ISO 13485 Certification Services

Listing ID #2292014

Get Latest Price

Business Type Service Provider
Preferred Buyer Location India only

What is an ISO 13485 Quality Management System? ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production,....

View More Details

Send Enquiry

Service Details

What is an ISO 13485 Quality Management System?

ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. This is a process-based system and contrasted to the procedure-based system of QSR and ISO 9001.
Manufacturers of Medical Devices are subject to specific legislative fulfilments. Medical Devices intended for diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness .The medical device industry throughout the world will move toward adopting the new ISO 13485:2003 as the preferred quality system standard.
Another important aspect of ISO 13485:2003 is the inclusion of risk management throughout the quality system process, thus providing for a risk-based approach for determining a level of rigor when implementing the standards.
ISO 13485 is based on ISO 9001, there are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements. ISO 13485 calls for risk management to be in place for all stages of product realization, training and supervision of staff, project site specs, and prevention of contamination. Clinical evaluation must be carried out as part of design and development evaluation in line with regulatory requirements. The cleanliness of products and contamination control must be considered, as must the status of the product with respect to monitoring and measurement.
In brief, ISO 13485 provides system where the experience, clear point of view and judgement are applied systematically in order to manage the risks related to medical device use. This system was specially developed for medical device manufacturers that use principles based on risk management. For all other participants for example, the ones from the health industry, this standard can be used as informative guidance in the development and maintenance of the system and the risk management processes. This standard manages the risk management processes primarily to patient/user, but also to the operator, other equipment and the environment.
According to the International Standards Organization, from 2004 through 2013 a total of 22,950 ISO 13485 certificates were issued worldwide throughout 93 countries.

What are the benefits of being certified to ISO 13485?

Companies with this certification communicate a commitment to quality to both customers and regulators.
Improved stakeholder relationships
Guarantees high quality of provided services and products.
Is recognized globally as the best quality management practices within the medical device industry.
Increase efficiency, cut costs and monitor supply chain performance.
Demonstrate that you produce safer and more effective medical devices.
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty and widen market opportunities.
Meet regulatory requirements and customer expectations.

Service Images

Company Details

Acumic management consultant pvt.ltd.is one of the largest & fastest growing business management consulting organization offering business consulting services to all kind of organizations.
We provide one of the most comprehensive suites of consulting services,products & training in the fields of quality management, marketing management,human
resources management, finance management & strategic managementto the organizations across all the industry verticals for building aprogressive and profitable
organization by creating a sustainable competitive advantage in the market.
Acumic management consultant pvt.ltd. Provides diverse services in management systems - quality, environment, safety, food, information technology, and social accountability. Training in allied areas like lead auditor, internal auditor & awareness courses. Third party inspection, product certification (ce), automotive homologation, six sigma etc.
We work with the, most reputed leading iso certification bodies across the word like bureau veritas, sgs, tuv, dnv, urs, moody & bsi etc. To ensure your certificate have the proper national and international recognition.
Our iso consulting services cover training, gap analysis, documentation, implementation assistance, internal audit, pre-assessment audit, assistance in selection of the iso certification body and ensuring successful completion of the iso certification audit.
Once your organization is iso certified, we make sure that you continue getting benefits from our post certification iso consultancy services to continually improve effectiveness of the system and maintain compliance level required to ensure that the regular surveillance audits and recertification audit is completed without any problem.
With us, you just don’t get an iso certification but you get a management system that helps your organization its true potential by improving processes and performance.
vision & mission
our mission is to provide effective, competitive, result oriented & practical business solutions to the organizations to optimize their operational efficiency in order to maximize return on investment & ultimately to achieve their goal.
Acumic management consultant pvt.ltd. specializes in value added consultancy for the entire range of management system certifications. we specialize in iso 9001:2008,kosher, halal,gmp , ce marking & iso 14001,haccp,iso 22000,ohsas 18001,sa 8000,ts 16949, bs 17799, iso 17025, iso 22000 ,iso 27001, iso 28000, etc
acumic management consultant pvt.ltd. specializes in value added consultancy for the entire range of management system certifications. we specialize in iso 9001:2008,iso 14001,haccp,iso 22000,ohsas 18001,sa 8000,ts 16949, bs 17799, iso 17025, iso 22000 ,iso 27001,kosher, halal,gmp , ce marking & iso 28000, etc
we help you transform your business so that it responds quickly to ever-changing levels of competition, customer expectation and market flux
across the world covering europe, australia, africa, india, usa, uk & saudi arabia.
why us ?
we are engaged in providing reliable training & auditing, certification consultancy, inspection & expediting services. Provided by professionals, our services are widely appreciated for their authenticity and time-execution. Furthermore, there several attributes which have enabled us to secure a sky scraping status in this industry.
* ethical business policies
* unmatched quality services
* ability to combine world-class expertise from a variety of disciplines
* regular & efficient client consultations
* efficient technical support team works actively by means of our sophisticated telecommunications system
* instant access to information and assistance
* reliable and prompt service
* best solutions and strategies
* believes in quality and not quantity
* comprehensive integration of our services and capabilities
* innovative
* cost effectiveness
* use only experienced auditors who are trained to carry out assessment with minimal disruption of work
our policy
acumic is committed to:
• total compliance with regulatory requirements.
• maintaining impartiality and confidentiality in certification process.
• achieving customer satisfaction.