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What is ISO 9001?

ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).

Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.

Why is ISO 9001 important?

With more than one million certificates issued to organizations in 189 countries, ISO 9001 is the most widely used quality management standard in the world. Within the ISO 9000 family, which defines seven quality management principles including a strong customer focus and continual improvement, ISO 9001 is the only standard that can be certified to (though certification is not mandatory).

Business benefits include:

Customer confidence: The standard ensures that organizations have robust quality control processes in place, leading to increased customer trust and satisfaction.

Effective complaint resolution: ISO 9001 offers guidelines for resolving customer complaints efficiently, contributing to timely and satisfactory problem-solving.

Process improvement: The standard helps identify and eliminate inefficiencies, reduce waste, streamline operations, and promote informed decision-making, resulting in cost savings and better outcomes.

Ongoing optimization: Regular audits and reviews encouraged by ISO 9001 enable organizations to continually refine their quality management systems, stay competitive, and achieve long-term success.

INTRO 14001:2015

What is ISO 14001?

ISO 14001 is the internationally recognized standard for environmental management systems (EMS). It provides a framework for organizations to design, implement, and continually improve their environmental performance. By adhering to this standard, organizations can ensure they are taking proactive measures to minimize their environmental footprint, comply with relevant legal requirements, and achieve their environmental objectives. The framework encompasses various aspects, from resource usage and waste management to monitoring environmental performance and involving stakeholders in environmental commitments.

Why is ISO 14001 important?

In an age of heightened environmental consciousness and increasing global challenges such as climate change, biodiversity loss, and resource depletion, organizations have a pivotal role to play. ISO 14001 offers a structured approach for businesses to address these pressing concerns. By adopting this standard, organizations signal a commitment not only to regulatory compliance but also to ongoing environmental improvement. This proactive approach to environmental management can result in tangible benefits, such as reduced waste, energy conservation, and cost savings.

Furthermore, it enhances an organization’s reputation, fosters stakeholder trust, and often meets a critical criterion for engaging in global trade and supply chains. Simply put, ISO 14001 stands as a testament to an organization’s dedication to a sustainable future, blending environmental responsibility with strategic business growth.

INTRO 45001:2018

ISO 45001 is an International Standard that specifies requirements for an occupational health and safety (OH&S) management system, with guidance for its use, to enable an organization to proactively improve its OH&S performance in preventing injury and ill-health. ISO 45001 is intended to be applicable to any organization regardless of its size, type and nature. All of its requirements are intended to be integrated into an organization’s own management processes. ISO 45001 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing; however, it should be noted that an organization can be required by applicable legal requirements to also address such issues.

Benefits

An ISO 45001 based OH&S management system will enable an organization to improve its OH&S performance by:

• developing and implementing an OH&S policy and OH&S objectives
• establishing systematic processes which consider its “context” and which take into account its risks and opportunities, and its legal and other requirements
• determining the hazards and OH&S risks associated with its activities; seeking to eliminate them, or putting in controls to minimize their potential effects
• establishing operational controls to manage its OH&S risks and its legal and other requirements
• increasing awareness of its OH&S risks
• evaluating its OH&S performance and seeking to improve it, through taking appropriate actions
• ensuring workers take an active role in OH&S matters In combination these measures will ensure that an organization’s reputation as a safe place to work will be promoted, and can have more direct benefits, such as:
• improving its ability to respond to regulatory compliance issues
• reducing the overall costs of incidents
• reducing downtime and the costs of disruption to operations
• reducing the cost of insurance premiums
• reducing absenteeism and employee turnover rates
• Recognition for having achieved an international benchmark (which may in turn influence customers who are concerned about their social responsibilities)

Intro 13485:2016

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). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

INTRO HACCP

What is HACCP?

HACCP Certification is a management system which is internationally recognized to reduce hazards in food. Through the analysis and control of the system, it helps to address the food safety of biological, chemical, and physical hazards from raw materials production, procurement and handling, to manufacturing, distribution and consumption of the finished products. GMP (good manufacturing practice) is one of the elements in HACCP.

HACCP meets the requirements of the Codex Alimentarius Commission (CAC) to bring together international food standards, guidelines and codes of practice to ensure fair trade

Who is HACCP for?

HACCP is suitable for all types of organizations which is handling/related to food no matter big or small sizes.

Organization involved in food production, food packaging, food trading, food handling, food processing, etc.

HACCP-based procedures provide businesses with a cost-effective system for control of food safety, from ingredients right through to production, storage and distribution to sale and service of the final consumer. The preventive approach of HACCP-based procedures not only improves food safety management but also complements other quality management systems. The main benefits of HACCP-based procedures are:

Saves your business money in the long run

Avoids you poisoning your customers

Food safety standards increase

Ensures you are compliant with the law

Food quality standards increase

Organizes your process to produce safe food

Organizes your staff promoting teamwork and efficiency

Due diligence defence in court.

INTRO 22000:2018

ISO 22000:2018 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2018 can be accomplished through the use of internal and/or external resources.

ISO 22000:2018 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— To demonstrate compliance with applicable statutory and regulatory food safety requirements,

— To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— To ensure that the organization conforms to its stated food safety policy,

— To demonstrate such conformity to relevant interested parties, and

— To seek certification or registration of its food safety management system by an external organization or make a self-assessment or self-declaration of conformity to ISO 22000:2018.

INTRO 22000:2018

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— To demonstrate compliance with applicable statutory and regulatory food safety requirements,

— To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— To ensure that the organization conforms to its stated food safety policy,

— To demonstrate such conformity to relevant interested parties, and

— To seek certification or registration of its food safety management system by an external organization or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

INTRO 22301:2019

ISO 22301 is the international standard for business continuity management, and builds on the success of British Standard BS 25999 and other regional standards. It’s designed to protect your business from potential disruption.  This includes extreme weather, fire, flood, natural disaster, theft, IT outage, staff illness or terrorist attack. The ISO 22301 management system lets you identify threats relevant to your business and the critical business functions they could impact. And it allows you to put plans in place ahead of time to ensure your business doesn’t come to a standstill. 

