ISO 9001:2015
Introduction of ISO 9001:2015 certification:
Adaption of ISO 9001:2015 should be an planned Decision of any Organization; Design & Implementation & time required is basically depend on the following factor:
- Organizational Environment
- Its Changing need
- Its particular Objective
- Products or Services in which organisation deal with.
- The Process adopted
- Size & organizational Structure
Benefit of ISO 9001:2015 Certification:
- ISO 9001:2015 helps Organisation to produce Desired Outcome
- ISO 9001:2015 ensures Ongoing Controls
- ISO 9001:2015 Enhance Customer Satisfaction by meeting Customer requirement
- Continual Improvement through ISO 9001:2015
- QMS Certification also help to Increase Profitability
- ISO 9001:2015 help organization for avoidance of Risk
ISO 14001:2004
Environment Management System Introduction of ISO 14001 certification: Fast growing era of Industrialization has created environment risk in different aspect. Considering Global Warming Risk, all the countries have to fulfill its environment commitment. Considering Environmental Crisis, ISO have issued ISO 14001:2004 Standards to deal with environmental issues globally. Adaption of ISO 14001:2004 should be a strategic Decision of any Organization; Design & Implementation & time required is mainly depend on the following factor Present Policy, Procedure & Practice
Benefit of ISO 14001:2004 Certification: Considering today’s world concern of global warming and environmental aspect, each country have its commitment towards environmental issues. In such scenario EMS Certification help organisation in much way, some of these may be as below: · ISO 14001 helps Organisation to reduce waste handling cost. · Reduces environmental liability risks · ISO 14001 increases profitability by saving energy & better utilization of natural resources. · ISO 14001 Enhance branding of Organization. · Continual improvement of environmental performances. · EMS Certification also help to Increase Profitability · EMS helps business to ensure better compliance of legal & regulatory requirement.
Roadmap for QMS ISO 14001:2004
: Roadmap and plan for ISO 14001 Certification basically depend on various factors, but mainly following are the main factors of the EMS (ISO 14001:2004) Certification. Identify the applicability of ISO 14001:2004 to your organisation. Make Decision for ISO Implementation/Certification. Get skilled team or hire services of consultant. Identify GAP Analysis. Make Implementation Plan. Design, implement, aware about the Environmental Policy, Environmental Objectives, Impact Aspect Study & Documentation Establish & evaluate the system and procedure. Identify the boundaries of the management system and produce documented procedures as required.ISO 22000:2005
Introduction of ISO 22000 Certification:
Food Safety means adequate controls on presence of food based hazards in food at the time of its consumptions. Food safety is not single stage controls but is combined efforts of all the party participating in the food chain, this includes Feed Producers, Primary Producers through manufacturer, Transporter, Store operator, wholesalers, retailers, Caterers, Food Service Outlets and Producers of Equipments, Packaging Materials, Cleaning Agents, Additives & preservatives & Ingredients and Service providers. Even this includes Pesticides, fertilizers and veterinary drugs. Successful Implementation of FSMS helps the organisation to prevent problems like presence of Microbes, Toxins and Adulteration etc before its occurrence & Suggest Corrective action.
Key Elements of FSMS (ISO 22000:22005) Certification:
- Interactive Communication: Effective communication is essentials to ensure that all possible hazards are duly identified & adequately controlled at each step within the food chain.
- System Management: Compatible with ISO 9001
- Prerequisites Programmes: (PRPs)
- HACCP Principals: HACCP Plan
Adaption of ISO 22000:2005 should be a planned Decision of any Organization; Design & Implementation & time required is basically depend on the following factor:
- Organizational Environment
- Chain involved
- Products or Services in which organisation dealt with.
- The Process adopted
- Size & organizational Structure
- Risk associated with the Products & Processes.
ISO 18001:2007(OHSAS)
The OHSAS 18000 series of standards that includes OHSAS 18001 Occupational Health and Safety Management Systems (OHSMS) grew out of the international success of the ISO 9000 and ISO 14000 series of Standards and the need for managing safety in the work environment. This Standard was created from the British Standard for Occupational Health and Safety Management Systems BS 8800:1996. In addition to the OHSAS 18001 Occupational Health and Safety Management Specifications there is a guidance document in this series known as OHSAS 18002:2000 Occupational Health and Safety Management Systems Guidelines for the implementation of OHSAS 18001. Organizations self certify or register to only the OHSAS 18001 Standard.
