03 Apr
ISO 50001 – ENERGY MANAGEMENT SYSTEM

ISO 50001 – ENERGY MANAGEMENT SYSTEM

DEVELOPING AN ENERGY MANAGEMENT SYSTEM

ISO 50001 is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management. ISO 50001 provides a framework of requirements for organizations to: Develop a policy for more efficient use of energy
Fix targets and objectives to meet the policy
Use data to better understand and make decisions about energy use
Measure the results
Review how well the policy works, and
Continually improve energy management.

CERTIFICATION TO ISO 50001

Like other ISO management system standards, certification to ISO 50001 is possible but not obligatory. Some organizations decide to implement the standard solely for the benefits it provides. Others decide to get certified to it, to show external parties they have implemented an energy management system. ISO does not perform certification.
03 Apr
ISO 29990 – LEARNING SERVICES FOR NON-FORMAL EDUCATION

ISO 29990 – LEARNING SERVICES FOR NON-FORMAL EDUCATION

ISO 29990 – LEARNING SERVICES FOR NON-FORMAL EDUCATION AND TRAINING – AUDITOR CONVERSION TRAINING

In recent years corporations around the world have recognized the importance of shared knowledge as a key to success. Non-formal and in-company learning is now regarded as an important non-business service by many organizations.
ISO 29990 Certification – Learning Services Management Systems, has been developed in response to the need for a generic model for professional practice and quality performance of learning service providers. Globus Group provides comprehensive ISO29990 audits against the standard, certifying that every stage of your operation aligns with ISO learning service quality assurance requirements. ISO 29990:2010 provides a unified standard for learning service providers, including corporations, vocational institutions, and life-long learning centers, around the globe. Certification against the standard ensures that the design, development, and delivery of the learning experience you provide meet the ISO requirements. The audit and certification process also provides you with a transparent analysis of your present program and a valuable tool for developing effective, learner-centered training. Globus Group is a recognized leader in certification and training services, and our independent audits set the standard for excellence in a broad range of industries. When you partner with Globus Groupfor your ISO 29990 – Learning Services Management Systems certification you benefit from our many years’ experience ensuring compliance and assisting organizations as they develop quality training programs. Contact Globus Group today to learn how you can incorporate the principles of ISO 29990 to provide a more valuable learning service.
03 Apr
ISO 22000 – FOOD SAFETY MANAGEMENT SYSTEM

ISO 22000 – FOOD SAFETY MANAGEMENT SYSTEM

Whatever their size, or product, all food producers have a responsibility to manage the safety of their products and the well-being of their consumers. That’s why ISO 22000 exists.

The consequences of unsafe food can be serious. ISO’s food safety management standards help organizations identify and control food safety hazards, at the same time as working together with other ISO management standards, such as ISO 9001. Applicable to all types of producer, ISO 22000 provides a layer of reassurance within the global food supply chain, helping products cross borders and bringing people food that they can trust.
03 Apr
ISO 21001 – EDUCATIONAL ORGANIZATION MANAGEMENT SYSTEM

ISO 21001 – EDUCATIONAL ORGANIZATION MANAGEMENT SYSTEM

ISO 21001 Educational Organizations Management Trainings

ISO 21001 is an international standard developed by the International Organization for Standardization which provides management tools for organizations that offer educational products and services. It intends to help educational providers meet students requirements and needs. ISO 21001 is based on ISO 9001 - Quality Management Systems, but it provides a specific framework for educational organizations that aim to enhance the satisfaction of their learners by improving the educational processes and ensuring conformity to learners’ requirements. The standard can be applicable to all organizations that provide a curriculum for the development of knowledge, skills and attitudes by means of different lecturing methods.

Why is Educational Organizations Management important for you?

Education is a fundamental need for everyone in the society; therefore, everyone should be concerned with the quality of education delivered by education providers. However, even though the outcomes cannot be guaranteed, educational institutions can play a crucial role in ensuring that learners receive the expected quality of education. The ISO 21001 certification will enable you to provide educational services in a more effective and efficient manner, and to offer a more personalized experience to all learners, particularly to those with special education needs and distance learners. Moreover, by becoming ISO 21001 certified, you can demonstrate to stakeholders that you are committed towards improving your educational system.

