Conduct Initial Status Survey In ISO 9000 Standards

Conduct Initial Status Survey In ISO 9000 Standards

ISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of the standard (ISO 9001:2008).

For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.

With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.

Unless they are very much out of date, these documents should not be discarded.

Rather, they should be incorporated into the new quality management system.

Documents requiring modification or elaboration should be identified and listed. This exercise is some times referred to as ” gap analysis”. During these review processes, wide consultation with executives and representatives of various unions and associations within the organization is required to enlist their active cooperation.

In the review process, documents should be collected, studied and registered for

further use, possibly after they have been revised. Before developing new quality

management system documentation, you need to consider with which quality

requirements or department you should start. The best is to select an area where

processes are fairly well organized, running effectively and functioning satisfactorily.

The basic approach is to determine and record how a process is currently carried out.

We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.

Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g. inspection/test reports, inspection/test certificates).

In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.

In general, the steps to follow are the following:

a. Ascertain and establish the following:

What is the present operation/process? What already exists?

b. Analyze the relevant sections of the quality standard – ISO 9001:2008:

What is actually required?

c. If necessary, supplement and change operational arrangements in accordance

with the standard, develop documents and records, and describe operations/

processes:

What is the desired operation/process?

The gap analysis can be done internally, if the knowledge level is there. Or a formal pre-assessment can be obtained from any one of a large number of ISO 9000 consulting, implementing, and registration firms.

Create a Documented Implementation Plan In ISO 9000 Standards

Create a Documented Implementation Plan In ISO 9000 Standards

Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.

The implementation plan should be thorough and specific, detailing:

a. Quality documentation to be developed

b. Objective of the system

c. Pertinent ISO 9001:2008 section

d. Person or team responsible

e. Approval required

f. Training required

g. Resources required

h. Estimated completion date

These elements should be organized into a detailed chart, to be reviewed and

approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.

Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning.

ISO 14001 Certification

ISO 14001 certification is primarily concerned with the approach of Environmental Management System. Keeping in mind the growing worldwide concerns regarding the living environment, we have come up with expertise in providing certification services.Certification to the internationally recognised EMS standard, ISO 14001 from an accredited and reputable provider is becoming a preferred choice for organisations looking to demonstrate their environmental credentials.

What is ISO 14001?

ISO 14001 is the internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.

Implementing an Environmental Management System is a systematic way to discover and control the effects your company has on the environment. Cost savings can be made through improved efficiency and productivity. These are achieved by detecting ways to minimise waste and dispose of it more effectively and by learning how to use energy more efficiently. It verifies compliance with current legislation and makes insurance cover more accessible.

Advantages of ISO 14001 certification:

* Environmental legal liability.
* Improved corporate image; strategic investment; improved regulatory relations.
* Improving the quality of the environment.
* Assuring commitment to manage and improve environment
* Reducing incidents that may be detrimental to working in the long run and causing liability
* Conserve natural resources and energy and help in getting the required legal consent
* Sharing environmental solutions and improving industry and government relationship
* Evaluates system performance through management review and correct management system deficiencies.

The ISO 14001 certification provided by OSS, offers quality control system defines the organisation, responsibilities, objectives and procedures used to assure quality and reliability of products and services. The policies of the ISO 9001:2008 quality control program should be implemented and maintained at all levels of the business operation and be accessible to all employees.

The ISO 14000 standardization series establishes standards, guidelines, and policies governing correct environmental management by certified organizations. ISO 14001 is, thus far, the most recognized of the ISO 14000 series, as well as the sole ISO standard that can be certified. In an era of environmental consciousness, this certification is crucial for a business or corporate entity to remain competitive in not only a national market, but the international market.

Wide acceptance- ISO certification is recognised in more than 120 countries and is the logical choice for any organisation involved in international business or committed to quality.

The certification process is undertaken by a third party uninvolved in any way with the organization seeking certification. A sizable number of certification organizations, known as auditors, will provide materials, mentoring, and monitoring to ensure that organizations recognize and comply with the various management guidelines. Once the standards have been met, the auditing organization will certify the applicant organization as ISO 14001-compliant.

OSS is considered as a professional organisation which holds some of the highly qualified individuals in the pool, serving for a wide range of areas by providing customer preferred and efficient certification services. The company toils for rendering a complete suite of consulting services and training in the field of Quality Management and Environmental Management to the organisation across all the industries verticals for building a progressing and profitable organisation by creating competitive advantage in the market.

