Benefits of ISO 13485 Certification in Medical devices manufacturing

Organizations seek ISO 13485 Certification to enjoy several financial-operational and other benefits. Here is a information of some main advantage of getting ISO 13485 Certification. Read More Click here –

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ISO 27001 Certification support to ensure your ability to understand strengths and weaknesses. Hence-forth adopting precautionary measures for the anticipated hazard. The organizations must educate them-selves with the cyber-security. Read more Click –

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There are many ISO standards that can be applied in a telecom sector for improving its quality, limiting its impact on the environment, ensuring information security, any many-more. Let us have a look at these standards individually:

Carefully read the paragraph and know which iso standard can be applied in telecom sector. Read more link –

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How to process ISO 27001 Certification in any type of organization?

How is ISO 13485 certification beneficial for Medical Devices

ISO 13485 Certification- Quality Management System for Medical-Devices accommodate standard for safe manufacturing to distribution of medical-devices. The primary objective of the standard is to maintain harmony between the legal-requirements and the management-system. It is obligatory to accomplish ISO 13485 Certification for companies exporting medical-devices to other nation.

ISO 13485 is suitable for all type of company dealing with medical-devices in all the countries. Obtaining ISO 13485 Standard provide the companies a competitive-edge. This support them to exhibit that their tendency to manufacture products according to worldwide procedures.

The organization dealing with medical-devices can benefit in opening door of worldwide markets. This ISO Certification will boost their profitability & productivity . The compliance with the standard benefits in demonstrating your ability on proffering safe and quality-product. The reliability of the product increases in the eyes of customers/client. This will build a high-level confidence in you. Also it builds an effectively efficient system.

One of major advantage of obtaining ISO 13485 is that it mandates you to conduct regular self-assessment and evaluation for adding required improvements. All the employees must be educated about quality-policy stated in the standard. They must be provide responsibilities to dig out the weaknesses and work on continual-improvement. It can be beneficial constructing an environment of engaged and participatory employees.

Perhaps the most critical advantage of ISO 13485 Certification is that it represents a preventive approach to assuring medical device quality as opposed to a reactive-approach to inspection and rejection at the end of the manufacturing sector.

In a summarized way the one liner advantage of ISO 13485 are given as follow-

  • Creates a systematic framework for monitoring and analyzing customer-feedback
  • Meets the worldwide standard in implementing quality system standard
  • Gives a brand name in the market
  • Opens door for international market
  • Reduction in costs

The explained blog defined how ISO 13485 Certification constructs an effective-system. We at SIS Certifications will support you obtain the standard legitimately. The ISO Certification will support in gaining more customers. Apply ISO 13485 Certified today.

Is SIS Certifications offer ISO 13485 Cortication services in USA?

Yes, SIS Certification offer ISO 13485 Certification services in Los Angeles, Chicago, Houston, Phoenix, San Diego, Dallas, Austin, Columbus, Washington, Las Vegas, Miami, Texas and other city of USA. SIS Certifications is a best ISO Certification body in USA. We offer ISO 9001, ISO 14001, ISO 27001, ISO 37001, ISO 22000, ISO 45001 and other ISO Certification.

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Should your company need ISO 37001 Certification ?

iso 37001 certification

For all either it’s large or small, ISO 37001 are often employed by any organization or whether it’s within the public, private or voluntary sector, and in any country. As per the size and nature of the organization, The ISO 37001 certification anti-bribery management system may be a flexible tool, which may be adapted and therefore the bribery danger it faces.

The ISO 37001 standard, issued in October 2016 is meant to assist the organization’s work and maintain an efficient anti-bribery program. The ISO 37001 standard provides a variety of independent requirements round the world document for the fight against bribery. the quality deals with corporate bribery and bribery organizations.

To run the program in accordance with the speed significantly reduces the danger of malpractice, by inserting control points there it’s worthwhile. Additionally, ISO 37001 isn’t just focused on preventing bribery, but also in handling it effectively if possible. Likewise, different partners worked together on ISO 37001, remembering specialists for different fields; legitimate, consultative, and research panels; and scholastics and governments.

