Sunday, June 12, 2011

What Are The Differences Of ISO 9001 And ISO 14001?

The International Organization for Standardization (ISO) is a managing body that was founded to provide quality and environmental management systems to industries across the world. The ISO 14001 and ISO 9001 standards are accreditations that are issued to organizations that meet or exceed the criteria set by the ISO. The certifications, which differ in criteria, have been proven to increase profitability and commercial status for the holding parties.

Some of the core differences between ISO 14001 and ISO 9001 stem from the criteria covered by each standard. As a quality management certification, ISO 9001 is awarded based on set standards being met in key areas. These areas include quality management systems, management responsibility, resource management, and how quality performance is measured, analyzed, and improved.

The standard ISO 14001 is an environmental management certification that is designed to assist organizations as they develop in-house environmental management systems. This standard is based on a model of continual improvement, which differentiates it from the fixed criteria that must be met to be awarded ISO 9001 accreditation. For an organization to achieve the certification, it must develop an ISO 14001-compliant environmental management system through a process of planning objectives, implementing processes, measuring and monitoring the processes, and improving the system based on the results of the monitoring stage.

As a part of ISO 14001 accreditation, a continual improvement process (CIP) is required. This CIP is based on expanding the environmental management system across all sectors of the business, using the system to enrich other processes and improving over time by continual monitoring. Many organizations seek to be awarded both ISO 14001 and ISO 9001 certification as it demonstrates a high overall standard of quality and environmental management structures.

The scope of each standard is what defines the differences between ISO 14001 and ISO 9001. The routes to accreditation and methods of maintaining the systems once certification has been achieved are similar across both standards. Both ISO 14001 and ISO 9001 standards can be applied for once a compliant management system has been implemented following the ISOguidelines. An intensive external audit will be required for either standard with an additional internal audit required for ISO 9001.

Both ISO 14001 and ISO 9001 are measures of the processes used by an organization, not the end product. This means that a company that holds ISO 9001 accreditation can still produce a poor end product providing the correct paperwork is in place and the quality is consistent. Similarly, ISO 14001 certification simply means that there is a system in place to meet that organization’s specific environmental targets.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Integrating Management Systems

At times, it seems like we’re being inundated with ISO standards these days. Scott Adams has found a lot of material for his Dilbert comic strips from the ISO requirements. If developed and implemented properly though, companies find that these systems do in fact have value beyond meeting customer requirements. Improvements can occur in efficiency, quality, compliance, environmental impacts, health & safety risk reduction, and even costs (cost savings tend not to occur until after the initial investment to develop the systems). For companies that need or want to develop systems that conform to more than one of these management system standards, a cost-effective way to do so is to integrate these systems.

The International Organization for Standardization (ISO) has issued ISO 9000 standards for Quality Management Systems (QMS), and the ISO 14001 standard for Environmental Management Systems (EMS). More recently, a consortium of standards bodies have issued the OHSAS 18001 occupational health & safety management systems (HSMS) standard. It is anticipated that the OHSAS 18001 standard will also become a future ISO standard. Additional standards exist for specific applications such as the automotive industry QS 9000 and TS 16945 standards. Many organizations have seen the benefits of these systems of management, and have encouraged or required their suppliers and vendors to implement similar systems.

Consider some of the following opportunities for integrating systems:

  • Combine EMS and HSMS manuals, particularly if the same department is involved in the implementation of both systems
  • Combine Objectives, Targets, & Programs, especially in cases where there is overlap. For example, substituting less hazardous chemicals or alternative processes can have a positive impact on the environment AND it can also reduce occupational health & safety risks and hazards.
  • Combine Audit Systems. Often, the same internal auditors can audit areas for environmental as well as health & safety at the same time. Additionally, internal EMS audits can be combined with internal HSMS audits in the many areas of overlap.
  • Combine Corrective & Preventive Action Systems. The standards for the quality management systems (QMS), the environmental management systems (EMS), and the health and safety management systems (HSMS) all require similar corrective & preventive action systems. When non-conformances to these systems are identified, corrective actions must be identified and implemented to fix the specific non-conformance. In addition, the root cause of the specific non-conformance must be identified so that a preventive action can be identified and implemented to prevent similar non-conformances or repeat instances of nonconformance’s from occurring. The same or similar tracking systems can be used for QMS, EMS, and/or HSMS. Electronic forms and databases are a very effective way of tracking these items to closure and ensuring the responsible persons identify, implement, and verify actions.
  • Combine Documentation Systems. Many companies already have formal documentation procedures for engineering design and manufacturing specifications. Companies who have already implementedISO 9000 systems often have very sophisticated electronic document control systems. Avoid “re-inventing the wheel” by taking advantage of existing systems that already meet the ISO standards or just need minor “tweaking” to meet the standard. Using the same system makes it easier for employees to use too.
  • Combine Management Review Systems. Consider incorporating the environmental, health and safety (EH&S) management reviews into existing management review systems. Take advantage of processes learned through quality management systems (such as development of effective process and result metrics) to present useful and meaningful information to management.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Thursday, November 25, 2010

