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System Certification , ISO 13485:2016 ,

Certification of compliance Disposable medical gloves

Post at 16/03/2021

After masks, antibacterial hand sanitizers, medical gloves and disposable gloves are the next product at risk of ‘burning’ goods due to the COVID-19 pandemic caused by the new corona virus (SARS-CoV- 2). Many people wear disposable medical gloves to avoid touching potentially contaminated surfaces in public.

As with other medical devices, gloves must be certified to be compliant with gloves before being marketed. Certification of single-use glove compliance, which is a must. Therefore, reputable manufacturers need to seek quality standard certification for disposable medical gloves.

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Legal grounds

TCVN 6343-1:2007 (ISO 11193-1:2002) Disposable medical gloves

>>> Download ISO 11193-1: 2002, Disposable medical examination gloves https://clv.vn/tcvn-6343-1-2007-gang-kham-benh-su-dung-mot-lan/

What are disposable medical gloves?

Medical gloves (disposable gloves) are disposable gloves for medical use; procedure to help prevent cross-contamination between caregivers and patients.

The distinction of left and right hands plus softness of the product brings a sense of comfort and integrity for the user. In addition, there will be a sense of comfort with the function of reducing hand sweat, not causing discomfort.

  • Smooth surface feels natural, comfortable and easier to handle. At the same time, the wrists are contoured, making them easy to wear and avoid tearing.
  • Made from various polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they must not be mixed with flour, or mixed with cornstarch to lubricate gloves, making them easier to put on their hands.
  • Protein and chemical levels on gloves are lowest to limit skin allergies for the user.

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Certification of compliance with disposable gloves

Scope of application
  • This International Standard specifies the specifications for sealed non-sterile sterile rubber gloves or gloves to be used in medical examination and diagnosis or treatment, to protect against disease transmission. between patient and user.
  • This International Standard also includes latex gloves for handling contaminated medical specimens and gloves with a smooth or rough surface on part or all of the glove.
  • This International Standard specifies the performance and safety of medical latex gloves. The safety and proper use of glove and disinfection procedures with subsequent handling, packaging and storage procedures are not covered by this International Standard.
Procedures for certifying the standard conformity of disposable gloves
Step 1: Register for a certificate

Step 2: The Vietnamese Quality Expert evaluates the factory condition; Sampling products for testing

Step 3: Issue product certificate of conformity with standards (valid for 03 years)

Step 4: Announcing product standard conformity

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Deployment time

The implementation time for glove standard conformity certification depends on many factors such as internal implementation progress, factory condition assessment results, quality assurance conditions, and time to return results. product of the laboratory.

A typical timeframe is as follows:

  • Certification evaluation + Sample test: 15 to 30 days.
  • Announcing product standard conformity from 15 to 20 days.
Benefits apply
  • Reducing product costs by reducing costs of handling defective products;
  • The standard conformity certificate is a reliable and accepted proof of bidding;
  • Increasing competitive opportunities in the market;
  • Meet national statutory requirements;
  • Gain the trust of customers and consumers;
  • Satisfy the needs of consumers.
Related services

