Services

• CE Marking
• FDA 510 k approval
• NABH
• NABL
• ISO 9000, ISO 14000, ISO 22000, ISO 13485, ISO TS/16949, ISO 27000, SA 8000, OHSAS, RFA.
• GMP
• BRC
• School Accreditation

CE Mark

We have the expertise in helping organization to achieve CE marking for their product as per any EU directive in the shortest possible time. Our aim is to help our client in making the CE marking process simple, transparent and cost effective.

We guide you in

• Determine which directive is applicable to your product
• Classify your product
• Determine your certification process based on your device class
• Identify any Harmonized European Standards applicable to your product
• Fulfill the essential requirements
• Preparation of technical file
• Maintain Technical Documentation required by the Directive
• Risk analysis on your product
• Compliance with labeling requirements
• Prepare the Declaration of Conformity and the required supporting evidence
• Testing of your product to establish device safety
• Arranging EU representative
• Identification of right notified body
• Affix CE marking on your product

What is CE Marking?

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters 'CE' are an abbreviation of Conformité Européenne, French for European conformity.

CE marking can be regarded as the products trade passport for Europe.

For further details on CE mark please visit
www.ec.europa.eu/enterprise/faq/ce-marking_en.htm

FDA 510 (k) approval

What is 510 (k)

A 510(k) is a premarket submission made to US FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device in the US market.

We guide you in

• Identify the device classification
• Find out product code and regulation number
• Establishment registration with US FDA
• Device Listing with USFDA
• Identification of predicate device
• Identification of test requirements
• Identification testing lab
• Preparation of 510( k ) documents
• Electronic transfer of payment to USFDA
• Submission of 510(k) document

We can arrange US agent for your organization at attractive rate

For further details on USFDA 510 k Please visit
www.fda.gov

NABH

NABH stands for "National Accreditation Board for Hospitals & Healthcare providers" Organisations like the Quality Council of India [QCI] and its National Accreditation Board for Hospitals and Healthcare providers [NABH] have designed an exhaustive healthcare standard for hospitals and healthcare providers. This standard consists of stringent 500 plus objective elements for the hospital to achieve in order to get the NABH accreditation.

To comply with these standard elements, the hospital will need to have a process-driven approach in all aspects of hospital activities – from registration, admission, pre-surgery, peri-surgery and post-surgery protocols, discharge from the hospital to follow-up with the hospital after discharge

NABH is equivalent to JCI and other International standards including HAS: Haute Autorite Sante, Australian Council on Healthcare Standards ,SHQS, Finland , Japan Council for Quality in Health Care , National Committee on Quality Assurance, NCQA, USA.

For further details on NABH please visit
www.qcin.org/nabh/index.php

National Accreditation Board for Testing and Calibration Laboratories (NABL)

The National Accreditation Board for Testing and Calibration Laboratories (NABL) undertakes the assessment and accreditation of Testing and Calibration Laboratories, in accordance with the international standard ISO / IEC 17025 and ISO 15189.

Achievements & International Linkages

The Board is a signatory of Mutual Recognition Arrangement (MRA) of International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Laboratory Accreditation Co-operation (APLAC).

For more information logon to NABL website :
www.nabl-india.org

ISO

ISO stands for International Organization for Standardization, created in 1947. It is a worldwide federation of “Member Bodies” (i.e, National bodies Government Institution or Organization incorporated by Public Law) with its headquarters at Geneva, Switzerland. India is represented by BIS (Bureau of Indian Standards).

If your organization is considering implementing a quality management system, the time is just right! As the industry starts to recover, your considerably improved system and processes and new registration status will significantly increase your chances to get new business.

We at QMS are ready to assist you with services exactly designed to meet upgrading, maintenance or new implementation needs. Contact us today for a FREE procedure on implementing an ISO standard  in your organization.

ISO 9001:2008

We provide affordable custom tailored Coaching, Training and Consulting in the design and implementation of ISO 9000:2008 Quality Management Systems.

The Design, Accreditation and Running of an ISO 9000 QMS can place heavy burdens on the limited resources of Small and Medium size Enterprises and Business Units (SME's). Our unique.

For more information log on to
www.iso.org

ISO 14001:2004

ISO 14001 is a standard for environmental management systems to be implemented in any business, regardless of size, location or income. The aim of the standard is to reduce the environmental footprint of a business and to decrease the pollution and waste a business produces. The most recent version of ISO 14001 was released in 2004 by the International Organization for Standardization (ISO) which has representation from committees all over the world. The ISO 14000 environmental management standards exist to help organizations minimize how their operations negatively affect the environment. In structure it is similar to ISO 9000 quality management and both can be implemented side by side. In order for an organisation to be awarded an ISO 14001 certificate they must be externally audited by an audit body that has been accredited by an accreditation body

For more information log on to
www.iso.org

ISO 13485:2003

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they should demonstrate the quality system is implemented and maintained. Other specific differences include:

• The promotion and awareness of regulatory requirements as a management responsibility, will providing resources and during reviews. An example of the market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States & and Schedule’M’ Requirements related to manufacturing of Medical Device in India.
  
