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We are a Delhi, India based company, engaged in providing dependable solutions with our FCC certification services. When you choose as your FCC certificate procuring partner, you will receive assistance for everything right from the filling of application to the final approval of the certificate. FCC certification is mandatory for those electronic products that are either manufactured or sold in the US. It requires that the electromagnetic interference from the device is under the limits approved by the Federal Communications Commission.

Note : For any assistance and query, reach us through our website.

Use ISO 13485 :

• To establish a Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services.
• To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
• To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
• To become certified or registered.
• ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a Quality Management System (QMS) that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.

ISO 13485 Vs ISO 9001 :

• ISO 13485 is based on the ISO 9001 Quality Management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification.
• However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services.
• ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their Quality Management Systems, not to improve them. And customer satisfaction is excluded because committee members thought it was too subjective.

When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements, activities, and special arrangements. More precisely :

• When ISO 13485 wants you to document a procedure, the standard also wants you to implement and maintain it.
• When ISO 13485 wants you to document a requirement, the standard also wants you to implement and maintain it.
• When ISO 13485 wants you to document an activity, the standard also wants you to implement and maintain it.
• When ISO 13485 wants you to document an arrangement, the standard also wants you to implement and maintain it.

Whenever a procedure, requirement, activity, or special arrangement must be documented, it does so by explicitly asking you not only to document it but also to implement and maintain it. ISO 13485 also places a greater emphasis on the use of procedures to regulate and control how activities and processes should be performed. In this sense, ISO 13485 is somewhat more prescriptive than ISO 9001. ISO 9001 often leaves it up to you to decide how work should be controlled, whereas ISO 13485 seems to have removed some of this flexibility by insisting on the use of formal procedures. Since ISO 13485 is all about medical devices and related services, it of course adds many new requirements to address the specific needs of this industry such as ISO 14971 Risk Management.

Possible exclusions :

• ISO 9001 says that you may exclude or ignore some requirements if you can justify doing so. You can exclude section 7 product realization requirements if you cannot apply them because of the nature of your organization and its products. Similarly, ISO 13485 2003 says that you can exclude section 7 requirements if they are not applicable in your situation and does not violate the organization's medical devices statutory regulations.
• You may also exclude section 7.3 design and development if official regulations allow you to do so and if you have made alternative arrangements that comply with these regulations.
• Occasionally ISO 13485 uses the phrase “if appropriate? or “where appropriate? When a requirement uses this phrase, you may ignore or exclude it if you can justify doing so.
• Whenever you decide to exclude or ignore an ISO 13485 requirement make sure that you’ve got a good reason. Make sure you can justify and explain why, and make sure this explanation is documented in your quality manual.

How to develop a QMS :In order to become certified, you need to develop a Quality Management System (QMS) that complies with the ISO 13485 standard. But how do you do that? One common approach is to carry out a Gap Analysis. Such an analysis will identify the gaps that exist between the new standard and your organization's processes. Once you know exactly what and where your gaps are, you can take steps to fill them. And once all of your gaps are filled, your Quality Management System will be ISO 13485 compliant. By using this approach, you will not only meet the new ISO 13485 standard, but you will also improve the overall effectiveness of your Quality Management System. If you're currently ISO 13485:1996 or ISO 9001:2000 certified, you can call us to conduct Gap Analysis Tool on your Quality Management System to the new ISO 13485:2003 standard.
Once we've completed the Gap Analysis and filled all of the gaps, you're ready to ask a Registrar to audit the effectiveness of your Quality Management System. If your QMS meets ISO 13485:2003 requirements then the Registrar will then issue an official certificate to you and record your achievement in their registration.

• Identify your organization’s environmental aspects. Study normal and abnormal operating conditions, as well as accidents, disasters, and emergency situations. Identify the environmental aspects associated with all operating conditions and situations.
• Clarify the legal and other requirements that apply to your organization’s environmental aspects. Legal requirements include National and International as well as local and regional laws and regulations. Other requirements include agreements that have been established with governments, customers, community groups and others as well as commitments, guidelines, principles, or codes of practice that influence how your environmental aspects ought to be handled.
• Examine your organization’s current environmental management policies, procedures, and practices. Pay special attention to your organization’s purchasing and contracting policies, procedures, and practices.
• Define the scope of your EMS. When ISO 14001 asks you to define the scope of your EMS, it is asking you to define its boundary. You can choose to apply ISO 14001 to the entire organization or only to a specific operating unit or facility. Once you’ve made this decision, you’ve defined the scope or boundary of your EMS. Henceforth, all activities, products, and services that falls within this boundary must comply with the ISO 14001 standard.