Jeffrey | 24/05/2021

ISO 9001:2015 – Quality management system

Building and maintaining the application of a quality management system according to the ISO 9001:2015 standard is now not too strange for businesses. This is a standard that sets requirements for an enterprise's quality management system, helping businesses achieve efficiency, improve customer satisfaction and develop more sustainably. So what is ISO 9001:2015? How important is ISO 9001? What is ISO 9001:2015? ISO concept: ISO was established on February 23, 1947. The headquarters of the ISO Secretariat is located in Geneva, Switzerland. As of 2018 ISO has 161 national standards bodies. Vietnam joined ISO in 1977, the 77th member of this organization. ISO (abbreviated as International Organization for Standardization) - ISO International Standardization Committee. The ISO Committee is an independent non-governmental organization. The main task of the organization is to develop and issue standards. These standards often become statutory through agreements or national standards. As a result, the standard issued by ISO is valid worldwide. The number of standards that ISO issues is more than 20,000 standards. This standard covers everything from product, manufacturing, and technology to food safety, agriculture and healthcare. The ISO 9001 standard is one of the sets of standards issued by the ISO Committee. ISO 9001:2015 concept ISO 9001 is part of ISO 9000, which is one of the most popular standards worldwide. The full name of ISO 9001 is ISO 9001:2015 – Quality management systems – Requirements. ISO 9001 is a Standard that sets out the principles, principles and requirements to establish a quality management system in an enterprise and applies to all types of businesses regardless of size or type. production, business or service. In particular, the standard has mandatory provisions applicable to two fields: building materials and fertilizer production. Versions of ISO 9001: ISO 9001:1994 Quality systems – Model for quality assurance in design, development, production, installation and servicing design, production, installation and technical services). (Expired) ISO 9001:2000 Quality management systems – Requirements (Vietnamese standard equivalent: TCVN ISO 9001:2000 Quality management – ​​Requirements). (Expired) ISO 9001:2008 Quality management systems – Requirements (Vietnamese standard equivalent: TCVN ISO 9001:2008 Quality management – ​​Requirements). (Expired) Currently ISO 9001:2015 Quality management systems – Requirements (Vietnamese standard equivalent: TCVN ISO 9001:2015 Quality management – ​​Requirements). An improvement of ISO 9001:2015 compared to previous versions is the approach to risk-based thinking. This way of thinking will help the organization identify factors that can cause its management systems and processes to deviate from planned results. As a result, the organization can put in place preventive controls to minimize negative impacts and make the most of opportunities when they arise. The quality management system ISO 9001:2015 applies the process of "Plan - Do - Check - Act" to adjust the quality of goods and services. The essence of ISO 9001 1. Clearly define work - clear people - clear how to do It's clear The organization needs to standardize the activities of the stages into operating procedures/instructions. Make sure every position in the organization understands the work they need to check, deploy and perform. Clear people The leadership of the organization needs to decide to select and appoint a number of key recipients of the departments to establish an ISO Project Board to develop and apply ISO. The ISO project team needs to understand the work, responsibilities and rights of each person in each department to develop specific procedures/instructions that are best suited to each job position. Clear how to do it Operating procedures/instructions need to be specific and accurate. Divided into easy implementation steps, implemented for each position in the organization. 2. Standard procedures/guidelines that have been established must be followed As a result, enterprises can control the production process and ensure stable product quality. Towards improving product quality. Importance of ISO 9001:2015 1. Create a competitive advantage with competitors – increase the probability of winning the bid Obtaining ISO 9001:2015 certification is a huge competitive advantage compared to competitors in promoting the brand image and quality of products/services of the business. ISO certificate is an opportunity for customers to receive bidding packages for large projects/enterprises. Because now, in addition to the provisions of many state bidding packages, many corporations or businesses require their partners to achieve ISO certification before agreeing to buy and receive products or services. 2. Create trust with customers/partners About the quality of products/services of the business. An enterprise that has achieved ISO 9001:2015 certificate means that it has established a quality management system according to international standards. It is like a commitment to quality for customers and partners. From there, build trust, build a brand with the quality of the products that we bring. 3. Quality of products/services is guaranteed Due to being managed scientifically and strictly by standards and requirements of an international quality management system. Help control input well, stabilize product/service quality. Improve the quality of sales service and continuously improve the quality of products/services. 4. Create a good and effective working environment When applying ISO, procedures and work instructions are standardized -> managers and employees within the enterprise will understand what their work must be? Understanding their responsibilities and rights -> leading to stabilizing the production / service provision process and creating products or services of stable quality, reducing errors, waste products and failures. 5. Manage risk When ISO is applied, awareness of risks and opportunities will be enhanced. Become a mandatory compliance requirement for each business. Therefore, enhancing the ability to be aware of risks and respond promptly to risks and incidents in each business.

