July 20, 2017
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The Most Comprehensive
Document Management System

For Your Comprehensive Business System

ISO Document Management System (DMS)

A Web Based Document Management System

Our ISO Document Management System (DMS), using the Odoo (OpenERP) platform, is truly comprehensive and integrated. With this electronic document management system, you are assured that all of your documents are organized the right way. The web based features ensures that your records and documents are just clicked away from your finger click. Having such a nimble document tracking system would ensure that your business performs far more efficiently and effectively. Alongside our partner Premysis Consulting, one of the Largest ISO consultant in Indonesia, we provide integration in Document Management System (DMS) for your Comprehensive Business System which covers:

  1. Quality Sustem
  2. Food Safety Quality
  3. Environmental Management
  4. Occupational Health & Safety
  5. Healthcare Management

Quality System

ISO 9001

In today’s global market, low operation or production cost alone are no longer sufficient to survive in the future. Whether you are a small business owner or a multinational corporation, a manufacturing or service company, consistent quality product or service as a result of reliable and quality processes is a must to meet the challenges ahead. Today’s successful companies are those that have a strong commitment in quality, from back office operation to the service and products delivery. ISO 9001 which represents an international consensus on good management practices is a powerful tool that can be used by any organizations, regardless of the size or type of business, in developing a solid management system. ISO 9001 provides a framework for taking a systematic approach in managing your business processes in order to consistently produce a conforming products which lead to customer satisfaction. ISO 9001 is not a legal requirement in cooperating with foreign market, however international business perceive ISO 9001 standard as a key in doing business worldwide and improving the standard of the company itself. In addition, nowadays customers often use the standard as a way to differentiate the cooperated companies, particularly when products and services are similar. Finally, quality management system developed using ISO 9001 is an excellent foundation for continual improvement.

ISO 9001 IWA 1

The additional guidance was provided by the ISO International Workshop Agreement (IWA) 1, Guidelines for process improvements in health service organizations. ISO has published a new version of IWA 1. The new version has been made even more “user friendly” for organizations in the sector by incorporating improvements based on developments in the fields and comments by health care providers since the original was published in 2001. The guidelines include much of the text of ISO 9004, Quality management systems – Guidelines for performance improvements, supplemented by text specifically aimed at assisting health services organizations to implement a QMS, regardless of whether they decide to pursue certification to ISO 9001. The objective is the systematic pursuit of process improvement in order to attain continual improvement, the prevention of error and other adverse outcomes, and the reduction of variation and organizational “waste” – such as non-value added activities. The principal improvements to the new version of IWA 1 include the following :

  • The “translation” of quality-related terminology into language and situations readily understood by health care professionals
  • The addition after many of the ISO 9004:2000 requirements of paragraphs of related advice on “what to look for” and “Guidance/examples”.

The expert who developed IWA 1 stated, “Implementing this guidance and maintaining the system with discipline and rigour through the organization should produce effectiveness and efficiencies with a cost benefit of up 17:1 based on experience of other sectors.” One of the authors, Mickey Christensen, who was Chair of the committee that developed the original proposal for IWA 1, cites the case of Southern Pharmaceutical Corporation as an example of the benefits of ISO 9001:2000 implementation, supplemented by guidance from IWA 1. The company delivers medicines and medical equipment such as oxygen breathing apparatus (as well as setting it up) to patients at their homes. Please click here for more information about advanced healthcare management system.

ISO 9001 IWA 2

ISO 9001 IWA 2 provides guidance for a quality management system in educational organizations. The guidelines contained within IWA 2:2007 do not add to, change or otherwise modify the requirements of ISO 9001:2000, and are not intended for use in contracts for conformity assessment or for certification. This International Workshop Agreement provides guidance to educational organizations for implementing an effective quality management system in conjunction with and based on ISO 9001. The objective is to assure the overall effectiveness of the education organization’s quality management system and the delivery and continual improvement of its educational service to the learner. The educational organization should define the scope of the quality management system and the areas included for its application. Examples include departments within a larder educational organization, an entire educational organization, or all educational organizations in a given government. The educational organization should define and manage the processes for the quality management system. Process related to the aim of the organization should be included during and following the provision of the educational service :

  • Education design
  • Curriculum development
  • Education delivery
  • Assessment of learning.

