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CE MARKING
Most all products must be assessed for conformity by either the manufacturer or an accredited body and bear the CE marking before entry into the EU. CE marking, an acronym for the French "Conformité Européenne", is since 1993 a key indicator of a product’s compliance with EU legislation regarding safety, health and environmental protection. . The term CE mark was changed to CE Marking in the New Approach Directives.
This symbol is not a registered mark, in fact it is a declaration for the inspectors (i.e., customs) and allows the product to be "placed on the market.’’ It symbolizes that the person affixing the CE marking has verified that the product conforms to all the Community provisions and has been subjected to the appropriate evaluation procedure.
The CE logo ensures the free movement for products within the European Economic Area (EEA), consisting of the 27 member states of the EU and European Free Trade Association countries Iceland, Liechtenstein and Norway. This mark certifies that a product protects consumer safety by meeting minimum European Union expectations for health, safety, and environmental requirements.
CE Marking is a legislative requirement. It is not a mark of safety, nor a mark of quality, and has never been intended as a mark for consumers. It is directed at market surveillance authorities and customs authorities. It should not continue to be a marking able to confuse and mislead consumers.
EU standards are being drafted by three European Standards Organisations: CEN, CENELEC and ETSI. Besides, all EU Member States have their own national standardisation bodies which adopt European standards. You can buy the standards from these national bodies.
Products that are subject to CE marking as the result of various European Council Directives include :
The following list clearly states what the CE marking is and is not :
‘’As a designer and user of European electronic products, you should be aware that a product's CE marking does not imply a particular level of quality, it simply indicates that a product conforms to relevant European directives and standards.’’
Restriction of Hazardous Substances (RoHS)
RoHS stands for Restriction of Hazardous Substances adopted in February 2003 by the European Union is a directive for restriction in usage of hazardous substances in electrical and electronic equipments.
Any RoHS compliant component is tested for the presence of certain hazardous substances like Lead (Pb) , Cadmium (Cd), Mercury (Hb), Hexavalent chromium (Hex-Cr), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ethers (PBDE)
For more information, please feel free to write to us at info@acumic.in
HALAL CERTIFICATION :-
Islam is the fastest growing religion and second largest in the world are true. The increasing awareness of Muslims all over the world on their obligation to consume food that meets Islamic dietary requirements has created a much greater demand for HALAL food and products. The food industry is an evergreen industry and Halal food is the latest trend in the world market. HALAL stands not only for just and fair business transactions but also for animal welfare, sustainable environment and social justice.
The global market demand for Halal products and services. Halal is an Arabic word which means allowed or permitted according to Islamic laws. In the context of food consumption, the term indicates that a particular food is permissible to be consumed by Muslims. In general Islam is a way of life for every Muslim.
The label used as a certification mark will be evidence that the company's products meet the specific standards required for the use of the certification mark. The purpose of Halal certification marks on product packaging is to satisfied Muslim consumers. This mark represents a high level of hygiene, cleanliness, safety, and nutrition and production under the strict requirements of Islamic dietary law. Halal products are now being produced and originated from all parts of the world, the question of whether the products remain Halal or not at the point of consumption is a matter of concern. Therefore, it is a challenging work for all the parties involved in manufacturing, transportation and storage of Halal products to ensure that the integrity of the Halal product is not broken throughout the supply chain. It is important for food manufacturers be aware of not only the Halal requirements for different countries and the principles of Halal, but, also, understand the organizations which meet their needs the best. Halal covers the aspects of slaughtering, storage, display, preparation, hygiene and sanitation. This certification means complete and accurate information about Halal status of products from all point of view. ‘’HALAL trademark is an important marketing tool in the international arena, it opens the door to marketing products globally.’’
Cost :
What is the cost of an audit to HALAL?
Charges for ISO HALAL Certification may depend on the size, location, complexity of operation, processes and it’s inter relevance. Acumic produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to info@acumic.in or call us at 0522-4072356, Tel: +91-9918766617.
Apply :
Contact Us: If you plan to go for ISO Certification, you may ask for Quotation by providing your organization’s information in application form, you can download the application form by clicking on Download link available at the website or submit your inquiry through feedback. Alternatively you may send your inquiry through mail to info@acumic.in or call us at 0522-4072356 Tell: +91-9918766617 Sector-specific applications of HALAL.
ISO 9001 - Quality Management System
Every Organization wants to be successful but without continual efforts & improving quality, no organization can achieve its objectives and quality is the best business plan. How can a company improve its quality & productivity? The answer is ISO 9001.
