System Certifications

ISO 9001: 2008  Quality Management System
ISO 9001: 2008 is a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements. It emphasizes on customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

ISO 13485: 2003 Quality Management System (Regulatory Requirements for the Medical Devices)

ISO 13485 represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 certification is the first step in achieving compliance with European regulatory requirements.

ISO 14001: 2004 Certification Environment Management System

ISO 14000 applies to environmental aspects, upon which the organization has control over and is expected to have an influence.

ISO 14001 is an internationally recognised standard, which specifies requirements for an environmental management system. The standard requires an organization to formulate environmental policy and objectives, taking into account legislative requirements and information about significant environmental impacts.

OHSAS 18001:2007 (Occupational Health & Safety Standard)

OHSAS 18000 is to help an organization to control occupational health and safety risks. It was developed in response to widespread demand for a recognized standard against which to be certified and assessed.

OHSAS, essentially helps the organisation minimise risk to employees, improve an existing OH&S management system, demonstrate diligence, gain assurance besides a number of other benefits.

HACCP (Hazard Analysis and Critical Control Point)

Hazard Analysis and Critical Control Point or HACCP is a Systematic Quality Method for the Food, Dairy Products and Beverage Industry including services to detect and control the possible chemical, physical and biological hazards within a process.

It involves the following elements:

Ÿ Analyze hazards
Ÿ Identify critical control points
Ÿ Establish preventive measures with critical limits for each control point
Ÿ Establish procedures to monitor the critical control points
Ÿ Establish corrective actions to be taken when monitoring shows that a critical limit has not been met
Ÿ Establish procedures to verify that the system is working properly
Ÿ Establish effective record keeping to document the HACCP system

ISO 22000: 2005 Food Safety Management System

ISO 22000: 2005 is an internationally recognised standard specifically developed for the Food Industry. The standard aims to harmonise the requirements for food safety management throughout the food supply chain.

ISO 22000 is the only internationally recognised standard for the food industry, covering all organisations in the food chain from farmers to catering and defines the requirements of a food safety management system.

cGMP

"cGMP," stands for "current Good Manufacturing Practice," and is an extension of GMP. As per cGMP, it is necessary for the manufacturers, processors and packagers of drugs, medical devices, food and blood, to employ technologies and systems that are up-to-date in order to comply with the existing regulations. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors

WHO GMP (Good Manufacturing Practices for Pharmaceuticals and Medical Devices)

WHO 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 including:

Ÿ Defined manufacturing process
Ÿ Validated critical manufacturing steps
Ÿ Suitable premises, storage, transport, qualified and trained production and quality control personnel
Ÿ Adequate laboratory facilities
Ÿ Approved written procedures and instructions
Ÿ Records to show all steps of defined procedures have been taken
Ÿ Full traceability of a product through batch records and distribution records
Ÿ Systems for recall and investigation of complaints

5-S (Effective Work Place Organization and Standardized Work Procedures)

The 5S Philosophy focuses on effective work place organization and standardized work procedures. 5S simplifies the work environment, reduces waste and non-value activity while improving quality, efficiency and safety.

It takes into account the following aspects:

Ÿ Space crowded with parts and tools
Ÿ Unneeded items stacked between workers
Ÿ Excess inventory on the floor
Ÿ Excess items and machines make it difficult to improve process flow
Ÿ Equipment is dirty and a collection point for miscellaneous materials
Ÿ Needed equipment such as tools are difficult to find

GLP (Good Laboratory Practices)

Good Laboratory Practice (GLP) is an internationally recognised set of principles, which provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.

Laboratories undertake studies to generate data, on the basis of which, hazards and risks to users, consumers and others including environment, can be assessed. Studies can be conducted on a variety of subjects including pharmaceuticals, agrochemical, veterinary medicines, industrial chemicals, cosmetics, food, food additives and biocides.

GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when

The various elements of GLP includes the following:

Ÿ Standard Operating Procedures (SOP)
Ÿ Statistical procedures for data evaluation
Ÿ Instrumentation validation
Ÿ Reagent/materials certification
Ÿ Analyst certification
Ÿ Lab facilities certification
Ÿ Specimen/Sample tracking

ISO 17025 Good Laboratory Practices for Testing and Calibration Labs

ISO 17025 is the Management system that refers to the organization's structure for managing its processes or activities that transform inputs of resources into a product or service. The organization's objectives can be classified as satisfying the customer's quality requirements, complying with regulations or meeting environmental objectives.