ISO 9000 Standards Document Control System


ISO 9000 Standards Document Control System
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

ISO 9000 Standards Document Control System


ISO 9000 Standards Document Control System
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

Saturday, October 9, 2010

Aligning At ISO 9001 Standard Requirements


Aligning At ISO 9001 Standard Requirements

In conformity with the explanations of international series of standards elaborated in the 2008 year, the

implementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be done

in every kind of organization, indifferent of its field of activity , size or number of personnel. This means that

SMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to their

limited resources. The success of this action depends on more elements, mainly, the following ones:

· Strong commitment and decision of top management;

· Adopting an organization structure accordingly both with business plan of SME, and with the

requirements and guides of standards from quality management field, too.

This means that SME (sector in continuously development in Romania starting from 1990) can align to

these requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources.


The success of this demarche depends on several elements, mainly, the following:

· The decision and the strong commitment of the top management ;

· Adopting an organizational structure according to the business plan of SMEs, but also with the

requirements and the directions of the norm/standards in the quality management field.

· Accurate planning of the implementation project of a quality management system

· Allocation of the m a t erial, financial and human resources necessary for developing and

maintaining of the system;

· Suitable training of the personnel of the organization for the documentation and implementation of the system, but also for its supervising;

· Maintaining of an efficient communication and collaboration with business partners, first, with the

suppliers and the clients of SMEs, but also with other interested parts, including their own

personnel;

And one more remark: the success of a quality management system in a SME depends on endowment degree and on technological level of the equipments and working and controlling installation of the processes.

In conformity with the explanations of international series of standards elaborated in the 2000 year, theimplementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be donein every kind of organization, indifferent of its field of activity , size or number of personnel. This means thatSMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to theirlimited resources. The success of this action depends on more elements, mainly, the following ones:· Strong commitment and decision of top management;· Adopting an organization structure accordingly both with business plan of SME, and with therequirements and guides of standards from quality management field, too.This means that SME (sector in continuously development in Romania starting from 1990) can align tothese requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources. Thesuccess of this demarche depends on several elements, mainly, the following:· The decision and the strong commitment of the top management ;· Adopting an organizational structure according to the business plan of SMEs, but also with therequirements and the directions of the norm/standards in the quality management field.· Accurate planning of the implementation project of a quality management system· Allocation of the m a t erial, financial and human resources necessary for developing andmaintaining of the system;· Suitable training of the personnel of the organization for the documentation and implementation ofthe system, but also for its supervising;· Maintaining of an efficient communication and collaboration with business partners, first, with thesuppliers and the clients of SMEs, but also with other interested parts, including their ownpersonnel;And one more remark: the success of a quality management system in a SME depends on endowmentdegree and on technological level of the equipments and working and controlling installation of the processes.

A transparent quality management system, well conceived and applied, with adequate trained and motivated personnel, will be efficient and if technological level of endowments (working, supervising, measuring and monitoring equipments of the processes and product, working environment and infrastructure) will be comparable with the level of endowment of the top firms in the same activity area, as of the organization we refer to.

So, adopting a quality management system based on the requirements of the ISO 9001 standard is a strategic decision of the top management of an organization, much more for the management of SME that first of all has to analyse very well all the necessary resources, to put in balance both the necessary costs of the implementation and sustaining in function of a quality management system and the benefits brought, then to decide advisedly. Developing a quality management system gives both direct benefits and a contribution at the cost and risk management, being important not only for organization but also for the satisfaction of its clients and other interested parts.

The decision of designing and implementation of a quality management system in SME is influenced by proposed objectives, by the demand of the market, by products and services offered, as well as by objectives tendency of developing and the continuously improving of the performances of the processes of any organization.