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ISO 9001 Standards Certification

The ISO 9001 accreditation is part of the International Organization for Standardization 9000 standards. They are awarded to businesses for quality. The ISO 9001 is recognized worldwide as an award for a company’s internal quality management or actions that the company takes to ensure the product or service they provide is of the highest quality. Customer satisfaction is a major factor in whether a company will be awarded an ISO 9001 accreditation.
The International Organization for Standardization in Geneva, Switzerland publishes thousands of international standards to help companies throughout the world more efficiently do business with one another. The 27 page ISO 9001 standard is focused on defining minimum business practices for the production and delivery of a company’s products and services through the implementation of a formal “quality management system”, or QMS. An ISO QMS is made up of certain processes, documentation and other formal practices that control internal company operations to ensure customer requirements are consistently met.
To pass an audit, an organization must follow these guidelines:
• Develop a Quality Management System (QMS) manual.
• Develop the procedures required by the ISO Standard.
• Determine the additional processes and procedures that are needed by the organization to perform work and satisfy the requirements in the ISO Standard.
• Operate in accordance with the organization’s documented QMS.
• Provide evidence that the organization is operating according to the QMS.
The achievement of an ISO 9001 certification is a milestone in demonstrating to your customers that you have implemented a reliable system of producing and delivering your products and services. The focus of this “system” is twofold: providing consistent products and services; and continual improvement in your processes leading to better results.
The ISO 9001 certification is granted by a third-party auditing firm called a Registrar who specializes in quality system auditing. There are a wide variety of Registrars located in every ISO participating country. Some firms have offices internationally; others have a more regional focus. The selection of your Registrar is one of the more important decisions you will make to ensure the best alignment with your type of business, your location(s) and overall cost of maintaining the certification.
The initial certification audit is conducted in two parts. The Stage 1 audit is a general review of your QMS documentation to ensure you have addressed all of the requirements of the standard. Depending upon the size of your business, this can be conducted in a one to two day visit to your facility or virtually via phone. Any discrepancies noted during the Stage 1 audit will be documented in a formal report and must be corrected before the Stage 2 audit.
The main part of the ISO audit is the Stage 2 audit which is always conducted onsite at your location(s) and will be focused on the implementation and effectiveness of your QMS. During this audit which can take 1 day (for very small companies) to several days, the auditor(s) will tour your company, speak to managers and employees, and review documentation and records (along with any Stage 1 discrepancies) to ensure that your system is fully implemented. If non-conformances are found, they will be documented in a formal report for correction. Following the Stage 2 audit, you are generally given thirty (30) days to submit corrective action plans for all audit non-conformances. Once corrective actions are received, your certification is complete and your certificate is issued.
In order to maintain the certification, you will participate in an annual surveillance audit from your Registrar where they confirm that you are maintaining your QMS. Every third year, a more comprehensive re-certification audit is conducted, similar to the initial certification audit.

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Introduction To ISO 14001 Standards

An environmental policy should reflect the vision, intentions, philosophy, values, and beliefs of the organization with respect to the environment. Top management should put a great deal of thought and imagination into developing and crafting the policy, since it will become the code of conduct by which the organization lives and operates. The policy should be practical and inspirational, providing a framework and a compass for business and technical decisions and actions, and at the same time motivate and encourage all personnel in the organization to achieve excellence in environmental performance.

The ISO 14001 Standard specifies several requirements for the development, content, intent, and implementation of an environmental policy:

1. Top management is responsible and accountable for defining the organization’s environmental policy. They must, as a minimum, carefully review, approve, and commit to abiding by an environmental policy that has been developed for their consideration.

2. The policy must completely cover the organization’s (i.e., facility’s) range of operations, including where appropriate, raw material acquisition, transportation, packaging, and shipping of product,as well as all on-site operations that may impact the environment.

3. The policy must contain three core commitments that are ISO 14001 absolute requirements:

(i) A commitment to continual improvement of the EMS and environmental performance.
(ii) A commitment to the prevention of pollution (i.e., this means taking all reasonable steps to eliminate, or at least minimize, pollution).
(iii) A commitment to comply with relevant environmental legislation and regulations, and with other requirements to which the organization subscribes. This means the organization commits to meet local, regional, and national legislated environmental standards.

4. The policy must give direction and a framework for progress through new environmental objectives and targets that will be set during the course of implementing and maintaining the EMS.

5. The policy must be documented, and it must be implemented through the day-to-day functioning of the EMS.

6. The policy must be maintained, meaning kept up to date and relevant to current operations and conditions.

7. The policy must be communicated to all employees. This implies active, intentional efforts by the organization, led by top management, to ensure all employees know about, understand, and apply the principles, ideas, and commitments in the policy.

8. The policy must be made available to the public, i.e., it must be accessible to all members of the public who wish to see it.