What are OHSAS 18001 and OHSAS 18002?
OHSAS 18001 is an assessment specification for Occupational Health and Safety Management Systems. It was developed in response to the need for companies to meet their health and safety obligations in an efficient manner. To compliment OHSAS 18001, BSI published OHSAS 18002, which explains the requirements of the specification and shows you how to work towards implementation and registration. Together, this integrated package will provide your business with the practical means of registration: - Identify elements of your business that impact on health and safety and gain access to the relevant legislation Produce objectives for improvement and a management program to achieve them, with regular reviews for continual improvement BSI Management Systems will periodically assess the system and, if compliant, register your company or site to OHSAS 18001
ISO 13485
Most global medical device market regulators require manufacturers to implement a quality management system (QMS) as part of their product registration effort. In most countries, ISO 13485 certification is the preferred or required method of meeting QMS requirements.
This international standard is based off the ISO 9001 international standard with specific requirements to meet regulatory needs. This standard, applicable on a voluntary base, was designed in particular for medical device manufacturers; ISO 13485 addresses most or all of the quality system requirements in markets including Europe, Australia, Japan and Canada. The US Food and Drug Administration does not formally recognize ISO 13485 certification, but US Good Manufacturing Practices quality system requirements overlap with the standard in many areas. ISO 13485 is also the basis for quality system regulations in other markets such as South Korea and Brazil.
The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.Though replicating the format of ISO 9001, ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical devices manufacturers. ISO 13485 can be achieved by upgrading from ISO 9001 or as a standalone certification. Learn more about upgrading to ISO 13485 from 9001.
ISO 27001:2012
An Information Security Management System (ISMS) provides a systematic approach to managing sensitive information in order to protect it. It encompasses employees, processes and information systems.
An Information Security Management System (ISMS) provides a systematic approach to managing sensitive information in order to protect it. It encompasses employees, processes and information systems.
ISO 20000 Standard
ISO/IEC 20000 benchmarks provision of IT service management:
With up to 80% of information technology budgets of most organizations directly linked to service management processes, a new ISO/IEC standard that benchmarks this activity is expected to result in cost savings for users, whether large or small enterprises, as well as increased productivity and improved customer service.
Published by ISO (International Organization for Standardization) and IEC (International Electro technical Commission), ISO/IEC 20000 will enable organizations to benchmark their capability in delivering managed services, measuring service levels and assessing performance. The new standard is based on the British Standard BS 15000 and is integrated into ISO and IEC collection of software and systems engineering standards. Today, IT service providers are under sustained pressure to deliver high quality service at minimum cost. Concerns have been raised that IT services, whether provided by an in-house IT department or an external organization, are not aligned with the needs of the business and its customers. ISO/IEC 20000 will reduce operational exposure to risk, meet contractual and tendering requirements, demonstrate service quality and deliver best value. The implementation of ISO/IEC 20000 (ITIL) will ensure proactive working practices able to deliver high levels of customer service to meet their business needs. ISO/IEC 20000:2005, which is issued in two parts under the general title, Information technology - Service management, will enable service providers to understand how to enhance the quality of service delivered to their customers, both internal and external.
Part 1: ISO 20000-1 Specification provides requirements for IT service management and is relevant to those responsible for initiating, implementing or maintaining IT service management in their organization.
Part 2: ISO 20000-2 Code of practice represents an industry consensus on guidance to auditors and assistance to service providers planning service improvements or to be audited against ISO/IEC 20000-1:2005.
ISO/IEC 20000 integrates the process-based approach of ISO's management system standards - ISO 9001 and ISO 14001:2004 - including the Plan-Do-Check-Act (PDCA) cycle and requirement for continual improvement.
Isn't ITIL best practices?
