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ISO 9001

ISO 9001 is an international standard established by ISO about quality management system. The purpose of this standard is to seek a convenience of international trade through standardizing a quality management system of organization under global business circumstance.

This standard was established in 1987. ISO 9001:2008 certification has been implementing, and hundreds of thousands organizations are acquiring and maintaining this certification.

An applicable fields of this standard are not only industrial sections such as manufacturing, construction, servicing but also public service section such as school and local autonomy. Therefore the importance of this standard is emphasizing more and more.

For the acquiring of this certification, an organization can acquire it through objective assessment conducted by third party such as CYRUS after completing quality management system.

The effects of ISO 9001

An effective approach of ISO 9001 can provide management effectiveness as below.

Through effective management of process, it prevents non-conformity. And through elimination basic cause, and exact detection of already existed non-conformity. it can protect customers.

Through continuous seeking of the most suitable management system, it can eliminate unnecessary process. Therefore it can pursuit the maximum management efficiency. Through ensuring higher lever products, servicing, and process than now, organizations can achieve customer's satisfaction. And it contributes to organization members' improvement of ability and extension of organization members' business achievement scope.

It provides self-importance and strong motive endowment as a quality management system certification of international model.

ISO 22000

ISO 22000 is an international standard that defines the requirements of a food safety management system covering all organizations in the food chain from “farm to fork”.

The standard combines generally recognized key elements to ensure food safety along the food chain, including:

  • » Interactive communication
  • » System management
  • » Control of food safety hazards through pre-requisite programmes and HACCP plans
  • » Continual improvement and updating of the food safety management system

Who is it relevant to?

ISO 22000 is a truly international standard suitable for any business in the entire food chain, including inter-related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients.

ISO 22000:2005 is also for companies seeking to integrate their quality management system, for example ISO 9001:2008, and their food safety management system.


Certifying your food management system against the requirements of ISO 22000:2005 will bring the following benefits to your organization:

  • » Applicable to all organizations in the global food supply chain
  • » A truly global international standard
  • » Provides potential for harmonization of national standards
  • » Covers the majority of the requirements of the current retailer food safety standards
  • » Complies with the Codex HACCP principles Provides communication of HACCP concepts internationally
  • » An auditable standard with clear requirements which provides a framework for third-party certification
  • » Suitable for regulators
  • » The structure aligns with the management system clauses of ISO 9001 and ISO 14001
  • » Enables communication about hazards with partners in the supply chain
  • » System approach, rather than product approach
  • » Resource optimization – internally and along the food chain
  • » All control measures are subjected to hazard analysis
  • » Better planning - less post process verification
  • » Improved documentation
  • » Systematic management of prerequisite programmes
  • » Increased due diligence
  • » Dynamic communication on food safety issues with suppliers, customers, regulators and other interested parties
  • » A systematic and proactive approach to identification of food safety hazards and development and implementation of control measures

Benefits of ISO / TS 16949

The Members Of IATF Will Recognize ISO / Ts 16949 Certification As Equivalent To Qs-9000.

ISO/Ts 16949 Specifies The Quality System Requirements For The Design/ Development, Production, Installation And Servicing Of Automotive- Related Products


Qs - 9000 Is A Harmonization Of Chrysler Suppliers Quality Assurance Manual, Ford’s Q-101 Quality System Standard, & General Motor’s Nao Targets For Excellence With Input From Truck Manufacturers.

ISO 9001:1994 Section 4 Has Been Adopted As The Foundation For Qs-9000.


Qs - 9000 Defines The Fundamental Quality System Expectations Of Chrysler, Ford, General Motors, Truck Manufacturers & Other Subscribing Companies For Internal & External Suppliers Of Production & Service Parts And Materials.

These Companies Are Committed To Working With Suppliers To Ensure Customer Satisfaction Beginning With Conformance To Quality Requirements, And Continuing With Reduction Of Variation & Waste To Benefit The Final Customer, The Supply Base, And Themselves


Qs-9000 Applies To All Internal & External Supplier Sites Of :

  • » Production Materials.
  • » Production Or Service Parts

Heat Treating, Painting, Plating Or Other Finished Services Directly To Oem Customers.


Chrysler, Ford, General Motors, The Truck Manufacturers And The Other Subscribing Companies Require That Suppliers Establish, Document, & Implement Effective Quality Systems Based On Qs-9000 In Accordance With Timing Requirements Established By Their Customers The Term Qs-9000 Is A Copyright Protected Property Of Chrysler, Ford & General Motors.

Only Those Third Party Certification Bodies / Registrars Qualified For Qs-9000 By These Big Three Recognized Accreditation Body Are Permitted To Issue A Registration Certificate With The Term Qs-9000.