Once you’ve considered the above factors, you can begin the development of your organization’s unique Environmental Management System. But if you’ve already established an EMS and you simply need to update it to meet the new standard, you need to do a Gap Analysis. A Gap Analysis will compare your current EMS with ISO’s new ISO 14001 standard. This comparison will pinpoint the areas that fall short of the standard (the gaps). Once you know where to focus your attention, you can begin to make the changes that are needed to comply with the new ISO 14001 standard.

What is HACCP? :Management Systems such as HACCP when granted by an International Registration Body provides organizations with the basic management requirements assisting in the implementation of effective food safety and good practices (cGMPs) and demonstrating to others. HACCP is endorsed by the United Nations “Codex Alimentarius? USA FDA - USDA, European Union, Canada, Australia, New Zealand, and Japan etc.
We provide recognized ISO 22000 Certification Services in most competitive fee. ISO 22000:2005 specifies requirements for a food safety management system. In this, an organization in the food chain needs to demonstrate its ability to control food safety hazards to ensure that food is safe at the time of human consumption and it can be accomplished through the use of internal and/or external resources. It enable an organization to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer. Also, to evaluate and assess customer requirements, we demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction.

What is ISO 22000? :

• The International Organization for Standardization (ISO) has developed the ISO 22000 Food Safety Management Systems Standard. Officially called ISO 22000, Food Safety Management Systems - Requirements for any organization in the food chain, ISO 22000 is an international standard and defines the requirements of a Food Safety Management Systems covering all organisations in the food chain from “farm to fork? including catering and packaging companies.
• There has been a continuous increase in consumer demand for safe food. This has led to the development of numerous food safety standards. The growing number of national standards for food safety management has led to confusion. Consequently, there is a need for international harmonization and ISO aims to meet this need with ISO 22000.
• 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; and continual improvement and updating of the management system.
• ISO 22000 is intended to define the requirements for companies that desire to exceed the regulatory requirements for food safety.

Who should use the standard? :As food safety hazards may be introduced at any stages of the food chain, adequate control throughout the food chain is essential. Thus food safety is a joint responsibility that is principally assured through the combined efforts of all the parties participating in the food chain.

ISO 22000 may therefore apply to, and not be limited to :

• Primary food producers through to food manufacturers, including food
• Retail and food service outlets
• Feed producers
• Transport operators and storage operators
• Producers of equipment and packaging material
• Producers of cleaning agents, additives and ingredients

Benefits to users :

• Benefits for organizations implementing ISO 22000 include :
  • Resource optimization - internally and along the food chain More efficient and dynamic food safety hazard control
  • All control measures subjected to hazard analysis
  • Better planning, less post process verification
  • Improved documentation
  • Saves resources by reducing overlapping system audits - how?
  • Systematic management of prerequisite programmes
  • Control focused on what is necessary
  • Widely applicable because it is focused on end results
  • Organized and targeted communication among trade partners (repeated below)
  • Valid basis for taking decisions
  • 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.

Further benefits include :

• Confidence that the organizations which are implementing the standard have the ability to identify and control food safety hazards
• Provides a reference for the whole food chain
• Contributes to a better understanding and further development of Codex HACCP
• System approach, rather than product approach
• Fills a gap between ISO 9001 and HACCP
• Provides a framework for third party certification
• Auditable standard with clear requirements
• Suitable for regulators
• Provides potential for harmonization of National standards.

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.

• Systematically examines the organization’s information security risks, taking account of the threats, vulnerabilities and impacts;
• Designs and implements a coherent and comprehensive suite of information security controls and/or other forms of risk treatment (such as risk avoidance or risk transfer) to address those risks that it deems unacceptable; and
• Adopts an overarching management process to ensure that the information security controls continue to meet the organization’s information security needs on an ongoing basis.

