ISO Certification

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ISO 9001 : 2008

ISO 9001 is sweeping the world. It is rapidly becoming the most important quality standard. Thousands of businesses in over 100 countries have already adopted it, and many more are in the process of doing so.

Why? Because it controls product and service quality; it saves money; customers expect it; and competitors use it. In ISO 9001 Certification, highly competent market industries with ISO 9001:2008 certification hold a distinguished position. These industries hold an advantage over others and have gained trust & credibility. The ISO 9001:2008 quality certification is based on the following eight fundamental quality management principles:

  • Customer focus
  • Leadership
  • Involvement of people
  • Process approach
  • System approach to management
  • Continual improvement
  • Factual approach to decision making
  • Mutually beneficial supplier relationships

BENEFITS

  • It is Cost effective.
  • Overall improved product and service reliability.
  • Customers will have confidence in your product or service.
  • Effective Marketing opportunities.
  • You will consistently meet Customer needs and requirements.
  • Effective control over business processes.
  • Your Competitors may not have ISO 9001, giving you a distinctive lead above anybody else.
  • Not having ISO 9001 may be a barrier to working with certain businesses e.g. Government bodies and local authorities. Some larger organisations are now making it a requirement to even get on the tender list.

HOW CAN ANDRONOVO HELP TO ACHIVE ISO 9001 : 2008

We will help you design, document, implement and operate a simple quality management system that meets all the requirements of ISO 9001.

We will design the system around your existing business practices wherever possible, and if necessary help you identify and solve the areas of your business that do not conform to the ISO 9001 standard.

Once the system has been implemented, we will arrange for your system to be fully audited by one of our very own auditors, before recommending you for your ISO 9001 assessment by an external Assessment Body


 

ISO 22000– Food Safety Management Systems

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.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

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 ISO 22000

ISO 22000 was published by ISO (The International Organization for Standardization) on the 1st of September 2005. The standard was published in response to 15 countries, among them Denmark, US & UK, interested in the creation and realization of a standard to ensure safe food supply chains worldwide.

ISO 22000 will exert influence in both directions of the food chain as we know it, but there will also be focus on other interested parties, including public authorities and both customers and suppliers of the food industry.

Four Key Elements

  • Management, Including Policy, Obligation, Organization and Resources: The contents of the standard includes a corporate requirement to demonstrate effective internal communication within the company, and that the management should lead the way in doing this. There are also demands regarding communication to both suppliers and customers. This includes a definition of the systems necessary to ensure agreement between the expectations of sales staff and purchasers regarding products.
  • HACCP Plan and Principles: Food safety is defined as the absence of risk factors above a certain acceptable level. By employing the well-known HACCP principles, a decision is made as to where there are critical control points (CCPs) in the process, how these are to be monitored and how they can be brought back under control. The management system must be focused, which means the number of CCPs should be kept to a minimum.
  • Other Measures: Other conditions that require control are described as “other measures”. These should be present, documented and working well to ensure the efficiency of the system. The standard describes how a controlling measure is categorized as regards CCPs and other measures, but does not include a decision tree.
  • Communication: There are also demands regarding accessible information about products, storage conditions and the development of new foodstuffs and food products, as well as the education and training of staff whose work has an impact on food safety

How can ANDRONOVO help you achieve ISO 22000/HACCP?

We will help you design, document, implement and operate a food safety management system that meets all the requirements of ISO 22000/HACCP.

We will design the system around your existing food safety management system where ever possible, including the completion of risk assessments as necessary. We will help you to establish the necessary controls to ensure you are in compliance with relevant legislation, and help you identify and solve the areas of your business that do not comply to the ISO 22000 standard.

Once the system has been implemented, we will recommend you for the initial audit visit from an external assessment body. We will then arrange for your system to be fully audited by one of our very own auditors; with the final

ISO 22000 external assessment taking place within 3 months of the initial audit visit (depending upon the external assessment body).


 

ISO 27001 2005

ISO/IEC 27001, part of the growing ISO/IEC 27000 family of standards, is an Information Security Management System (ISMS) standard published in October 2005 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Its full name is ISO/IEC 27001:2005 - Information technology -- Security techniques -- Information security management systems

ISO 27001, titled "Information Security Management - Specification With Guidance for Use", is the replacement for BS7799-2. It is intended to provide the foundation for third party audit, and is 'harmonized' with other management standards, such as ISO 9001 and ISO 14001.

The basic objective of the standard is to help establish and maintain an effective information management system, using a continual improvement approach. It implements OECD (Organization for Economic Cooperation and Development) principles, governing security of information and network systems. 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.

In order to implement an Information Security Management System (ISMS) in your organization you need to have sufficient ISO 27001 domain expertise and experience. ANDRONOVO can offer these to you and assist you in implementing an Information Security Management System that fits your needs up to certification if needed. ISO 270001 Steps


 

OHSAS 18001

The management of Health and Safety is becoming a growing problem in the INDIA. Recent figures from the Health and Safety Executive indicate that there were 241 fatalities in the period 2006/2007, with very little change in this figure over the last 5 years.

