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ISO 22000:2018 Food Safety Management System

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.
 

Requirements of ISO 22000:2018

Scope
Normative Reference
Terms and Definitions
Context of the Organization
Leadership
Planning for the Food Safety Management System
Support
Operation
Performance Evaluation
Improvement
 

How can ELITE assist you?

ELITE provides food safety 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
 
 

ISO 14001:2015 Environmental Management System

ISO 14001:2015 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 to help reduce the impact of its business to the environment. It also provides assurance to the company management as well as stakeholders of its commitment to monitor and measure its environmental performance. It can be used by any organization regardless of its activity or sector.

Requirements of ISO 14001:2015

Scope
Normative Reference
Terms and Definitions
Context of the Organization
Leadership
Planning
Support
Operation
Performance Evaluation
Improvement
 

Benefits of ISO 14001:2015

Reduced cost of waste management
Savings in consumption of energy and materials
Systematic approach in addressing environmental protection
Continual improvement of environment management system to prevent pollution
Improved corporate image among regulators and environmentally aware customers
 

How can ELITE assist you?

ELITE provides 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
 

ISO 13485:2016 Medical Devices Quality Management System

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 System

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
 

Good Manufacturing Practices (GMP)

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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