GB/T 19001/ ISO 9001QMS certification　　
ISO 9001 quality management is a globally recognized quality management standard. ISO 9001 certification allows your company's quality management system to be globally recognized. Show that your company follows and promises to fulfill the quality assurance practices this industry focuses on, remain competitive, and exploit new business opportunities. 

What is ISO 9001?

The ISO 9001 quality management system (QMS) is the world's most popular quality improvement standard, with more than one million certified organizations in 180 countries worldwide. Companies can ensure consistency in the quality of their products and services through the quality management framework provided by ISO 9001. The certification of companies with ISO 9001 demonstrates that they have taken appropriate steps to maintain a high standard. This reduces the risk of product failure, recall, or service deficiencies and can reassure customers to purchase.

What are the advantages of ISO 9001 certification?

ISO 9001 certification demonstrates the ability of your organization to consistently meet and surpass customer expectations. For this reason, many purchasers and retailers require that suppliers have ISO 9001 certification, minimizing their risk of purchasing inferior products and services, through which your company can boost its sales potential. Companies are accredited with ISO 9001 and will be able to achieve significant improvements in organizational efficiency and product quality, minimize waste and errors, and increase productivity. We provide comprehensive guidelines related to ISO 9001 to help you understand the requirements and advantages.

Third Party Certification Service from NCE (Beijing)

Necessity Certification (Beijing) Co., LTD. has enough leading experience in managing system solutions, and our professional reviewer team has extensive experience in helping you explore how ISO 9001 certification can be actively integrated with other management systems. We also serve as a one-stop provider to provide you with a variety of quality qualification needs, including integration of product testing and qualification services.

In addition to providing comprehensive evaluation and reporting, we can provide you with CE / FDA certification technology service that addresses corporate export certification needs in a one-stop fashion.

Steps to pass ISO 9001 qualification

Before starting the qualification process, your company needs to implement a quality management system in accordance with the requirements of ISO 9001 and have the relevant effectiveness fully documented.

The certification process itself is divided into the following established steps:

1. Document review: NCE evaluates your documents and company records

2. Site review: NCE reviews whether your actual activities meet the requirements of ISO 9001 and company records.

3. Close the gap: Your company has developed and implemented corrective actions to eliminate any root causes of non-compliance identified by the review.

4. Issuing a certificate: NCE issues ISO 9001 certificates.

5. Monitoring audit: Completes the annual audit, ensuring the validity of the certification (unexpected audit may occur in exceptional circumstances)

6. Temporary additional audit as required by the company, supplier audit as required by the company, etc.

　　
ISO13485 Medical device quality management system certification　　
ISO 13485 is the world's widely recognized standard for medical devices, offering assistance to institutions of all sizes.

What is a medical device quality management system certification?

ISO 13485, as a quality management system standard in the medical device industry, originates from the ISO 9000 family of quality management system standards recognized by the International Accreditation Forum (IAF). ISO 13485 uses a process approach of ISO 9000 that combines a " plan，Do，Check Act" (PDCA) cycle with risk-based thinking, Its purpose is regulatory compliance, supporting the organization of medical devices to establish and maintain a quality management system consistent with the regulatory requirements for medical devices, and ensuring continuous safety in the design, development, production, installation, and delivery of medical devices.

ISO13485 certification is based on basic guidelines for the production and quality management of medical devices and is applicable to the quality management of medical device organizations to safeguard the safety of instruments by improving and guaranteeing the quality level of products; ISO13485 certification provides confidence in the stability of the products quality of the enterprise, which is conducive to enhancing product competitiveness and improving the market occupancy of the products, so that the enterprise obtains greater economic benefit; It is beneficial to eliminate barriers to trade and get access to international markets.

Those are the scope of the ISO13485 quality system certification?

