ISO 9001 Quality Management System
The ISO 9001 Quality Management System is an international certification system established and implemented by the International Organization for Standardization (ISO). It provides objective evaluations by third-party certification bodies regarding the fulfillment of requirements in terms of minimizing supply chain risks and conditions for the products and services supplied to customers. This system offers credibility to both buyers and suppliers.
By improving the overall quality level of enterprises, it ensures competitive advantages and enhances Client satisfaction, thereby boosting the company’s competitiveness. This system aims for the long-term growth and development of enterprises.
Necessity of ISO 9001 Certification
ISO 9001
Quality Management System
-
Adherence to Global Trends of
Quality Management System (QMS)- Adoption of ISO certification systems in 170 countries worldwide
- Enhancement of corporate capabilities to implement Client requirements as they are
- Response to Product Liability (PL)
-
Efficient Countermeasures to International Trade Barriers
- Essential for actively responding to intensifying global competition due to OECD membership
- Requirement for obtaining ISO 9001 certification for CE Marking (European Conformity)
-
Demand for ISO 9001 Certification for
Strategic Support Companies, Leading Small
and Medium-sized Enterprises (SMEs),
or Export Companies- Improvement of technology, product quality, and raw material management for competitive advantage
- Provision of integrated management solutions based on sales, production, and technical capabilities
- Promotion of Client Satisfaction (CS), Quality Management
(ISO 9001), and Environmental Management (ISO 14001) - Enhancement of corporate image and differentiation from competitors
-
Establishment of an Optimal Management
System to Meet Client Expectations
and Requirements- Improvement of product and service quality to match the standards and suitability of Client and cooperative systems
- Activation of Client Satisfaction (CS) by establishing, evaluating, and managing QA systems within Client and cooperative systems
Effects of ISO 9001 Certification
-
1
Establishment of an appropriate quality management system and management procedures in accordance with international standards
2Continuous improvement through the standardization and documentation of quality manuals and other processes
3Elimination of irregularities within the company
4Facilitation of international trade transactions
5Assurance of benefits by eliminating defective products and quality issues
6Assurance of quality competitiveness through systematic cooperation
7Efficient use of management resources
-
8
Enhancement of trust and marketing capabilities regarding Clients
9Improvement and internalization of quality awareness
10Assurance of quality competitiveness through consistent and reliable operations
11Enhancement of corporate image
12Response to Product Liability (PL)
13Competitive advantage in government procurement
14Smooth inspection and assessment during buyer factory audits (priority given to certified companies)
ISO 9001 Certification Procedure
ISO 14001 Environmental Management System
The ISO 14001 standard defines a set of management activities aimed at improving the sustainable environmental performance of an organization throughout all stages of its operations. This international standard, established by the International Organization for Standardization (ISO), pertains to environmental management systems. The certification system assesses and objectively certifies whether an organization's environmental management system complies with this standard by a third-party certification body.
ISO 14001, unlike various international regulations, evaluates and certifies the comprehensive environmental management system applied across all corporate activities. It goes beyond mere compliance with environmental laws or international standards, assessing how effectively a company conducts comprehensive environmental management, including environmental audits, planning, implementation, operation, monitoring, corrective actions, management review, and continuous improvement.
Necessity of ISO 14001 Adoption
- Objectively certifies the level of a company's environmental friendliness
- Pressure on environmental management in the international market
- Expands corporate responsibility for environmental pollution
- Increases consumer awareness of environmental importance and preference for environmentally friendly products, enhancing the competitiveness of eco-friendly products
- Expands the importance of corporate environmental management systems due to growing interest in ESG (Environmental, Social, and Governance) outside of Korea
Effects of ISO 14001 Certification
ISO 14001
Environmental
Management
System
-
Reduction of Indirect Costs
- Reduction in production loss accidents
- Increased awareness of employee health and safety
- Reduced liability for damage compensation
-
Reduction of Direct Costs
- Reduction in raw material input
- Reduction in hazardous material input
- Waste management
-
Overcoming Trade Barriers
- Promotion of purchases for GREEN products
- Fulfillment of purchase requirements
- Regulatory compliance (international)
- Enhancement of credibility in international trade
-
Improvement of Corporate Image
- Increase in market share
- Encouragement of investment sentiment due to fulfillment of Client requirements
- Enhancement of relationships with local communities
-
1
Improvement of corporate image as an environmentally friendly company
2Reduction of major environmental risks and enhancement of customer reliability
3Reduction in the likelihood of violating environmental laws/regulations
4Strengthened relationships and responses with stakeholders (government, investors, insurers,
creditors, etc.)5Reduction in waste treatment costs
6Savings in raw materials and energy
-
7
Reduction of costs through environmental, safety, and zero-accident initiatives
8Enhanced ability to predict and respond to laws and regulations for business sustainability
9Customer acquisition through environmental improvement
10Improvement of environmental performance and environmental health
11Continuous reduction and management of environmental impacts
12Expansion of market competitiveness
ISO 14001 Certification Procedure
ISO 22000 Food Safety Management System
Entering the 21st century, as the global economy accelerates and knowledge-based industries grow, various technologies and management innovations are being strategically deployed worldwide. In line with this global trend, international standardization activities in management systems are also being fundamentally established. In response to these international movements, the International Organization for Standardization (ISO) established and announced the international standard for food safety management, ISO 22000, in September 2005.