For sure it is; and in fact ISO 20000 incorporates all the ITIL Service Support and Service Delivery processes but goes further, by separating out Service Reporting and introducing 3 new processes and management system processes covering:
- Business Relationship Management
- Supplier Management
- Information Security Management.
TS 16949 Certification
SO/TS 16949:2008 was developed by IATF (International Automotive Task Force) members and approved by ISO (International Organization for Standardization) for publication. It is an industry specific Quality Management System (QMS) catering for automotive industries with the following objectives:
- Promote continue improvement
- Emphasis defect prevention, and
- Continual waste and variation reduction.
HACCP Certification
The HACCP system is a procedure control system guidelines which is applicable to any organization those who are dealing with Manufacturing, trading, supply, retailing, packing, transportation, farming etc of food product. The HACCP system offers the guideline to recognize the food safety Hazards (Physical Hazards, Chemical Hazards & Biological Hazards), evaluation of Food safety Hazards and Food safety Risk analysis, establishing the PRP’s, setting of product characteristics, Critical control points, critical control limits, validation , verification , identification of potential emergency situations related to food safety etc.
HACCP (Hazard Analysis and Critical Control Points) is a preventative food safety management system in which every step in the manufacture, storage and distribution of a food product is analyzed for microbiological, physical and chemical hazards. The effective implementation of HACCP will improve the ability of companies to: protect and increase brands and private labels, promote consumer confidence and conform to regulatory and market needs. HACCP can be applied to all stages of a food supply chain, from food production and preparation procedures, to packaging and distribution. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) both require HACCP programs for juice, seafood and meat and poultry.
GMP Certification
Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMP takes quality assurance approach, 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 is aimed primarily at diminishing the risks inherent in any Pharmaceutical or Food production.
Benefits of GMP :
It is believed that GMP is a good business tool, which will help to refine both compliance and performance of the Company. GMP requirements are largely common sense practices, which will help companies better itself as it moves toward a quality approach using continuous improvement. GMP is also sometimes referred to as “cGMP”. The “current,” methodologies of manufacture, testing, design and control. The Manufacturers must employ technologies and systems, which are up-to-date. Systems and equipment used to prevent contamination, mixups, and errors are adequate by today’s standards. Thus, Good Manufacturing Practices GMP, when certified of an organization, is an authorization and certification of Companies product & process that quality standards are adequate, up to date and controlled for the intended use by the consumer
CE Marking Certification
The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. For a list of countries that require the CE marking, see: CE Marking Countries. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 32 countries with a population of nearly 500 million.
Unfortunately, there is no comprehensive list of the products that require a CE marking. Therefore, it is the manufacturer's responsibility to determine if a product requires a CE marking. The "New Approach Directives" are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU. In order to determine if your product needs a CE marking, you should look in each directive that you judge as related to your product. Our Guide to navigating the CE marking process is organized by directives: CE Marking Guide. Under each directive, we explain the route to CE marking certification step-by- step and in one place. Some products require conformance to more than one directive. For example, the Safety of Machinery directive, the Electromagnetic Compatibility (EMC) directive, and the Low Voltage Equipment directive may all apply to one product.
Principles of the CE Marking
- Only the manufacturer or his authorised representative shall affix the CE marking.
- Only the manufacturer or his authorised representative shall affix the CE marking.
- The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonization legislation providing for its affixing.
- The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
- Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Benefits of CE Marking Certification
There are a significant number of advantages of CE marking for the manufacturer and for the consumer. In particular:
- CE marking provides manufacturers with market access to the whole European Economic Area, since countries within this area may not restrict the placing on the market of products bearing the CE marking.
- It guarantees that the product conforms to the regulations in the specific directive(s)
- It is a guarantee for the manufacturer that the product is safe for consumers
- It may significantly reduce damage claims and liability premiums.
SA 8000 Certification
SA 8000 is an international certification standard that encourages organisations to develop, maintain and apply socially acceptable practices in the workplace.
It was created in 1989 by Social Accountability International (SAI), an affiliate of the Council on Economic Priorities, and is viewed as the most globally accepted independent workplace standard. It can be applied to any company, of any size, worldwide.
SA 8000 certification addresses issues including forced and child labour, occupational health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation, and management systems.
