Thursday, December 23, 2010

What Is CE Marking?

The CE Mark is a mandatory European marking for certain product groups to indicate conformity with the essential heath and safety requirements set out in European Directives. The letters ‘CE’ are an abbreviation of Conformity Europeans, French for European conformity. The CE Marking of products as “passport” which can allow a Manufacturer to freely circulate their products within the European market place.
The CE Mark declares that your product complies with the Essential Requirements of the applicable EU Directives.
CE Marking

Applicable requirements are set forth in various European Directives that replace individual country safety standards. The Directives apply to products manufactured within but also exported to the European Union.
The CE Mark is placed on a product as the manufacturer’s visual identifier that the product meets the requirements of relevant European Directives. It is mandatory for a wide range of products sold within or exported to the European market.
To facilitate free trade and ensure the safety of certain products, European countries have developed a series of standards, or Directives as they are called. Compliance is mandatory. It is a legal obligation on the part of the manufacturer or his agent. Penalties for failing to get CE-Marking for a product can be severe.
If you wish to sell your products within the European Union member states and the European Economic Area, the product in question must comply with the Directive(s). This also applies if you are a manufacturer who wants to export products into the European Member countries.
The Directives replace individual country standards as they relate principally to the safety of these products.

What products do the Directives cover?
The Directives apply to a wide range of products. The most notable products that likely need CE-marking are:

    * pressure equipment
    * machinery of almost any description
    * electrical and electronic equipment
    * medical devices and equipment
    * personal protective equipment
    * equipment for use in potentially explosive environments

There are certain exclusions, but if you manufacture any of the above types of equipment or products then one or more of the Directives almost certainly apply.


EU Directives
Directives apply to 99% of all industrial and domestic products sold in Europe; it is the distinctive CE mark that signifies compliance with the applicable Directives. Without the CE mark and the correct documentation, manufacturers and importers are at an immediate disadvantage when competing against compliant competitors.

Complying with Directives
The requirements of the Directives are to ensure that manufacturers have identified and addressed all aspects of design and manufacturing that could impact safety and the safe operations of the equipment.

The actions required to become compliant with the Directives vary according to which Directive(s) apply and the type or classification of the equipment as defined by the Directive(s). However, there are some general steps you should follow:

   1. Determine which, if any, EU Directives apply to your product(s),
   2. Determine the extent to which your product already complies with the essential requirements of the Directives.
   3. Choose conformity assessment routes. Depending on the nature of the equipment or product, you may be able to implement and declare compliance and affix the CE mark without assistance or service from an external company.

A Notified Body is an independent body appointed by an agency within one of the European countries, usually governmental, as being capable of performing the duties of a Notified Body as defined by the Directives.


Source:  ISOQualityKit.com

Tuesday, June 1, 2010

ISO 9001 Helps In Improvement of Supply Chains

Just what can purchasers reasonably expect from suppliers who put forward their company's ISO 9001 certification as an argument in favor of their products or services? ISO provides answers to this and related questions in an updated edition of its online brochure, ISO 9001 What does it mean in the supply chain?

The document is particularly aimed at purchasing managers of business enterprises and public sector officials responsible for procurement, but it will also be useful for organizations representing consumer interests as well as for consumers themselves.

ISO 9001 is implemented by organizations in more than 136 countries and has become the global benchmark for quality management systems (QMS). The standard is used as a framework for providing assurance about the supplier's ability to satisfy quality requirements and ISO 9001 certification is often a market requirement for suppliers to participate in supply chains or to bid for procurement contracts. It is also widely used as a marketing argument by companies selling goods or services to consumers.

For these reasons, the update of ISO 9001 What does it mean in the supply chain? is timely. It provides concise answers to common questions such as:

* What does conformity to ISO 9001 mean?
* How does ISO 9001 help you in selecting a supplier?
* How can purchasers be sure that the products they receive will meet their requirements?
* How can you have confidence that your supplier meets ISO 9001?
* Can suppliers claim that their goods or services meet ISO 9001?
* What can a customer do if things go wrong?

In addition, the document serves as a "mini-primer" to ISO 9001 because it includes brief, but essential, explanations of the standard, quality management systems and the options for claiming conformity with ISO 9001.

"The documents provides purchasers with the information needed to ensure that the ISO 9001 standard is used to its full potential in the business-to-business supply chain."


Source: Globalmanagergroup.com

Tuesday, February 9, 2010

Need Of ISO 14001 Documents

ISO: 14001 are a generic document and it does not specify "how" to do, but only states "what" to do. As per the standard, the Environment Management System should be documented and be demonstrable in the manner consistent with the requirements of ISO 14001 models. The total demonstration in the Environment Management System consists of four tiers of documents.

1.Environment Manual
2.Procedure Manual
3.Work Instruction/Operating Procedure Manual
4.Forms, Records

The amount of documentation should support and efficient Environment assurance system without creating a paper bureaucracy. The details for documenting above four tiers of documents is described in this paper.

NEED FOR DOCUMENT CONTROL: -

The Environment System consists of a number of documents. Some system should be provided for safe keeping of complex records. It is important to clearly define as to where they should be kept and for how long, and who is responsible for them. Each written procedure should be checked and signed by an authorized person, with issue number and issue date. The management representative should have a list of all completed ISO procedures, applicable to the individual departmental activities. Against each listed document the number should be shown together with the date of the latest change. It is also called a "Master Copy". It is a yardstick against which any other controlled copy can be judged.