ISO 9000 is the series of standards which provide guidance & tools for organizations who want to ensure that their products & services consistently need customer requirement. The goal of ISO 9001 is increasing productivity, reducing unnecessary cost, customer satisfaction, business efficiency & ensuring quality of process & products.
"Without a ISO Standard, there is no logical basis for making a decision or taking a action"
This is based on the concept that certain minimum characteristics of a QMS could be usefully standardized giving mutual benefits to suppliers and customers and undoubtedly focus on process rather than product/service quality. This can be used by internal and external parties including certification bodies to assess the organization's ability to meet customer statutory and regulatory requirements.
ISO 9001:2015
ISO 9001:2015 is based on "High Level Structure" which is developed by highly reputed organization is to improve alignment among its international standards for management system. This new and revised structure is Risk Based Thinking and Risk Assessment. Organizations should recognise and evaluate potential risks and after identifying these risks, organization can avoid it or develop appropriate and effective actions to minimize its impact.
ISO 9001:2015 has eliminated the terms "Documents, Procedures, Records". All of these terms have been replaced with the ubiquitous, Documented Information. The rationale of this change is that it opens the door to greater understanding and acceptance of alternative methods of controlling QMS.
This new revised standard has three informative annexes - Annex A gives clarification on the new structure, terminology and concepts; Annex B provides refreshed QMS principles; Annex C gives details related to QMS standards from ISO 10000 series.
Key Changes
In brief, this new and revised standard of QMS can also enhance work productivity; employment growth will be proportionately less than sales growth, leading to.
What are the benefits of ISO 9001 Quality Management?
ISO 14001 Environment Management System
Businesses often forget about the culture/environment and ultimately they suffer for it because they cannot deliver good service from unhappy employees. To be competitive on both in national and global basis organization must adopt a forward thinking approach in developing their managing strategies. Management system standard such as ISO 14001 help an organization to better control its processes. It is the world’s recognised framework for EMS (Environment Management System).
ISO 14000 series includes generic standards which may be broadly classified according to the six Categories: EMS, Auditing, Performance, Evaluation, Labelling, Life cycle assessment and Environmental aspects of product standard. It is voluntary, consensus-based and market-driven standard which is based on Plan-Check-Do-Review-Improve cycle. The main purpose of this standard is to systematically control adverse environmental impacts and ensure that established objectives and targets are met.
What is ISO 14001 ?
ISO 14001 is the international standard for environmental management of businesses. The actual environmental standards of ISO 14001 deal with how a company manages the environment insight its facilities and immediate outside environment. However the standards also call for analysis of the entire life cycle of the product from raw material to eventual disposal. ISO 14001 do not mandate a particular level of pollution or performance but focus on awareness of the processes and procedures that can affect the environment. The standards seek to provide cost effective tools that make use of best practices for organising and applying information about environmental management.
Benefits:-
Occupational health and safety Assessment Series :
Companies that invest in their employees will gain competitive edge over their rivals. When companies understand the importance of employees, in revert employees will take care of customers and thus business will take care itself. All we know that work injuries and illnesses can affect every aspect of life for workers and their families. That’s why it is foremost responsibility of any organization towards its employees is to ensure that they are secure and satisfied with their workplace.
Over 6300 people die each day from work-related accidents or diseases- that’s nearly 2.3 million every year. Thus for providing safe and secure environment ISO introduced OHSAS 18001 Occupational, Health and Safety Management System.
What is OHSAS 18001
The OHSAS 18001 standard is based on the ISO 9001 & 14001 Plan-Do-Check-Act (PDCA) structure.
OHSAS 18001 enables an organization to have control over & knowledge of all relevant hazards resulting from normal operations & abnormal situations and improve its performance. By obtaining OHSAS 18001, any organization can prove to their stakeholders, customers & employees that organization is aware of their health & safety obligation and looking to minimize risks.
World’s first occupational health & safety standard is currently being developed ISO-45001, a new standard consolidating the best practice knowledge on OHSAS.
Benefits of OHSAS 18001 Certification – Health and Safety Certification
Cost :
What is the cost of an audit to ISO 18001:2007?
Charges for ISO 18001:2007 Certification may depend on the size, location, Complexity of operation, Processes and it’s inter relevance. Acumic produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to info@acumic.in or call us at 0522-4072356 Tell: +91-9918766617 Sector-specific applications of OHSAS 18001.