International Workshop Agreement IWA 2 was approved at a workshop held in Acapulco, Mexico, in October 2002, which was hosted by the Mexican General Bureau of Standards (DGN).

ISO 9001 IWA 4

The ISO 9001 IWA 4 provides local governments with guidelines for the voluntary application of ISO 9001:2008 on an integral basis. These guidelines do not, however, add, change or modify the requirements of ISO 9001:2008. The present general guidelines aim to help local government organizations relate the concepts of quality management as described in the ISO 9000 family of standards with the practice and terminology commonly employed in the local government context. It is expected that a development plan or work programme in the short or medium term is received, understood, and applied by the employees, officers and representatives of the local government. However, the plan or programme itself does not ensure that the needs and expectations of the local community will be covered if the processes needed for the effective implementation of such plans or programmes are deficient or nonexistent. The need to avoid these deficiencies has motivated the elaboration of this guide to help local governments in the implementation of an effective quality management system. Certification of the quality management system by external parties is not a requirement of this guide, though local governments may choose to seek certification to ISO 9001:2008 if they wish. Internal quality audits can provide the verification of compliance with the requirements, in conjunction with the control of complaints or claims from customers, users, citizens and the local community in general. Any quality management system will be influenced by the different policies, objectives, diverse work methods, resource availability and administrative practices that are specific for each local government. Therefore, it may be expected that the details of each quality management systems will vary in each local government. It is not the detailed method of implementation of the quality management system that is important; what matters is that it yields effective, consistent and reliable results. The quality management system should be as simple as possible in order to function properly. It needs to be understandable enough to meet the policies and quality objectives of the local government. ISO 9000:2005 (Quality management systems – Fundamentals and vocabulary) states that, in order for an organization to be successful, it needs to be guided and controlled in a systematic and transparent way. This is particularly true for local government, where transparency and accountability to its citizens are vital in order to gain their trust and confidence. Sustainable success will only result from the implementation of an integral quality management system that addresses the needs and expectations of all interested parties. The quality management system of a reliable and successful local government should therefore cover all activities and processes that can affect its ability to satisfy the requirements of its “customers”/citizens as well as those of other interested parties, such as regional or national governments.

ISO 9001 IWA 9

ISO 9001 IWA 9 is a framework for managing sustainable development in business districts, which provides a framework for managing sustainable development in a business district, including the evaluation, comparison and improvement of its performance. It also identifies and describes factors to be considered when developing and evaluating the economic, environmental and social performance of new and existing business districts. This international standard can also be used to compare or to assess the performance of business districts regarding the provisions described within it and does not set benchmarks or expected levels of performance regarding the impacts of business districts. It is intended to be used in conjunction with, and in accordance with the principles set out in, ISO 15392, ISO 26000 and the standards on environmental management prepared by ISO/TC 207.

ISO 13485

In the field of medical products, devices and components, regulatory requirements and customer expectations are demanding. Manufacturers and their world-wide suppliers are expected to comply with the highest standards of quality and regulations. ISO 13485 is the standard for organizations engaged in the manufacturing of medical devices. The standard is aimed to provide guidelines for the organizations that need to demonstrate its ability in providing medical devices and related services that consistently meet customer and applicable regulatory requirements. According to the most recent survey by the International Organization for Standardization (www.iso.org, 2006), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States. According to the survey, the 2006 total represent an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel. ISO 13485 is now commonly used as the basis of regulatory requirements. The standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality.