ISO 22000 is an international standard that specifies requirements for food safety. It defines a food safety management system that encompasses all elements needed to control food safety hazards throughout the food supply chain. This standard aims to enhance food safety by systematically managing all organizations involved in the food supply chain.
Necessity of ISO 22000 Adoption
It is Necessary to Secure Food Safety and Secure and Maintain International Reliability.
- Adopt a systematic management system based on scientific analysis to meet the requirements of various stakeholders. The food industry can no longer rely solely on experience.
- Apply the system throughout the entire food supply chain, as international regulations demand that all organizations in the supply chain comply with this standard.
- Ensure trust and reliability with consumers and related parties through the adoption and maintenance of this system.
- Expand the adoption of advanced management systems to resolve recent food safety issues.
- Integrate the ISO 9001 and HACCP systems to avoid additional burdens during the initial implementation stages.
- Address challenges by adopting ISO 22000, which enhances food safety management systems.
Effects of ISO 22000 Certification
- Establishment of a systematic food safety and hygiene management system
- Ensuring product safety
- Maximizing the efficiency of the hygiene management system
- Enhancing corporate image and customer trust
- Increasing economic benefits through reduced product defects, customer complaints, and inventory
ISO 22000 Certification Procedure
ISO 45001 Occupational Health and Safety Management System
ISO 45001 (Occupational Health and Safety Assessment Series) is an occupational health and safety management system. Unlike previous safety activities focused mainly on safety managers, ISO 45001 requires the active participation of the highest management and all members of the organization. This proactive participation aims to predict and prevent risks that may occur in actual activities, ensuring the safety and health of employees and systematically managing the organization's safety.
ISO 45001 is not merely a standard for auditing and guiding occupational health and safety management systems; it is a system that enhances the performance of industrial conditions and safety activities.
Furthermore, ISO 45001 is designed to be integrated with the systems of ISO 9001 and ISO 14001, providing a unified direction for management.
Necessity of ISO 45001 Adoption
Effects of ISO 45001 Certification
-
1
Establishment and continuous improvement of a systematic occupational health and safety management system at the workplace
2Promotion of effective occupational health and safety management through competitive evaluation
of corporate risks3Enhancement of public trust and social image regarding stakeholders
4Contribution to the reduction of accidents, occupational diseases, and other liabilities, improving productivity and employee welfare
-
5
Increase in export competitiveness by overcoming trade barriers in the safety sector
6Reduction of non-conformities due to workplace environment improvements
7Possibility of optimal integration with ISO 9001
and ISO 140018Contribution to labor-management stability through participation in the overall safety management system
ISO 22716 (Cosmetics Good Manufacturing Practices)
ISO 22716 provides guidelines for the production, control, storage, and shipment of cosmetic products to ensure their quality. However, it does not apply to aspects related to the safety and environmental protection of employees working in the factory. These safety and environmental aspects are the company's responsibility and must comply with current laws and regulations. Additionally, this guideline does not apply to research and development activities or the distribution of finished products.
ISO 22716 is currently offered as a self-certification service.
Necessity of ISO 22716
- Requirement for ISO 22716 in the international market
- Overcoming trade barriers caused by differences in industrial standards between countries
- Ensuring the efficacy and safety of cosmetics, with an increasing emphasis on quality
- With intensifying market competition, obtaining ISO 22716 certification is essential for improving service quality
Expected Effects of ISO 22716
Scope of Certification (ITS)
-
1
Creams, emulsions, lotions, gels, and oils for the skin (hands, face, feet, etc.)
2Face masks
3Foundation bases (liquid, paste, powder)
4Makeup powders, after-bath powders,
hygiene powders, etc.5Perfumes
6Bath and shower preparations
7Deodorants (antiperspirants), sweat inhibitors
-
8
Hair care products
9Shaving products (creams, foams, lotions, etc.)