Apply :
Contact Us: If you plan to go for ISO Certification, you may ask for Quotation by providing your organization's information in application form, you can download the application form by clicking on Download link available at the website or submit your inquiry through feedback. Sector-specific applications of ISO 18001.
Success of every business depends on accurate analysis choosing right technology and future vision. Research from last two decade has proved that those organization that do invest in technology and choose the path of innovation, increase their market share, financial figures and overall competitiveness.
ISO 20000/IEC is the Information Technology :
Benefits of ISO 20000
ISO 20000 can assist your organisation in benchmarking its IT service management, improving its services, demonstrating an ability to meet customer requirements and creating a framework for an independent assessment.
Some of the most common benefits of ISO 20000 certification for service providers are that it :
What is the cost of an audit to 20000 ?
The charges are depend on the size, Complexity of operation, location, Processes and it’s inter relevance. It produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to info@acumic.in or call us at 0522-4072356, Tell: +91-9918766617.
Apply :
Contact Us : If you plan to go for ISO Certification, you may ask for Quotation by providing your organization?s information in application form, you can download the application form by clicking on Download link available at the website or submit your inquiry through feedback. Alternatively you may send your inquiry through mail to info@acumic.in or call us at 0522-4072356, Tell: +91-9918766617 Sector-specific applications of ISO 20000.
ISO 22000 - Food Safety Management
Food safety is the global concern not only because of the importance of public health but also because of its impact on international trade. Globalization of food production and procurement makes food chain longer & more complex and increases the risk of food safety incidents. Hence food safety is the most important quality feature for the consumers hence food law regulates this issue in detail, assure the consumer that food fulfil its safety expectations. In a nutshell food safety is more than just the function of quality assurance and operations.
ISO 22000 is an international and unique food safety management system standard. This standard provides both opportunities and challenges to organization that desire to implement the requirements. This standard is not prescriptive which do not define what specific action and organization must taken to meet the requirements so organization must determine these actions and then show auditor that these actions are effective in controlling the identified a food safety hazard. The main objective of ISO 22000 is to control and reduce to an acceptable level, any safety hazard identified for the end products delivered to the next step of food chain. The standard provides international harmonization in the field of food safety standards, offering a tool to implement HACCP (Hazard Analysis and Critical Control Point) throughout the food supply chain.
There are many other food safety standards available but most of them are limited in scope. ISO 22000 is only the one to cover all organization that produce, manufacturers, handle or supply food or feed such as retailers, storage providers, biochemical manufacturers, feed and food manufacturers, processors, transportation operators, agriculture producers, packing material manufacturers etc. Overall it ensures that process used to control food safety is validated, verified, implemented, monitored and managed.
Production of safe food requires the active involvement of most of business functions including R&D engineering, purchasing, sales and human resources.
What is ISO 22000 ?
ISO 22000 FSMS is an auditable standard which specifies that when an organization in the food channel needs to demonstrate an ability to control hazards related to food safety then this standard provides the basis for demonstrating company compliance to quality system by establishing the documentation and procedural standard must be met. In brief, it is intended for organization directly or indirectly associated with food supply chain is irrespective of size and complexity and is regarded as being able to bring transparency since it has been designed to cover every link in the food supply chain.
ISO 22000 Benefits
KOSHER Certification
Some religions specify dietary rules to follow. One of the most confusing sets of guidelines applies to kosher foods. Kosher foods are items approved by Kashrut, the body of Jewish law that supplies the guidelines for food preparation. Not all Jews follow these guidelines but if they do, they are said to ‘’keep Kosher’’.
KOSHER is a Jewish or Hebrew word which means fit, proper or acceptable. Kosher laws have their origin in the Bible and detailed in Talmud. Foods which Jews are allowed to eat according to the Jewish Dietary laws are described as ‘KOSHER’. In addition to Islam, many other religions also forbid certain foods or have specific requirements related to food. There are Islamic, Buddha, Hindu and Jewish dietary laws.
Food has always been the subject of obligations and taboos means which food we prefer and what we consider fit for consumption and faith we adhere to. Kosher laws deal predominately with three issues: prohibited foods (pork, shellfish, and rabbit), prescriptions for religious slaughter and prohibition and preparing and consuming dairy products and meat together.