ISO 15189

During autumn 2008, College of Patolog America (CAP) launched a laboratory accreditation program based on ISO 15189:2007 for Medical Laboratory. ISO 15189 can be defined as a quality management standard system which is specifically designed for the accreditation of medical laboratory. This standard is conducted by the medical laboratory in term of quality management system improvement and competency value of the laboratory itself. Moreover, it is also explained about the risk management system for the result of laboratory and customer satisfaction. ISO 15189 is a standard which has been recognized worldwide by organization of accreditation which conducted ISO15189 in 44 different countries. In several countries, this laboratory standard has been modified. Although this standard has not been formally used in USA, but CAP said that this standard will help the laboratory in achieving the best practice of quality management system.  The accreditation of Medical Laboratory based on ISO 15189:2007 which has modified to SNI ISO 15189:2008 Medical Laboratory is an important guideline to acquire the recognition of quality and competency for the laboratory. ISO 15189 and ISO 17025 are connected, because ISO 15189 is just the medical laboratory version of ISO 17025. Moreover, because of its connection with ISO 9001, ISO 15189 is a recognition for a medical laboratory competency, whereas ISO 17025 and ISO 9001 is only a recognition of competency and laboratory system management. One of the main objectives of ISO 15189 is to ensure that the client knows about the procedure which supports the quality management system as well as to convince that the result is valid. ISO 15189 has several advantages for hospital laboratory system which includes the quality of health services, patient and employees’ satisfaction, cost of the treatment, and its delivery.

ISO 15489

International Standard ISO 15489, Information and Documentation – Records Management (Geneva, 2001) was developed by an international committee of records management professionals, was launched by ARMA International ic October 2001 and is supported by the Standards Council of Canada. This International Standard provides guidance on creating records policies, procedures, system and processes to support the management of records in all formats. It is widely used internationally in both private and public sector organizations. This standard was designed to meet the ongoing need for efficient and cost effective best practice recordkeeping in a business environment. It is also used as the basis for other practical guidelines and specifications. There are many benefits that you can get, among other things :

  • It meets the recordkeeping needs of organizations worldwide
  • It provides comprehensive guidance to assist staff with routine, yet critical, records management tasks
  • As an international standard, it gives an widely accepted framework to help managers set up and maintain best practice recordkeeping systems
  • It provides a monitoring and auditing framework, so compliance and benefits can be measured in an objective fashion.

ISO/TS 16949

It is expected that the Technical Specification (TS) will become the common and unique basis for the automotive industries quality management system as worldwide requirement, and will gradually replacing the multiple national specifications which is now mainly used in this sector (e.g. QS 9000, AVSQ, VDA6.1, and EAQF). Therefore, ISO/TS 16949 has a potential market comprising more than 30,000 companies, which are now currently certified by one or other national specifications.

The new version aims at the development of a quality management system that provides continual improvement, defect prevention, and the reduction of variation and waste in the supply chain. Incorporating the requirements of ISO 9001:2008 and ISO/TS 16949:2009 also includes details, sector specific requirements for employee’s competence, awareness, training, design, development, production, service provision, control of monitoring, measuring devices, measurement, analysis and improvement.

This standard was developed by a partnership comprising the international Automotive Task Force (IATF) and the Japan Automobile Manufacturers Association (JAMA), with the support of ISO technical committee ISO/TC 176, which is responsible for ISO 9000 family of quality management system. The individual OEM members of the IATF, including PSA Peugeot Citron, Renault, BMW and Volkswagen, are now in the process of formulating or announcing their policies for implementation of the technical specification by their respective supply bases.

Henry Gryn, leader of the IATF delegation, commented, “The IATF is pleased to announce the release of ISO/TS 16949:2002 for the global automotive supply chain. This technical specification is a value-adding document for the automotive sector. The process of completion was rapid and participated by original equipment manufacturers (OEM’s), suppliers and ISO/TC 176 members. We believe that this technical specification, when coupled with its accompanying registration scheme, has significant benefits for the suppliers to whom it is applicable and for subscribing OEM’s.

