000. Some use of acceptance
sampling still remains.
1
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Verification (disambiguation)
1
* Verification and validation, in engineering
or quality management systems, it is the
act of reviewing, inspecting or testing, in
order to establish and document that a
product, service or system meets
regulatory or technical standards.
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ISO/TC 176 - Overview
The scope of the committee is
‘Standardization in the field of quality
management (generic quality
management systems and supporting
technologies), as well as quality
management standardization in
specific sectors at the request of the
affected sector and the ISO Technical
Management Board’.
1
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ISO/TC 176 - ISO/TC 176/SC 2: Quality systems
1
* ISO 9001:2008 Quality
management systems—
Requirements
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ISO/TC 176 - ISO/TC 176/SC 2: Quality systems
* ISO 10006:2003 Quality management
systems—Guidelines for quality management in
projects
1
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APM Terminals - APM Terminals' recent developments
In 2012 APM Terminals Tangier
received IMS certification in ISO 9001
(Quality Management Systems), ISO
14001 (Environmental Management
Systems) and OHSAS 18001 (Health
and Safety Management Systems)
1
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ISO 13485:2012
1
'ISO 13485' is an International Organization for
Standardization (ISO) standard, published in 2003,
that represents the requirements for a
comprehensive quality management system for
the design and manufacture of medical
devices.[http://www.iso.org/iso/iso_catalogue/catal
ogue_tc/catalogue_detail.htm?csnumber=36786
ISO Catalogue: ISO 13485:2003 Medical devices - Quality management systems -- Requirements
for regulatory purposes] This standard supersedes
earlier documents such as EN 46001 and EN
46002 (both 1997), the ISO 13485 published in
1996 and ISO 13488 (also 1996).
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Temperature data logger - Construction
1
Depending on the use, governing quality
management systems sometimes require
calibration to national standards and
compliance with formal verification and
validation protocols
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Heat sealer - Seal quality
Heat sealing processes can be
controlled by a variety of quality
management systems such as HACCP,
statistical process control, ISO 9000,
etc. Verification and validation
protocols are used to ensure that
specifications are met and final
materials/packages are suited for
end-use.
1
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Heat sealer - Seal Strength Testing
Quality management systems
sometimes ask for periodic subjective
evaluations: For example, some seals
can be evaluated by a simple pull to
determine the existence of a bond and
the mechanism of failure
1
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International Academy of Management and Economics - History
1
On March 21, 2003, I/AME became the
first Makati City-based business school
to fulfill the requirements of
International Organization for
Standardization|ISO 9001:2000 for
establishing a Quality Management
System for the Provision of Higher
Education in Management, specifically
for the design, delivery, and testing of
business courses, and overall facilities
management.I/AME Newsletter, April
2006 Issue, IAME Press.
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Kitemark - History
With the introduction of quality
management systems standards in the
1970s Kitemark schemes were
developed in areas such as double
glazing and fire safety. Today there are
more than 450 individual Kitemark
schemes covering everything from
printed circuit boards to cattle tags.
1
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Kitemark - Availability
1
In addition, delivery of the product or
service is audited against an accredited
quality management system
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Verband der Automobilindustrie
The VDA published a series of VDA
6.1|standards and recommendations.
Among those is the Germany|German
Quality Management System (QMS) for
the automobile industry. The fourth edition
was issued in December 1998, and
became mandatory for all German car
makers on April 1, 1999.
1
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Bühler Motor
Bühler Motor is certified for its
quality management system under
ISO/TS 16949|ISO/TS 16949:2002 and
for its environmental management
system under ISO 14001|DIN EN ISO
14001:2004. The Nuremberg and
Monheim locations are also certified
for its medical management system
under EN ISO13485:2003/AC:2009
since 2011.
1
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Global Load Control - Controversy
Since then, Global Load Control has
received its Dekra ISO 9001:2008
certification, and states on its corporate
website that it is committed to ...producing
a quality service by focusing on the
principles of safety, punctuality and
economy..., and that its quality
management systems are continually
reviewed and improved.
1
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Hostelling International - Quality
1
HI-Q is Hostelling International's quality
management system. It takes the best
practice from quality systems around
the world and enables hostels to
consistently improve and deliver high
standards.
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