ISO 13485 Certification Services

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Use ISO 13485 : To establish a Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services. To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements. To become certified or registered. ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a Quality Management System (QMS) that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations. ISO 13485 Vs ISO 9001 : ISO 13485 is based on the ISO 9001 Quality Management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification. However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services. ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their Quality Management Systems, not to improve them. And customer satisfaction is excluded because committee members thought it was too subjective. When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements, activities, and special arrangements. More precisely : When ISO 13485 wants you to document a procedure, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document a requirement, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an activity, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an arrangement, the standard also wants you to implement and maintain it. Whenever a procedure, requirement, activity, or special arrangement must be documented, it does so by explicitly asking you not only to document it but also to implement and maintain it. ISO 13485 also places a greater emphasis on the use of procedures to regulate and control how activities and processes should be performed. In this sense, ISO 13485 is somewhat more prescriptive than ISO 9001. ISO 9001 often leaves it up to you to decide how work should be controlled, whereas ISO 13485 seems to have removed some of this flexibility by insisting on the use of formal procedures. Since ISO 13485 is all about medical devices and related services, it of course adds many new requirements to address the specific needs of this industry such as ISO 14971 Risk Management.Possible exclusions : ISO 9001 says that you may exclude or ignore some requirements if you can justify doing so. You can exclude section 7 product realization requirements if you cannot apply them because of the nature of your organization and its products. Similarly, ISO 13485 2003 says that you can exclude section 7 requirements if they are not applicable in your situation and does not violate the organization's medical devices statutory regulations. You may also exclude section 7.3 design and development if official regulations allow you to do so and if you have made alternative arrangements that comply with these regulations. Occasionally ISO 13485 uses the phrase “if appropriate? or “where appropriate? When a requirement uses this phrase, you may ignore or exclude it if you can justify doing so. Whenever you decide to exclude or ignore an ISO 13485 requirement make sure that you’ve got a good reason. Make sure you can justify and explain why, and make sure this explanation is documented in your quality manual. How to develop a QMS :In order to become certified, you need to develop a Quality Management System (QMS) that complies with the ISO 13485 standard. But how do you do that? One common approach is to carry out a Gap Analysis. Such an analysis will identify the gaps that exist between the new standard and your organization's processes. Once you know exactly what and where your gaps are, you can take steps to fill them. And once all of your gaps are filled, your Quality Management System will be ISO 13485 compliant. By using this approach, you will not only meet the new ISO 13485 standard, but you will also improve the overall effectiveness of your Quality Management System. If you're currently ISO 13485:1996 or ISO 9001:2000 certified, you can call us to conduct Gap Analysis Tool on your Quality Management System to the new ISO 13485:2003 standard.Once we've completed the Gap Analysis and filled all of the gaps, you're ready to ask a Registrar to audit the effectiveness of your Quality Management System. If your QMS meets ISO 13485:2003 requirements then the Registrar will then issue an official certificate to you and record your achievement in their registration. Identify your organization’s environmental aspects. Study normal and abnormal operating conditions, as well as accidents, disasters, and emergency situations. Identify the environmental aspects associated with all operating conditions and situations. Clarify the legal and other requirements that apply to your organization’s environmental aspects. Legal requirements include National and International as well as local and regional laws and regulations. Other requirements include agreements that have been established with governments, customers, community groups and others as well as commitments, guidelines, principles, or codes of practice that influence how your environmental aspects ought to be handled. Examine your organization’s current environmental management policies, procedures, and practices. Pay special attention to your organization’s purchasing and contracting policies, procedures, and practices. Define the scope of your EMS. When ISO 14001 asks you to define the scope of your EMS, it is asking you to define its boundary. You can choose to apply ISO 14001 to the entire organization or only to a specific operating unit or facility. Once you’ve made this decision, you’ve defined the scope or boundary of your EMS. Henceforth, all activities, products, and services that falls within this boundary must comply with the ISO 14001 standard. Once you’ve considered the above factors, you can begin the development of your organization’s unique Environmental Management System. But if you’ve already established an EMS and you simply need to update it to meet the new standard, you need to do a Gap Analysis. A Gap Analysis will compare your current EMS with ISO’s new ISO 14001 standard. This comparison will pinpoint the areas that fall short of the standard (the gaps). Once you know where to focus your attention, you can begin to make the changes that are needed to comply with the new ISO 14001 standard.

ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. Certification to the standard requires an organization's quality management system to pass a third party Medical Device Single Audit Program, or “MDSAP” Audit

Uplift your medical device manufacturing with ISO 13485 Certification Services. Ensure compliance with international quality standards, demonstrating a commitment to safety and regulatory requirements. Our expert team guides you through the meticulous certification process, fostering excellence in product development and manufacturing. Achieve ISO 13485 certification, signaling to the world that your organization prioritizes quality, risk management, and customer satisfaction. Elevate your market position, build trust among stakeholders, and embark on a journey of continuous improvement. Opt for ISO 13485 Certification Services to navigate the complex medical device landscape with confidence and precision.

