Transparency in business process/work procedures/administration in government agencies has too often become an obstacle. Many matters that should be done promptly often have to run without definite process because there is no good management system. Therefore, changes in management system are indispensible in order to boost the efficiency in the governance and services, and to change the mental of the state apparatuses as well. In this case, National Agency for Drug and Food Control (NADFC) strive to improve its management, which has been formatted in a kind of management system through SOP, which has been implemented since 2009. The quality management system is used as the standard as it is the need of each organization regardless the size of the organization - big or small- and the type of products it produces. The quality management system requires an organization to seek for minimal requirements/standards so it can achieve customer satisfaction through consistent provision of goods or services that meets customer expectation. This includes continuous improvement effort.
The quality management system is a system outlining policy guideline and procedures necessary to improve and control various processes which will eventually lead to an increase in business performance. The quality management system includes a series of interrelated and interacted elements that lead and control the organization to refer to quality. Therefore, the quality management system is applied to all activities and units within an organization.
The goal of implementing quality management system within an organization is to manage various activities in a systematic approach and to continuously improve its effectiveness according to international standards that prioritize the needs of stakeholders.
Based on study, the SOP issued in 2009 is considered insufficient to reflect the process occurring in NADFC. Therefore, starting at the end of 2010 there has been mapping on relationship map, NADFC business process map, and sub-business process map.
With the 3 maps, the quality management system documents of NADFC have been arranged, which consist of:

Is a policy document explaining the quality of policies and objectives set by NADFC, containing structure and methods in implementing quality management system.
Is a document that provides information about the structure and scopes of the Quality Management System Inspectorate CPOB/CPOTB, among other quality policies, objectives, authorities and responsibilities to ensure quality in the execution of the work and output (product and service) provided by the organization.
*CPOB Inspectorate is a unit within the NADFC responsible for coordinating and conducting the inspection of CPOB in Pharmaceutical Industry. CPOB Inspectorate Unit at the central level is Directorate of Production Control of Therapeutic Product and Household Medical Supplies.
*CPOTB Inspectorate is a unit within the NADFC responsible for coordinating and conducting the inspection of CPOTB in Traditional Medicine Industry and Natural Ingredients Extract Industry. CPOTB Inspectorate Unit at the central level is Directorate of Inspection and Certification of Traditional Medicine, Cosmetics and Complementary Products.
CPOB/CPOTB Inspectorate Unit at the local level is Provincial Office of NADFC in its supervised territory where there is Pharmaceutical and/or Traditional Medicine Industry and/or Natural Ingredients Extract Industry.
Is an operational document and is used to describe whoever was involved in a quality control activity, when, where and how to implement it and references used to ensure the implementation of quality control activities in accordance with the provision.
Work instructions are used to explain in more details the activities/tasks which have not been described in standard procedures so with that instructions, the result quality of each task can be confirmed and refers to relevant standard procedures.
Is a supporting document to identify and prove the implementation of quality activities in order to achieve the specified quality requirements. Quality documents are communicated, coordinated, distributed, understood, implemented and developed by all personnel. Included in the Level IV document are: Implementation Guidelines, Technical Instruction, Guidelines, Circular Letter, external documents etc.
NADFC acquired ISO 9001: 2008 for the first time in 2012 which was valid for three (3) years. In 2015, NADFC, 23 (twenty three) work units and 31 (thirty one) Provincial Offices of NADFC was re-awarded with ISO 9001: 2008. Nevertheless, the process of management improvement did not just happen with ISO 9001: 2008. In the testing field, nowadays all of NADFC laboratories have already got International Standard Certification which is ISO 17025. In the future, NADFC attempt to become a reference laboratory at the regional level. Additionally, this agency is also routinely assessed by WHO, and the result of the last assessment done in 2008 showed 97 out of 100. In the field of post-distribution monitoring (post-market vigilance), NADFC tries to become a member of international organization for Drug and Food supervision, for the inspection process - PIC/s (Pharmaceutical Inspection Cooperation Scheme). In 2011 an audit had been conducted by PIC/s and since 2012 NADFC has officially become a member of PIC/s. The entire procedures, which are assembled within the management process and enhanced by the support of the quality management system and e – Gov. Improving the implementation of public information disclosure, applying the electronic procurement policy in accordance with Presidential Decree and The regulation of the Chairman of LKPP and increasing the implementation of reliable archival management in NADFC environment.
Subsite of NADFC’s quality management system: (link is external)