ISO/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. ISO/TS 16949:2009 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centre, corporate headquarters and distribution centre), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949:2009.

ISO 28000

ISO 28000:2007 is a management system specification for the protection of people, property, information and infrastructure; in companies and organizations participating in local national and international supply chain operations.

It is suitable for all sizes and types or organizations that are involved in the production of goods, manufacturing, services, storage or transportation at any stage of the products’ development or movement in the supply chain.

Supply chain security is an essential requirement for companies involved in the international supply chain, especially those having to comply with stronger security demands from Customs and/or their business partners.

This standard is a risk-based standard, similar to ISO 14001, integrating the management system process-based approach of Plan-Do-Check-Act (PDCA) and the requirement for continual improvement. It provides a system approach for any organization to manage its security program and can be the foundation for a variety of international security initiatives.

Companies, which use ISO 28000, will implement a protective security program based on the identification of risks. This security-risk assessment provides the means for an organization to identify and prioritize risks and implement management strategies to mitigate or eliminate those risks. And this will allow companies to plan and to manage the security program, while at the same time directing budgets towards the areas of importance.

ISO 31000

Organizations of all types and sizes face internal and external factors and influences that make it uncertain whether and when they will achieve their objectives. The effect this uncertainty has on an organization’s objective is “risk”.

All activities of an organization involve risk. Organizations manage risk by identifying it, analyzing it and then evaluating whether the risk should be modified by risk treatment in order to satisfy their risk criteria. Throughout this process, they communicate and consult with stakeholders and monitor and review the risk and the controls that are modifying the risk in order to ensure that no further risk treatment is required.

ISO 31000 was prepared by the ISO Technical Management Board Working Group on risk management. It sets out principles, a framework and a process for the management risk that are applicable to any type for organization in public or private sector. It does not mandate a “one size fits all” approach, but rather emphasizes the fact that the management of risk must be tailored to the specific needs and structure of the particular organization.

According with this International Standard, the implementation and maintenance of  management of risk will enable an organization to increase the likelihood of achieving objectives, to encourage proactive management, to be aware the need in identifying and treating risk throughout the organization, to improve the identification of opportunities and threats, to improve controls, to improve stakeholder confidence and trust, to improve operational effectiveness and efficiency, to improve loss prevention and incident management, to minimize losses, and others.

This international standard is intended to meet the needs of a wide range of stakeholders, including:

  • Those responsible for developing risk management policy within their organization
  • Those accountable for ensuring that risk is effectively managed with the organization as a whole or within a specific area, project or activity
  • Those who need to evaluate an organization’s effectiveness in managing risk
  • Developers of standards, guides, procedures and codes of practice that, in whole or in part, set out how risk is to be managed within the specific context of these documents.

Food Safety Quality

ISO 22000:2005

ISO 22000:2005 is the requirements for any organization in the food chain. Food industry is a long food chain.

A food chain will be a strong one, unless one of the parts is not strong enough, and it means that one weak part possibly can make the food chain broke. A weak food safety system in industry will debilitate all of supply chain. Contamination or maybe food poisoning can’t be avoided in consumer. As a consequence, unquestionably it will give a bad impact for food business chain.

ISO 22000:2005 comes as the standards, which offer the solutions for assuring the food safety in a food chain, from the farming to consumers’ level.

For more information please visit Food Safety-Quality Website

HACCP

Doing business in food industries, you are required to have a great of care for safety in what will be consumed by your market. One of them is you need to have and ‘to drive’ the responsibility in preventing food poisoning.

Contaminated or poisoned by food can cause the customer’s credibility fades away and it could lead to business collapse. That is why the food industries need the system in preventing it.

HACCP provides you an academic-proved and a systematic solution. Start from hazard-potencies identification and preventive action to minimize the risks.