The iso13485:2016 standard was released in 2016 and this standard sets out the QMS requirements that can be adopted by organizations involved in one or more phases of the medical device lifecycle, including medical device design and development, production, storage and sale, installation, services, final shutdown and disposal, and design development or provision of associated activities, such as technical support. The requirements of this international standard may also be used by suppliers or other external parties who provide the product (e.g., raw materials, accessories, components, medical devices, sterilization services, calibration services, distribution services, and maintenance services). Suppliers and external parties may voluntarily choose to comply with the requirements of this international standard or under contract requirements.

Relationship between ISO13485 and ISO14971 system certification and current regulations

NCE integrates the current QMS specifications for medical device manufacturing and appendices, Inspection Guidelines for the corresponding products, and ISO14971:2019 into the management system certification audit scope. To meet the requirements of ISO13485:2016 and ISO14971 standards and integrate into the current regulations is an effective solution to meet the comprehensive requirements of QMS.. Obtaining ISO 13485 and ISO14971 system certification provides a practical basis for certifying enterprises to meet medical device directives, regulations and commit to product safety and quality.

ISO 13485 and ISO14971 certification can help you improve your overall quality system and risk system level, maintain the post marketing risk control of medical devices within acceptable limits, continuously refine the quality management and product risk control by collecting post marketing information and expand market opportunities. Obtaining this certification is an organization's quality management and risk management commitment to customers and regulators.

ISO 13485, as an independent QMS standard, is derived from the internationally recognized and accepted family of ISO 9000 QMS standards. ISO 13485 adopts a model of the ISO 9000 process，It is applied to medical device manufacturing environment regulated by laws and regulations. Although ISO 13485 is based on the "" Plan, Do, Check, Act "" philosophy of the ISO 9001 process model, it is established with the aim of regulatory compliance. It is inherently more regulatory in nature and requires a more thoroughly documented QMS.

The purpose of writing ISO 13485 is to support manufacturers of medical devices in designing quality management systems and in establishing and maintaining the effectiveness of their processes. It ensures the continuing safety of the medical device in its intended use, as designed, developed, produced, installed, and delivered for use.

System compliance is maintained with ISO 13485 certification

ISO 13485 standard is an effective solution to meet the combined QMS requirements.

Certification with ISO 13485 provides a practical basis for manufacturers to meet medical device directives, regulations, and a commitment to product safety and quality.

NCE has multiple system reviewers worldwide and the ISO 13485 certificate issued by NCE is recognized and trusted by competent agencies, suppliers and manufacturers around the world in the medical device industry.

Advantages of ISO 13485 certification

ISO 13485 certification can help you improve your overall quality system level, remove uncertainties, and expand market opportunities. Obtaining this certification is an organization's quality commitment to customers and regulators.

• outline how processes can be assessed and improved

• improve efficiency, cut costs, and monitor performance

• demonstrate that you produce safe medical devices

• compliance with regulatory requirements and customer expectations

Third party certification services provided by NCE

Necessity Certification (Beijing) Co., LTD. has sufficient lead experience in managing system solutions and our professional team of reviewers has extensive experience to help you explore how ISO 13485 certification can be actively integrated with other management systems. We also serve as a one-stop provider to provide you with a variety of quality qualification needs, including integration of product testing and qualification services.

In addition to providing comprehensive evaluation and reporting, we can provide you with CE / FDA certification technology service that addresses corporate export certification needs in a one-stop fashion.

Steps to pass ISO 13485 certification

Before starting the qualification process, your company needs to implement a quality management system as required by ISO 13485 and have the relevant effectiveness fully documented.

The certification process itself is divided into the following established steps:

1. Document review: NCE evaluates your documents and company records

2. Site review: NCE reviews whether your actual activities meet the requirements of ISO 13485 and company records.

3. Close the gap: Your company has developed and implemented corrective actions to eliminate any root causes of non-compliance identified by the review.

4. Issue certificates: NCE awaits ISO 13485 certificates.

5. Monitoring audit: completes the annual audit, ensuring the validity of the certification (unexpected audit may occur in exceptional circumstances)

6. Temporary additional audit at company request (Simulated flight inspection,Pre-audit before system assessment etc.), supplier audit at company request, etc.