In addition to the essential requirements for an environmental policy, other considerations that may be incorporated into the policy include:

Principles of sustainable development, resource renewal, and preservation • of biological diversity

A commitment to use the most effective pollution abatement technology and • equipment, consistent with economic viability of the business (i.e., BEAT – Best Economically Achievable Technology)

Use of environmental performance indicators to quantitatively monitor • progress

Life cycle thinking – consideration of ‘cradle to grave’ impacts of a • product, which would require the organization to assess cumulative environmental impacts from all stages, from design of the product; acquisition of raw materials; processing to finished product; packaging; shipment; end-use; and ultimate re-use, recycle, or disposal.

For all components of this element of the Standard to be brought to fruition, it is essential that there is clear allocation of responsibilities for developing, approving, communicating, disseminating, implementing, maintaining, and when necessary, revising the environmental policy.

Although environmental policy is the first element of ISO 14001, it may be prudent for an organization to defer finalization of the wording of their policy until work has been done to identify the scope of environmental impacts from the operation, and other planning and preliminary preparation for the EMS has been done. This will help to ensure the policy is authentic and appropriate for the organization’s purpose.

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Global Warming & ISO 14001 Standards

It is not difficult to become a believer in global warming. According to the U.S. National Climatic Data Center 2001 was the second warmest year on record and it was the 23rd consecutive year of above normal temperatures. Perhaps most troubling is the fact that the rate of temperature increase is accelerating. Add to this the data just released from insurer Munich Re stating that deaths from natural disasters were more than double in 2001 versus 2000 and insured losses were up more than 50%.UNEP estimates that the extra economic costs of disasters attributable to global warming are running at more than $300 billion annually.

Some 180 countries are proceeding toward an expected ratification of the Kyoto Protocol by the end of this year. Of the six gases it will control CO2 is by far the largest contributing nearly 90% of the global warming impact. The primary source of CO2 is the burning of fossil fuels. Therefore the focus on energy will continue to increase.

Throughout the world different methods are being used to encourage reduced energy use. Japan has enacted the Energy Conservation Law in 1999 mandating huge efficiency improvements by 2004 for nearly all air conditioning products. The U.S. has revised ASHRAE Standard 90.1 for buildings to raise the minimum COP level for centrifugal chillers from the current value of 5.2 to 6.1 effective in October 2001. DOE and Green Seal have revised their recommended efficiency levels to an even higher level of 6.27.

Some countries use laws. Others use codes and standards. An increasing number of countries are using environmental costing which increases the price of energy thereby increasing the financial attractiveness of high efficiency products. European countries have been using such “carbon taxes” for more than a decade. However a rapidly growing trend in developing countries is the reduction of subsidies to energy industries “so prices more accurately reflect environmental impacts” according to OECD’s Environmental Strategy for the First Decade of the 21st Century.

China has shown leadership by reducing subsidies to the coal industry from $24.5 billion in 1990 to $10 billion in 1996 resulting in 7% emissions reduction while seeing a solid economic growth of 36%! China is now moving aggressively into environmental costing with the just announced (1/13/2002) 5-year environmental plan that commits 700 billion yuan ($84 billion) to help protect the environment. The government will provide the fist 65 billion yuan to initiate the project but will apply the “polluter pays” principle for the rest. The “environmental protection authorities will collect funds from the pollution-producing companies”. The impact on the price of energy is not known at this time. However it is clear that the addition of environmental costing will increase energy prices. According to a European Research Commission Report of July 2001 “The cost of producing electricity from coal or oil would double if costs such as damage to the environment and health were taken into account”.

The global movement to high efficiency is accelerating just like the rate of temperature increase. But this is not all that is changing. This second environmental threat of global warming is making it clear that we need to give combined consideration to ozone depletion and global warming. But more important is the need to focus on the real issue which is the total environmental impact not address each individual environmental threat in isolation. This includes the concept of environmental risk exposure, which recognizes that there are other environmental threats that are less well understood today. However, there are “no regrets” decisions we can make today (such as minimum refrigerant charge, minimum atmospheric life refrigerants, etc.) to minimize these risks.

Combined consideration would place more emphasis on reducing the use of CFCs, which are still being produced in developing countries until 2010 in accordance with the Montreal Protocol. Little attention is being given the large contribution to global warming from CFCs. Actions which cause confusion and delay the phaseout of CFCs cause increased environmental damage rather than lessening the environmental impact.

The other rapidly changing factor in the HVAC industry is the shift to becoming a hermetic industry, where refrigerant is contained throughout the life of a chiller and recycled for further use when the chiller is replaced. This simple understanding that “if it doesn’t get into the environment it does no harm” is a powerful argument, which will lead to the continued use of the most efficient refrigerants in such closed hermetic applications as chillers. In just 15 years annual refrigerants emissions from chillers have been reduced from 25% to well below 1% today. This defines a whole different world than that which existed when the Montreal Protocol was crafted some 15 years ago.