HACCP certainly is the key solution for your food safety.

For more information please visit Food Safety-Quality Website

Environmental Management

ISO 14001

Throughout the world, the pressure on the organizations to demonstrate the performance of their environmental management system and compliance to environmental regulations is increasing. Many major companies now prefer to use suppliers that conduct an environmental management system. By looking at this trend, poor record of environmental performance may become the main obstacle in entering certain market in the future.

The development of ISO 14001 has influenced the importance of environmental management system. Increasing of public concerns over industrial impact on environment needs to be taken as a consideration for every company. This standard has to be understood and applied in a company before the competitor gain the market advantages or a litigation is brought against them for the harmful activities on the environment and surrounding community.

Implementing an ISO 14000 based on environmental management system will give an organization more than just a confidence, because it complies with various environmental legislations. The systematic approach of ISO 14000 ensures a comprehensive assessment of all areas and activities that affect environment. Genuine implementation of ISO 14001 which is supported by full management commitment will lead to many benefits for an organization. These benefits include cost savings in consumption of energy and materials, reduced cost of waste management, and improved corporate image among regulators, customers and public.

These benefits could easily be lost if the organizational management is too pre-occupied with managing short term needs. Companies must realize that ISO 14001 standards are the management tools that will help them to achieve a better environmental and financial performance.Throughout the world, the pressure on the organizations to demonstrate the performance of their environmental management system and compliance to environmental regulations is increasing. Many major companies now prefer to use suppliers that conduct an environmental management system. By looking at this trend, poor record of environmental performance may become the main obstacle in entering certain market in the future.

The development of ISO 14001 has influenced the importance of environmental management system. Increasing of public concerns over industrial impact on environment needs to be taken as a consideration for every company. This standard has to be understood and applied in a company before the competitor gain the market advantages or a litigation is brought against them for the harmful activities on the environment and surrounding community.

Implementing an ISO 14000 based on environmental management system will give an organization more than just a confidence, because it complies with various environmental legislations. The systematic approach of ISO 14000 ensures a comprehensive assessment of all areas and activities that affect environment. Genuine implementation of ISO 14001 which is supported by full management commitment will lead to many benefits for an organization. These benefits include cost savings in consumption of energy and materials, reduced cost of waste management, and improved corporate image among regulators, customers and public.

These benefits could easily be lost if the organizational management is too pre-occupied with managing short term needs. Companies must realize that ISO 14001 standards are the management tools that will help them to achieve a better environmental and financial performance.

Occupational Health and Safety

OHSAS 18001

Health and Safety Managements Risk in industrial segment is increasing along with its growth in Indonesia. It is very important to control this risk well in order to avoid loss caused by customer complaint, delayed in delivery process, and cost that has to be paid for the treatment of injured employees.

Nowadays, organizations operational system which conducted Health and Safety management has become customer’s requirements in cooperating with other organizations.

In connection with the background, Premysis Consulting is one of the consultancy providers which could help your organization in creating an organization with a high commitment in Health and Safety management system. Application of OHSAS 18001 will help your organization in building a good Health and Safety management system.

In the last decade, Premysis Consulting has already assisted large amount of organizations in developing Health and Safety management system. By applying this system, we tried to give advantages to the organization which include:

  • OHSAS 18001:2007 certification
  • Information about how to fulfill the requirement on Health and Safety regulations
  • Accommodating the system to control health and safety, and in achieving cost savings for organization
  • Integrated Management System

By applying Health and Safety management system in your organization will produce several benefits for your own organization. These benefits include:

  • Reductions in staff absence
  • Reductions in claims against the organization
  • Reductions in adverse publicity
  • Improved insurance liability rating
  • Improved productivity
  • A positive response from customers who want to deal with you organization.

Healthcare Management

Hospital Accreditation (JCI)

Joint Commission International (JCI) is one of the most high-respectable accreditation bodies that accredit the best healthcare organizations in all over the world. The accreditation standards always ensure that the healthcare organization will provide safe environment for all patients, staff and visitors.