10Makeup and makeup removers (face, eyes, lips)
11Dental and oral care products
12Nail care and makeup products
13Anti-wrinkle products
14Skin whitening products
15Suntan and sun care products
16Others
Calculation Table for Audit Days [M/D]
Audit days (MD) refer to 8-hour workdays, including time for breaks, meals, and preparation/administrative tasks for the audit (up to 20% of the total time).
| Number of Employees | Initial Audit (Stage 1 and 2) | Surveillance Audit (Stage 2) | Recertification Audit (Stage 1, 2, or Stage 2) |
|---|---|---|---|
| 01 ~ 20 | 3 | 2 | 2 |
| 21 ~ 50 | 4 | 2 | 3 |
| 51 ~ 100 | 5 | 2 | 3 |
| 101 ~ 300 | 6 | 2 | 4 |
| 301 ~ 1,000 | 7 | 3 | 4 |
| 1,001 ~2,000 | 8 | 3 | 5 |
| 2,001 ~4,000 | 10 | 3 | 6 |
| Over 4,000 | - | Increase as above | - |
*The number of employees in the company eligible for ISO 22716 certification audit is used as the basis (including part-time, temporary, and contract workers).
*The number of audit days may be adjusted based on the certification process submitted by the company when applying for certification (this applies at the time of data submission).
For example, if you submit documents such as process flowcharts, organizational charts, proof of employee numbers, or photos of products or services, employees not involved in the scope of certification will be excluded.
ISO Certification Procedure
ISO/IEC 27001 Information Security Management System
An ISMS (Information Security Management System) is a management system based on a systematic business risk approach to establish, implement, operate, monitor, review, maintain, and improve information security. ISO/IEC 27001 is the international standard that defines the requirements for an ISMS, allowing for the only auditable and certifiable standard for information security management systems. This standard is designed to ensure that companies can manage their valuable information assets securely and consistently through a comprehensive control framework. Failure to ensure information security can pose significant risks, not only to the company but also to the sensitive information of customers associated with the company.
ISO/IEC 27001 Certification Necessity
The ISO 27001 certification involves a step-by-step process of thoroughly examining the organization's information assets and assessing the risks associated with these assets. Personnel involved in this process can analyze and monitor the likelihood of threats or breaches from external sources, the impact of these external threats or breaches on the organization, and the effectiveness of controls to protect the assets. This enhances the reliability and security of the system.
Effects of ISO/IEC 27001 Certification
-
1
Increased business opportunities as customers
/suppliers recognize a reliable partner.2Independent verification of compliance with applicable laws and regulations.
3Business differentiation factors providing a competitive edge over similar organizations.
-
4
Prevention of leakage of internal information assets
and personal data.5Enhanced monitoring and management controls.
ISO 13485 Medical Devices Quality Management System
ISO 13485:2016 specifies the requirements for a quality management system that an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This includes organizations involved in one or more stages of the life cycle, including the design and development, production, storage and distribution, installation, servicing (e.g., technical support), and associated activities (e.g., technical support). The requirements of ISO 13485 are applicable to any organization regardless of its size and regardless of its type except where explicitly stated. ISO 13485 can also be used by suppliers or external parties providing products or services, including quality management system-related services to such organizations.
Necessity of Implementing ISO 13485 Certification
- Required for exporting manufactured products to overseas markets.
- Ensures compliance with laws and requirements related to medical devices in various countries.
- Efficient management of the design and development, production, storage, and distribution of medical devices.
- Aids in maintaining consistent product quality of medical devices and obtaining certifications such as CE (Europe) and FDA (USA).
Effects of ISO 13485 Certification
-
1
Outlines methods for reviewing and improving processes across the organization, increasing efficiency, reducing costs, and monitoring supply chain performance.
2Demonstrates the production of safer and more effective medical devices.
3Enhances global market access through certification.
4Provides an overview of methods for reviewing and improving processes throughout the organization.
-
5
Improves efficiency, reduces costs, and monitors supply chain performance.
6Demonstrates the production of safer and more effective medical devices.
7Meets regulatory requirements and customer expectations.
| Certification Sectors | |
|---|---|
| Non-Active Medical Device Technical Area |
General Non-Active, Non-Implantable Medical Devices |
| Active Medical Devices (Non-Implantable) |
General Active Medical Devices |
| Parts and Services |
Raw Materials |
| In Vitro Diagnostic Medical Devices (IVD) |
- Reagents and reagent products, calibrators and control |