ISO 27001 Consultant – Benefits :

• The provision of a for resolving security issues
• Independently verifies that your risks are properly identified, assessed and managed, while formalizing information security processes, procedures and documentation.
• Enhancement of client confidence and perception of your organisation
• Provides confidence that you have managed risk in your own security implementation
• Enhances security awareness within an organisation
• The regular assessment process helps you continually monitor and improve your ISMS.

How can Sai Quality Certification help to get ISO 27001 Consultant? :full-time trainers and consultants having huge international experience and exposure in ISO 27001:2005 ISMS certification, implementation and training.

ISO 14001 is an Environmental Management Standard (EMS). It defines a set of environmental management requirements for environmental management systems. The purpose of this standard is to help all kinds of organizations to protect the environment, to prevent pollution, and to improve their overall environmental performance. ISO 14001 certification provides an organization’s customers, suppliers, employees and other stakeholders with evidence of the operations commitment to environment protection.
Since it was first published in 1996, ISO 14001 has rapidly become the most important environmental standard in the world. Thousands of organizations use it, environmentalists support it, and governments actively encourage its use. ISO 14001 applies to all types of organizations. It doesn’t matter what size they are or what they do.

Benefits of ISO 14001 :

• ISO 14001 drives protection of environment and help organizations :
  • Reduce costs and increase profit through reduced waste and energy, reuse and recycle through 3R concept.
  • Optimize use of resources (electrical, water and materials).
  • Increase competitiveness.
  • Reduce costs as a result of potential lower insurance rates.
  • Environmentally responsible and commitment to environment protection.
  • Cost saving through improved efficiency and productivity.
  • Boost company’s public image.

   

How to use ISO 14001 :If you don’t already have an Environmental Management System (EMS), you can use this ISO 14001 standard to establish one. And once you’ve established your EMS, you can use it to manage the environmental aspects of your organization’s activities, products and services, and to improve its overall environmental performance. Environmental performance is all about how well you manage and control your environmental aspects and the impact they have on the environment.
You can also use this standard to demonstrate that you are doing everything you can to protect the environment and improve your environmental performance. You can demonstrate your organization’s commitment in several ways :

• You can simply announce to the world that your EMS complies with the ISO 14001 standard (if it actually does).
• You can ask your customers or other interested parties to confirm that your EMS complies with the ISO 14001 standard.
• You can ask an ISO 14001 registrar or external auditor to verify that your EMS complies with the ISO 14001 standard.

ISO 14001 expects organizations to comply with all of the requirements that make up the standard. No exceptions. According to ISO, every ISO 14001 requirement must be built into every EMS. However, the size and complexity of Environmental Management Systems vary quite a bit.
How far you go is up to you. The size and complexity of your EMS, the extent of your documentation, and the resources allocated to it will depend on many things. How you meet each of the ISO 14001 requirements, and to what extent, depends on many factors, including :

• The size of your organization
• The location of your organization.
• The scope of your organization’s EMS.
• The content of your environmental policy.
• The nature of your activities, products, and services.
• The environmental impact of your environmental aspects.
• The legal and other requirements that must be met.

Your general approach :

• If you don’t already have an EMS, ISO 14001 suggests that you start with a review of your organization’s environmental status. Your environmental review should :
  • Identify your organization’s environmental aspects. Study normal and abnormal operating conditions, as well as accidents, disasters, and emergency situations. Identify the environmental aspects associated with all operating conditions and situations.
  • Clarify the legal and other requirements that apply to your organization’s environmental aspects. Legal requirements include National and International as well as local and regional laws and regulations. Other requirements include agreements that have been established with governments, customers, community groups and others as well as commitments, guidelines, principles, or codes of practice that influence how your environmental aspects ought to be handled.
  • Examine your organization’s current environmental management policies, procedures, and practices. Pay special attention to your organization’s purchasing and contracting policies, procedures, and practices.
  • Define the scope of your EMS. When ISO 14001 asks you to define the scope of your EMS, it is asking you to define its boundary. You can choose to apply ISO 14001 to the entire organization or only to a specific operating unit or facility. Once you’ve made this decision, you’ve defined the scope or boundary of your EMS. Henceforth, all activities, products, and services that falls within this boundary must comply with the ISO 14001 standard.