ISO13485 : 2003

Data Under Updation

OHSAS 18001 – An Overview

  • » Internationally recognized model for Occupational Health and Safety Assessment Series (OHSAS) for management systems.
  • » Enable organizations to control their OH&S risks and improve their performance.
  • » Specification is intended to address occupational health and safety rather than product and services safety.
  • » In response to urgent customer demand for a recognizable occupational health and safety management system standard.
  • » Need for health and safety management system that could be audited and certified.
  • » Thirteen co­operating organizations from around the world assisted in development of this series.
  • » Spain, Malaysia, United Kingdom and several other European standards organizations.


1992 British Health & Safety Commission publishes management of health and safety at work 1993 British Health and Safety Executive publishes HS(G)65, successful health and safety management 1996 British standard BS 8800 launched, used as model OHSMS 1999 OHSAS 18001 Specification published based on BS8800 2000 OHSAS 18002 Guidelines published to assist in the implementation of OHSAS 18001 .

What is OHSAS 18000 …...

Published in April 1999 by British Standards Institution.
It is not a formal standard, an official British Standard, nor is it an official International Standard.
Not mandatory ­voluntary basis.
OHSAS 18001 is compatible with: ISO 9001:2008 (Quality) and ISO 14001:2004 (Environmental) management systems standards.
With ISO 9001:2008 based on the ISO 14001:2004 model ­Integration of QEH&S MS is easier.
Applies to general industry and fills gap of health and safety issues not covered by:

  • » Responsible Care (RC), Chemical Plant (PSM) industries or other health and safety programs e.g. ISM Code (Marine Safety).
  • » It is an auditable protocol, against which a company's health and safety management system can be assessed.
  • » Intended to address OH&S for employees, temporary employees, contractors, visitors and other personnel on­site.
  • » Not intended to cover product and service safety.


A Health and Safety Management System must be established and maintained
Instructions and procedures to ensure the health and safety of all personnel in compliance with relevant national and international regulations

  • » Defined levels of authority and lines of communication between, and among, company personnel
  • » The Health and Safety Management System must be monitored by your own internal audit system
  • » Accidents & nonconformities are reported and corrective actions taken
  • » Part of planning must include hazard identification, risk assessment and risk control

OHSAS 18001 Benefits

EHS managers can't be every place at the same time ­
Provides tools to ensure health & safety is everyone's responsibility
Integrate health and safety into all aspects of your business
Effective safety and health programs earn positive returns on their health and safety investment by:

  • » Reducing work­ related accidents and ill­ health and the costs associated with them
  • » Improving performance through heightened employee morale and adherence to policies and procedures
  • » Reinforcing a responsible and well­ managed reputation with customers, stakeholders, and communities
  • » OHSAS 18001 provides a structure to incorporate health and safety into the business
  • » Includes health and safety impacts as part of the business process and planning activities and achieving the goal of an accident­ free workplace

ISO 14001

A new paradigm for controlling indiscriminate development and seeking a continuous development is a global trend. And definite system is required for realization of environmental improvement. ISO 14001 is international standard for environmental management system legislated by ISO (International Standardization Organization) and it is a standard among representative standards with ISO 9001 in organization's management system certification field.

This standard is requiring construction of environmental management system for continuous improvement of environmental results about organization's product and process, and this is a system that acquire certification through the objective assessment conducted by third party certification body about whether constructed environmental management system meets the requirements of standard or

Now in case of global trade, the needs of quality management system and environmental management system are spreading over the whole industrial fields. In some industrial fields, this is operating as an important and obligatory factor.

Applications of this standard are the same as ISO 9001. Therefore it can be applicable not only manufacturing, construction, servicing but also public service section such as school, local autonomy. And it can cover all various size companies.

The effects of ISO 14001

  • » Preparation of the regulation reinforcement for environments.
  • » Decrease of pollution material and wastes. & Precaution of environmental accident.
  • » Taking competence according to the increase of customer's purchase preference for friendly environmental relation products.
  • » Contribution to the safety and health of members of organization.
  • » Increasing profits through curtailment of wasteful resources.
  • » Enhancement of organization's image from customers and the interested party.

What is CE Marking

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters 'CE' are an abbreviation of Conformité Européenne, French for European conformity. The CE mark must be affixed to a product if it falls under the scope of the approx. 20 so called 'New Approach' Directives. Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and Norway, Iceland and Liechtenstein. However, if the product meets the provisions of the applicable European Directives, and the CE mark is affixed to a product, these countries may not prohibit, restrict or impede the placing in the market or putting into service of the product. Thus, CE marking can be regarded as the products trade passport for Europe.

