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.
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 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:
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:
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 :
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.
Data Under Updation
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 .
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:
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
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:
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 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.
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.
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.
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.