Strength of process is integral to who MMS is as an organization.
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 more than one million companies and organizations in 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. Using ISO 9001:2015 helps ensure that all customers receive consistent, good quality products and services.
ISO/IEC 27001:2013 covers all types of organizations, specifying 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 stipulates 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/data assets and give confidence to interested parties. This is intended to be suitable for several forms of use, including the:
- 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 the pharmaceutical 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 – 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 colleagues realize efficiencies in the speed and quality of work when designing, implementing, reporting, and submitting high-quality clinical study and integrated summary submissions for sponsors.
Standardization through CDISC implementation is congruent with MMS philosophies on quality and continuous improvement. These opportunities to advance research, and at the same time provide efficiencies to the maximum benefit of sponsors, really make CDISC standards worthwhile and appreciated. That is why MMS is a member.
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