   

Once you’ve considered the above factors, you can begin the development of your organization’s unique Environmental Management System. But if you’ve already established an EMS and you simply need to update it to meet the new standard, you need to do a Gap Analysis. A Gap Analysis will compare your current EMS with ISO’s new ISO 14001 standard. This comparison will pinpoint the areas that fall short of the standard (the gaps). Once you know where to focus your attention, you can begin to make the changes that are needed to comply with the new ISO 14001 standard.

The ISO/TS 16949 was jointly developed by the International Automotive Task Force (IATF), whose vehicle manufacturer members include: BMW, Daimler-Chrysler, Fiat, Ford, General Motors (including Opel Vauxhall), PSA Peugeot-Citron, Renault SA, Volkswagon and their respective trade associations - AIAG (USA), ANFIA (Italy), FIEV (France), SMMT (UK) and VDA (Germany).
The newly formed International Automotive Oversight Bureau (IAOB) in Southfield, Michigan USA is responsible for the implementation and registration process of ISO/TS 16949 and providing support to the IATF. ISO/TS 16949 is an automotive quality system requirement catalogue based on ISO 9001:2000, QS9000 3rd Edition (U.S.), AVSQ (Italian), EAQF (French) and VDA6.1 (German) automotive catalogues.
ISO/TS 16949, when coupled with customer specific requirement, will be recognised by IATF members as the global equivalent to the existing automotive standards. This would benefit those companies who trade with multiple International Automotive Companies. However, those companies who deal solely with North America and Europe vehicle manufacturers need only certify to ISO/TS16949. N.B. ISO/TS 16949: 2002 does not replace QS9000, AVSQ, EAQF, VDA6.1. Tooling & Equipment suppliers should continue to use Quality System Requirements TE supplement second edition.

ISO/TS 16949 Implementation Guide :Suppliers are required to transition to ISO/TS 16949 by December 14th 2006 or as specified by their customer. The weakest part of QS9000 was the implementation of the standard, both from a supplier and registrar's perspective.

How this document fills the need :This implementation guide gives us an opportunity to improve ISO/TS 16949 implementation based on lessons learned from QS9000 by :

• Defining what's new and different between QS9000 Third Edition and ISO/TS 16949
• Providing an explanation of the process approach
• Developing strategies for implementation
• Explaining pitfalls to avoid

Supporting documents for ISO/TS 16949 :

• Rules for Achieving Iatf Recognition :
  • This contains the requirements or “Rules for the automotive registration scheme for ISO/TS 16949 certification bodies?with regard to implementation including criteria for certification body recognition, certification body audit process, certification body auditor qualifications and, certificates. For certification bodies that are recognised by IATF for ISO/TS 16949 certification, these requirements are binding.

IATF Guidance to Iso/ts 16949 :This document is limited to providing assistance in the application of ISO/TS 16949. It is not intended as a requirement for certification and is for reference only. It supports the ISO/TS 16949, with examples, applications, practices or explanations. This guide is intended to apply to sites of organisations where production and/or service part specified by the customer are manufactured. It may also be applied to organisations throughout the automotive supply chain.

(QMS) Checklist Based On Process Audit Approach :This document is based on the content of ISO/TS 16949 and it is effective for the life of this standard. This checklist is to be used as a guide in auditing the requirements of ISO/TS 16949.

HACCP Certification Service HACCP stands for Hazard Analysis Critical Control Point. HACCP system that includes a series of procedures for process control and sensitive points in the food chain, with the ultimate aim that the consumer uses the food in the state and in a manner that will be safe for his health. HACCP system in seventies became recognized as an international standard for food production. The certification process for HACCP is similar to any other certification schemes. This process is divided into 5 steps: Preparation of HACCP Development of HACCP plan Implementation of HACCP plan HACCP certification the system by the international certification body Maintenance and monitoring of the HACCP system

HACCP Principals : The implementation of hazard analysis Determine Critical Control Points (CCP). For each risk identified. Establishing critical limits, maximal and/or minimum value, by which biological, chemical and physical hazards in order to control the pedagogical prevention. Determination of procedures/processes for monitoring CCPs Determination of corrective measures in case the monitoring shows that the CCP is not within the critical limits. Establish procedures/processes for verification and certification procedures and the HACCP system is effective and it works well. The verification activities should be included authorized persons employed in production, the HACCP team. The establishment and effective management of records and documents

The CE marking 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. 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 27 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.