• Controls in the work environment to ensure product safety
• Focus on risk management activities and design transfer activities during product development
• Specific requirements for inspection and traceability for implantable devices
• Specific requirements for documentation and validation of processes for sterile medical devices
• specific requirements for verification of the effectiveness of corrective and preventive actions

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488 by a Conformity Assessment Body (CAB)

CMDCAS QMS Requirements

You will need to establish and maintain a Medical Quality Management System compliant with ISO 13485:2003 and with the quality system requirements of the Medical Devices Regulations (MDR).

A Registrar accredited to the Canadian Medical Devices Conformity Assessment System (CMDCAS) scope must register the Medical Quality Management System before you apply for a medical device license.

The scope of your Medical Devices Regulations (MDR) compliant Medical Quality Management System depends on the classification of your device.

ISO TS/16949

The aim of ISO/TS16949 is the development of a quality management system that provides for continual improvement, emphasizing defectprevention and the reduction of variation and waste in the supply chain. TS16949 applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. It is based on ISO9000.

The requirements are intended to be applied throughout the supply chain. For the first time vehicle assembly plants will be encouraged to seekISO/TS16949 certification.

If your company wishes to have QMS  drive the implementation to comply and be certified with ISO/TS 16949:2002, we offer an implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. We will provide and generate all the required documentation to meet the requirements of the standard. The implementation usually involves streamlining and simplification of your operation to take full advantage of the benefits of the standard, as well as training on the core tools such as:

• Statistical Process Control (SPC).
• APQP/CP: Advanced Product Quality Planning and Control Plans).
• PPAP: Production Part Approval Process.
• FMEA: Failure Mode and Effects Analysis.
• MSA: Measurement Systems Analysis.

ISO 22000:2005/HACCP

Increasing consumer demand for safe food has led many companies to develop both food quality and safety management systems, based on the Hazard Analysis and Critical Control Point (HACCP). In 2001, ISO started the development on an auditable standard, which further defines HACCP’s role in food safety management systems and culminated in the newly formed ISO 22000. The ISO 22000 standard intends to define the food safety management requirements for companies that need to meet and exceed food safety regulations all over the world. One standard that encompasses all the consumer and market needs. It speeds and simplifies processes without compromising other quality or safety management systems.

ISO 22000 is an international certification standard that defines the requirements of food safety management systems. It can be used by all organisations, in the supply chain - from farmers to food services, to processing, transportation, storage, retail and packaging.

ISO 22000 creates a harmonised safety standard that’s accepted the world over. By integrating multiple principals, methodologies and applications, ISO 22000 is easier to understand, apply and recognise. That makes it more efficient and effective as an entry-to-market tool than previous combinations of national standards.

ISO 22000 specifies the requirements for a food safety management system that combines well-recognized key elements to ensure food safety along the food chain, up to the point of final consumption:

• Provide interactive communication, internationally and across the supply chain
• Compliance with the HACCP principles – Hazard Analysis, Identify Critical Control Points (CCP’s), Establish Critical Links, Monitor CCP’s, Establish Corrective Action, Record Keeping, Verification.
• Harmonise the voluntary and prerequisite standards.
• 4Create a structure that’s aligned with ISO 9001:2000.
• System management.
• Process control.

GMP

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

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

BRC CERTIFICATION

The British Retail Consortium is the lead trade association representing the whole range of retailers, from the large multiples and department stores through to independents, selling a wide selection of products through centre of town, out of town, rural and virtual stores.

The BRC Global Standards are a leading global product safety and quality certification program used throughout the world by over 14,000 certificated suppliers in over 90 countries

The BRC has produced a series of Best Practice and Standard Specific Guidelines to accompany the BRC Global Standards. It is vital for retailers and brand owners to have confidence in their suppliers and equally important for suppliers to demonstrate the quality, safety and legality of their products and services to retailers. The BRC's range of Guidelines enables both retailers and suppliers to achieve their aim by providing these simple 'how to' guides to assist companies to meet the relevant BRC Global Standards requirements.

The best practice guidliness

• Complaint Handling Issue
• Foreign Body Detection Issue
• Internal Audit Issue
• Pest Control
• Traceability Issue
• Product Recall

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