- FSSC 22000 FOOD SAFETY SYSTEM CERTIFICATION
- HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)
- GMP+
- HALAL CONSULTANCY
- GDPMD (GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES)
- AS 9100 AEROSPACE QUALITY MANAGEMENT SYSTEMS
- BRCGS (BRAND REPUTATION COMPLIANCE GLOBAL STANDARDS)
- BSCI (BUSINESS SOCIAL COMPLIANCE INITIATIVE)
- ESG (ENVIRONMENTAL, SOCIAL AND CORPORATE GOVERNANCE)
- FSC (FOREST STEWARDSHIP COUNCIL)
- GMP (GOOD MANUFACTURING PRACTICES)
- GRS (GLOBAL RECYCLE STANDARD)
- IATF 16949:2016 AUTOMOTIVE QUALITY MANAGEMENT SYSTEMS
- IMS (INTEGRATED MANAGEMENT SYSTEMS)
- ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
- ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEMS
- ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEMS
- ISO 22716:2007 GMP FOR COSMETICS
- ISO 28000:2022 SUPPLY CHAIN SECURITY MANAGEMENT SYSTEMS
- ISO 37001:2016 ANTI-BRIBERY MANAGEMENT SYSTEMS
- ISO 41001:2018 FACILITY MANAGEMENT SYSTEMS
- ISO 45001:2018 OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS
- ISO 50001:2018 ENERGY MANAGEMENT SYSTEMS
- ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS
- ISO/IEC 17025:2017 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
- ISO/IEC 27001:2022 INFORMATION SECURITY MANAGEMENT SYSTEMS
- MALAYSIAN BRAND
- RBA (RESPONSIBLE BUSINESS ALLIANCE)
- SA8000 (SOCIAL ACCOUNTABILITY 8000)
- SEDEX (SUPPLIER ETHICAL DATA EXCHANGE)
- TAPA (TRANSPORTED ASSET PROTECTION ASSOCIATION)
- URSA (UNDERSTANDING RESPONSIBLE SOURCING AUDIT)
- ISO Training Courses
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ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
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 requirements and regulatory requirements applicable to medical devices and related services.
The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices.
Requirements of ISO 13485:2016
• Clause 4: Quality management system
• Clause 5: Management responsibility
• Clause 6: Resource management
• Clause 7: Product realization
• Clause 8: Measurement, analysis and improvement
Benefits of ISO 13485:2016
• Increase access to more markets worldwide
• Savings in cost from reduction of defects and rejects
• Meet relevant regulatory requirements and customer expectations
• Demonstrate ability to produce safer and more effective medical devices
• Improve operation efficiency through continual improvement processes
How can ELITE assist you?
ELITE provides ISO 13485 system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS
ISO 9001:2015 sets out the criteria for a quality management system. It can be used by any organization of any size, of any industry and field of activity. There are over one million companies and organizations in over 170 countries certified to ISO 9001. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
The 2015 version features important changes. It is now less prescriptive than its predecessor, focusing instead on performance. Among the significant changes include:
• Structure of the standard where it is now a high level structure
• Context of the organization where you are expected to understand organization’s context prior to establishment of system
• Risks-based thinking and the organizations are expected to identify risks & opportunities
• Elimination of distinction between documents and records; they are now referred to as documented information
Requirements of ISO 9001:2015
• Scope
• Normative Reference
• Terms and Definitions
• Context of the Organization
• Leadership
• Planning for the Quality Management System
• Support
• Operation
• Performance Evaluation
• Improvement
Benefits of the ISO 9001:2015
• Improved operational efficiency
• Reduced costs
• Reduce customer complaint and enhance customer satisfaction
• Access to new markets
• Consistency of output
• International recognition through ISO 9001 certification by accredited certification body
How can ELITE assist you?
ELITE provides ISO 9001 management system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)
HACCP outlines the principles defining the requirements for effective control of food safety. The HACCP food safety management system helps organizations focus on the hazards that affect food safety and systematically identify them by setting up critical control limits at critical control points during the food production process.
The 7 principles of the HACCP system set the basis for the requirements for the application of HACCP, which are:
1. Analysis of food hazards
2. Identification of Critical Control Point (CCP)
3. Establish critical limits
4. Establish CCP monitoring system
5. Establish corrective action when CCP is deviated from critical limit
6. Verification to confirm HACCP system is working effectively
7. Establish documents and records
Benefits of HACCP
• Cost savings from lower wastage and rejects
• Demonstrate commitment to provide safe food products
• Able to continuously improve for better business performance
• Ensure proper food safety controls is implemented and maintained
• Recognition for attaining the international recognised level of food safety
How can ELITE assist you?
ELITE provides HACCP system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
GMP (GOOD MANUFACTURING PRACTICES)
Good Manufacturing Practices (GMP) is a pre-requisite program (PRP) for Food Safety Management System. It outlines the minimum common hygiene and processing requirements applicable to all food processing establishment and intended as the foundation towards achieving higher food safety management systems like such as HACCP and ISO 22000.
There are several guidelines outlining the GMP requirements, e.g.
1. Design and layout of premises
2. Supplies of water, air and energy
3. Management of waste
4. Equipment suitability and preventive maintenance
5. Cleaning and sanitation
6. Management of purchased materials
7. Pest control
8. Prevention of cross contamination
9. Personal Hygiene
Benefits of GMP
1. Cost savings from lower food wastage and rejects
2. Ensuring your basic food safety requirements are fulfilled
3. Facilitates the ability to improve for better business performance
4. Demonstrate your commitment to produce safe and healthy products
5. Provide confidence to stakeholders on the manufacturing facility processes
How can ELITE assist you?
ELITE provides GMP system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
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