The CE mark is not a quality-mark. First, it refers to the safety rather than to the quality of a product. Second, most quality markings are voluntary opposite to the CE marking, which is mandatory for the products it applies to. CE indicates conformity with mandatory European safety requirements. European conformity is certified by following clear and understandable procedures, the so-called ‘conformity assessment procedures’.

The CE Mark is a conformity marking consisting of the letters CE. The CE Marking applies to products regulated by certain European health, safety and environmental protection legislation. The CE Marking is obligatory for products it applies to: the manufacturer affixes the marking in order to be allowed to sell his product in the European market.

CE is an abbreviation for Conformité Européenne, French for European Conformity. The CE Mark indicates that the product it is affixed to conforms to all relevant essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedure's. The essential requirements refer, among other things, to safety, public health and consumer protection.

How do you benefit from CE Marking

The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 28 countries of the European Economic Area (EEA). There is only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims


HACCP, is a non-traditional, non-continuous inspection technique recommended by the National Academy of Sciences as a more scientific, analytical, and economical approach than that provided by traditional inspection and quality control methods. HACCP, which focuses on problem prevention and problem solving, relies heavily on proper monitoring and record keeping by the industry. One of the primary economic benefits of HACCP is that it provides for reduced destructive sampling of the finished product as compared to the end-product sampling required under traditional inspection systems, including the current NMFS Integrated Quality Assurance program.

In addition, the application of HACCP principles to seafood inspection has been adopted by several countries, including Canada, Iceland, and Thailand, and is becoming more broadly recognized by the international community as a mechanism to apply uniform inspection procedures.


The HACCP-based inspection program will allow participants an opportunity to apply their existing quality control systems more efficiently, receive the management benefits of producing safe, wholesome, and properly labeled products more consistently and obtain the marketing benefits of using marks associated with the program. It will also allow for more efficient use of NMFS resources. The new program is structured so that NMFS inspection frequencies can be varied depending on an individual facility's compliance history. That is, firms that demonstrate the ability to maintain consistent control can be inspected less frequently.

In summary, the HACCP-based service is consistent with global activities to harmonize inspection protocols. In addition, NMFS believes that the HACCP-based service will enhance the safety, wholesomeness, and economic integrity of seafood available to consumers, as well as improve seafood industry quality assurance and regulatory oversight.


  • A. Control Point: Any step in a process whereby biological, chemical, or physical factors may be controlled.
  • B. Corrective Actions: Procedures to be followed when a serious or critical deficiency is assessed or when a critical limit is reached or exceeded.
  • C. Critical Control Point (CCP): Any step in a process which, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk.
  • D. Critical Deficiency: A hazardous deviation from plan requirements such that maintenance of the safety, wholesomeness, and economic integrity is absent; will result in nsafe, unwholesome, or misbranded product.
  • E. Critical Limit: An established point which must not be exceeded if a hazard is to be controlled at a CCP.
  • F. HACCP Plan: A document that describes the firm's HACCP-based inspection system.
  • G. Hazard: A chance for, or the risk of, a biological, chemical, physical, or economic property in a food product that could violate established program criteria or cause the consumer distress or illness.
  • H. Low risk products: Seafood that poses no significant risk to the health of the public when prepared for consumption by conventional or traditional means.
  • I. Major Deficiency: A significant deviation from plan requirements, such that maintenance of safety, wholesomeness, or economic integrity is inhibited.
  • J. Minor Deficiency: A failure of the part of the HACCP-based system relative to facility's sanitation which is not likely to reduce materially the facility's ability to meet acceptable sanitation requirements.
  • K. Monitoring Procedures: Scheduled testing and/or observations recorded by the firm to report the findings at each CCP.
  • L. Preventive Measure(s): Any action that will inhibit the introduction of hazards into the product.
  • M. Process: One or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products.
  • N. Serious Deficiency: A severe deviation from plan requirements such that maintenance of safety, wholesomeness, and economic integrity is prevented; and, if the situation is allowed to continue, may result in unsafe, unwholesome, or misbranded product.
  • O. Substantial risk products: Seafood that may pose a significant danger to the health of the public when prepared for consumption by conventional or traditional means. For example, ready-to-eat; heat and/or brown and serve products; products which may contain a microbial pathogen, biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at the time of consumption.
  • P. Systems Audit: On-site NMFS evaluation of the firm's effectiveness in following the plan after validation.
  • Q. Validation: On-site NMFS evaluation of the plant's completeness and workability, and the firm's effectiveness in following the plan.
  • R. Verification: Periodic review by the firm to determine the overall effectiveness of the HACCP plan.
  • S. Verification Audit: Unannounced on-site NMFS review of the effectiveness of NMFS field inspection personnel in following established procedures


GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and Efor drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.

