presentation dsgs-iso-certification 2017
TRANSCRIPT
Dynamic Strategies Global Solutions Pvt. Ltd.
Quality Certification 2016-2017
Chandigarh
ABOUT US
http://www.dynamic-strategies.in
Dynamic Strategies is dedicated to providing results
oriented services and programs that are consistently
value-added. We are committed to exceeding client
expectations, providing products and services of
superior quality, and demonstrating uncompromising
integrity.
Dynamic Strategies aims to be a major player in
Consulting, Training and Recruitment Industry.
Dynamic Strategies Global Solutions Pvt. Ltd. is
founded by a group of highly experienced experts from
technology, business solution and service domains
with a vision to provide high-value solutions at an
affordable Global delivery model.
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© 2016 – 17 - Dynamic Strategies Global Solutions Pvt. Ltd.
QUALITY CONSULTING
1. ISO 9001:2015 2. ISO 14001:2004 3. ISO 13485:2012 4. ISO 14971:2012
8. ISO 20000:2011
5. ISO 22000:2005
9. ISO 27001:2013
http://www.dynamic-strategies.in
10. ISO 28001:2007
7. ISO 50001:2011 6. OHSAS 18001:2011
11. CE Marking 12. CMMi Consulting
Certification Associates:
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QUALITY CONSULTING SERVICES
ISO 9001:2015
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ISO 9001:2015 specifies requirements for a quality management system where an organization:
• Needs to demonstrate its ability to consistently provide product that meets customer and
applicable statutory and regulatory requirements, and
• Aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer
and applicable statutory and regulatory requirements.
A well designed and implemented Quality Management System, based
on ISO 9001 has been shown to provide organizations with the
following benefits:
• You will have consistent, repeatable processes and a common system.
• You will have fewer problems with failures in service or product
quality.
• You will have more business, because you can sell to new markets or
having the endorsement will distinguish you in the marketplace.
• Better management control and reporting - which means that you
know how your business is doing.
All requirements of ISO 9001:2015 are generic and are intended to be
applicable to all organizations, regardless of type, size and product
provided.
1.
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ISO 14001:2004
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Put environmental management at the heart of your operations to achieve sustainable success. This
international standard helps you reduce your environmental impact as well as grow your business.
ISO 14001 is an internationally accepted standard that outlines how
to put an effective environmental management system in place. It is
designed to help businesses remain commercially successful without
overlooking environmental responsibilities.
It can also help you to grow while reducing the environmental impact
of this growth.
An ISO 14001 system provides the framework to allow you to meet
increasingly high customer expectations of corporate responsibility as
well as legal or regulatory requirements.
2.
QUALITY CONSULTING SERVICES
ISO 14001 is based on two concepts one is continual improvement &
regulatory compliance. It lays forth a best practice for proactive
management of the environmental impact of your organization and
may be combined with certification to other management system
standards, e.g. ISO 9001 and OHSAS 18001.
Certification Associates:
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ISO 13485:2012
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ISO 13485 is a key standard to measure the quality of medical equipment, medical instruments and
medical technology. This standard sets out the requirements for a quality management system and
quality assurance systems relating to the design, development, production, installation and servicing
of medical devices. ISO 13485 can also be used by internal and external parties, including
certification bodies to test an organization’s ability to meet both customer and regulatory
requirements.
Specifying the requirements for a quality management system, ISO 13485
helps organizations to provide medical devices and related services that
live up to the expectations of customers and regulatory bodies. Its main
objective is to deliver harmonized medical device regulatory
requirements, and provide quality management system specifications
that complement the technical aspects of related products and services.
How does it work?
3.
QUALITY CONSULTING SERVICES
Organizations dealing with the design, development, production,
installation or servicing of medical equipment, devices and technology.
Who should be certified?
Certification Associates:
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ISO 14971:2012
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ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards
associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and
evaluate the associated risks, to control these risks, and to monitor the effectiveness of the
controls. The requirements of this standard are applicable to all stages of the life-cycle of a medical
device.
ISO 14971 was developed specifically for medical device/system
manufacturers using established principles of risk management. For
other manufacturers, e.g., in other healthcare industries, this standard
could be used as informative guidance in developing and maintaining a
risk management system and process.
It does not apply to clinical decision making, does not specify acceptable
risk levels and does not require that the manufacturer have
a quality management system in place. However, risk management can
be an integral part of a quality management system.
4.
QUALITY CONSULTING SERVICES
Organizations dealing with the design, development, production,
installation or servicing of medical equipment, devices and technology.