It is blatant that the daily industrial food production aimed to worldwide consumption requires supervision on the ingredients and on the whole production lines. Actually, an increasing number of companies decide to acquire a Kosher certification so that not only many Jews but also many vegetarians for example, can eat according to the rules of their cult or for natural choices. The basic guidelines of Kosher and non-Kosher depend on two variables: the source of the ingredients and the status of the production equipment. Kosher certification is the guarantee that the food meets these kosher requirements.
The Kosher symbol identifies for the consumer the food products that have been officially inspected, approved, and verified as being in compliance with this standard. We guidelines for the sources of Kosher and non-Kosher materials originate in the Bible.
Validity of Kosher certification is one year.
For more information, please feel free to write to us at info@acumic.in
What is an ISO 13485 Quality Management System?
ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. This is a process-based system and contrasted to the procedure-based system of QSR and ISO 9001.
Manufacturers of Medical Devices are subject to specific legislative fulfilments. Medical Devices intended for diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness .The medical device industry throughout the world will move toward adopting the new ISO 13485:2003 as the preferred quality system standard.
Another important aspect of ISO 13485:2003 is the inclusion of risk management throughout the quality system process, thus providing for a risk-based approach for determining a level of rigor when implementing the standards.
ISO 13485 is based on ISO 9001, there are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements. ISO 13485 calls for risk management to be in place for all stages of product realization, training and supervision of staff, project site specs, and prevention of contamination. Clinical evaluation must be carried out as part of design and development evaluation in line with regulatory requirements. The cleanliness of products and contamination control must be considered, as must the status of the product with respect to monitoring and measurement.
In brief, ISO 13485 provides system where the experience, clear point of view and judgement are applied systematically in order to manage the risks related to medical device use. This system was specially developed for medical device manufacturers that use principles based on risk management. For all other participants for example, the ones from the health industry, this standard can be used as informative guidance in the development and maintenance of the system and the risk management processes. This standard manages the risk management processes primarily to patient/user, but also to the operator, other equipment and the environment.
According to the International Standards Organization, from 2004 through 2013 a total of 22, 950 ISO 13485 certificates were issued worldwide throughout 93 countries.
What are the benefits of being certified to ISO 13485?
ISO/IEC 27001 - Information Security Management
Main drivers for security are government directive, undoubtedly globalization, terrorist activities, and threats from hackers because digital world is very dangerous as it is silent. Access to high- quality, complete, accurate and up-to-date information is vital in supporting managerial decisions- making process that leads to sound decisions. Thus information security system is extremely important to ensure that the resources are well protected. It controls in reducing the organization overall risk profile. There are several standards for IT governance which leads to information security but from all of this ISO 27001 is most widely used standard in the world because it is systemic approach for establishing, implementing, operating, monitoring, maintaining and improving.
Information security includes three main dimensions: confidentiality, integrity and availability. The adoption of ISMS is expected to be a strategic decision for an organization and it is necessary that this decision is seamlessly integrated, scaled and updated in accordance with needs of organization.
The true success of ISO 27001 is its alignment with the business objectives and effectiveness in the realizing those objectives.
What is ISO 27001 ?
ISO/IEC 27001 is an international standard which offers set of specifications, codes of conduct and best practice guidelines for organization to ensure strong IT Service management. It is a technology-neutral, vendor-neutral information management standard but it is not a guide.
The IAF ensures that ISO 27001 certification is recognized across the world through a mutual recognition arrangement agreed by more than sixty national accreditation bodies.
ISMS is important to both private and public sector business. It supports e-business and is essential for business risk activities. Through the use of ISO 27001, organization can develop and implement a same work for managing the security of their informations assets including financial information, intellectual properties and employee details or information entrusted to them by customers and third parties.
Benefits of ISO 27001
Good Manufacturing Practices (GMP)
GMP stands for Good Manufacturing Practices. It is the part of quality assurance. It is concerned with both production and quality control that means. A GMP certificate is granted when the manufacturing facility has been audited and found to demonstrate satisfactory compliance with the required GMP standard.
GMP is an important part of a comprehensive system of quality assurance. Quality control is the base of GMP that is concerned with sampling, specifications, testing, documentation, and release procedures. Its aim is developing new regulatory policies based on the latest science of risk management and quality assurance. The new standards are being designed to encourage cost-reducing and precision enhancing innovation in manufacturing and technology.
GMP is the set of principles that must be observed during the manufacturing process. It helps in reducing operating cost and boost export opportunities. Every company has a moral and legal responsibility to provide safe products and well trained employees who follow the practices that result in safe products. It also help in increasing customer's long-term confidence in the enterprises.
