Presentation dsgs-iso-certification 2017

16
Dynamic Strategies Global Solutions Pvt. Ltd. Quality Certification 2016-2017 Chandigarh

Transcript of Presentation dsgs-iso-certification 2017

Page 1: Presentation dsgs-iso-certification 2017

Dynamic Strategies Global Solutions Pvt. Ltd.

Quality Certification 2016-2017

Chandigarh

Page 2: Presentation dsgs-iso-certification 2017

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.

Page 3: Presentation dsgs-iso-certification 2017

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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Page 4: Presentation dsgs-iso-certification 2017

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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Page 5: Presentation dsgs-iso-certification 2017

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.

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Page 6: Presentation dsgs-iso-certification 2017

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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Page 7: Presentation dsgs-iso-certification 2017

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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Page 8: Presentation dsgs-iso-certification 2017

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

Certification Associates:

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Page 9: Presentation dsgs-iso-certification 2017

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.

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Page 10: Presentation dsgs-iso-certification 2017

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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Page 11: Presentation dsgs-iso-certification 2017

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:

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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.

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Page 12: Presentation dsgs-iso-certification 2017

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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Page 13: Presentation dsgs-iso-certification 2017

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

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Page 14: Presentation dsgs-iso-certification 2017

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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Page 15: Presentation dsgs-iso-certification 2017

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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Page 16: Presentation dsgs-iso-certification 2017

CONTACT US

http://www.dynamic-strategies.in

[email protected]

Dynamic Strategies Global Solutions Pvt. Ltd. SCO 57, Royale Estate

Chandigarh – Delhi Highway,

Zirakpur (Chandigarh)

[email protected]

Mobile: +91-7696007767

Mobile: +91-8283037767

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