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FAQs of ISO Certification

Quality is the standard degree of something measured upon similar things, Quality management means managing of quality of products of an organization whether the work is done as prescribed. So, we learned the meaning of quality and quality management, combining these ISO 9001:2015 is ISO International Standard for Quality Management System (QMS), it is widely recognized in the world for maintaining and improving the quality of products and services regardless of size or industry. It was first time introduced in 1987 by the International Organisation of Standardization (ISO). It is a very powerful ISO standard that helps an organization to consistently meet the constant product quality and improvised it to meet the world’s standard expectations.
Implementing ISO 9001:2015 can lead to a variety of benefits for an organization, including improved customer satisfaction, enhanced reputation, increased efficiency, better risk management, and increased profitability.
ISO 9001:2015 can be used by any organization, regardless of its size, type, or sector. It is applicable to both manufacturing and service-oriented organizations, as well as to the public and private sectors.
ISO 9001:2015 is structured around ten sections, with the first three sections providing introductory information about the standard and the remaining seven sections specifying the requirements for a QMS. These sections cover topics such as context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.
Top management has a critical role to play in ISO 9001:2015. They are responsible for providing leadership and ensuring that the QMS is effectively implemented and maintained. They are also responsible for communicating the importance of quality to the organization, and for ensuring that the QMS is aligned with the organization's strategic objectives.
It is a system that operates as a mentor to the organization in order to provide better products and services to the customer and tries to reduce any defects in the process of the organization. This standard is globally applicable. It also includes Food Safety Management System ISO 22000 standard and Hazards analysis and critical control points (HACCP). It gives an outline for businesses on how to monitor, develop and improve the food quality of the business. ISO 22000:2018 contains 10 sections called clauses.
ISO 22000:2018 is an international standard that specifies the requirements for a food safety management system (FSMS). It is designed to help organizations ensure the safety of food products throughout the food supply chain.
The benefits of implementing ISO 22000:2018 include improved food safety, enhanced customer confidence, reduced risk of product recalls, increased efficiency and productivity, and compliance with regulatory requirements.
ISO 22000:2018 is not a mandatory requirement, but it can help organizations comply with regulatory requirements and demonstrate their commitment to food safety.
ISO 22000:2018 can be implemented by any organization involved in the food supply chain, including food manufacturers, processors, packagers, distributors, and retailers.
An environmental management system is a systematic approach with the help of standards it tries to reduce a negative impact on the environment which is happened by organizational behavior. It helps in the improvement of the organization's system. This standard can be used by any organization irrespective of the nature of the business or the size or complexity of the organization. The latest version of ISO 14001:2018 includes 10 clauses and these clauses are divided according to the Plan do check act approach.
Implementing ISO 14001:2015 can bring several benefits to an organization, including improved environmental performance, increased efficiency, cost savings, compliance with legal and regulatory requirements, enhanced reputation, and better stakeholder engagement.
ISO 14001:2015 can be used by any organization, regardless of its size, type, or sector. It is particularly relevant for organizations that have significant environmental impacts, such as those involved in manufacturing, construction, or transportation.
The process for implementing ISO 14001:2015 typically involves the following steps: 1) Establishing the scope and boundaries of the EMS, 2) Conducting an initial environmental review, 3) Developing the environmental policy, objectives, and targets, 4) Implementing the EMS, 5) Monitoring and measuring performance, and 6) Continuously improving the EMS.
ISO 14001:2015 is part of a family of ISO standards that relate to environmental management, including ISO 14004 (guidelines for implementing an EMS), ISO 14006 (guidelines for incorporating eco-design), and ISO 14064 (guidelines for measuring and reporting greenhouse gas emissions).
ISO 45001 generally deals with the health and safety of employees in the workspace. It is created for improving workers' safety reducing work risk and making sure employees are surrounded by a safe environment.
ISO 45001:2018 can be used by any organization, regardless of its size, industry, or sector. It is relevant to organizations of all types, including public and private, for-profit and non-profit, and governmental and non-governmental.
The benefits of implementing ISO 45001:2018 include improved OHS performance, reduced risk of accidents and incidents, increased employee morale and motivation, enhanced reputation and credibility, and improved compliance with legal and regulatory requirements.
To become certified to ISO 45001:2018, an organization must implement an OHSMS that meets the requirements of the standard, and undergo an audit by an accredited certification body. The certification process involves a stage 1 audit (document review) and a stage 2 audit (on-site audit), followed by ongoing surveillance audits.
Top management has a key role in implementing ISO 45001:2018, as they are responsible for establishing the OHS policy, ensuring that the OHSMS is implemented and maintained, and providing the necessary resources and support. Top management also has a responsibility to communicate the importance of OHS to all levels of the organization.
Medical devices are tools, and instruments that are used for medical purposes. The manufacturers should ensure that the tools which are produced are useful for customers. In order to improve your business and maintain a good management system, it is required to implement some international standards such as ISO Standard For Medical Devices 13485:2016. This standard helps in maintaining the quality of products, consistent services, and the good process from production to delivery of goods which attracts more customers to the organization and thus moves forward in the market. Organizations of any size, complexity and especially medical device companies can implement this standard. An individual cannot use the standard. ISO 13485:2016 version was published on 1 March 2016. The previous version of ISO 13485 was ISO 13485:2003
ISO 13485:2016 is applicable to organizations involved in the design, development, production, installation, and servicing of medical devices. This includes manufacturers, suppliers, and service providers in the medical device industry.
ISO 13485:2016 is specifically tailored to the medical device industry, whereas ISO 9001 is a more general quality management standard applicable to any industry. ISO 13485:2016 places more emphasis on regulatory compliance, risk management, and product safety than ISO 9001.
ISO 13485:2016 certification can provide several benefits to an organization, including improved product quality and safety, increased customer satisfaction, better risk management, and enhanced regulatory compliance. It can also improve an organization's reputation and provide a competitive advantage in the medical device industry.
Yes, ISO 13485:2016 can be used as evidence of compliance with regulatory requirements in many countries. However, compliance with ISO 13485:2016 does not guarantee regulatory approval in all jurisdictions.
    It will keep your confidential information safe and only the approved person gets access to such information.
    No changes can be made to the data without prior approval.
    It makes sure that the data is available for the users whenever required
Any organization, regardless of size or industry, that handles sensitive information can benefit from implementing ISO 27001:2013. This includes businesses, non-profit organizations, and government agencies.
The requirements for implementing ISO 27001:2013 include:
Conducting a risk assessment to identify potential threats and vulnerabilities
Developing policies and procedures for information security
Implementing controls to mitigate identified risks
Monitoring and reviewing the effectiveness of the ISMS
Continually improving the ISMS based on the results of monitoring and reviews
ISO 27001:2013 is a comprehensive standard that provides a framework for organizations to manage their information security risks. Other standards, such as PCI DSS or HIPAA, focus on specific areas of information security, such as payment card data or healthcare information. Organizations may need to comply with multiple standards depending on their industry and the types of information they handle.
Certification for ISO 27001:2013 is valid for three years, after which the organization must undergo a recertification audit to maintain its certification.
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