What are the benefits of ISO 22301 business continuity management?

Identify and manage current and future threats to your business

Take a proactive approach to minimizing the impact of incidents

Keep critical functions up and running during times of crises

Minimize downtime during incidents and improve recovery time

Demonstrate resilience to customers, suppliers and for tender requests

INTRO GMP

The full term of GMP is Good Manufacturing Practice. GMP certification is a system which design to ensure the products are consistently produced follow the quality standards. Therefore, manufacturers, processors, and packagers are encouraging proactively adopt this system as a result ensure their products are safe and pure. Besides, GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-up, and errors.

Good Manufacturing Practice GMP guidelines are applied to:

• Hygiene
• Protection of environment
• Control of manufacturing process
• Distribution methods
• Control of procedures and record-keeping
• Procedures to follow when there is a recall or investigation of defects

Who is GMP for?

• GMPis suitable for food manufacturers, food processors, and packagers, beverage manufacturer, feeds manufacturer, pharmaceutical, etc.

Benefit for GMP:

• Increase food safety, prevent contamination
• Reduce product defect
• With GMP implementation, can give more confident to the buyer
• More competitive in the market
• Improve brand image

Better comply to legal regulation

What is Code of Conduct (CoC)?

A Code of Conduct (CoC) serves as a framework governing corporate and business practices, ensuring adherence to both ethical and legal standards. By instituting a CoC, a company underscores its dedication to conducting business with the utmost integrity, surpassing mere legal requirements. Brands and importers have the option to craft their own CoC standards for vendor compliance or adopt internationally recognized ones. These standards are typically tailored to meet specific retailer criteria, aligning with the guidelines set forth by the International Labor Organization.

Why Developing a Code of Conduct is Essential?

In today’s consumer landscape, there’s a growing expectation for brands to exhibit social responsibility throughout their supply chains. Establishing a Code of Conduct that all suppliers must adhere to offers several advantages:

Ensure fair and ethical treatment of workers across the entire supply chain.

Enhance attractiveness as an employer and boost employee retention rates.

Safeguard the brand’s reputation and mitigate negative publicity.

Gain a competitive advantage by showcasing ethical credentials to consumers.

Elevate workplace standards, leading to enhanced productivity and increased profitability.

QESI: Your Partner in Code of Conduct Implementation and Auditing

QESI, a globally recognized standards, testing, and auditing entity, boasts extensive experience in assisting international businesses in achieving superior standards across their supply chains. Whether creating a tailored Code of Conduct for your business or implementing existing standards, we’re here to help.

Our global network offers multidisciplinary expertise in auditing and CoC certification services across key markets. Acting as a comprehensive service provider, we cater to companies seeking social compliance programs and management systems standards. Our proficiency spans auditing and implementation across various systems, including ISO 9001, ISO 14001, ISO 45001, ISO 13485, HACCP, ISO 22000, ISO 31000, ISO 22301 and GMP.

QESI’s Code of Conduct Certification and Auditing Services

Our team of auditors, situated strategically across the globe, is well-equipped to conduct social compliance audits on your supply chain and issue a CoC certificate for your business. Additionally, we can audit existing supply chain management systems in place.

We’ve devised a streamlined five-step auditing process for Code of Conduct compliance:

Assess the necessity of developing a company-specific CoC or adopting existing social compliance standards.

Implement a custom CoC certificate, if required.

Establish a monitoring system to ensure transparent and reliable verification of your supply chain.

Educate and train suppliers on CoC and audit protocol requirements.

QESI conducts audits on your suppliers.

What is CTPAT?

CTPAT, which stands for the Customs-Trade Partnership Against Terrorism, is a supply chain security initiative introduced by US Customs and Border Protection in 2001. Since its inception, this voluntary program has grown significantly, boasting 11,400 certified members. Its primary aim is to bolster US border security through collaborative efforts between US Customs and Border Protection and various stakeholders in the supply chain, including manufacturers, importers, and customs brokers.

The CTPAT program requires participating businesses to implement stringent security protocols across their supply chains and ensure their enforcement. In return for their commitment, these businesses are recognized as low-risk entities and are granted access to Free and Secure Trade (FAST) lanes for expedited customs clearance at US borders.

What is a CTPAT Audit?

A third-party CTPAT audit serves to evaluate, validate, and ensure the implementation of security measures by overseas manufacturers exporting to the United States. Conducting an audit enables verification of compliance and identification of potential vulnerabilities, allowing for their prompt mitigation. The insights gleaned from these audits contribute to the vulnerability and risk assessments mandated for CTPAT members.

Our Solution

QESI’s qualified CTPAT auditors conduct independent assessments of manufacturing facilities, conducting comprehensive checks aligned with CTPAT criteria. These checks encompass various aspects, including personnel security, facility security, storage and distribution processes, shipment information control, information access controls, contractor controls, export logistics, and records and documentation processes. Following an audit, a corrective action plan is provided, outlining necessary security enhancements, with agreed-upon implementation timelines negotiated with factory management.

Benefits of CTPAT Membership

– Enhance US border security

– Strengthen security measures across supply chains

– Reduce customs inspections and expedite clearance processes

– Accelerate time-to-market for products

QESI Benefits

– Extensive local knowledge, with auditors well-versed in regional culture, laws, and practices
– Continuous training for CSR experts on regulations and best practices
– Embrace a continuous improvement approach, fostering long-term change and empowering suppliers
– Convenient online program management facilitating audit booking, payments, and report downloads.