adminici | 01/04/2021

USDA Organic Certification Process American Standards

The USDA organic certification is the most stringent US organic standard certification. The agency requires products containing 95% organic ingredients to use their logo. In addition, this agency also does not allow the use of synthetic preservatives and most of the chemical ingredients during processing as well as organic operations must prove that they are protecting natural resources, conserving Biodiversity. USDA organic certification process How is the USDA organic certification process done? And which products are certified in the USDA organic food certification scheme. What is USDA organic certification? USDA stands for United States Department of Agriculture, a state agency responsible for managing the development and implementation of policies adopted by the US government related to agriculture, forestry, and fisheries. Karma. It also licenses agricultural commodities to organic standards, and only products with more than 95% organic ingredients are licensed. Organic agriculture produces agricultural products using methods that protect the environment and uses almost no artificial materials such as pesticides and antibiotics. Organic farmers, farms using organic farming methods and organic food processing processes must follow the standards for organic and fiber food production. These standards will cover the entire production process and product from on-farm to consumer meals, including soil quality, irrigation water, pest control, farming practices, and other rules about food additives. Organic certification in Vietnam needs to comply with the general criteria in current organic farming, 3 popular certification standards in the world and widely known in Vietnam are organic certification. USDA of the United States Department of Agriculture, EU organic certification of the European Union and Japanese JAS organic certification. USDA organic certified product According to the US Department of Agriculture, USDA standards certify four categories of organic production as follows: Crops: The crops to harvest are used for animal feed processing, food, cotton fiber or used to add nutrients to grasslands. Livestock: Animals raised for food or used in the production process for food, fiber or animal feed. Processed products: Processed and packaged (eg cut carrots) or combined, processed, packaged (eg bread, soup, etc.) Natural trees: Plants that grow in places where there is no cultivation USDA organic certification process USDA organic certification application Detailed description of the production process to be certified. Record information on substances used on the soil during the previous three years. List of organic products grown, cared for or processed. An organic system plan describing the activity and substances used. Implementation process Step 1: Submit your documents and fees to the Organic Certification Body listed on the USDA's Authorized List. Step 2: The certification body evaluates whether the production activities are compliant with USDA organic regulations. Step 3: The Certification Body inspector examines the farm operations of the applicant. Step 4: The certification body reassesses the documentation in conjunction with the inspector's report to verify that the certification registrar has complied with the USDA organic regulations. Step 5: USDA organic certification Annually, the organic certified establishment must submit its production update report to the Certification Body. The inspector conducts performance inspections in the certified organic facility on a regular basis. The certification body reassesses the records in conjunction with the inspector's report to verify that the certified establishment is still complying with the USDA organic regulation. The certification body issues organic re-certification. The cost of the USDA organic certification process Depending on the certification body and the size, type and complexity of the production operation, the cost of certification will vary significantly. Usually the cost of the USDA certification process will include: Fee for submitting USDA certification application, testing fee, annual monitoring evaluation fee, ...

adminici | 31/03/2021

Consulting on registration for certification of cultivation according to VietGAP standards

VietGAP certification in cultivation is evidence for businesses to confirm that their fresh fruits and vegetables ensure food safety. Because at present, the situation of food unsanitary, poisoned fruits and vegetables has reached a warning level, causing confusion for consumers, so in order for the fruit and vegetable products to be trusted by consumers, VietGAP should be planted. Cultivation is very urgent. So how is VietGAP certification registration process? Please follow the article below. What is VietGAP? VietGAP (stands for: Vietnamese Good Agricultural Practices) means: Good Agricultural Practices Process in Vietnam, issued by the Ministry of Agriculture and Rural Development for each seafood product and group. production, cultivation and husbandry. VietGAP is the principle, order and procedures for guiding organizations and individuals to produce, harvest and handle post-harvest in order to ensure safety, improve product quality, ensure safety and social health. . healthy producers and consumers; at the same time protecting the environment and traceability of production. VietGAP is divided into 3 groups: VietGAP cultivation, VietGAHP livestock, VietGAP fisheries. What is VietGAP certification for farming? Growing according to VietGAP standards are requirements in production and preliminary processing to ensure the safety and quality of crop products. In order to improve the quality of crop products to help protect human health and labor safety of producers, improve environmental protection and know the origin. Objects of applying VietGAP cultivation VietGAP cultivation standards are applicable to all individuals and organizations at home and abroad that produce, trade and import safe fresh vegetables and fruits in the Vietnamese market. Specifically, VietGAP certification in crop production applies to products such as: root vegetables, fruit vegetables, leafy vegetables, fruits, ...