What is GMP?
This certification is something we are all quite proud of and believe is yet another step in the direction of differentiating ourselves and delivering a very high level of service to our clients. "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. It is the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Implementation of GMP is an investment in good quality medicines. It also helps in increasing the process efficiency and product quality by adopting the current, risk-based manufacturing approach and in turn optimizes manufacturing process and improves quality of the end-product. It focuses on quality management and risk control (HACCP), improve their corporate image and reliability.
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Hazard Analysis and Critical Control Point (HACCP)
Food safety is a global concern and now consumers are willing to know how food is produced, processed and marketed, and are increasingly calling for their Governments to accept greater responsibility for food safety and consumer protection. Today, governments, regulatory agencies, industries and consumers are greatly concerned for safe foods and there are many reasons behind this.
HACCP is the only system that protects ‘’public’’ from food borne diseases. It is so important for the food industry and also most cost - effective approach to food safety because it focuses on the analysis and the identification of the Critical Control Points (CCP) in the production, processing and preparation of food, feed, and water before the product ever leaves the premises.
HACCP based food safety assurance system rather than voluntary codes, have been made the legal and mandatory requirements in many countries. Thus, recognising its importance food and public health authorities have prompted HACCP world-wide. The main objective of HACCP is to enhance assurance in the food safety in order to prevent food borne illness more effectively, additionally it will reduce the cost of control and wasted food and it will protect the reputation of food processor and its entire industry.
What is HACCP?
Hazard Analysis and Critical Control Point (HACCP) concept is a systematic approach to the identification, assessment and control of hazards. Hazards are biological, physical or chemical properties that may cause a food to be unsafe for human consumption. It is a proactive strategy where hazards are identified and assessed, and control. It is a preventative approach where the focus is placed on the prevention of problems in order to assure the production of food products that are safe to consume.
The HACCP principles apply a logical and common sense approach to food control. A successful HACCP plan identifies and controls all food safety hazards found in the food processing operation. The main aim of this system is to control food safety that means the end product will be of good quality and meet all legal requirements. This system has been adopted worldwide by many food manufacturing companies.
Benefits of HACCP :
The WHO has recognised the importance of HACCP for the prevention of food borne disease and has played a significant role in the development and implementation of HACCP. In brief HACCP is rational, scientific and systematic approach to identification, assessment and control of hazards during production, manufacturing, preparation, distributing and use of food, to ensure that food is safe when consumed.
Social Accountability :
The Most relevant standards of social responsibility is the SA8000 developed by CEPA (Council of Economic Priorities Accreditation Agency - USA) now known as Social Accountability International (SAI). Social Accountability International is an international non-profit human rights organisation founded in 1997 with the mission to improve workplaces around the world by developing and implementing socially responsible standards.
SAI’s mission is to enable organizations to be socially accountable by :
SA 8000 :
"Responsible Business is a Good Business"
Benefits SA 8000 :
ISO 50001 Energy Management
What is ISO 50001 ?
Key factors for successful implementation of an EnMS include :
The benefits include :
Cost:
What is the cost of an audit to ISO 50001:2011?
Charges for ISO 50001:2011 Certification may depend on the size, location, Complexity of operation, Processes and inter relevance. Acumic produces a guidance price list based on company nature & size.
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ISO/TS 16949:2009
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 centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949:2009.
ISO/TS 16949:2009 can be applied throughout the automotive supply chain.
Cost:-
What is the cost of an audit to ISO/TS 16949:2009 ?
Charges for ISO/TS 16949:2009 Certification may depend on the size, location, Complexity of operation, Processes and it’s inter relevance. Acumic produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to info@acumic.in or call us at 0522-4072356, Tel: +91-9918766617.
Apply:-
Contact Us: If you plan to go for ISO Certification, you may ask for Quotation by providing your organization’s information in application form, you can download the application form by clicking on Download link available at the website or submit your inquiry through feedback. Alternatively you may send your inquiry through mail to info@acumic.in or call us at 0522-4072356 Tell: +91-9918766617 Sector-specific applications of ISO/TS 16949
WHO-GMP Compliance
Acumic provides consultancy service for GMP WHO certification to our clients. GMP (Good Manufacturing Practices) is a standard defined by WHO (World Health Organization). GMP WHO certification ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
W.H.O. defines Good Manufacturing Practices (GMP) as "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization". GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.
The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled - controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labelling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process.
WHO-GMP covers all aspects of the manufacturing process including:-