At the GMP Institute, we believe that GMP is a good business tool which will help to refine both compliance and performance at your company. GMP requirements are largely common sense practices which will help your company better itself as it moves toward a quality approach using continuous improvement. The diagram at left illustrates how we approach creating and maintaining a GMP lifestyle in a company. First, set standards of performance. These include GMP regulations and other standards which are necessary for your company. Then, train to those standards. All departments in the company should be trained (to varying degrees) on GMP and other standards. The diagram lists four types of employees which are especially critical to train: top management, managers and supervisors, operators and technicians, and support staff. Because training is such an important part of maintaining a GMP Lifestyle, the GMP Institute focuses heavily on training. We offer many workshops for a variety of types of people. GMP 101 is a great introduction to the concepts of GMP and the reason behind it. Additionally, we offer workshops to help in house trainers perfect the art of training, and to help them learn how to make GMP an interesting topic. We even offer a certification program for trainers.

The next step in the GMP Lifestyle is to reinforce what was learned in training. This falls on the managers and supervisors in a plant. Therefore, it is important that managers and supervisors be involved in training, so that they can support it through reinforcement. The same four job categories are listed as being the most critical in promoting and receiving reinforcement.

The third stage is to audit to ensure that your efforts have provided adequate controls by auditing. Audits fall in the following three categories: personal, whereby every individual does a self-check to make sure that he/she is complying with all appropriate standards; internal audit, which should be performed by the quality assurance department as required by GMP, and external audits, which can consist of an FDA audit, a consultant checking your compliance status, or you performing a supplier audit.

The GMP Institute also offers workshops for auditors needing training. Finally, the results of audits will help you to know if you need to modify your standards of performance. Of course, no procedures should be changed without appropriate change control and approval from quality assurance. The glue that sticks the whole process together is commitment. Commitment to GMP and quality is critical at all levels of the organization, starting with top management. If you foster commitment, use this process, and attend GMP Institute workshops when necessary, you will help you make GMP a Lifestyle, Not Just a Regulation in your company. You will then improve the overall performance of your workforce, as well as your FDA compliance.

SA 8000

SA8000 is an international standard for improving working conditions. Based on the principles of thirteen international human rights conventions, it is a tool to help apply these norms to practical work-life situations. Sufficiently specific to be used to audit companies and contractors alike in multiple industries and countries, SA8000 represents a major breakthrough: it was the first auditable social standard and creates a process that is truly independent (it is neither a government project, nor dominated by any single interest group).

To certify conformance with SA8000, every facility seeking certification must be audited. Thus auditors will visit factories and assess corporate practice on a wide range of issues and evaluate the state of a company's management systems, necessary to ensure ongoing acceptable practices. Once an organization has implemented any necessary improvements, it can earn a certificate attesting to its compliance with SA8000. This certification provides a public report of good practice to consumers, buyers, and other companies and is intended to be a significant milestone in improving workplace conditions.

Maintaining and improving the systems put in place to achieve SA8000 certification is an ongoing process and substantive worker participation can be the best means to ensuring systemic change. The benefits of adopting SA8000 are significant and may include improved staff morale, more reliable business partnerships, enhanced competitiveness, less staff turnover and better worker-manager communication.

Established in May,1997.

  • Undertakes impartial assessment of SA certification bodies to assure competence.
  • Monitor's ongoing compliance of SA certification bodies and their documented procedures.
  • Maintains list of accredited certification bodies available to the public.
  • Reviews and resolves complaints against auditors and /or certification bodies.
  • Continuous improvement of SA8000 system.
  • Respond to complaints and appeals

SA 8000 Mission

  • Improve working conditions globally; promote respect for worker's rights.
  • Provide universal standard in all business and country sectors.
  • Work in partnership with human rights and labor organizations worldwide
  • Provide an incentive which benefits the business and consumer community though a "win/win" approach.


  • Manufacturing, agriculture, consultancies.
  • Initial focus on FTC (manufacturing).
  • Divisions/branches not always covered under headquarters certifications.
  • Certification based upon scope definition
  • Registration must approve scope
  • Extractive industries and homework not yet covered under standard.
  • Developed and developing countries.

Benefits of SA 8000 to manufacturers and suppliers

  • Marketing advantage – more demand and value for goods from socially responsible manufacturers/suppliers.
  • Enhancement of company's productivity.
  • Compliance to the laws of the land.
  • Improvement of relationship with the Govt., NGOs, trade unions.
  • Better image and position in labour market.