Jeffrey | 17/03/2021

10 steps to register ISO 9001: 2015 certificate for businesses

ISO 9001 is a set of standards that set out the principles, principles and requirements to establish a quality management system in an enterprise and apply to all types of businesses regardless of size or type. production, sales or service. In particular, the standard has compulsory regulations applicable to 2 areas: building materials and fertilizer production. 10-step process to get ISO 9001: 2015 certification “The ISO 9001: 2015 Advisory Board” will be established prior to consulting. The Advisory Committee consists of members with expertise relevant to the unit's field of activity. The 10-step process of registering for the ISO 9001: 2015 certificate Implementation of the registration process for certificates of ISO 9001: 2015 Step 1: Make an implementation decision Does your current quality management system (QMS) meet the requirements of management, monitoring and inspection? Is it necessary for a company to change the existing QMS to ISO standards? If necessary, the organization's management should have an understanding of ISO. Therefore, when deciding to rebuild a quality management system in accordance with ISO 9001: 2015, companies need to learn about ISO through ISO awareness training courses. Step 2: Appoint a management representative and ISO Board Company leaders need to decide to select and appoint a number of key personnel of departments to form a team of personnel to develop and apply ISO. The quality manager must be knowledgeable about ISO 9001 in order to be able to effectively apply the qualified QMS into the company's existing system. This is also the person who conducts the ISO 9001 internal audits every month. Step 3: Develop an implementation plan After reviewing the terms and requirements of the ISO QMS, what requirements should an organization check if it can meet? What is missing? Can it be changed to meet that term? What actions should be taken if possible? Work volume like? Who will be in charge? All of those questions must be answered and be done step by step. This is called an execution plan. Having had an implementation plan in place, it is easy for an organization to determine when the certification audit will take place. Step 4: Notice within the organization Once an implementation plan for the implementation of ISO standards has been developed, it is important that the members of the organization be aware of the plan. There will be mixed opinions in changing to the ISO quality management system. You need to make it clear so that everyone knows the plan and implementation (for directly affected departments) or support (for relevant departments). This is an important information that determines all upcoming production and business activities. Step 5: Develop and set up procedures / instructions and forms ISO 9001: 2015 standard requires a document system, a mandatory process to be established according to the requirements in the standard. Writing these documents will take a lot of time and effort, but it also answers the question: "What will an organization get after applying the ISO 9001 quality management system"? There will be templates available for you to refer to and based on that to write in accordance with the actual conditions of the organization. Each item, there are many samples for your reference. It is also very important to choose these patterns accordingly. It must meet the construction and application of ISO 9001 quality standard system. ISO 9001 has compulsory regulations applicable to 2 areas: building materials and fertilizer production How long is the validity of ISO 9001: 2015 certification valid? The validity of ISO 9001: 2015 certification will be valid for 3 years from the date of certification. When businesses achieve ISO 9001 certification, businesses must follow what has been set out, in accordance with the initial process. The certification body will conduct an annual monitoring (no more than once every 12 months). If the enterprise does not maintain the system requirements, the certificate will be suspended or revoked