From time to time the Committee for Management Review and Corrective Action may put forward recommendations for change in the procedure. The Management Representative should be responsible for implementing the change. For making a change, the new page should be circulated to the keeper of the controlled copy of the document with an instruction to insert the new page in order and return the replaced page to the Management Representative. Thus outdated ISO documents will be removed from circulation. The change, which has been made, should be known to the staff and everyone should implement the new procedure. When a number of major changes have been made, a complete new manual has to be issued. The retention period for these records can be predefined either contractually or by the policy and it is to be mentioned in the Environment Manual.

Friday, February 5, 2010

ISO 14001 Environmental Management System

ISO 14001:2004 (Environmental Management System) - is a global standard for environmental management systems which provides the framework for businesses to demonstrate their commitment to environmental responsibility. ISO 14001 is a product of the International Organization for Standardization (ISO). ISO 14001 is the world's first generic, internationally recognized standard for environmental management the goal of the SIO 14001 standard is to give the top management of any organization a framework for managing environmental impacts.

ISO 14001 EMSCompliance to ISO 14001 can provide the mechanism for an organization to more definitively establish itself as a genuine performer. It is a foundation to develop future environmental initiatives. The overall ideas is to establish an organized approach to systematically reduce the impact of the environmental aspects of an organization and for the generation of options for improvement are improvement are provided by the concept of cleaner production.

ISO 14000 series of standards are based on the following principles :-

An organization should focus on what needs to be done - it should ensure commitment to the EMS and define its policy.

An organization should formulate a plan to fulfill its environmental policy.

For effective implementation, an organization should develop the capabilities and support mechanisms necessary to achieve its environmental policy, objectives and targets.

An organization should measure, monitor and evaluate its environmental performance.

An organization should review and continually improve its environmental management system, with the objective of improving its overall environmental performance


Learn more about ISO 9001 certificate here.


Source: globalmanagergroup.com

Friday, January 29, 2010

Benefits Of ISO 27001:2005 ISMS Certificate

Information Security ISO 27001:2005
ISO 27001:2005 (Information Security Management System). It is the standard, which specifies requirements for implementation, establishment, operation, monitoring, research, maintenance and improvement of documented Information Security Management Systems (ISMS). It specifies requirements for establishment of a safety control, adapted according to needs of an organization. The organization declares the assurance of information security management system requirements by certification according to BS 7799-2 / ISO 27001:2005.

ISO 27001 specifies the Plan-Do-Check-Act (PDCA) model for continual quality improvement. The PDCA cycle helps "the organization to know how far and how well it has progressed" and "influences the time and cost estimates to achieve compliance." ISMS as "a systematic approach to managing sensitive company information so that it remains secure. ISMS encompasses people, processes, and IT systems."
Information security is achieved by applying a suitable set of controls (policies, processes, procedures, organizational structures, and software and hardware functions).
ISO 27001 is suited to any organization that manages assets - data, people, software and intellectual property. This includes government departments (or their critical suppliers such as mailing houses, or data warehouses), energy providers and utilities, banks, insurance companies and corporate across all sectors of the economy.

Benefits of Information Security ISO 27001:2005

" A valuable framework for resolving security issues.
" Enhancement of client confidence & perception of your organization.
" Enhancement of business partners confidence & perception of your organization.
" Provides confidence that you have managed risk in your own security implementation.
" Enhancement of security awareness within an organization.
" Assists in the development of best practice.
" Can often be a deciding differentiators between competing organizations

Source: http://www.globalmanagergroup.com
You can find more about ISO Documents here.

Thursday, January 21, 2010

Principle Of ISO 9001:2008

ISO 9000 stands for International Organization of Standardization, created in 1947. It is a worldwide federation of “Member Bodies” with it's headquarter at Geneva, Switzerland. India is represented by BIS (Bureau of Indian Standards). ISO is important because of its systemic orientation. The assumption is that quality can only be created if workers are motivated and have the right attitude.

ISO 9001:2008 (QUALITY MANAGEMENT SYSTEM) is widely recognized standard. This is a basic quality management system that can be implemented in industries of any type, any size, anywhere in the world. Registration to ISO 9001 Standard provides objective proof that a business has implemented an effective quality management system, and that it satisfies all of the requirements of the applicable standard. An external, impartial expert called a register or CB (Certification Body) conducts an on-site ISO audit to determine whether or not a company is in conformance to the standard. If they are found to be in conformance, they will be issued a certificate showing their address, scope of operations and the seals of the accreditation bodies that give the register its legitimacy.

The ISO 9001 standards are based on eight dynamic Quality Management System Principles.

• Customer Focus
• Leadership
• Involvement of People
• Process Approach
• System Approach
• Continual Improvement
• Factual Approach to Decision Making

Benefits of ISO 9001:2008

o Provides a systematic and visible approach for continual improvement in the performance.
o Edges over competitors who are not accredit.
o Increased customer confidence and international acceptance.
o Structure the operations of the organization to achieve desired results.
o Creates brand name of the organization.
o Helps to increase the effectiveness and efficiency of the organization


You can read my business article here.