03
Apr
ISO 14000 FAMILY ENVIRONMENTAL MANAGEMENT
For companies and organizations of any type that require practical tools to manage their environmental responsibilities, there’s the ISO 14000 family.
WHAT YOU NEED TO KNOW ABOUT ISO 14001
WHAT DOES IT DO AND WHO IS IT FOR?
ISO 14001 sets out the criteria for an environmental management system and can be certified to. It maps out a framework that a company or organization can follow to set up an effective environmental management system.
Designed for any type of organization, regardless of its activity or sector, it can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
WHAT DO THE STANDARDS IN THE ISO 14000 FAMILY COVER?
The ISO 14000 family of standards are developed by ISO Technical Committee ISO/TC 207 and its various subcommittees. For a full list of published standards in the series see their standards catalogue.
ISO 14001 provides requirements with guidance for use that relate to environmental systems. Other standards in the family focus on specific approaches such as audits, communications, labelling and life cycle analysis, as well as environmental challenges such as climate change.
CAN AN ORGANIZATION BE ISO 14001 CERTIFIED?
There are more than 300,000 certifications to ISO 14001 in 171 countries around the world. Learn more about the ISO Survey of certifications.
We've also created a short document where you can find out more, not only on certification, but a wide range of benefits of ISO 14001.
03
Apr
ISO 14000 FAMILY ENVIRONMENTAL MANAGEMENT
For companies and organizations of any type that require practical tools to manage their environmental responsibilities, there’s the ISO 14000 family.
WHAT YOU NEED TO KNOW ABOUT ISO 14001
WHAT DOES IT DO AND WHO IS IT FOR?
ISO 14001 sets out the criteria for an environmental management system and can be certified to. It maps out a framework that a company or organization can follow to set up an effective environmental management system.
Designed for any type of organization, regardless of its activity or sector, it can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
WHAT DO THE STANDARDS IN THE ISO 14000 FAMILY COVER?
The ISO 14000 family of standards are developed by ISO Technical Committee ISO/TC 207 and its various subcommittees. For a full list of published standards in the series see their standards catalogue.
ISO 14001 provides requirements with guidance for use that relate to environmental systems. Other standards in the family focus on specific approaches such as audits, communications, labelling and life cycle analysis, as well as environmental challenges such as climate change.
CAN AN ORGANIZATION BE ISO 14001 CERTIFIED?
There are more than 300,000 certifications to ISO 14001 in 171 countries around the world. Learn more about the ISO Survey of certifications.
We've also created a short document where you can find out more, not only on certification, but a wide range of benefits of ISO 14001.
03
Apr
ISO/IEC 27001 INFORMATION SECURITY MANAGEMENT
When it comes to keeping information assets secure, organizations can rely on the ISO/IEC 27000 family.
ISO/IEC 27001 is widely known, providing requirements for an information security management system (ISMS), though there are more than a dozen standards in the ISO/IEC 27000 family. Using them enables organizations of any kind to manage the security of assets such as financial information, intellectual property, employee details or information entrusted by third parties.
CERTIFICATION TO ISO/IEC 27001
Like other ISO management system standards, certification to ISO/IEC 27001 is possible but not obligatory. Some organizations choose to implement the standard in order to benefit from the best practice it contains while others decide they also want to get certified to reassure customers and clients that its recommendations have been followed. ISO does not perform certification.
Read more about certification to ISO’s management system standards.
Many organizations around the world are certified to ISO/IEC 27001.
03
Apr
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.
03
Apr
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
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
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.
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 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.
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.
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 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.