Benefits of Implementing ISO 13485:2016 Certification Ensure compliance with the requirements of the standard and more Streamline your processes, increasing efficiency resulting in significant time and cost savings Gain a competitive edge with our independent, globally recognized third party certification Benefit from using a single source for all your testing and certification needs Take advantage of our wealth of international experience, expertise and global presence in the medical devices market. ISO 13485 is an international standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.

ISO 13485 certification from SGS helps you achieve approval, sell your devices more effectively and reduce the number of supplier audits. The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organisations involved in the life-cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions. Our wide range of regulatory approvals, our United Kingdom Accreditation Service (UKAS) accreditation and close links with medical authorities enable us to meet your certification requirements effectively. For many markets, ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for certification, we have the expert knowledge and global networks of auditors to help you achieve your objectives. Why Choose ISO 13485 Certification from SGS? We offer a global service for UKAS accredited ISO 13485 certification. Our worldwide presence means your audit will normally be carried out by local-language auditors. We can help you: Gain UKAS accredited ISO 13485 certification Demonstrate your commitment to meeting your customer requirements Comply with regulations and gain the additional local regulatory certification you need to manufacture and sell medical devices ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices. We can also help you build strong foundations for your medical devices certification strategy with our UKAS accredited ISO 13485:2016 audit, supporting regulatory approvals globally.

We are offering Need of ISO 13485:2012 (MDQMS) The objective of MDQMS i.e. ISO 13485:2003 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2003 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients. Benefits of ISO 13485:2012 Increase efficiency, cut costs and monitor supply chain performance Increase access to more markets worldwide with certification Demonstrate that you produce safer and more effective medical devices Outline how to review and improve processes across your organization Meet regulatory requirements and customer expectations

We are the leading main service providers of ISO 13485 Certification from North India & Haryana. ISO 13485 Certification is the international standard recognized for medical device regulations around the world. In today’s time and age, customers are increasingly becoming wary of the quality of the medial products. For the safety of everyone, it is imperative for the organizations, who manufacture medical devices, to undergo an array of regulatory systems, national and international standards, and deliver devices that are safe and effective. Certification is needed before entering new markets or before customers place orders. As a result, ISO 13485 has become the foundation for all regulatory requirements.   Benifits Increase the probability of making safe and effective medical devices Meet regulatory requirements Meet customer expectations Help monitor the effectiveness of your supply chain Increased Efficiency Cost Savings More Effective Risk Management and Quality Assurance Improved ability to respond to Customer Requirements

We are the leading Service Provider in the industry who provides ISO 13485 Certification services. These services are imparted under strict supervision of proficient professionals making use of best tools and techniques on offer to ensure we deliver the utmost quality. Our services are widely acknowledged by our clients for prompt response and impeccable execution. We make sure the services on offer are performed in the stipulated time frame. Apart from all these features, we also make sure to go easy on our clients’ pockets by offering these services for a nominal fee.What is ISO 13485? ISO 13485 is a version of the standard developed for the Medical Device Industry. It contains most of the requirements of ISO 9001 plus several additional requirements specifically for the Medical Device. It also eliminates sections of ISO 9001.ISO 13485 (and variations such as DIN EN ISO 13485) is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements. ISO 13485is an ISO Standard, published in 2003. The ISO 13485 was designed for organizations that provide medical devices or related services. It provides the requirements for a comprehensive management system for the design and manufacture of medical devices.ISO 13485 is generally harmonized with the ISO 9001 standard, though it is a stand-alone document. ISO 13485 removes ISO9001’s emphasis on continual improvement and customer satisfaction though it has been developed based on ISO 9001. It lays emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. Benefits of ISO 13485The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. To ensure this, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 because certain points have been excluded in ISP 13485.Benefits of ISO 13485 Once you get ISO 13485 certification, it will help your organization do business in this highly regulated sector. It will demonstrate that your organization is committed to quality, customers, and is willing to work towards improving efficiency.ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale. Contact us now, to get your organization ISO 13485 certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized ISO implementation methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective.

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The ISO 13485:2016 Medical Certification specifies the requirements for the QMS for providing the details related to the provision of medical devices. The requirement for this certification is essential for all companies regardless of their size and employees working for them. When the requirement is solely applicable to medical devices, it automatically gets associated with the services offered by the organization as well. Shine Certification is aided by a team of professional consultants that leave no stone unturned for the client to acquire ISO 13485:2016 Medical Certification.

• Product: ISO 13485:2016
• Product Name: quality management system FOR MEDICAL DEVICES
• Usage: ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The best way to meet the comprehensive requirements of QMS is obtaining ISO 13485 certification. And, if you are seeking professional assistance that can help you in obtaining the same, count on SMF. We are Maninagar (Gujarat, India) based company, known for providing inimitable solutions in prompt and cost effective manner. We ensure that the provided ISO 13485 Certification Services are as per the stated industry norms. So, call us anytime for getting professional assistance.