Jeffrey | 17/03/2021

ISO 22000: 2018 certification consulting services

Thanks to the successful application of the food safety management system ISO 22000: 2018, many businesses operating in the field of trading and food processing have improved product quality and working environment conditions. The application of ISO 22000 in food processing is considered as a safe food production solution according to international standards for domestic consumption. What is ISO 22000? ISO 22000 is an international standard developed by the International Organization for Standardization (ISO) with a focus on activities related to food safety in an enterprise. The full name of the ISO 22000 standard is ISO 22000 Food safety management systems - Requirements for any organization in the food chain means "Food safety management systems - Requirements for organizations in the food chain". ISO 22000 standard - Food safety management system is recognized and applied worldwide. The ISO 22000 standard that is built in the context of food safety and hygiene is of utmost importance. ISO 22000 - Food safety management systems ISO 22000 is built on the foundation of the principle of "Hazard analysis and critical point control - HACCP" combined with the requirements of "Quality management system - ISO 9001" applied to the production chain. Export and supply of food from cultivation, animal husbandry to processing and supply. ISO 22000 is a testament to your business units ensuring hygiene when producing safe food products. Which businesses need to apply ISO 22000? The ISO 22000 standard sets out the general requirements that are applicable to all organizations and businesses in the food chain, regardless of the size, type or complexity of the organization. This includes organizations that operate directly or indirectly. ISO 22000 is applicable to all organizations and businesses in the food chain Eg: Production and processing of animal feed Functional foods: for the elderly, children, sick people Enterprises processing vegetables, tubers, fruits, milk, eggs, and aquatic products. Beverage production and processing enterprises: soft drinks, purified water, wine, beer, coffee, tea, .. Spice production and processing enterprises Food transportation firms Enterprises producing and processing ready-made food and restaurants Supermarkets, wholesale and retail Enterprises producing food packaging materials Farming farming and breeding ... Why do businesses need ISO 22000 certification? Currently, the issue of food safety and hygiene is one of the most painful issues in society, especially in areas such as urban or big cities, where unsafe food can be walked on. next to consumer health Toxic chemicals, typically: pesticides, growth stimulants, pesticides, herbicides, antibiotics, and weight gainers, when left in the meat and fish, if consumed, they must be consumed. accumulates gradually in adipose tissue. Spinal cord,.....of human. This is the premise for many dangerous diseases such as cancer, memory impairment, osteoarthritis,..... Therefore, the Law on Food Safety was born with Decree 15/2018 / ND-CP providing detailed regulations to limit problems affecting food safety. ISO 22000 certification is recognized as proof that your business unit is capable of producing and trading food that is safe and meets the requirements of applicable law. In addition, according to the provisions of Point k, Clause 1, Article 12 of Decree No. 15/2018 / ND-CP at: Article 12: Establishments are not required to issue Certificate of Eligibility for Food Safety k) The establishment has been granted one of the Certifications: Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Point (HACCP), Food Safety Management System ISO 22000, Valid International Food Standard (IFS), Global Food Safety Standard (BRC), Food Safety System Certification (FSSC 22000) or equivalent valid. If your business unit has been granted ISO 22000: 2018 certification, your business will not need to have a certificate of eligibility for food hygiene and safety. Thus, businesses having certificates of conformity with standards of HACCP or ISO 22000 will have many advantages. Benefit from the ISO 22000 food safety management system An enterprise applying ISO 22000 food safety management standards will be recognized as having a food management system of international standards, creating a high competitive advantage, especially creating favorable conditions. for export to fastidious markets around the world. Besides, the application of ISO 22000 also brings many other benefits such as: Standardize all production and business management activities of the enterprise. Can replace many different standards: GMP, HACCP, EUROGAP, BRC, SQF, IFS. Reduce cost of sales. Minimize the risks of poisoning, lawsuits, and complaints of customers. Increase the reputation, trustworthiness, and satisfaction of distributors and customers. Improve the overall performance of the business. Convenient in integration with other management systems (ISO 9001, ISO / IEC 17025, ISO 