FAQs

 ISO 9001 is a collection of best practices for conducting business processes and a guide to a well-organized company. It’s a standard that sets the steps for adopting a quality management system and helps organizations meet the needs and expectations of customers and interested parties based on internationally recognized principles.

ISO 9001 certification means that a company’s quality processes have been verified to meet the ISO 9001 standard through an audit by a Certified Lead Auditor. It demonstrates the company’s commitment to quality in every aspect of its business and informs clients, suppliers, and business partners of its commitment.

Implementing ISO 9001 can improve a business in several ways, including streamlining internal processes, attracting more customers, increased staff motivation and commitment, and a better position to respond to opportunities. It also provides tools for quality monitoring and improvement, leading to a commitment to perpetual improvement.

The audit for ISO 9001 certification assesses a company’s quality processes for effectiveness based on 7 key principles, including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. The company has time to address any non-conformities before the final results are submitted to an Accredited Certification Body.

T-Next provides services to support and advise a business on the path to implementation and certification of ISO 9001 and other standards. Their goals are to implement a quality management system that is suitable for the organization, fully support the organization throughout the audit and certification process, and ensure the business is satisfied with the result. Their principal consultant is an IRCA approved ISO 9001 Lead Auditor with experience in implementing management systems in over 150 companies

ISO 14001 is the international standard for an effective environmental management system (EMS). It provides a framework for organizations to minimize their environmental footprint and achieve their environmental goals through regular evaluation and improvement.

ISO 14001 focuses on the production of hazardous chemicals and pollutants, the complete life cycle of products and services provided by organizations, the environmental impact of these products and services, and disposition and/or recycling.

 ISO 14001 benefits organizations by promoting environmental awareness, reducing waste and the carbon footprint, lowering operating costs, minimizing legal costs, minimizing reputational damage, and providing credentials to participate in environmental growth markets.

The requirements of ISO 14001 include the implementation of 6 components (clauses) out of 10, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.

T-Next can help a business gain ISO 14001 certification by providing support and guidance during the implementation and certification process. T-Next will help identify gaps in the organization and provide strategies to fill those gaps, with documentation and employee training. T-Next will also make a referral to an IAF approved certification body for certification and will continue as a partner and facilitator throughout the process

ISO 27001:2013 ISMS is an Information Security Management System standard considered the international standard for information security management. It outlines how to manage information security to protect an organization’s information assets.

Implementing and certifying ISO 27001 demonstrates an organization’s commitment and ability to protect its information assets and those of its clients, vendors, suppliers, and delivery partners.

ISO 27001 provides protection against various information security threats such as digital threats, data breaches, terrorism, fire, theft, and more.

ISO 27001 is neutral in technology and vendor management and can be implemented for any IT platform. It is compatible with other management systems such as ISO 9001, ISO 14001, ISO 45001, and others.

T-Next Services is an ISO and Quality Management Standards consultancy that offers SaaS-based GRC services as well as traditional implementation, training, and compliance services for ISO 27001 and other internationally recognized standards. Contact T-Next for a no-obligation consultation.

ISO 13485 is the International Standard for “Medical Devices — Quality Management System: Requirements for Regulatory Purposes”. It governs the quality management requirements for businesses dealing with medical devices and is universally recognized by global health agencies.

A device is considered a medical device if it is used for a medical purpose. Health agencies adopt a three-tier device classification system based on the risk associated with using the device.

An organization is considered a manufacturer if it is responsible for the design, manufacture, packaging, and labeling of a medical device before it is placed on the market under its own name. A company may also be considered a manufacturer if it buys and rebrands medical devices as its own.

For manufacturers of medical devices, 13485 certification is a regulatory necessity in most health agency jurisdictions. For distributors of medical devices, 13485 certification is not a direct regulatory requirement, but many requests for proposals, manufacturers, and end-buyers require it.

Some benefits of ISO 13485 certification include simplified and faster global recognition, lower cost of compliance and operating costs, improved product and safety, and simplified and faster access to global markets and supply chains

ISO 45001 is an international standard that deals with health and safety management in the workplace. It provides a set of requirements and guidance for companies to enhance their health and safety performance and place the responsibility for workplace health and safety with top management.

Organizations do not have to be ISO 45001 certified, but it is a demonstration of compliance that is recognized globally. Certification requires full compliance and full implementation of the standard, along with an independent audit. Compliance without certification can still be achieved by applying the standard to the organization’s activities and providing evidence of good health and safety management.