ISO 13485:2016 Medical Certification Services is required to establish a Quality Management System (QMS), which is directed towards the development, design, production, and installation of medical devices and services related to it. ISO 13485 is important if you are dealing in medical devices and its related services. It ensures that the supplier can be trusted as he is registered and the products delivered are of top-quality. Get in touch with us now if you seek to attain this certification.   Use ISO 13485 : To establish a Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services. To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements. To become certified or registered. ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a Quality Management System (QMS) that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations. ISO 13485 Vs ISO 9001 : ISO 13485 is based on the ISO 9001 Quality Management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification. However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services. ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their Quality Management Systems, not to improve them. And customer satisfaction is excluded because committee members thought it was too subjective. When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements, activities, and special arrangements. More precisely : When ISO 13485 wants you to document a procedure, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document a requirement, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an activity, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an arrangement, the standard also wants you to implement and maintain it.

ISO 13485- QMS – Medical Devices is an international standard that defines the requirements for the Quality Management system for the manufacturers, contract services, suppliers, distributors of the medical devices. The basis for ISO 13485 is ISO 9001 standard and the same is structure is referred for ISO 13485 completion. The ISO 13485 standard for the medical devices- Quality management system- Requirements for regulatory purpose, is one of the major basis for the regulatory compliance in the local and most of the international markets. ISO 13485 Certification is mandatory for the companies who are into the export of medical devices to other countries. The main objective of the standard is to bring harmony between the legal requirements and the management system being followed to manufacture or trade the medical devices.

The ISO 13485: 2013 Certification is a quality system certificate for organizations that design, develop, manufacture or service medical devices. If your company acquires an ISO 13485: 2013 Certification, it constructs a framework several regulatory and customer bodies like FDA. For obtaining it, our professionals make sure that organizations place special emphasis on meeting customer requirement and managing any hazards for specific designing and manufacturing of medical devices. Our ISO 13485: 2013 Certification services are reputed for their excellent value for money.

Other Details: • ISO 13485 is an international standard that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". • The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector. • ISO 13485 follows the process approach that ISO 9001:2008 establishes and compliance take the form of updates. • ISO 13485 provides a basis to effectively manage legal and regulatory requirements compliance as these are invoked by the USA FDA and equally EU CE medical device directives and equally other countries with due care. • ISO 13485 requires that we monitor organizations through on site assessment of an organization’s regulatory requirements and legal obligations. • Benchmarking of ISO 13485 provides recommendation, and thus granting a certificate confirms that the organization’s management system meet its regulatory requirement and legal obligations with due care. • This means that certification of a management systems carries impartiality and competence to fulfill accreditation requirement whether regulatory requirement legal obligation or contractual agreement with due care. Benefits: • Ensure compliance with the requirements of the standard and more • Streamline your processes, increasing efficiency resulting in significant time and cost savings • Gain a competitive edge with our independent, globally recognized third party certification • Benefit from using a single source for all your testing and certification needs • Take advantage of our wealth of international experience, expertise and global presence in the medical devices market. Service Details: Location Worldwide Services Mode Online, Offline Service Duration 1 week Type of Certification New Certification Type Of Service Provider Individual Consultant

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.  

ISO 13485 is an international standard that specifies the quality management system necessities for organizations committed medical devices at any stage of the product lifecycle. This is able to embrace the planning, development, production, storage, distribution, installation, service and technical support of the device. The ISO 13485:2016 revision is the third edition of the standard and supersedes the previous ISO 13485:2013. This latest revision of the standard contains substantial updates relating to risk-based quality processes, supplier management, and strict adherence to regulative necessities. This standard is also applied to parties that offer material, product or services to the organization and is applicable to organizations of all sizes massive and little. Additionally, any processes needed to get or maintain compliance with the ISO 13485:2016 standard that’s not performed inside the organization, remain the responsibility of the organization and should be enclosed among the quality management system. The organization should monitor, management and guarantee correct maintenance of the external processes.

Iso 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide .

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.

We provide iso 13485 certification services. the certification of a quality management system, specifically for medical devices to iso 13485 proves advantageous, and in many cases essential, for medical companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. an iso 13485 compliant management system adopt a risk management appoach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. iso 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. iso 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. the primary objective of iso 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of iso 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this international standard cannot claim conformity to iso 9001 unless their quality management systems conform to all the requirements of iso 9001. all requirements of iso 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. 13485 dictates that risk management must be thoroughly documented and conducted throughout a product's entire lifecycle, from initial concept to delivery and post-delivery. whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. Iso 13485:2003 is the international standard recognized for medical device regulations around the world. iso 13485: 2003 has been harmonized against the three directives (medical devices, in-vitro diagnostic devices and active implantable devices) so certification to this standard by an international certification body such as smc automatically demonstrates compliance with specific clauses in the regulations.