But perhaps the most important change coming to our industry is the realization that there are no new or “perfect” refrigerants waiting to be discovered. There are eight elements that can be combined for use in a vapor compression cycle. All feasible combinations of these eight have been evaluated. The reality is “what we have now is all there is”.

This recognition is why we are now seeing a shift from the search for a perfect refrigerant to a search for the right refrigerant(s) for the right application. Said another way, the highest efficiency refrigerants for the lowest emissions applications. Many in our industry call this “Responsible Use”.

It is not difficult to become a believer in global warming. According to the U.S. National Climatic Data Center 2001 was the second warmest year on record and it was the 23rd consecutive year of above normal temperatures. Perhaps most troubling is the fact that the rate of temperature increase is accelerating. Add to this the data just released from insurer Munich Re stating that deaths from natural disasters were more than double in 2001 versus 2000 and insured losses were up more than 50%.UNEP estimates that the extra economic costs of disasters attributable to global warming are running at more than $300 billion annually.
Some 180 countries are proceeding toward an expected ratification of the Kyoto Protocol by the end of this year. Of the six gases it will control CO2 is by far the largest contributing nearly 90% of the global warming impact. The primary source of CO2 is the burning of fossil fuels. Therefore the focus on energy will continue to increase.
Throughout the world different methods are being used to encourage reduced energy use. Japan has enacted the Energy Conservation Law in 1999 mandating huge efficiency improvements by 2004 for nearly all air conditioning products. The U.S. has revised ASHRAE Standard 90.1 for buildings to raise the minimum COP level for centrifugal chillers from the current value of 5.2 to 6.1 effective in October 2001. DOE and Green Seal have revised their recommended efficiency levels to an even higher level of 6.27.
Some countries use laws. Others use codes and standards. An increasing number of countries are using environmental costing which increases the price of energy thereby increasing the financial attractiveness of high efficiency products. European countries have been using such “carbon taxes” for more than a decade. However a rapidly growing trend in developing countries is the reduction of subsidies to energy industries “so prices more accurately reflect environmental impacts” according to OECD’s Environmental Strategy for the First Decade of the 21st Century.
China has shown leadership by reducing subsidies to the coal industry from $24.5 billion in 1990 to $10 billion in 1996 resulting in 7% emissions reduction while seeing a solid economic growth of 36%! China is now moving aggressively into environmental costing with the just announced (1/13/2002) 5-year environmental plan that commits 700 billion yuan ($84 billion) to help protect the environment. The government will provide the fist 65 billion yuan to initiate the project but will apply the “polluter pays” principle for the rest. The “environmental protection authorities will collect funds from the pollution-producing companies”. The impact on the price of energy is not known at this time. However it is clear that the addition of environmental costing will increase energy prices. According to a European Research Commission Report of July 2001 “The cost of producing electricity from coal or oil would double if costs such as damage to the environment and health were taken into account”.
The global movement to high efficiency is accelerating just like the rate of temperature increase. But this is not all that is changing. This second environmental threat of global warming is making it clear that we need to give combined consideration to ozone depletion and global warming. But more important is the need to focus on the real issue which is the total environmental impact not address each individual environmental threat in isolation. This includes the concept of environmental risk exposure, which recognizes that there are other environmental threats that are less well understood today. However, there are “no regrets” decisions we can make today (such as minimum refrigerant charge, minimum atmospheric life refrigerants, etc.) to minimize these risks.
Combined consideration would place more emphasis on reducing the use of CFCs, which are still being produced in developing countries until 2010 in accordance with the Montreal Protocol. Little attention is being given the large contribution to global warming from CFCs. Actions which cause confusion and delay the phaseout of CFCs cause increased environmental damage rather than lessening the environmental impact.

ISO 9001 Documents Control – Elements and Requirements

ISO 9001 Documents Control – Elements and Requirements

The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.
But it also cares that we won’t get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called “Documents Control”. In this procedure you must refer to the next line of issues.

Types of records
At first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to “swirl” around too many documents, let’s make it clear. Let’s define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documents
This requirement assures that always the last version is the version in use – and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don’t forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update. Although the ISO 9001 standard doesn’t require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.

Availability and distribution of documents
This is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization – to which it is authorized to use the document, the location of the document – where must the document be kept before and after use. Most of today’s process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that? Well, it depends on your organization and his substructures.

Identification of documents
Any document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer’s files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents – any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents. Again, you define the method according to your organization’s nature.

Documents removal
You must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization’s server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:
The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement.
The method must be presented as a documented procedure.
The documented procedure would be called “Documents control”.
You must include a definition of documents within the method – what is a document.
All documents must be approved before use. The purpose is to verify that the documents are suitable for work.
All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications.
All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it.
It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones.
You must define a method for documents removal. When and why to remove documents and in whose responsibility.