14000). ISO 22000 certification consulting services for businesses The ISO 22000 certification consultation process is carried out in a scientific and logical way to help businesses understand the procedures that need to be taken to achieve ISO 22000 certification. Step 1: Register for a certificate Business unit registered for certification at Vietnamese Quality (CLV). Need to provide basic information about the business, information about the field of activity, form of production, products, services being traded, ... After that, CLV will agree with the enterprise and sign a contract. . Step 2: Preliminary assessment Based on the specific application of ISO 22000 by enterprises, CLV will have a team of consultants who will come to the preliminary assessment of the actual food safety management system at the enterprise. Step 3: Document review When registering for ISO 22000 certification, CLV will provide a list of documents that enterprises need to prepare for the process of evaluating and verifying the ISO 22000 system. ISO 22000 will be based on the size and type of specific businesses. There will be awareness training and internal assessment at this stage. Step 4: Evaluate the management system Certification body (third party) comes to actual assessment of ISO 22000 application in enterprises. Consider the match between reality and the content in the records, documents that the business provides. Then, give recommendations to businesses to fix the mismatches in the system. Step 5: Check, fix and verify records CLV will re-check the condition that needs to correct the nonconformities indicated in the previous step. Once the nonconformities have been corrected, the Certification Body will re-examine all documents and the results of the management system audit to consider issuing ISO 22000 certification. Step 6: Issue the certificate and certification mark After examining the audit documents, if the results are appropriate, the certification body will issue the certificate with the ISO 22000 certification mark to the enterprise. Step 7: Monitoring and recertification ISO 22000 certification is valid for up to 3 years (from the date of issue). Up to the prescribed monitoring period, the Certification Body conducts periodic monitoring reviews. The results of the monitoring audit will be evidence to maintain the validity of the certification. The usual number of monitoring assessments is 2 times (every 12 months). The supervisory audits are basically the same as the first certified audit. Under what circumstances is ISO 22000 certificate revoked? After achieving ISO 22000 certification for food, it is imperative for your business to maintain the application of the food safety management system required by the standard in order for the certificate to remain valid. In case the enterprise does not apply or operate a system that does not comply with the requirements of ISO 22000, the validity of the certificate will be invalidated and the certification body will revoke the certificate. There are many businesses after getting the certificate but not maintaining the application of the system leading to delays or malfunctions in the operation process as well as revocation and the certificate will lose its effectiveness. . Cost of ISO 22000 certification consultation In fact, the cost of ISO 22000 certification per business unit varies. Some of the key factors involved in calculating the cost of ISO 22000 are as follows: Size and scope of business: What is the size of personnel and departments? This is the basis for the certification organization to define Manday (working day). And at the same time is the number of personnel participating in the assessment. Scope of business locations: What business locations does the company have? Is the production location different from the headquarters location? This information will have much to do with travel costs; accommodation of experts. Example: Travel expenses for 02 places or 01; In two different provinces or the same province. Areas of operation of the business: What industry does the business operate in: the complexity of the production process and the product. This is also one factor that the certification body will consider the cost. Because it will take time and need to be followed by technical experts. Depending on the size, scope, and quantity of products of the business. Construction costs applied and personnel costs involved as well as registration costs, testing costs, ... but the cost level also changes.

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HEADQUARTERS

No 10 Phan Ba Phien Street, Tho Quang Ward, Son Tra District, Da Nang City

0766 777 686

[email protected]

SOUTHERN OFFICE

134/78 No 1 Street, Ward 16, Go Vap District, HCM City

0907 116 626

[email protected]

NORTHERN OFFICE

No 81 Tran Cung Street, Nghia Tan Ward, Cau Giay Distric, Ha Noi City

0901 981 789

[email protected]

TAY NGUYEN OFFICE

No 45, Ly Tu Trong Street, Tu An Ward, Buon Me Thuot City, Dak Lak

0706 100 279

[email protected]