Benefits of ISO 21001 Educational Organizations Management

By becoming Globus Group ISO 21001 certified, you will be able to: Improve your education system
Enhance the reputation of your educational institution
Promote equal opportunities for all students regardless of their religious background, ethnic or cultural origin, gender, ability/disability
Provide personalized training and effective response to all learners
Stimulate excellence and innovation
Make education more accessible (physical or online settings)

How do I get started with the ISO 21001 Training?

If you are ready to start your journey towards obtaining a Globus Group consultancy, our team is more than willing to assist you in becoming part of our global network.
03 Apr
ISO 16949 – AUTOMOTIVE QUALITY MANAGEMENT SYSTEM

ISO 16949 – AUTOMOTIVE QUALITY MANAGEMENT SYSTEM

IATF 16949:2016 helps your automotive organization reduce variation and waste in the supply chain using continuous improvement.

IATF 16949 is the Quality Management Systems standard for the Automotive industry. The standard applies the ISO 9001:2015 Quality Management System as the foundation of the standard and incorporates the latest automotive standards spanning the globe. By adopting the standard organizations demonstrate an elite level of dedication to quality excellence. The Automotive Quality Management Systems standard ensures that your organization is creating quality products and performing services in accordance with stringent automotive industry expectations. It defines the quality management systems requirements for the design and development, production, assembly, and installation of automotive-related products, as well as relevant services to the automotive industry. Obtaining a certificate assures your customers that your organization is committed to an effective and consistent supply chain.

How IATF 16949 benefits your organization:

Demonstrates to your customers the ability to provide products that meet regulatory and safety requirements
Identifies and addresses the risks associated with your organization driving innovation and improvement
Provides you with a plan to increase productivity and efficiency
Ensures your organization demonstrates ethical practices and corporate social responsibility, such as an anti-bribery policy

The transition to IATF 16949

In October 2016, IATF 16949:2016 was published to replace ISO/TS 16949. As of September 2018, all ISO/TS 16949 certificates have expired. The major changes from ISO/TS 16949 to IATF 16949 included an emphasis on product safety, expansion of focus on risk management, supplier management, and others.

Certification with Intertek

Your management system's certification to the Automotive Quality Management Systems standard will help you continuously improve your products and customer satisfaction. Our industry-expert auditors deliver innovative and thorough auditing solutions, to help you see your business more clearly. Intertek’s Total Quality Assurance will give you the valuable tools to meet objectives, identify cost savings, adapt to standard revisions, and make measurable improvements to your business.

Additional Information and Resources on the Automotive Quality Management Systems standard

IATF – International Automotive Task Force - The International Automotive Task Force is an “ad hoc” group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide. This website has access to the 16949 standard, rules, communique, OEM requirements, and International Automotive Task Force publications.
IAOB - International Automotive Oversight Bureau - One of 5 oversight offices created by the International Automotive Task Force to oversee the certification bodies who perform the audits and issue certificates. The IOAB is Intertek’s oversight.
AIAG – Automotive Action Industry Group - Collaborates with the International Automotive Task Force and 5 oversight groups developing standard and core tools (FMEA, Control Plan, SPC, MSA, etc.)
03 Apr
ISO 13485 – QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

ISO 13485 – QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

How ISO 13485:2016 can help you comply with EU IVDR

Compliance with the new EU IVD regulation (IVDR) becomes mandatory in 2022. IVD medical device manufacturers can prepare by becoming certified to ISO 13485:2016, a key quality management system (QMS) standard that applies specifically to medical devices. Accredited ISO 13485 certification from Globus Group is the first step on your regulatory compliance journey and lays the foundation for meeting your regulatory obligations.
03 Apr
ISO 11197 – MEDICAL SUPPLY UNITS

ISO 11197 – MEDICAL SUPPLY UNITS

ABSTRACT

 

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.

ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on-site, including cabinetry and other enclosures, which incorporate patient care services.

03 Apr
ISO 10993 – BIOLOGICAL EVALUATION OF MEDICAL DEVICES

ISO 10993 – BIOLOGICAL EVALUATION OF MEDICAL DEVICES

EVALUATING THE BIOCOMPATIBILITY OF MEDICAL DEVICES AND MATERIALS WITH ISO 10993

A medical device or material that comes in contact with the patient's body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to evaluate the interaction between a device and tissue, cells or body fluids of the patient. The primary purpose of a device biocompatibility assessment is to protect patient from potential biological risks.