A quality management system contains two essential elements. First, the most critical, refers to human resources and the other necessary resources for constant delivery of the adequate products and services to the client. Second refers to the existence of “documented quality management system” that is, usually, defined by documented policies, objectives, plans, processes, procedures and fabrication standards. The documented quality management system has to reflect the planning and carrying on the activities, made by SME. Both for the audit reported to the ISO 9001 standard’s requirements but also for improving activities, will need to generate adequate registrations to document the effective performance and to demonstrate the concordance.

Top management of SME has to be aware that the implementation of a quality management system according to this standard has to be approached as a project, to which are assigned resources and which has to be managed by a defined schedule.

First step is represented by defining the objectives of the schedule with an accent on those that will bring benefits for SME. For each objective must be defined the way in which will be measured his achievement, as well as the reference level. Schedule must also establish:

· An identification, documentation and continue improving system of SME’s processes;

· Stages that must be carried out for achieving the objectives regarding to the quality of the product and for long-term improving of a quality management system of SME;

After establishing the objectives, the next decision of the top management of SME refers to the type of approaching that will appeal to [3].

There are two ways of approaching:

a) to design the whole quality management system and then to be implemented;

b) to evaluate the processes and to appeal to improving techniques to build the system step by step, starting from existing elements.

The advantage of designing the whole quality management system is represented by obtaining a distinct structure, the main disadvantage being the tendency of a theoretical approach, separated from the realities and practices of SMEs. The performances of the personnel can also suffer because of the necessity to apply simultaneous a great number of new procedures.

The essential advantage of step by step approach is that if through evaluation of processes are determined both the adequate practices and the less acceptable, the efforts can be focused on those areas that ensure a maximum benefit. This approach has the disadvantage of the tendency to achieve a quality management system that is not so well structured and so is more difficult to understand and to apply by the personnel of SME.

The optimum approach represents a combination of the two variants. So, initially it is good to be established a general structure of the quality management system and then to be established frame models for documentation of the processes. Implementation activities will have in view identification and solving the problems and then the improving key processes of SME.

Indifferent the approaching way, top management of SME can decide if the conceiving and implementation project of the quality management system will be carried out through internal forces, or will be carried out external appealing to a specialised advising. In case they appeal to an advising firm, must exist an abiding collaboration between the two firm and a well tuned up contract to which will be affixed a plain schedule, with responsibilities and achievement terms.

Designing and implementation project of the quality management system cannot ensure solving all the problems. Changing the culture of an organization takes time and patience. Project must be accomplished through a well defined series of phases, with well established terms and with objectives that can be reached.

Active Implication Of The Implementation Of Quality Management System



Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.
The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.
To achieve such a desideratum, top management must consider the following actions:
· defining the visions, policies and strategic objectives of SME;
· direct participation of the management to improving projects;
· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;
· developing an environment that encourages the involving of the personnel;
· ensuring the necessary resources for achieving the objectives.
Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.
These methods must allow the evaluation:
· financial performances of SME;
· performances of the processes of SME;
· client’s satisfaction, personnel’s and other interested parts’ satisfaction;
· other success factors identified by management.
Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving
the performances of SME.
In this way, top management can demonstrate its commitment through:
· understanding the necessities and present expectations and client’s perspective;
· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;
· adopting the principle of continue improving as a base principle for the processes of SME.
· Rigorous planning of all processes of SME and to operate the changes;
· ensuring an adequate background to satisfy the requirements of the interested parts.
Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.
The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:
· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;
· ensuring that incoming and outgoing elements are obvious defined and are kept under control;
· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;
· identification and administrate the risks and to turn to account the opportunities of improving
performances;
· doing the analysis of the information for continuously improving of the processes;
· designating the responsible of the processes;
· ensuring that every process is managed so that it allows the achievement of the established objectives;
· defining the necessities and expectations of the interested parts.
Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:
· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;
· defining the policy and objectives regarding the quality;
· managing the analysis of the quality management system;
· ensuring the necessary resources for the achievement of the objectives.
One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:
· getting client’s satisfaction as a main goal;
· clarifying the way in which it is ensured the quality of the products and services of SME;
· explicit commitment of the management regarding continue improving of the quality;
· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.
Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.
When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

Why do organizations implement ISO 9000 systems?


Why do organizations implement ISO 9000 systems?

More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.