ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2015 is implemented by over one million companies and organizations in over 170 countries.
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. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
ISO/IEC 27001:2013 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2013 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization’s overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.
ISO/IEC 27001:2013 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.
ISO/IEC 27001:2013 is intended to be suitable for several different types of use, including the following:
- use within organizations to formulate security requirements and objectives;
- use within organizations as a way to ensure that security risks are cost effectively managed;
- use within organizations to ensure compliance with laws and regulations;
- use within an organization as a process framework for the implementation and management of controls to ensure that the specific security objectives of an organization are met;
- definition of new information security management processes;
- identification and clarification of existing information security management processes;
- use by the management of organizations to determine the status of information security management activities;
- use by the internal and external auditors of organizations to determine the degree of compliance with the policies, directives and standards adopted by an organization;
- use by organizations to provide relevant information about information security policies, directives, standards and procedures to trading partners and other organizations with whom they interact for operational or commercial reasons;
- implementation of business-enabling information security;
- use by organizations to provide relevant information about information security to customers
CDISC – Clinical Data Interchange Standards Consortium
As an acronym, CDISC stands for “Clinical Data Interchange Standards Consortium,” but in reality it means much more than that to MMS and our industry in general. These industry-wide, platform-independent global standards support clinical research by providing data and submission models used from the beginning to end, that is, from protocol through analysis and reporting.
The benefits of CDISC are seen on every level. Standardization offers the industry opportunities for further research through data sharing that can advance medical science or improve patient care. MMS’ data managers, programmers and statisticians realize efficiencies in the speed and quality of their work when designing, implementing, reporting and submitting high-quality clinical study and integrated summary submissions for our sponsors.
MMS is a member and proponent to CDISC and fully supports their mission to improve healthcare. Standardization through CDISC implementation is congruent with our MMS philosophies on quality and continuous improvement. These opportunities to advance research, and at the same time provide efficiencies to the maximum benefit of our sponsors, really make CDISC standards worthwhile and appreciated.