General principles of the CE marking :

• The CE marking shall be affixed only by the manufacturer or his authorised representative.
• The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
• By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
• The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation 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.

How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?:

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents - Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.  Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).

Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below :

• Module A - internal production control
• Module Aa - intervention of a Notified Body
• Module B - EC type-examination
• Module C - Conformity to type
• Module D - Production quality assurance
• Module E - Product quality assurance
• Module F - Product verification
• Module G - Unit verification
• Module H - Full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Minimal Risk :Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Greater Risks :Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.

A Notified Body is usually able to offer some of the services required :

• Product testing
• Type examination certificate issue
• Technical File and design dossier evaluation
• Surveillance of product and quality system
• Identification of standards

ROHS of European Union harmful material limit use instruction ) have put into effect in July 1, 2006, beginning from this day, all electronic electrics in European sales must accord with the strict stipulation in instruction in equipment with the content of harmful material. Face new rule, enterprise do not when final juncture just face old mill gun, it is lucky to be more unfit for heart to store, ask horse the first line of a couplet on a scroll to be BEST, we can offer for you the sales that most accord with the accordance solving schema of economic benefits and ensure your product , do not get the influence of this instruction! This instruction stipulates , the lead Pb, cadmium Cd, mercury Hg and 6 price chromium Cr6s in the electronic electrical product of European sales + , much Xiu unite benzene PBBs , much Xiu unite benzene Mi PBDEs 6 kinds of harmful material restrict , afterwards, will also carry out restriction for more harmful material.

What is RoHS? : RoHS is known as the Restriction of Hazardous Substances Directive. It restricts the usage of six specific hazardous substances in the manufacture of certain electronic products.

When was RoHS released? : RoHS was initially released in 2003.

Who released RoHS? : RoHS was released by the European Union.

The Electrical and Electronic Equipment Act :This Directive bans placing on the EU market electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, Hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.
Product categories covered are household appliances (large & small), IT & telecommunications equipment, consumer equipment, lighting equipment, electrical / electronic tools, toys / sports equipment, medical devices, monitoring / control instruments and automatic dispensers.

Our Services :

• Analysis of Lead, Cadmium, Mercury, Hexavalent Chromium, PBB’s & PBDE’s :
  • We can take up testing of products, sub assembly, parts and raw materials to verify compliance and issue compliance test report by interpreting against requirements of directive
  • RoHS certification and issue attestation of conformity / COC RoHS Factory Inspection / Process Certification SSI RoHS Mark Training / Awareness on RoHS

ISO 17025 is the equivalent of ISO 9000 for calibration and testing laboratories. It applies to any organization that wants to assure its customers of precision, accuracy and repeatability of results. This includes in-house laboratories for which assurance of results is at a premium.
The growth in use of Quality Systems generally has increased the need to ensure that laboratories that form part of larger organizations or offer other services can operate to a Quality System that is seen as compliant with ISO 9000 as well as with ISO 17025. Testing and calibration labs that comply with this standard will also operate in accordance with ISO 9000. Certification to ISO 9000 alone does not demonstrate the competence of the lab to produce technically valid data and results, whereas certification to ISO 17025 does provide that evidence.
QS 9000, the Automotive Quality Management System, and its successor, TS16949, have stipulated that first tier suppliers of calibration and test services be ISO 17025 certified, and that suppliers upstream of them be compliant.

What is ISO 17025? :ISO 17025 was developed so that testing & calibration laboratories were recognized for their capabilities & areas of competence. All measurements and decisions should be based on accurate, repeatable, verifiable, cost effective, timely, and believable measurements, opinions, and recommendations. ISO 17025 helps assures this happens first time, every time, and on-time.
Without these assurances, the data, opinion, and recommendations are immediately suspect, questionable, risky, and of greatly reduced value and usability.
Customers should ensure that all data and opinions upon which they rely can be traced back through an unbroken chain of data based on ISO 17025.

