ISO 13485

ISO 13485 Medical Devices – QMS

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 ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

What are the benefits of being certified to ISO 13485?

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. Companies with this certification communicate a commitment to quality to both customers and regulators.

  1. Increase access to more markets worldwide with certification.
  2. Outline how to review and improve processes across your organization.
  3. Increase efficiency, cut costs and monitor supply chain performance.
  4. Demonstrate that you produce safer and more effective medical devices.
  5. Meet regulatory requirements and customer expectations.
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ISO 9001

ISO 9001 Quality Management System
Quality Management System The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes.

The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties.

A few steps to ISO 9001 certification:
  1. Application/Enquiry Submits the application form to Inspeed Global (Application for Certification)
  2. Review of Application Inspeed Global reviews the application to check if the requisite services can be provided and accordingly prepares the quotation/ estimate and the contract (Certification audit contract).
  3. Audit planning Once the contract is signed, Inspeed makes the audit program and inform the client
  4. Assessment Initial certification includes two stages assessment. Recertification includes only one stage. The assessment is carried out by the team at the sites against the applicable criteria. The report is provided to client identifying the compliance level including any nonconformities.
  5. Verification of Non-conformities Client submits the implemented or proposed action based on the classification of non-conformity. Inspeed reviews the actions.
  6. Certification Decision Inspeed takes certification decision based on the report submitted by the audit team. If decision is in favor of grant of certification, a Certificate is Issued to the client (see sample certificate)
  7. Surveillance assessmentSurveillance assessment are held as per the periodicity defined and agreed. First surveillance within 12 months from the date of the stage 2 audit. Certificate is maintained based on the outcome of the surveillance audit and compliance with the requirements.
  8. Recertification Before expiry of the certificate, recertification is planned and conducted
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ISO 14001


ISO 14001:2015 was published on 15th Sept, 2015. The standard sets out the criteria for an environmental management system. It maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization, large or small, regardless of its field of activity including manufacturing, services, institutions, health or any other sector.

Using ISO 14001:2015 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.There are more than 300,000 certifications to ISO 14001 in 171 countries around the world.

Using ISO 14001 helps in Demonstrating compliance with current and future statutory and regulatory requirements, increased leadership involvement and engagement of employees, improvement in company reputation and the confidence of stakeholders, achieving strategic business aims by incorporating environmental issues into business management, providing a competitive and financial advantage through improved efficiencies and reduced costs, encouraging better environmental performance of suppliers by integrating them into the organization’s business systems.

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ISO 45001

Occupational health and safety

ISO 45001 formulates requirements for comprehensive, modern occupational health and safety. Replacing the previously, widely-used OHSAS 18001 standard, ISO 45001:2018 has been in force since March 2018 and is the only international and independent standard for operational health and safety management systems. Our experts certify your occupational health and safety management system according to ISO 45001 and consider all aspects of occupational safety – both those related to operational processes as well as those arising from work-related stress that can trigger mental illness.

The benefits you get from the certification
  1. Continuous improvements to protect the health and safety of your employees.
  2. Prevention of unsafe behaviors that can lead to accidents at work.
  3. Reduction of accidental downtimes in the supply chain and in supplier management.
  4. Reliable management of risks and opportunities related to occupational health and safety.
  5. Standardized health and safety requirements for managers, employees and service providers taking into account their respective working environments and conditions.
  6. Similar structure to the international standards ISO 9001 and ISO 14001.
  7. Easy implementation in operational practice as part of an integrated management system.
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ISO 50001

Energy Management The new ISO 50001:2018 is based on the quality standard ISO 9001 and the environmental standard ISO 14001. This enables organizations to convert their existing energy and environmental management systems into a systematic energy management system:

  1. Development of a company policy for the more efficient use of energy
  2. Determination of characteristic values
  3. Data analysis of energy consumption in all major consumption areas
  4. Measurement of results
  5. Continuous monitoring of measures
The benefits you get from the certification
  1. Competitive advantages through higher efficiency and lower energy costs
  2. Higher economic efficiency due to lower energy consumption
  3. Detailed breakdown of energy consumption in the company
  4. Identification of potential savings in the energy sector
  5. Reduction of CO2 emissions
  6. Conformity with energy policy
  7. Systematic improvement of processes/li>
  8. Stronger awareness of energy efficiency among employees and management
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ISO 22301

ISO 22301 (Business Continuity Management System)

ISO 22301 is an international framework that has been developed to help businesses identify potential threats to critical business functions and design a business continuity management plan. The standard helps companies build effective backup systems and processes to safeguard against theft, natural disasters, disease outbreaks, terrorist attacks and other extraordinary incidents. ISO 22301 specifies the requirements to plan, implement, monitor, review and improve a company’s business continuity management system, thereby minimising the impact of disruptions.


