ISO

ISO 9001:2015 (QMS)

1) 9001:2015 certification has been in place for over a decade now and is used by both customers and companies as a method of controlling their quality.

The Standard provides a framework to manage your business and ensure a philosophy of continual improvement in all aspects of your business.

Involves Top management in the improvement of the Quality management System Facilitates the organization to become a customer-focused organization.

Ensures sustained customer satisfaction by producing, delivering services and providing support functions that meet customer's needs and expectations. Increases the effectiveness and efficiency of the organization through continual improvement in systems and products /services quality.

  • Customer focus
  • Leadership
  • Involvement of people
  • Process approach
  • System approach to management
  • Continual improvement
  • Factual approach to decision making
  • Mutually beneficial supplier relationships
  • Improved outcome of process
  • Professional image
  • Increased customer confidence
  • Better marketability
  • Clarity of responsibility and authority
  • Better and defined system
  • Consistent Quality

2) ISO-14001:2004 (EMS)

Establish an appropriate environmental policy.

Identify the environmental aspects arising from the organizations past, existing or planned activities, products and services, in order to determine the environmental impacts of significance

Establish an appropriate environmental policy.

Identify the environmental aspects arising from the organizations past, existing or planned activities, products and services, in order to determine the environmental impacts of significance

Advantages of ISO 14001:2004

  • Process improvement.
  • Marketing advantages
  • Environmental cost reduction.
  • Better control of liabilities
  • Better relationships with regulators
  • Educed regulatory burden
  • Better relationships with insurers, investors, and financial markets
  • Protection of company image and name
  • Product improvement
  • Demonstration of responsible management

3) OHSAS 18001:2007 (OHSAS)

OHSAS 18001 has been developed to be compatible with ISO 9001 and ISO 14001 to allow for easy integration. Legislative & regulatory commitment and continual improvement are two important aspects of OHSAS 18001.

Policy and commitment
Hazard identification, risk assessment & risk controls

Legal requirements Objectives & Programs Organization & personnel Training, Communication & Consultation

  • Documentation & records
  • Operational Controls
  • Emergency Readiness
  • Measurement & monitoring
  • Accident & incident investigation,
    corrective & preventive action

4) ISO 22000:2005 (FSMS)

This International Standard ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

This International Standard ISO 22000 specifies requirements to 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

To demonstrate compliance with applicable statutory and regulatory food safety requirements

To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction

To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain

To ensure that the organization conforms to its stated food safety policy

To demonstrate such conformity to relevant interested parties and To seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to this International Standard.

5) Good Manufacturing Practice (GMP)

is a part of quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, food, pharmaceutical products and medical devices. GMP Certification confirms the products identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products are given.

Benefits
Reduced dupliation of inspections
Enhanced market access
Export facilitation
Cost savings
Customers, employees, stockholders, regulators and competitors developed sustainable respect for an organization which demonstrates its proactive commitment to safety

6) ISO / TS 16949:2009

(This standard is Applicable in Automobile Industries) Benefits of ISO/TS 16949
1. Fosters improved product & process quality.
2. Incorporates the best lessons learnt from the global automotive realm.
3. Provides additional confidence for global sourcing.
4. Ensures a global quality system approach in the supply chain for supplier/subcontractor service consistency.
5. Reduces variation, waste & improves the overall efficiency in production levels.
6. Eliminates the need for multiple third party registrations.
7. Provides a common platform to address worldwide quality system requirements.
8. Formatted to allow easy conversion to ISO9001/2008.
9. Advantageous to the up gradation of existing quality systems

7) CE MARK

CE Marking is a specific procedure that is to be ensured for a wide variety of products and one, which manufacturers located in the EU or importers of goods into the EU must complete. The CE mark is affixed to the product as the final stage of this procedure and is effectively a statement from the manufacturer (or importer) that the process has been successfully completed and that the product meets the essential requirements of the relevant CE marking Directives

The CE Marking Is Required Only for the Following Types of Products:
Toys, Machinery, Electrical equipment, Electronic equipment, Personal protective equipment, Pressure equipment, Medical devices, Active implantable medical devices, In vitro diagnostic medical devices, Radio and Telecommunications terminal equipment, Simple pressure vessels, Gas appliances, Lifts, Recreational craft, Equipment and protective systems for use in explosive atmospheres, Non-automatic weighing instruments, Cableways, Construction products, Explosives for civil use, New hot water boilers, Measuring Equipment.

8) ISO 13485 ( Medical device)

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems. All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size

9) ISO -27001-2005 (Information security management system)

The final version of ISO 27001 was published in October 2005 to a great fanfare. It should be noted, however, that this is in fact only the first of a series of standards to support information security. Having stated this, it may well be the most important, at least from a 'top down' perspective, as it defines the information security management system

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