Overview of ISO 17025 :ISO 17025 is one of the most popular quality standards for all laboratories; whether or not they do business with international customers. In 1891, British physicist Lord Kelvin wrote, “When you can measure what you are speaking about, and express it in numbers, you know something about it.? Mikel Harry, a noted Six Sigma authority, extends this thought as, “We don't know what we don’t know; we can’t act on what we don’t know; we won’t know until we search; we won’t search for what we don’t question; we don’t question what we don’t measure?. Both imply that if you failed to quantify the results of what you were doing, in a way, it means that you might not understand what you were really doing. Hence, organizations that are unable to track their processes, their products, or their raw materials are unable to fully manage their businesses.
All other quality initiatives (eg. ISO 9001, QS-9001, TS-16949, Six Sigma, TQM, DOE, QFD, etc.) depend on reliable measurements, comparisons, and recommendations based on International Standards. ISO 17025 controls all aspects of how laboratories conduct their business (ie. who, what, when, where, how, how much, & why) of measurement, testing, certifying, recommending, & reporting.

ISO 17025 Success Factors :

• Research into what makes a ISO 17025 implementation a success has revealed 11 Critical Success Factors. They are, in order of importance :
• Top management leadership & commitment
• A simple, comprehensive implementation plan
• Training & support for everyone involved or affected by the implementation project
• Buy-in and voluntary support & commitment from a critical mass of people (>1 person, building to 25% of employees)
• Early successes that clearly prove that ISO 17025 will benefit customers, suppliers, management, and especially workers
• Adequate resources and time to achieve all that needs to be done
• Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done
• Expert, pre-experienced advise, coaching, cheerleading, pre-warnings, and technical expertise on ISO 17025 implementation.
• Auditing, training, and remedial assistance to achieve consistent compliance to minimum requirements.
• Dress-rehersal audit, final fixes, then formal Registration Audit by Accredited Registrar
• Continuous assessment, improvement, and re-registration of systems.

How SSI Cert can help with you ISO 17025 Implementation? :

• Executive Overview Training for ISO 17025
• Project Planning, Scheduling, & Management
• Worker Training
• Generic Templates for Policies, Procedures, Process Maps, and Documentation Systems
• Statistical Data Analysis of 7 Characteristics of a Metrology System
• Repeatability5
• Reproducibility
• Linearity
• Bias
• Hysteresis
• Accuracy
• Granularity
• Calibration Models
• Inter-Lab Calibrations
• Reducing measurement system sensitivity to Operator, Environmental, Common cause, and Special Causes
• Developing Customized tests and measurement criteria.
• Error Reduction Investigations & Program Implementations
• Management Reviews for Accountability, Cost Reduction, and Independent (Third Party) Verification

ISO 9001 standard deals with the fundamentals of quality management systems with the eight management principles as the base. ISO 9001 standard is one of the most widely used management tools across the globe. The ISO 9001 standard is generic in nature and is applicable to any sector regardless of type, size and product or service. The ISO 9001 standard is basically adopted from the MIL standards, later released as an ISO standard in 1987. First revision in 1994, second revision in 2000, third revision in 2008 (presently in use) The ISO 9001 standard requires six mandatory procedures and numerous records in any organization as a requiremen.

Main Requirements of the ISO 9001 Standard :

• Clause 1. Scope
• Clause 2. Normative References
• Clause3. Terms and Definitions
• Clause 2. Normative References Clause3. Terms and Definitions Clause 4. Quality Management System (2 Elements) Clause 5. Management Responsibility (6 Elements) Clause 6. Resource management (4 Elements) Clause 7. Product / Service Realization (6 Elements) Clause 8. Measurement, Analysis and Improvement (5 Elements)
• Clause 2. Normative References Clause3. Terms and Definitions Clause 4. Quality Management System (2 Elements) Clause 5. Management Responsibility (6 Elements) Clause 6. Resource management (4 Elements) Clause 7. Product / Service Realization (6 Elements) Clause 8. Measurement, Analysis and Improvement (5 Elements)
• Meet your needs and expectations
• Comply with applicable regulations

The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides. ISO 9001 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, National or International product standards, supplier’s catalogues or other documents as appropriate.