ISO 45001 is an evolution of OHSAS 18001, the former benchmark for occupational health and safety. The biggest difference between the two standards is their approach, with ISO 45001 being proactive and requiring risks and hazards to be assessed before problems arise, while OHSAS 18001 had a reactive approach. OHSAS 18001 has been retired and replaced by ISO 45001.

Implementing ISO 45001 may help organizations demonstrate compliance with health and safety laws and exceed legal requirements. Adopting the standard is not complicated, especially for organizations that have adopted other management standards or developed their own health and safety program.

Common challenges organizations face when adopting ISO 45001 include interpreting the standard, gauging a proportionate implementation, and adopting the standard as a supply chain requirement. These are common reasons organizations seek guidance from professionals in navigating the compliance landscape.

SSAE 18 stands for Statement on Standards for Attestation Engagements, a set of standards regulated by the American Institute of Certified Public Accountants (AICPA) for organizations to report on their compliance control measures.

A SOC (Service Organization Control) report is a form of reporting required by SSAE 18 that provides information about an organization’s compliance measures, usually in the form of an assessment of risks associated with external vendors.

There are three types of SOC reports: SOC 1 (reports on internal controls related to financial reporting), SOC 2 (examines internal security-related controls), and SOC 3 (confirms internal security controls without specific definitions).

It is important for a Data Centre to be SSAE 18 compliant because it provides evidence of the Data Centre’s best-known practices for protecting an organization’s data. SOC reporting can guarantee that the Data Centre has appropriate controls for the protection and accounting of financial data, as well as confirming that the institution’s security operations are in line with industry standards.

The benefit of SSAE 18 compliant SOC reporting for Data Centre customers is that it minimizes the risk of sub-standard participants in any service supply-chain and provides assurance that the same guarantees extend to all sub-contracted service-provider organizations affiliated with the Data Centre. It also confirms that the Data Centre is using best-known practices for protecting an organization’s data.

PCI DSS stands for Payment Card Industry Data Security Standard. It’s a set of information security standards developed by Visa, MasterCard, Discover, and American Express to protect credit and bank card transactions from data theft and fraud.

PCI SSC (Payment Card Industry Security Standards Council) manages the PCI DSS program, which aims to ensure the security of card data in businesses through a set of requirements established by PCI SSC.

Non-compliance with PCI DSS can result in significant financial fines and costs, and also negatively affect public relations through audits and surveillance.

PCI DSS compliance is divided into four levels based on the annual number of credit card transactions. They are Level 1, Level 2, Level 3, and Level 4.

The 12 requirements for PCI DSS compliance outlined by PCI SSC are:

• Firewall configuration
• Original system passwords
• Protection of stored cardholder data
• Encryption of cardholder data transmissions
• Anti-virus software use and updates
• Secure system and application development and maintenance
• Restricted cardholder data access
• Unique IDs for computer access
• Restricted physical access to cardholder data
• Network access and resource tracking and monitoring
• Regular security system and process testing
• Information security policy maintenance.

Risk Management Consulting is a professional service that assists companies in identifying, assessing, and mitigating potential risks that could impact their operations, growth, and overall success.

There are several benefits of T-Next’s Risk Management Consulting for manufacturing companies. These benefits include decreased probability of failures, increased growth opportunities, a positive working culture, reduced impact of risks, increased profitability, higher productivity, and increased customer satisfaction.

The process of T-Next’s Risk Management Consulting for manufacturing companies includes four stages: identification of risks, assessment of risks, developing a risk response plan, and implementation and monitoring of the risk response plan.

T-Next differs from other Risk Management Consulting companies in several ways. It focuses on the manufacturing industry, takes a comprehensive approach to risk management, has expertise in lean management, and provides a tailored approach to managing risks.

T-Next’s Risk Management Consulting Services can help manufacturing companies by identifying potential risks and threats to their operations, developing strategies to manage and mitigate these risks, and providing opportunities for growth while minimizing risks. By reducing the impact of risks, companies can focus on growth and expansion, leading to increased profitability and higher productivity. Additionally, by creating a culture of safety and security, T-Next can lead to increased employee satisfaction and motivation, and increased customer satisfaction by delivering higher-quality products and services.