The introduction of best anti-bribery strategies — ISO 37001 that end in the guidance of bribery management programs and, Countries and governments around the world are currently evaluating the effectiveness ISO 37001 certification standard, and other all countries and governments have expressed interest in requiring organizations are using this standard to participate in government contracts. i.e.Peru, Kuwait, China, Bangladesh are currently showing interest in requiring the company to submit an ISO 37001 certification to participate in public procurement.

ISO 37001 certification standard is meant to assist reduce the danger of bribery by a corporation or other person working on behalf of a corporation. Additionally, the utilization of this level allows organizations to demonstrate greater resistance to bribery through the existence of internationally known anti-bribery controls. ISO 37001 is taken into account a requirements standard that permits organizations that apply this standard.

 The organization is required to possess the subsequent best practices and/or controls included as a part of its bribery control plans:

  • Anti-bribery policy
  • Management leadership, commitment, and commitment
  • Human resource management and training
  • Risk assessment procedures
  • With due diligence on projects and out of doors business
  • Financial, commercial, and contract controls
  • Policies regarding reporting, monitoring, investigating, and reviewing

The ISO 37001 standard requires the organization to use its control measures effectively and equitably. The ISO 37001 certification standard, however, doesn’t directly define what it means in a logical and agreeable way. Level broadcasts allow managers to use their professional judgment to make appropriate controls to stop, detect and answer a variety of bribes supporting a variety of things, like company level, size and sort of contract, customer types (public or non-governmental, public or private, etc.), and value.

Iso 37001 Certification Worth It for organizations?

The decision of whether to incur the prices to implement a compliance program that meets the wants of ISO 37001 certification and would pass the audit phase may be a case-by-case decision. a corporation trying to make a decision whether to implement a compliance and ethics program that meets the wants of ISO 37001 should conduct an analysis that weighs the potential benefits and roadblocks outlined previously, among others. While an efficient compliance and ethics program would benefit the bulk of companies within the end of the day, each company has to assess the prices and benefits of implementing a program that might suit the wants of ISO 37001.

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Difference between ISO 13485 standard and ISO 9001 for medical devices

Fortunately, you simply got to worry regarding ISO 13485 certification if you are going to form and distribute medical devices. to get a CE marking certification, that indicates conformity with safety standards for products sold within the European Economic Area, medical device makers should either get a certification with a notified body or have a high-quality system in place.

ISO 13485 standard is a quality system for the medical device industry, and it effectively covers ISO 9001 with some further necessities.

What several medical device manufacturers fail to understand, however, is that comparing ISO 9001 and ISO 13485 may be a valuable exercise. By understanding the differences between these two standards, you learn wherever device manufacturers got to raise the bar on quality.

ISO 9001 and ISO 13485 for Medical Devices: How They Differ

The primary difference between ISO 13485 and ISO 9001 for medical devices is the scope of those quality standards.

ISO 9001 certification is the international standard that provides specifications for a high-quality management system that can be applied at any organization regardless of industry, product or service, or company size.

ISO 13485 may be a comprehensive management system specifically for the manufacture of medical devices. It places a more significant specialize in regulatory compliance and offers less flexibility within the organizational process.

 There are significant similarities between the two standards, including:

  • The standard’s role in helping organizations achieve a top quality management system
  • Risk mitigation and assessment may be a significant focus in both standards
  • A focus on the belief of quality products through understanding the customer
  • 13485 and 9001 emphasize employee competency and infrastructure for quality

There are several areas of difference in iso 9001 and iso 13485, however, which we’ll cover below. Medical device makers face extra requirements for creating a robust quality management system (QMS), the executive’s obligation, resource management, product realization, and more.

QMS (quality management system)

ISO standards define a QMS as a lot of “policies, processes, and methodology” required for the planning and execution of a core business area.  These strategies and methodologies are regularly upheld by an ISO-compliant electronic quality management system (eQMS) software. Organizations must address all requirements inside the standard, including documentation to achieve certification or a CE mark.

ISO 13485 certification standard expands on the requirements of ISO 9001 by specifically addressing the responsibility of the medical device manufacturer for “keeping up the effectiveness of the quality management system.” 

Management Responsibility

ISO 9001 allows the organization’s management group to appoint quality responsibilities without characterizing roles. ISO 13485 certification requires organizations to identify an individual from the management team who is responsible for every part of the QMS.  Also, the standard for medical device manufacturers specifically addresses the need for managers to plan regulatory consistency and survey new and modified cGMP regulations which impact the organization.

