Free Webinar | ISO 9001:2008 Formal Interpretations

Attend FREE Webinar:

"ISO 9001:2008 Formal Interpretations"

Date: November 8, 2011
Time: 1:00 P.M. ET
Cost: FREE

Webinar topics include:

• Does sub-clause 4.2.3 a) require that documents required for the QMS be reviewed as well as approved prior to issue?
  


• Does Clause 4.2.2 c), require that the manual include a description of the processes, in addition to a "description of the interaction between the processes of the QMS"?
  


• Is it a requirement of Clause 5.4.2 to have a document that describes the objectives, timeframe, action, and responsibilities?
  


• In our organization, we have a management representative appointed by top management, who works for the company in a managerial capacity. He is not a permanent member of staff, but works full-time on a contract basis. Is it allowable under the standard for such a person to act as the organization's management representative?
  


• Does Clause 6.3 require records of the maintenance of infrastructures?
  


• Does the word "specify" or "specified" quoted in various clauses require documentation?
  


• Does Clause 7.4.3 require records of the verification of purchased product?
  


• Is it correct that Clause 7.6 requires only the measuring and monitoring devices utilized by persons responsible for release of the product to be calibrated or verified?
  


• Does Clause 7.5.2, Validation of processes for production and service provision, require that any applicable statutory and regulatory requirements must be taken into account?
  


• And much more

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ISO 13485:2003 | Medical Devices Certification

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The main purpose is to facilitate alignment of regulatory requirements regarding production of medical equipment. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

This standard contains specific requirements for manufacturers, installation and maintenance by asking:

1. 
   
   Application of Quality Management System with several factors increase


2. 
   
   Risk management-based approach to product development and realization processes of validation


3. 
   
   Compliance with the requirements of legislation and regulations


4. 
   
   Effectiveness ability to scan products and product recall system fails
   

What are the benefits gained from ISO 13485:2003 certification?

1. 
   
   Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal compliance


2. 
   
   Reduced operating costs - through continual improvement of processes which resulted in operational efficiencies


3. 
   
   Improving relations with the parties concerned - including employees, customers and partners


4. 
   
   Legal compliance requirements - with an understanding on how the requirements of regulations and legislation that affect an organization and your customers


5. 
   
   Increase in the risk management control - with the consistency, the product traceability and use of risk management techniques


6. 
   
   The achievement of public trust in business is run - as evidenced by the existence of an independent third party verification on recognized standards


7. 
   
   The ability to get more business - particularly procurement specifications require certification requirements to become a partner for the sector that has been set

Who can use ISO 13485?

ISO 13485 contains requirements essential for every organization in medical equipment operation and supply chain related to pharmaceuticals. It is especially associated with the medical equipments manufacturers who hope to comply with the regulatory requirements that may be used, and any organization that has support services for manufacturers of medical equipment.

How to get certified?

There are many Certification Body in the world can certified the organization. There are NQA Services or DEKRA Certification, Inc

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ISO/TS 29001 | Petroleum, petrochemical and natural gas industries— Requirements for product and service supply organizations

ISO/TS 29001 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.

ISO/TS 29001 is available for use by manufacturers of oil and gas industry equipment and materials (upstream and downstream), service providers to the oil and gas industry, purchasers of equipment, materials, and services. The document can also be used for organizations to perform 2nd party auditing of their suppliers, as well as for 3rd party certification purposes.

Due to the inherent risks associated with the oil and gas industry, rigorous conformity to engineering, user and regulatory requirements are required. The industry handles fluids (liquids and gases), often at extreme high pressures, through a variety of products and processes. Considerations for the safety of personnel are of major importance. Additionally, protection of the environment and of business continuity (maintenance of revenue streams, both for companies and for national economies) require a high level of operational integrity. Conformance to ISO TS 29001 should assist in mitigation of operational risks as a result of products being in full conformance with specifications and regulations.

Organizations may benefit from this standard if they are:

• 
  
  Involved in exploration, production, pipelines, transportation, and refining of petroleum and natural gas products


• 
  
  Involved in the design, manufacture, installation, service, and repair of equipment used in the exploration, production, transportation, and refining of petroleum and natural gas products


• 
  
  Providing technical, operational, and support services to the various industry sectors identified above

Click here to get in touch with us or learn more about how to get started.

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ISO 50001: Energy Management

Improve energy performance and efficiency while reducing environmental impacts

Energy management and conservation is a fundamental area of focus across all sectors of industry, and with today’s rising energy prices and tough economic climate, businesses are looking for more ways to reduce energy costs while improving environmental performance.

Implementing an energy management system certified to ISO 50001 will help organizations to improve their energy performance, increase energy efficiency and reduce climate change impacts.

What is ISO 50001?

Published June 15, 2011, ISO 50001 will establish a framework for industrial plants, commercial facilities or entire organizations to manage energy.

The standard is targeted for broad applicability across any industry, and it is estimated that ISO 50001 could influence up to 60% of the world’s energy use.

ISO 50001 is based on common elements found in other ISO standards such as 9001 and 14001, assuring a high level of compatibility.

Benefits of ISO 50001 certification

ISO 50001 certification creates an internationally recognized framework for integrating energy efficiency into management and manufacturing practices throughout your organization and supply chain.

In addition, ISO 50001 certification enables:

• 
  
  Better use of existing energy-consuming assets


• 
  
  Benchmarking, measuring, documenting, and reporting energy intensity improvements and their projected impact on reductions in greenhouse gas (GHG) emissions


• 
  
  Transparency and communication of energy resource management


• 
  
  Energy management best practices and good energy management behaviors


• 
  
  Evaluating and prioritizing the implementation of new energy-efficient technologies


• 
  
  A framework for promoting energy efficiency throughout the supply chain


• 
  
  Energy management improvements in the context of GHG emission reduction projects
  
  For more assisstance click here

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Chiquitos: Best place to have the delicious food

Have you ever tried the Mexican food at chiquitos vouchers ? If your answer is no, then you need to try it. Chiquitos is one of the best places to get the true Mexican food. It has more than 65 restaurants in various parts of the world. But you can see most of its restaurants located in Leicester Square of Leeds. It offers some of the best Mexican dishes for its customers. All the restaurants are well maintained and you find traditional work and pottery lining the walls. The Chiquitos restaurant offers various colorful and spicy foods to its customers. You can choose anything from Acapulco Chicken to Roasted Vegetables. Chiquitos is the best place to enjoy the traditional Mexican specialties with your family and friends. Some of the American Classics are also seen the Chiquitos menu. The nacho is the prefect dish to be shared among the group of friends. Chiquitos is not only the best place for adults but also for kids. The restaurants serve some of the excellent menu for kids like pasta bolognaise or fish finger. Not only food, but also they offer some games to kids for free. Along with the menu, you are served with a colorful cocktail throughout the day. Chiquitos is the great place for food, atmosphere and fun. Also Chiquitos offers some chiquitos vouchers where you can get the food at much discounted prices. You can use these vouchers and get the best prices.

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