ISO 10993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES

ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body. According to the standard, an assessment for biological effects from the exposure of a medical device or material to human body can include testing such as cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, implantation and haemocompatibility, etc. Biocompatibility testing shall be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025.

WHY CHOOSE Globus Group

Globus Group Product Service’s industry specialists and clinical practitioners have extensive experience with all types of medical devices and the compliance of regulatory requirements for medical devices in major medical device markets.

OUR SERVICES AT A GLANCE

Conformity assessment of data on biocompatibility – Globus Group experts provides a regulatory review of validation protocols for compliance to state-of-the-art biocompatibility standards within conformity assessment procedures.
Submission Forms for regulatory data compilations – Globus Group assures by guiding submission documents for the whole 10993 standard series. This minimizes the risk of delays during assessments due to missing data to a minimum by clear communicated transparent requirements.
Risk management expertise - Globus Group Product Service and Globus Group experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conduct thousands of in-depth risk management audits each year.

YOUR BENEFITS AT A GLANCE

Recognized medical device expertise - Globus Group Product Service is recognized around the world for its extensive experience with all types of medical devices. All Globus Group experts stand for the highest quality and have a strong educational and professional background.
Active involvement in standards development and implementation - Globus Group Product Service technical professionals are actively involved in standards development activities related to medical devices and participate in a number of key standards committees.
Expert partnership - Globus Group Product Service has a long record of technical and regulatory expertise for medical devices and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
03 Apr
ISO 9001 – CERTIFICATION – QUALITY MANAGEMENT SYSTEMS

ISO 9001 – CERTIFICATION – QUALITY MANAGEMENT SYSTEMS

WHAT IS AN ISO 9001:2015 QUALITY MANAGEMENT SYSTEM?

Supporting an organization’s aims and objectives, an ISO 9001 QMS documents the processes, procedures, and responsibilities for achieving quality policies and objectives. Based on eight quality management principles, the ISO 9001:2015 standard defines the way an organization operates to meet the requirements of its customers and stakeholders: Customer focus
Leadership
Involvement of people
Process approach
Organizational context
Continual improvement
Fact-based decision making
Risk-based thinking

WHAT ARE THE BENEFITS OF ISO 9001:2015 CERTIFICATION?

ISO 9001 certification helps organizations to develop and improve performance, as well as demonstrate high levels of service quality when bidding for contracts. Certification follows successful completion of an audit against the ISO 9001 standard and enables organizations to: Operate more efficiently
Meet statutory and regulatory requirements
Reach new markets
Identify and address risks

WHY CHOOSE Globus Group TO CONDUCT AN ISO 9001 CERTIFICATION AUDIT?

We are known as the global leader in certification, working with clients in virtually any sector. An ISO 9001:2015 audit from Globus Group will help your organization to develop and improve performance. In addition, to ISO 9001 audits we also offer a range complimentary services: ISO 9001 training courses
ISO 9001 Gap Assessment – to assess readiness for certification
Integrated Management Systems Certification – audit solutions against bespoke quality performance criteria
Process improvement solutions
With a global presence, Globus Group has a history of successfully executing large-scale, complex international projects. Our people speak the language, understand the culture of the local market, and operate globally in a consistent, reliable, and effective manner.
03 Apr
ISO 9001 – CERTIFICATION – QUALITY MANAGEMENT SYSTEMS

ISO 45001 OCCUPATIONAL HEALTH AND SAFETY

For organizations that are serious about improving employee safety, reducing workplace risks and creating better, safer working conditions, there’s ISO 45001.

According to the International Labour Organization, more than 7 600 people die from work-related accidents or diseases every single day. That’s why an ISO committee of occupational health & safety experts set to work to develop an International Standard with the potential to save almost three million lives each year. Structured in a similar way to other ISO management systems, the approach will be familiar to users of standards such as ISO 14001 or ISO 9001. ISO 45001 builds on the success of earlier international standards in this area such as OHSAS 18001, the International Labour Organization’s ILO-OSH Guidelines, various national standards and the ILO’s international labour standards and conventions.
Group of multi-ethnic young business people meeting.

MANAGEMENT SYSTEM STANDARDS

Providing a model to follow when setting up and operating a management system, find out more about how MSSs work and where they can be applied.

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