How does it work?
Who should be certified?
Certification Associates:
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ISO 22000:2005
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The ISO 22000 family of standards relate to food safety management systems and are designed to
help organizations of any size and at any stage in the food chain to ensure they meet the needs of
customers and other stakeholders. The standards are published by ISO, the International
Organization for Standardization and are available through National standards bodies.
ISO 22000:2005 specifies requirements for a food safety management system
where an organization in the food chain needs to demonstrate its ability to
control food safety hazards in order to ensure that food is safe at the time of
human consumption.
ISO 22000 deals with the fundamentals of food safety management
systems. ISO 22000:2005 deals with the requirements that organizations
wishing to meet the standard have to meet. It has been designed to be
compatible with other management system standards such as ISO 9001 and
can be implemented within an integrated management system.
5.
QUALITY CONSULTING SERVICES
ISO 22000 is a safety standard that is accepted and trusted the world over.
Organizations that implement the ISO 22000 standard demonstrate
compliance with all relevant regulatory food safety requirements. The
intention of this standard is to plan, implement, operate, maintain and
update a food safety management system aimed at providing food products
that are safe for the consumer
Your Gateway to Food Safety from Farm to Fork
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OHSAS 18001:2007
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OHSAS 18000 is an international occupational health and safety management system specification.
• Create the best possible working conditions across your organization
• Identify hazards and put in place controls to manage them
• Reduce workplace accidents and illness to cut related costs and downtime
• Engage and motivate staff with better, safer working conditions
• Demonstrate compliance to customers and suppliers
Benefits:
OHSAS 18001 is a truly international standard which sets out the
requirements for occupational health and safety management good practice for
any size of organization. It provides guidance to help you design your own
health and safety framework – allowing you to bring all relevant controls and
processes into one management system.
6.
QUALITY CONSULTING SERVICES
OHSAS 18001 can also be adapted to all types of organizations to help
eliminate or minimize operational risks and hazards. The standard is designed
to help you create the best possible working conditions in your organization –
helping you to meet legal, industry and customer requirements.
OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety
management systems. It is intended to help an organizations to control occupational health and
safety risks.
Certification Associates:
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ISO 50001:2011
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ISO 50001 Energy Management is not one size fits all. The way you use, manage and monitor your
energy consumption and carbon emissions is specific to the way you operate. And we know you’re at a
different stage with your energy management to your peers and competitors. That’s why we offer
customized packages to help you achieve energy efficiency as swiftly as possible. An ISO 50001 package
can include only the products and services that your business needs. We can help you cut the cost of
unnecessary products and services and overcome the particular challenges you face.
ISO 50001 outlines the best way to achieve energy
efficiency, whatever the nature of your business. The
standard will help you meet your environmental and
carbon reduction targets as part of improved energy
performance. It shows you how to take a structured
approach towards measuring and monitoring how much
energy you use – helping you to get more from less.
ISO 50001 will pave the way to improved performance,
lower energy bills and reduced carbon emissions – all at
the same time and also identifies and manages the risks
surrounding your future energy supply.
7.
QUALITY CONSULTING SERVICES
Certification Associates:
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ISO 20000:2011
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ISO/IEC 20000-1:2011 is a service management system (SMS) standard. It specifies requirements for
the service provider to plan, establish, implement, operate, monitor, review, maintain and improve an
SMS. The requirements include the design, transition, delivery and improvement of services to fulfil
agreed service requirements.
• A service provider that intends to demonstrate its capability for the
design, transition, delivery and improvement of services that fulfil service
requirements;
• A service provider to monitor, measure and review its service management
processes and services;
• An organization seeking services from service providers and requiring
assurance that their service requirements will be fulfilled;
• An organization that requires a consistent approach by all its service
providers, including those in a supply chain;
ISO/IEC 20000-1:2011 can be used by:
8.
QUALITY CONSULTING SERVICES
• A service provider to improve the design, transition, delivery and
improvement of services through the effective implementation and
operation of the SMS;
• An assessor or auditor as the criteria for a conformity assessment of a
service provider's SMS to the requirements in ISO/IEC 20000-1:2011.
Certification Associates:
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ISO 27001:2013
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ISO/IEC 27001:2013 specifies the requirements for establishing, implementing, maintaining and
continually improving an information security management system within the context of the
organization. It also includes requirements for the assessment and treatment of information security
risks tailored to the needs of the organization. The requirements set out in ISO/IEC 27001:2013 are
generic and are intended to be applicable to all organizations, regardless of type, size or nature.
