Biopharmaca BiofarmakaIn House Training of Introductin of ISO 9001:2008


Pusat Studi Biofarmaka

On Saturday (16/10/10), Biopharmaca Research Center (BRC) held an in house training for introduction of ISO 9001:2008, as a follow up action to fulfill the requirements to get certification of quality management system (QMS). The activity followed by division heads, researchers, and staffs of BRC. It was opened by Director of BRC, Prof. Dr. Ir. Latifah K Darusman, MS.

in house training

The materials were given by Mr. Agus Sunaryo and Mrs. Seri Wartini, from PT. Bumi Hijau Cermerlang, a company which engaged in research, consultancy and training, supported by experienced human resources in standardization and audit system field, and have affiliations with "Quality Certification” international certification institution.

The material given by Mr. Sunaryo was about introducing the Comprehension & Development of Quality Management System (ISO 9001:2008). A QMS is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization's ability to meet customer requirements.) ISO 9001:2008 is an example of a Quality Management System. Some people generically refer to the group of documents as a QMS, but specifically it refers to the entire system - the documents just describe it. A QMS is nothing more than good business sense. ISO 9001 is an international standard that gives requirements for an organization’s quality management system. It is part of a family of standards published by the International Organization for Standardization (ISO) often referred to collectively as the “ISO 9000 series” or "ISO 9000 family". The words “being ISO 9000 certified”, or “having an ISO 9000-compliant QMS”, normally mean the company has a QMS meeting the requirements of ISO 9001, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand, however, that ISO is the body that develops and publishes the standard – ISO does not “certify” organizations. ISO 9001 applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world. ISO 9001 has been widely known throughout the country, implemented by approximately 887,770 organizations (Management Unit) in 161 countries. It’s abstracted into generic standard requirements, so it can be applied to all organizations in either organizations that produce products or services (what type and size), using the structure of the logical relationships between processes. The purpose of the implementation of ISO 9001 is helping organizations to increase customer satisfaction through the effective application of the system and comply with the rules / requirements that have been set ISO 9001 became the basis of all types of certification. "ISO 9000 Certified" is technically incorrect as ISO 9000 does not have requirements, means an organization has met the requirements in ISO 9001. ISO 9001:2000 was replaced by ISO 9001:2008 in the year 2008. ISO 9001:2000 is now obsolete, focused on meeting customer expectations and delivering customer satisfaction.

Mrs. Wartini gave material more about The Understanding of ISO 9001:2008. ISO 9001:2008 is part of the ISO 9000 family of standards, and is the document that lists the requirements an organization must comply with to become ISO 9001 Registered. ISO 9001:2008 allows organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. ISO 9001:2008 has eight quality management principles as base. These are Customer Focus; Leadership; Involvement of People; Process Approach; System Approach to Management; Continual Improvement; Factual Approach to Decision Making; Mutually Beneficial Supplier Relationships. Organizations are recognizing that an effective Quality Management System leads to reduced costs and greater operating margins. A well designed and implemented Quality Management System based on ISO 9001 has been shown to provide organizations with the benefits obtained through: Improved product reliability, Better process control and flow, Better documentation of processes, Greater employee quality awareness, Reductions in product scrap, rewords and rejections. When ISO 9001 is implemented in an organization, there will be Well defined and documented procedures improve the consistency of output; Quality is constantly measured; Procedures ensure corrective action is taken whenever defects occur; Defect rates decrease; Defects are caught earlier and are corrected at a lower cost; Defining procedures identifies current practices that are obsolete or inefficient; Documented procedures are easier for new employees to follow; Organizations retain or increase market share, increasing sales or revenues. “We hope this event is very useful for us and we can apply this ISO 9001:2008 at our center”, said Prof. Latifah in her closing ceremony.

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