　　
ISO14971 Medical device risk management system certification　　
What is medical device risk management system certification?

ISO 14971 as risk management system standard of medical device industry, details the risk management principles and risk management specifications that referred in several major international standards for medical devices (e.g., IEC 60601-1 electrical safety, IEC 62366 usability engineering, ISO 10993 biological evaluation, IEC 62304 software life cycle process) ，Compliance with ISO14971 is of great significance for medical device manufacturers seeking regulatory approval in China, as well as in the United States, European Union, Japan, Australia and other international markets. effective risk management systems can support the design and development, production and sales of various types of medical devices as well as post marketing risk management, thereby creating and protecting value.

NCE ISO 14971: 2019 risk management certification relying on the advanced experience of the international certification body, set up by the expert group according to the demand of the medical equipment manufacturers, Through a deep understanding of risk management principles and processes, focus on integrating the risk management requirements of applicable medical device regulations and standards into product design and quality management systems, Help medical device organization to do a good job in product life cycle risk management; To promote the improvement of the quality of medical devices is conducive to entering domestic and international markets.

What is the scope of ISO14971 quality system certification?

ISO14971 certification is synchronized with ISO13485:2016. Risk management requirements are integrated into each link of the quality system, and operation is also penetrated into the daily operation and maintenance. These requirements can be adopted by organizations involved in one or more stages of the medical device life cycle, including medical device design and development, production, storage and sale, installation, service, eventual decommissioning and disposal, and the design, development or provision of related activities (such as technical support). The requirements of this international Standard may also be used by suppliers or other external parties who provide products such as raw materials, accessories, components, medical devices, sterilization services, calibration services, distribution services and maintenance services. Suppliers and external parties may voluntarily choose to comply with the requirements of this international standard or under contract requirements.

Relationship between ISO13485 and ISO14971 system certification and current regulations

NCE integrates the current "Medical Device Production Quality Management Practice", the corresponding product appendix, inspection guidelines, and ISO14971:2019 "Medical Device Risk Management for Medical Devices" into the scope of management system certification audit. Integrates ISO13485:2016 and ISO14971 as well as the current regulatory requirements into QMS are effective solutions to meet the comprehensive requirements of QMS. Through ISO 13485 and ISO14971 certification, regulations and standards are integrated into a one-stop audit, which provides a practical basis for certifying enterprises to meet medical device directives, regulations and commitment to product safety and quality.

ISO 13485 and ISO14971 certification can help you improve your overall quality system and risk system level, control the post marketing risk of medical devices within acceptable limits, Continuously improve quality management and product risk control by collecting post-market information and expand market opportunities. Obtaining this certification is an organization's commitment to the quality of its customers and regulators.

 

ISO27000 Certification of information security management system

ISO/IEC 27001 Information security management system can ensure the security of your confidential information.Information is a valuable asset that can make or break your business.

When managed properly, information allows you to go to work with confidence. Information security management gives you the assurance that all confidential information is secure, allowing you the freedom to develop, innovate and expand your customer base.

How to obtain ISO / IEC 27001 certification

We make the certification process simple and easy. After receiving your application, we will assign a client manager to direct you to the following steps.

Gap analysis

This is an optional pre-evaluation service, during which we will carefully examine your existing information security management system and compare it with the requirements of ISO/IEC 27001. This helps us identify areas of data security that need to be improved before a formal evaluation, saving you time and money.

Formal evaluation

The process has two stages. First, we will review your entire company's existing information security management system against the ISO/IEC 27001 checklist. We will give you detailed results so you can make improvements to the gaps we have identified. If you meet all the requirements, we will begin to evaluate your premises and operations to complete the formal inspections required for certification.

Issuing certificates and follow-up work

When your company has passed the formal assessment, you will be awarded the ISO/IEC 27001 certificate valid for three years. Your account manager stays in touch with you throughout this period and visits regularly to ensure that your company's data security system is not only compliant, but also constantly improving.