ISO 17025 incorporates all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.

ISO/TS 16949: 2002 Quality Management System for Automotive Components and Automobile Manufacturers

ISO/TS 16949 QMS defines the quality management system for the design, development, production and wherever applicable, installation and service of automotive related products. The main aim of the system is to have continual improvement, emphasizing defect prevention and reduction of variation and waste in the supply chain.

ISO/TS 16949 QMS technical specification is applicable to sites of the organization where customer specified parts, for production and/or service, are manufactured. And it differs from other ISO standards in two important ways: it is restricted to automotive companies and their suppliers; and it requires compliance with a customer's requirements worldwide, not just regionally.

ISO 27001: 2005 Information Security Management Systems

ISO 27001 is the international best practices, the organisations follow for the secured management of information. It specifies measures, what effects they have and how to implement them.

The standard defines the desired best practice methods for controlling (Protecting) information - Confidentiality, Integrity & Availability and it requires to be audited and registered by a third party Certification Body.

In today's IT driven world, organisations are seeking to demonstrate to their stakeholders, business partners and customers, some form of 'fit for purpose' assurance regarding their information security.

CMMI (Capability Maturity Model Integration)

Capability Maturity Model Integration (CMMI) is a process improvement system that provides organizations with the essential elements of effective processes. It can be used to guide process improvement across a project, a division or an entire organization.

CMMI helps integrate traditionally separate organizational functions, set process improvement goals and priorities, provide guidance for quality processes, and provide a point of reference for appraising current processes.

SA 8000 (Social Accountability)

SA 8000 is an International Standard for Social Accountability and is developed by Social Accountability International (SAI). The objective of SA 8000 is to ensure ethical sourcing of goods and services. SA 8000 is a voluntary standard and can be applied to any size of organization or business across all industries.

SA 8000 is used around the world to assure just and decent working conditions by protecting widely accepted labour rights. SA 8000 sets basic standard for:

Ÿ Child Labour
Ÿ Forced Labour
Ÿ Health and Safety
Ÿ Freedom of association and the right to collective bargaining
Ÿ Discrimination
Ÿ Working Hours
Ÿ Compensation.

Kaizen Japanese Management Concept for Incremental (Gradual, Continuous) and Change (Improvement)

Kaizen Japanese Management Concept for Incremental (Gradual, Continuous) Change (Improvement)

Ÿ Teamwork
Ÿ Personal discipline
Ÿ Improved morale
Ÿ Quality circles
Ÿ Suggestions for improvement

The basic principle used in the implementation of Kaizen concepts are:

Ÿ Human resources are most important company assets
Ÿ Bringing gradual improvement in the processes rather than making radical changes
Ÿ Improvement based on statistical evaluation of process performance

Six-Sigma

Six Sigma is a business process that allows companies to drastically improve their profitability. Six Sigma is a highly controlled methodology. It demands that you choose only the very best projects that meet your company's goals. And once they are chosen, it demands that the proper resources be dedicated to it. It requires the project be put through an entire process called DMAIC (Define, Measure, Analyze, Improve & Control).

BRC - British Retail Consortium.

Companies exporting to UK have to reach the BRC's standards and need to be certified against their stringent requirements.

Ace Group Worldwide provides you, training, consultancy - documentations, implementation as well as audits.

IFS - International Food Safety.

This is Quality and Safety Standard published by the Union of German supermarket chains.

Ace Group Worldwide provides you, training, consultancy - documentations, implementation as well as audits.

US FDA (21 CFR)

FDA 510K Clearance

For medical devices classified as Class II and III, a 510K clearance is necessary in order to market the product in the US. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use. Ace Group Worldwide can provide training on GMP and assist in the filing the 510K clearance application, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.

Ace Group Worldwide provides you, training, consultancy - documentations, implementation as well as audits for US FDA 21 CFR which is a GMP standard for US FDA for Pharmaceutical and Allied Products, such as Pharmaceutical formulations, OTC products, Cosmetics, Dietary Supplements, Medical Devices.

Company Establishment Registration and Device Listing:

Ace Group Worldwide can also provide assistance in getting your Establishment Registration and Device Listing done for 510K exempt products.

NABH : National Accreditation Board For Hospitals
This is a quality system for Hospitals & Healthcare providers. This standards aims at high quality of care and safety for patients. Ace Group Worldwide provides training, consultancy, documentation, implementation and certification for NABH.

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