Resource Management

Both ISO 9001:2015 and ISO 13485:2016 adopted a more in-depth focus on resource management, defined as the different gear, structures, and IT assets required for quality product realization. Specific requirements for device manufacturers are focused on ecological norms and sullying control for item security.

 Product Realization

ISO 9001 positions product realization as a result of effective systems and strategies.. The 9001 certification standard focuses on customer needs as a proportion of value, and sets forth operating standards which support quality item acknowledgment.

ISO 13485 certification provides a more in-depth interest to improve wellbeing and consumer loyalty. Approval of cycle, hardware, neatness, and danger of the board all through the item life cycle are basic drivers of value. ISO 13485 doesn’t deemphasize the part of strategy and system in quality or remove customer satisfaction as the result of a quality-driven culture Instead, Rather, it expands on these necessities with explicit principles for creation and the graceful chain.

Measurement, Analysis, and Improvement

ISO 9001 takes a process-driven strategy for persistent improvement. ISO 13485 certification makes a more granular meaning of the sorts of progress exercises gadget makers need to guarantee items are sheltered and compelling. Some key differences between 9001 and 13485 standards for customer feedback, monitoring product performance, and how to address a non-adjusting item.   

Electronic Quality Management Systems for ISO 13485 certification

Comparing ISO 13485 standard to ISO 9001 standard reveals the extensive actions medical device manufacturers must take to ensure product quality. A process and customer-driven QMS is a highly helpful apparatus for making a quality-driven culture and consistent improvement in numerous businesses. ISO 13485 certification builds on ISO 9001 while providing additional requirements for effective management, documentation, and estimation to deliver safe medical devices.

The requirements of  ISO 13485 standard are more extensive and specific than the guidelines of ISO 9001 certification. An eQMS designed specifically for medical device manufacturers can simplify the way toward accomplishing the exceptionally explicit necessities for information catch, maintenance, and documentation. A solution designed under ISO 13485 can smooth out your chance of accreditation and make robotized work processes that help your organization satisfy necessities all through the item life cycle.

For more information :

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How to get ISO 22000 Certification in a organization?

How to get ISO 22000 Certification in a organization

The ISO 22000 Certification depends on Food Safety Management System . ISO 22000 Certification can be applied by any if the association of food packing supply chain. With the assistance of ISO 22000 Certification, you can introduce your organization as a food safety management system, your food is made sure about and all around made for wellbeing, your food packing and food fixings which gracefully structure provider are absolutely protected which makes client commitment, It likewise gives ISO safety to your purchasers that you have executed a proficient food safety plan and the management system.

How to get ISO 22000 Certification?

The first thing you should learn about ISO 22000 Certification, When you decided that ISO 22000 Certification is right for your organization, you are required to achieve a food safety management system manners to meet the specifications of the standard. These requirements go behind PRPs and HACCP Certification and combine processes to manage the system throughout the company. This means planning, documenting, designing and implementing a complete system of food safety management. This can take organizations 6-7 months or further to complete implementation in their organization.

Once the system is in place and being used as part of day to day business you will have a Registrar come and perform a Certification Audit. If the auditor determines that the system is obedient with the standard and is continually followed throughout the company, they will suggest your office for certification.

Basic key parts of ISO 22000 Certification

1.     System management

2.     Prerequisite-programs

3.     Interactive communication

4.     HACCP Certification principles

Also, check — →> ISO 22000 Certification In Delhi

Learn how to make ISO 22000 standard beneficial for our organization –

1.     Reduce, rework-defects, customer rejections, wastage and cost of operation.

2.     Improve company profit.

3.     Reduce attrition of customers & employees.

4.     Enhance customer delight.

5.     Increase brand image in market

6.     Enhance the confidence of all stakeholders

Requirements Of ISO 22000:2018

ISO 22000 Standard asks that you create and document a Food Safety Management System . The ISO  standard includes several specifications to be marked by the Food Safety Management System.