What does "Conformity to ISO 9001 mean? :This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How does ISO 9001 help you in selecting a supplier? :ISO 9001 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics -  Requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs. the ways in which supplied products can be verified as meeting the requirements of the customer.
Note that whenever ISO 9001 refers to “products? this also includes intangible products like services, or software.You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.

To help in this task you may consider the following :

• What is the specific product (goods or service) you are buying?
• What impact does this product have on your own business?
• What are the risks to your business if you experience problems with this product?
• How can you be sure that the product you receive will actually meet your requirements?
• What do you know about the reputation and historical performance of your supplier?
• What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
• If you decide that conformity to ISO 9001 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001 requirements?
• Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)

How can you have confidence that your supplier meets ISO 9001? :

• There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001. These include :
• Supplier’s declaration of conformity? A declaration by your supplier itself affirming that its QMS meets ISO 9001 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits;
• Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001 requirements and your own requirements - sometimes used in contractual “business-to-business?transactions;
• Third party assessment: (often referred to as certification or registration): your supplier hires an impartial third party (a Certification Body, or “Registrar? to conduct an assessment to verify conformity to ISO 9001 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001
• Additional confidence may be derived from the fact that some Certification Bodies (“Registrars? are accredited by nationally or internationally recognized Accreditation Bodies, who verify the certification body’s independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.

Can suppliers claim that their goods or services meet ISO 9001? :No. The reference to ISO 9001 indicates that the supplier has a quality management system that meets the requirements of ISO 9001. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.

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.

How can DBS CERT help?

• DBS CERT consists of full-time trainers and certification with a unique combination of manufacturing experience, business and financial expertise,
• A “hands-on” approach creates a recipe for our clients’ success.
• System Study, Documentation-GMP Manual Preparation, Records Implementation, GMP Trainings, Internal Audits.

 
Clients choose us! :

• Bring world-class quality standards to your business :
  • Specialized in ISO certification, ISO Documentatiom, ISO Record, Iso Implementation, ISO Internal Auditing, ISO Certification, CE Marking, Training-Internal Auditing / is based in Mumbai, delhi, nce, India, Singapore, Tanzania, Nigeria, UK, Saudi Arabia, Sri Lanka, UAE

Halal certificate issued by the Board is an assurance that a particular product has been thoroughly investigated and found to conform to the Islamic Shariah Laws and therefore is suitable for use by Halalconsumers. all is any object or an action which is permissible to use or engage in, according to Islamic law.The term covers and designates not only food and drink but also all matters of daily life Halal is an Arabic word meaning lawful. It refers to things or actions permitted by Shariah law without punishment imposed on the doer. As a concept, halal does not only pertain to food. Halal means permissible and can refer to any aspect of life covered by the teachings of Islam. Halal is a part of sharia as a system of morals to guide Muslims' actions and behaviour, but this should not be confused with halal as part of a codified system of sharia law. Classification of food products as Halal is a very serious and can only be carried out by a Muslim who is an expert in the Islamic dietary laws. The Islamic dietary laws define what food and drinks are Halaal. These Islamic dietary laws are defined in the Holy Quran (the revealed book), the Hadith (sayings of the last Prophet, Muhammad, Peace and blessing of Allah be upon him) and in the fiqh (jurisprudence) of the Muslim Jurists - Hanafi, Shafii, Maliki and Hanbali. World Quality Certification will arrange Halal certification through different prominent Halal certification agencies(Indian or foreign organisations). So contact us today for Halal certification.

We are a pre-eminent organization in Delhi (India), offering prompt services to various organizations. GMP stands for good manufacturing practice. WHO-GMP Certification ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. We offer WHO-GMP Certification Services in compliance with the international standards. To render our prompt services, we have hired an adept team of professionals, which helps us in the timely execution of our services. Our services are known for their hassle-free execution. We charge very nominally for our result-oriented services.

We are one of the leading names in Delhi (India), indulged in offering BIFMA Certification Services to our valuable clients. The full form of this abbreviated word is Business and Institutional Furniture Manufacturer's Association. Since 1973, BIFMA has been the voice of the commercial furniture industry. Our BIFMA Certification Service based on different attributes of a specific furniture product. We work with an adept team of professionals who helps us to render our services in the most efficient ways. We charge very nominally for our customer centric services.