Combined with the poor publicity and subsequent loss of reputation arising from incidents, it makes good sense to establish a safety management system.

OHSAS 18001 is intended to help businesses control occupational health and safety risks. It was developed in response to a widespread demand for a recognised standard for which to be certified too and falls neatly in line with the ISO 14001 standard.

It is a framework that allows a business to consistently identify and control its health and safety risks, reduce the potential for accidents and legislative requirements and improve overall performance.

BENEFITS

  • A reduced risk of accidents and therefore lower staff absence.
  • Reduced risk of citations and penalties.
  • Improved operational performance through policies and procedures.
  • Ensures compliance with health and safety legislation and regulations.
  • Potential reduced Insurance premiums.
  • Increased access to new customers through an improved corporate image.
  • A positive reputation and Health and Safety track record.
  • Increased staff awareness of Health and Safety.

HOW CAN ANDRONOVO TO HELP YOU ACHIEVE OHSAS 18001

We will help you design, document, implement and operate a simple health and safety management system that meets all the requirements of OHSAS 18001.

We will design the system around your existing health and safety practices where ever possible, including the completion of risk assessments as necessary. We will help you to establish the necessary controls to ensure you are in compliance with relevant legislation, and help you identify and solve the areas of your business that do not comply to the OHSAS 18001 standard.

Once the system has been implemented, we will recommend you for the initial audit visit from an external assessment body. We will then arrange for your system to be fully audited by one of our very own auditors; with the final

OHSAS 18001 external assessment taking place within 3 months of the initial audit visit (depending upon the external assessment body).


 

ISO 14001—Environmental Management

ISO 14001 is slowly becoming the world’s most up and coming international standard. Environmental impacts, global warming and local environmental issues are now on the news regularly or every other day.

It is everyone's job to look after the environment, in order to make it a better place for us, and for future generations….what is your business doing to limit its environmental impact?

What is ISO 14001?

ISO 14001 or an Environment Management System (EMS) is a tool for managing the impacts of an organisation's activities on the environment. It is a pro-active approach, and allows business to consider environmental issues before they become a problem.

ISO 14001 exists to allow businesses to establish those operations that have a negative impact on the environment and to minimize these as determined necessary. Thus it can be a powerful tool for businesses to both improve their environmental performance, and enhance their business efficiency.

BENEFITS

  • Its Cost effective – reduces utility bills and waste streams.
  • Higher control of risk and better planning.
  • Ensures compliance with environmental legislation.
  • Builds awareness of environmental concern amongst employees.
  • Improved corporate image with customers and the public.
  • Reduce environmental liability.
  • Not having ISO 14001 may be a barrier to working with certain businesses e.g. Government bodies, local authorities and some commercial businesses who will prefer their suppliers to be ISO 14001 registered.

How can ANDRONOVO help you achieve 14001

We will help you design, document, implement and operate a simple environmental management system that meets all the requirements of ISO 14001.

We will design the system around your existing business and environmental practices where ever possible. We will help you to establish the necessary controls to ensure you are in compliance with relevant legislation, and help you identify and solve the areas of your business that do not comply to the ISO 14001 standard.

Once the system has been implemented, we will recommend you for the initial audit visit from a external assessment body. We will then arrange for your system to be fully audited by one of our very own auditors; with the final ISO 14001 external assessment taking place within 3 months of the initial audit visit (depending upon the external assessment body).


 

ISO 13485 & CE MARKING

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.

BENEFIT OF ISO 13485

If ISO 13485:2003 management system is appropriately implemented, the organization will be benefited by the following ways:

  • Provides international recognition.
  • Enables your organization to become more cost-effective.
  • Improves internal communications, efficiency and resilience to change.
  • Improves product and process quality and provides a basis for meeting regulatory requirements.
  • Requires your organization to monitor and improve key business and customer satisfaction measures.
  • Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.
  • When systems are implemented properly, organizations profitability increases by 5-10%.
  • Reduced wastage/ rejections.
  • Cost savings due to reduced time and effort.
  • Professional Image.
  • Increased customer confidence.
  • Makes organization systematic and reduces dependence on individuals.
  • Better chances of getting national/International orders through tenders.

The CE Mark, CE Marking and CE Certification

If you are manufacturer and are planning to export a product which falls within the scope of one or more of the markets in any of the member states of the European Union (EU) or European Economic Area (EEA) then it is necessary that you apply for CE marking of your products against the essential requirements of all the applicable directives. Please note that CE Mark is a mandatory mark for most (around 70%) of the products sold on the EU market (totaling 28 countries).

The New Approach Directives will provide a range of compliance routes for your product and show you, usually in a modular format, the available routes to compliance. You must then decide which is the best fit for your company set up and follow the routes detailed in the Directive. In many cases the compliance route will require you to use a Notified Body to assist with your certification. The essential requirements of the New Approach Directives differ from directive to directive and product to product.

If the new product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking will be crucial to your success.

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