As well as setting workplace standards worldwide, SA 8000 also embraces existing international agreements, including conventions from the International Labour Organisation, the Universal Declaration on Human Rights and the United Nations Convention on the Rights of the Child.
Adopting SA 8000 certification means an organisation must consider the social impact of their operations in addition to the conditions under which their employees, partners and suppliers operate. It can be applied to any company, of any size, worldwide. Working with our experienced auditors to implement the most globally accepted workplace standard demonstrates social accountability when bidding for contracts and expanding your organisation.
Benefits of SA 8000 Certification
- Proves your commitment to social accountability and to treating your employees ethically and in compliance with global standards
- Improves the management and performance of your supply chain
- Allows you to ensure compliance with global standards and reduce the risk of negligence, public exposure and possible litigation
- Supports your corporate vision and build and reinforce the loyalty of your employees, customers and stakeholders
- Enables you to demonstrate proper social accountability when bidding for international contracts or expanding locally to accommodate new business
RoHS Certification
RoHS, short for Restriction of Hazardous Substances, is specific to the European Union. The law revolves revolves the handling of hazardous materials, ranging from the manufacturing to the disposal of the material. While created inside of Europe for members of the European Union, other regions around the world have utilized and created offshoots of the RoHS. This includes nations throughout Asia (China, Japan and South Korea) and versions of it inside of North America as well. Manufacturers of hazardous material must become RoHS compliant in order to sell and distribute the product inside of the European Union, which is exactly why it is so vital for a company to obtain these credentials. The specific process set in place to assist these companies is rather straight forward though, so it should not prove difficult to follow through with the RoHS certification and RoHS compliance regulations.
In order to obtain the certification, it is necessary to seek out a third party company that provides test reports of the material, material declarations directly from the supplier and what is known as a Declarations of Conformity. It is all about testing the material, making sure its housing, manufacturing and distributing is aligned with the set forward regulations of RoHS, When working with these third party organizations, they test the presence of different chemical compounds and components, including lead, mercury, cadmium, hexavalent chromium, polybrominated diphenyl ethers and polybrominated biphenyls.
Benefits of RoHS
- Increase of communication across the supply chain serves as a platform for the implementation of REACH and other initiatives.
- Tighter process control, overall reduced number of defects and increased production efficiency (contradicts information appearing elsewhere in the report)
- Increased skill levels in the global workforce due to retraining and the knowledge transfer to Asia and less developed countries (assumes that globalization is driven by RoHS). In addition, "Japanese people and knowledge are seeking inspiration in Europe and the US" (the condescension toward Japan is hard to understand given the statistics on innovation contained within the report).
- Less leaching in landfills because WEEE contains less hazardous material and increased incentives for recycling because lead-free solder contains silver and gold
- Pressure on other sectors (such as aerospace and IT industrial controls) and countries to move to cleaner processes and reduced use of hazardous materials (such as China RoHS and Korea RoHS)
- Competitive advantage for EU manufacturers in markets where RoHS legislation is pending or contemplated
ISO/IEC 17025
ISO/IEC 17025 is the global recognized standard that was developed specifically for testing and calibration laboratories that intended seeking accreditation. It is also the basis for accreditation from an accreditation body. The current release was published in 2005. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory namely competence of staff; environment control; testing methodology; equipment and measurement traceability; and reporting of test and calibration results.
Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements as well as at the same time are able to generate technically valid results for which they hold accreditation. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.
Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s symbol or endorsement, as an indication of their accreditation. Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation, issued by the accreditation body. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory or testing and calibration service. Laboratory accreditation bodies publish the scopes of accreditation for their accredited laboratories in either hardcopy directories or on the internet.
Benefits of ISO/IEC 17025 Certification
- Increase of confidence in Testing/ Calibration data and of personnel performing work.
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
- Potential increase in business due to enhanced customer confidence and satisfaction.
- Customers can search and identify the laboratories accredited by The Accreditation Member Body for their specific requirements from their website or Directory of Accredited Laboratories.
- Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
- Improved national and global reputation and image of the laboratory.
- Continually improving data quality and laboratory effectiveness.