ISO 22301 certification provides formal business continuity guidelines that will keep your organisation operational during and following a disruption. It seeks to minimise the impact to critical business functions, ensuring they are still capable of being delivered or recovered promptly. The ISO 22301 standard is applicable for companies of all sizes across any industry, particularly those operating in high risk or complex environments where the ability to function without delay is of paramount importance. ISO 22301 business continuity certification also helps you avoid loss of revenue and customers should a major problem occur.

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ISO 26000

ISO 26000 (Social Responsibility)

ISO 26000 is an international standard providing guidelines for social responsibility in business and other organizations. It aims to improve the conditions for workers, the natural environment and the health and welfare of society. Corporate social responsibility (CSR) is a vital part of business today. Organizations and stakeholders around the world are becoming increasingly aware of the need for and benefits of socially responsible behavior. By acting in a socially responsible way, a company gains recognition as a credible and equitable employer and business partner.

IG can support you in understanding the purpose of ISO 26000 and how you can improve the sustainable development of your company. Our experts provide ISO 26000 verification, gap assessment, training in social responsibility and translate the key principles of ISO 26000 into effective actions. Furthermore, we inform you of best practices relating to socially responsible behavior.

Benefits of ISO 26000 Services
  1. Contribute to sustainable development, including the health and welfare of society.
  2. Develop a consistent and thought-through social responsibility strategy tailored to your needs thanks to our professionally trained Certified Sustainability Assurance Practitioner (CSAP) and multi-disciplinary team.
  3. Ensure compliance with applicable laws and international norms of behavior.
  4. Gain verification of your social responsibility actions compliance.
Our services include:
  1. ISO 26000 training to better understand the corporate social esponsibility guidelines.
  2. Gap assessment, evaluating social responsibility principles, fundamental practices and core subjects.
  3. Strategy development to attain conformance with ISO 26000 guidelines.
  4. Verification of compliance, in the form of a detailed report rather than a certificate, as the ISO 26000 standard is non-certifiable.
With the support of our experts, you can be sure that your organization is on the right path to a more sustainable development.
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ISO 27001

ISO 27001 Information security management

Implementing an information security management system will provide your organization with a system that will help to eliminate or minimize the risk of a security breach that could have legal or business continuity implications.

An effective ISO 27001 information security management system (ISMS) provides a management framework of polices and procedures that will keep your information secure, whatever the format. Following a series of high profile cases, it has proven to be very damaging to an organization if information gets into the wrong hands or into the public domain. By establishing and maintaining a documented system of controls and management, risks can be identified and reduced.

Achieving ISO 27001 certification shows that a business has:
  1. Protected information from getting into unauthorized hands
  2. Ensured information is accurate and can only be modified by authorized users
  3. Assessed the risks and mitigated the impact of a breach
  4. Been independently assessed to an international standard based on industry best practices

ISO 27001 certification demonstrates that you have identified the risks, assessed the implications and put in place systemized controls to limit any damage to the organization.

Benefits include:
  1. Increased reliability and security of systems and information
  2. Improved customer and business partner confidence
  3. Increased business resilience
  4. Alignment with customer requirements
  5. Improved management processes and integration with corporate risk strategies
Achieving ISO 27001 is not a guarantee that information breaches will never occur, however by having a robust system in place, risks will be reduced and disruption and costs kept to a minimum.
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Our Services

Accreditation is an independent assessment that ensures certification bodies have the technical competence and integrity of impartiality to deliver credible certification services. This is essential to building confidence and trust in certification.

Achieving ISO Certification

Contact our team today to receive a FREE no-obligation competitive quotation from our dedicated business development team. We will devise a comprehensive quote which will be in line with your requirements.

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