  1. ISO 22000 Certification requires food-safety policy for your organization or firm, generated by the best management-system.
  2. It requires a management system and documenting the system to Plan & design.
  3. you have to Set up some goals that will motivate your company’s efforts to fulfill this policy.
  4. Holding management audit meetings to test the performance of the Food-Safety-Management-System.
  5. Maintain records to executive the system.
  6. Organize a group of adequate people to make a Food secured Team.
  7. Follow the HACCP rules and regulation.
  8. Implementing an improving business system and control of the non-conforming product.
  9. It needs Checking to observe and measure the devices.
  10. Setting up a traceability policy for a description of the product.
  11. Organize to maintain an internal audit program.
  12. Constantly updating and improving the Food Safety Management System.
  13. Prepare a documented method to manage the departure of the product.

Mandatory Procedures Documents Required for ISO 22000 Certification (FSMS)?

Following is the list of mandatory ISO 22000  procedures helped in food safety certification.

  1. Emergency readiness and reaction.
  2. Product Withdrawal.
  3. Pre-essential Program.
  4. Procedure For HACCP Plan.
  5. Preliminary Analysis of Production Process.
  6. Control Of Monitoring And Measuring Devices.
  7. Management Audit
  8. Document & Data Control.
  9. Control Of Quality Records.
  10. Correction, Corrective & Preventive Action.
  11. Hazard Identification Procedure.
  12. Control Of Non-Conforming Products.
  13. Internal Quality And Food-Safety Audit.

Who require ISO 22000 Certification?

ISO 22000 standard can be executed by any organization/association in the evolved food supply chain, from field to store including packagers, processors, cultivators, carriers, bottlers, retailers & restaurants.

To make the ISO 22000 Certification measure basic. You should employ an advisor when an expert got your application they select a customer administrator who will direct you and your business through the accompanying advances.

  • Certification and beyond
  • ISO 22000 Plan & how to get Certified
  • Gap analysis
  • Formal assessment

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ISO 22000 Certification – What you need to know?

ISO 22000 Certification -fsms

Food safety  is one of the most significant basic in the Food safety business. This point concerns the end purchasers as much as each organization engaged with the stock and generation chain. This is the motivation behind why certification and lawful guidelines are so significant in the administration of value in the food business. just a straightforward and unequivocal arrangement of rules and observing of the entire procedure can ensure a decent food quality for the end consumer.

Certifications and ISO standards ensure that determinations and necessities are watched, reported and controlled. While a few measures are industry explicit, and other item explicit, the ISO 22000 Certifications brings together various guidelines and standards to ensure global food safety.

To assist you with understanding the ISO 22000 certification, here are the most significant parts of the standard and what you have to know.

ISO 22000 certification is a universal certification for food safety. a certification can be compelling up and down the generation chain, permitting organizations, for example, food bundling or added substances makers to get certified also.

Content of the ISO 22000 Certification:

The requirements of the standard spread a few phases of food safety in the generation procedure, for example, provider observing, individual cleanliness or even execution of rules with respect to the treatment of control focuses (HACCP). A focal capacity of actualizing the ISO Standard is the straightforward and ensuing documentation of exceedingly significant procedures.

The standard covers among other:

  • Structure and documentation of an administration system
  • Execution of a hazard investigation
  • Preparation and usage of a HACCP idea and a Prerequisite Program (PRP) just as an Operative Prevention Program (OPRP)
  • Effective correspondence, inside and outer (with providers, dealers, end shoppers, and so on.)
  • Evaluation (approval and check) of all measures expecting to a relentless improvement of foods safety.

Procedure of the ISO 22000

The ISO 22000 certification has a legitimacy of 3-years and is controlled yearly by a checking review. To get the affirmation, you should experience the accompanying steps:

  • Pre audit
  • Certification audit
  • Issue of the certificate
  • Monitoring-audit
  • Re-Certification audit

The audits required for a fruitful certification are isolated in two parts. In the first-audit, the controlling body will check if the organization is appropriate for the usage of the standards. Archives will be kept an eye on area and potential food risk will be related to a hazard investigation or an examination of the avoidance program. This will set the measures for the subsequent review prompting the usage of the standard and to the certification itself.

Planned revision of the ISO 22000

ISO 22000 Certification was first distributed in 2005 and has been often refreshed from that point forward. A bigger modification is being made and we are anticipating that the update should be distributed in the coming a very long time of 2017. The accompanying parts of the affirmation ought to be improved:

  • Better guidelines implementation for SMEs
  • Details should be added to some domains such as control points or risks evaluation