With the accrediting experience for over 10 years, JCI experts from various countries have developed the international standards and set uniform, achievable expectations. JCI will also be the source for international community in benchmarking, risk reduction strategies, best practices, and reducing adverse events. JCI has also been a dedicated partner for the World Health Organization (WHO) to establish the patient safety solutions.

By gaining accreditation and certification from JCI your organization will:

  • Improve quality and patient safety that will increase public trust
  • Create the involvement of patients and families in making the decisions in care process
  • Enhance open learning culture from adverse events and safety concerns
  • Provide safe and efficient work environment that will increase staff satisfaction
  • Establish collaborative leadership to gain the quality care and patient safety.

ISO 9001 IWA 1

The additional guidance was provided by the ISO International Workshop Agreement (IWA) 1, Guidelines for process improvements in health service organizations. ISO has published a new version of IWA 1. The new version has been made even more “user friendly” for organizations in the sector by incorporating improvements based on developments in the fields and comments by health care providers since the original was published in 2001.

The guidelines include much of the text of ISO 9004, Quality management systems – Guidelines for performance improvements, supplemented by text specifically aimed at assisting health services organizations to implement a QMS, regardless of whether they decide to pursue certification to ISO 9001.

The objective is the systematic pursuit of process improvement in order to attain continual improvement, the prevention of error and other adverse outcomes, and the reduction of variation and organizational “waste” – such as non-value added

The principal improvements to the new version of IWA 1 include the following :

  • The “translation” of quality-related terminology into language and situations readily understood by health care professionals
  • The addition after many of the ISO 9004:2000 requirements of paragraphs of related advice on “what to look for”  and “Guidance/examples”.

The expert who developed IWA 1 stated, “Implementing this guidance and maintaining the system with discipline and rigour through the organization should produce effectiveness and efficiencies with a cost benefit of up 17:1 based on experience of other sectors.”

One of the authors, Mickey Christensen, who was Chair of the committee that developed the original proposal for IWA 1, cites the case of Southern Pharmaceutical Corporation as an example of the benefits of ISO 9001:2000 implementation, supplemented by guidance from IWA 1. The company delivers medicines and medical equipment such as oxygen breathing apparatus (as well as setting it up) to patients at their homes.

Please click here for more information about advanced healthcare management system.

ISO 15189

During autumn 2008, College of Patolog America (CAP) launched a laboratory accreditation program based on ISO 15189:2007 for Medical Laboratory. ISO 15189 can be defined as a quality management standard system which is specifically designed for the accreditation of medical laboratory. This standard is conducted by the medical laboratory in term of quality management system improvement and competency value of the laboratory itself. Moreover, it is also explained about the risk management system for the result of laboratory and customer satisfaction.

ISO 15189 is a standard which has been recognized worldwide by organization of accreditation which conducted ISO15189 in 44 different countries. In several countries, this laboratory standard has been modified. Although this standard has not been formally used in USA, but CAP said that this standard will help the laboratory in achieving the best practice of quality management system.

 The accreditation of Medical Laboratory based on ISO 15189:2007 which has modified to SNI ISO 15189:2008 Medical Laboratory is an important guideline to acquire the recognition of quality and competency for the laboratory.

ISO 15189 and ISO 17025 are connected, because ISO 15189 is just the medical laboratory version of ISO 17025. Moreover, because of its connection with ISO 9001, ISO 15189 is a recognition for a medical laboratory competency, whereas ISO 17025 and ISO 9001 is only a recognition of competency and laboratory system management.

One of the main objectives of ISO 15189 is to ensure that the client knows about the procedure which supports the quality management system as well as to convince that the result is valid. ISO 15189 has several advantages for hospital laboratory system which includes the quality of health services, patient and employees’ satisfaction, cost of the treatment, and its delivery.