Benefits of ISO/IEC 27001 Information Security Management
• Identify risks and put controls in place to manage or reduce them
• Flexibility to adapt controls to all or selected areas of your business
• Gain stakeholder and customer trust that their data is protected
• Demonstrate compliance and gain status as preferred supplier
• Meet more tender expectations by demonstrating compliance
9.
QUALITY CONSULTING SERVICES
Small businesses that implement ISO/IEC 27001 can achieve the same levels
of success as larger companies. We know that you may have tighter budgets
and less time to manage the information security risks you face. And we
know that those risks are as unique as the information you want to secure.
That’s why we provide packages that can be customized to include only the
services and products you need – removing the unnecessary cost and
complexity of achieving ISO/IEC 27001. We can help you secure all your
information, regardless of format, to minimize security breaches and avoid
fines.
Shaping ISO/IEC 27001 for SMEs
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ISO 28001:2007
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The global transportation of goods has never been so complex, and poses many threats for organizations
including theft, terrorism, smuggling, preservation of brand integrity and product safety. However,
organizations can demonstrate that they have identified critical aspects to the security of their supply
chain and have policies, procedures and controls in place to manage security risks with ISO 28000
With the growth of international commerce, it has become harder for
countries to manage supply chain security on their own. ISO 28000 helps by
providing the basis for an overarching Security Management System.
ISO 28000 helps organizations to better assess security risks in their supply
chain (e.g. theft, terrorism, etc.), manage new threats as they emerge and
implement appropriate controls to manage potential security threats.
ISO 28000 requires organizations to assess the security of their supply
chain and operational environment, determine if adequate security
measures are in place and ensure compliance with the law.
10.
QUALITY CONSULTING SERVICES
ISO 28000 brings big benefits to companies of all sizes. Confidence,
consistency, a market advantage and more business can come with an ISO
28000 security management system as more customers require you to
demonstrate your competence.
Security Management System for the Supply Chain
Certification Associates:
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CE Marking
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CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of
French phrase "Conformité Européene" which literally means "European Conformity". The term initially
used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993.
"CE Marking" is now used in all EU official documents.
Dynamic Strategies can help you gain easier access into the
European market by ensuring your product meets all the CE
mark requirements. If you manufacture or import products
which fall into the scope of one or more of the New Approach
Directives you will then need professional guidance on how to
meet all the essential requirements of these directives.
11.
QUALITY CONSULTING SERVICES
The New Approach Directives will provide a range of
compliance routes for your product and show you, usually in a
modular format, the available routes to compliance. The
essential requirements of the New Approach Directives differ
from directive to directive and product to product.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential
requirements of the relevant European health, safety and environmental protection legislation, in
practice by many of the so-called Product Directives.*
Your Passport to Europe
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CMMi Consulting
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CMMI is a Process Model Framework for process-improvement developed by Software Engineering
Institute (SEI), Carnegie Mellon University (CMU), Pittsburgh, USA. CMMI, standing for Capability
Maturity Model Integration, is a structured and systematic collection of best practices for process-
improvement.
CMMI Assessment is an activity to evaluate compliance and measure
the effectiveness of Specific Practices (SPs) of Process Areas (PAs) as
specified in CMMI Process Model Framework. The CMMI Assessment
Results are delivered in form of Maturity Level Rating when CMMI
Framework is implemented as per Staged Representation.
The CMMI process model framework is currently available in
three constellations - CMMI for Development (CMMI-Dev), CMMI for
Services (CMMI-SVC), and CMMI for Acquisition. These three
constellations cover entire spectrum of industries including Software
Engineering, Manufacturing, Financial, Aerospace, Computer
hardware, Defense, and Telecommunications, etc.
CMMI Assessments are also known as CMMI Appraisals. The SEI has published following
guidelines for conducting appraisals:
• Appraisal Requirements for CMMI (ARC) Document: ARC document provide information on the
Appraisal Requirements.
• Standard CMMI Appraisal Method for Process Improvement (SCAMPI) Method Definition
Document: SCAMPI MDD Document provides information on the CMMI Assessment
Methodology.
12.
QUALITY CONSULTING SERVICES
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CONTACT US
http://www.dynamic-strategies.in
Dynamic Strategies Global Solutions Pvt. Ltd. SCO 57, Royale Estate
Chandigarh – Delhi Highway,
Zirakpur (Chandigarh)
Mobile: +91-7696007767
Mobile: +91-8283037767
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