ISO 9001 Standard - ISO 9001 Standards

ISO 9001 Standard - ISO 9001 Standards

The Implementation Steps Of ISO 9001 Standard Certification

The Implementation Steps Of ISO 9001 Standard Certification

ISO 9001 implementation steps, and prerequisites for a successful ISO certification success of ISO 9001 quality management system depends on the entire implementation was carried out. The implementation steps for ISO 9001 Standards are as below:

(1) with a well-defined awareness training program started. You have to separate awareness training programs for top management, middle management and lower management. You need to the quality management, ISO 9001requirements and how quality management is to discuss making a difference in your organization. You can hire an outside consultant / trainer for the confidence in a professional manner.

(2) The next step is to perform a gap analysis. Gap analysis is a detailed and complete study of the current business processes of your organization vs. the request of the ISO 9001 standard. This is the most important and crucial stage during the entire ISO 9001 implementation process. Whether you are a manufacturer or a service organization, you need to benchmark your current business processes with ISO 9001 requirements. Results of the gap analysis study was created generating a gap analysis, you need to be circulated to all process owners and department heads. It is always advisable that you appoint a reputable and experienced consultants to carry out gap analysis of your company as an external consultant as a management consultant.

(3) gap analysis, you must complete workshop for the derivation of quality policy and quality objectives as process. These tasks will be the driving force behind the organization to improve performance and measurement.

(4) Based on the gap analysis and process as quality goals, you need to develop various documents such as quality manual, functional Procedures (SOP), formats, instructions, systems and checklists .

(5) is being developed by the Documentation, Procedures should owners officially approved and issued by a board representative. You need to training for the employees of your organization have to provide documents and it’s effective implementation.

(6) Process owners are required together with department heads and representatives of management to monitor effective implementation of the ISO 9001 system of organization and their processes / departments. Type help / assistance to users on the new system and ISO 9001 requirement if necessary to facilitate the proper implementation of ISO 9001 in the organization.

(7) Choose to be a team of employees trained as internal auditors. Talk to your consultant or trainer for the implementation of a comprehensive quality internal auditor training. This training allows your employees Auditing skills to understand process-oriented approach to the implementation of audit according to ISO 9001 clauses and requirements.

(8) Plan an internal audit and ensure that ISO 9001 internal audit is carried out according to schedule. If you wish, to facilitate wire in an external consultant will first round of internal audit. MR and auditors should ensure coordination with the auditee that the non-conformities are found during the audit is closed and the corrective measures are effective in nature.

(9) to discuss organizing management review meeting several points such as quality and objectives of the audit results, supplier performance, customer complaints and their redressal, customer feedback, and it is analysis, customer requests and their status, education, and it is the effectiveness, change in process or QMS, etc. Agenda and minutes of MRM is to be worked out with an action plan.

(10) Select a CA depending on your budget and your specific requirements. They have a practical experience of your advisor in selecting the most appropriate certification body.

(11) It is advisable to do a pre-assessment test before the final certification audit. Under the supervision of the results of the preliminary examination of the final exam schedule and communicate to everyone in the organization.

(12) Get out of the final certification audit and ensure that you close all non-matches (if any) in the stipulated time.

(13) you get a recommendation for ISO 9001 quality management system and you will receive a certificate as an ISO 9001 certified company

ISO Certification – A Standard For a Quality Business

ISO certification is accepted as the worldwide stamp of approval for business wanting to demonstrate compliance to quality systems. It is an organization working across 161 countries around the world looking to established standards for quality of materials, products, process, etc. It provided unique identification and goodwill to the organization to conduct business with any other, to deal in a global market.

The importance of ISO certification is that it provides assurance of Quality management which gives assurance to the customers. ISO Standard assessment and certification is recognized worldwide for giving your business the competitive edge, client confidence and market place leverage.

ISO provides the necessary tools to improve and unite work force of a business to increased profit margins, work efficiency, improved accuracy and customer base right through business operations. So although the process seems daunting and time consuming, the benefits of taking the time and putting the initial hard work into certification is well worth it for the long term benefit achieved. The process also includes regular internal audits of a company, to identify any nonconformity in procedures or documentation. By this it is easy catch small errors in processes or procedures before they become costly problems.

There are many ISO Companies that provides ISO Certification, Quality management, ISO standards, ISO 9001, ISO 9000, ISO 14001, ISO 27001, ISO 17025, ohsas, ohsas 18001 etc. It helps to ensure and keep the organization focus in terms of standard and quality. This is made possible in the course of certification. The organization will be given standards to work with and other training or enlightenments. The organization is to continue to follow if it must remain in the good book of the ISO. It helps in building customers trust and confidence in the company and its products. All an all ISO certification is very important for the growth and trust of customer on the business.

IMPLEMENTATION OF ISO 9001 STANDARD IN EDUCATION

The economy has already met with various endeavours and concepts to build an effective quality management system. From the historical point of view, the most important ones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) and

international standards pertaining to ISO 9000 (1987) family. The implementation of this last standard grows continuously, either in Europe or in the world. In the period from 2001 to 2003, there was a slight stagnation, which was the consequence of the organisations having to adapt to the requests of ISO 9001:2000 edition of the standard. Croatia also actively participates in this trend, which show that at the end of 2004, organisations were certified, of which 970 of them were from Croatia.

The economy has already met with various endeavours and concepts to build aneffective quality management system. From the historical point of view, the most importantones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) andinternational standards pertaining to ISO 9000 (1987) family. The implementation of thislast standard grows continuously, either in Europe or in the world, as shown in the picture1. In the period from 2001 to 2003, there was a slight stagnation, which was theconsequence of the organisations having to adapt to the requests of ISO 9001:2008 editionof the standard. Croatia also actively participates in this trend, as illustrated by figures fromthe table 2, which show that at the end of 2004, 670,399 organisations were certified, ofwhich 970 of them were from Croatia.

The implementation of the stated standard in educational activities took a somewhat slower pace. Trends in Croatia do not completely follow the World ones . The 2002 and 2003 stagnation, which, as already mentioned, was mainly caused by transfer from one issue of the standard to the next one, had no particular impact to Croatia, partially because the data for Croatia includes standards from both the previous and the new issue of the ISO 9001 standard.

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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.

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

Introduction to ISO 9001 Standard Certification

Introduction to ISO 9001 Standard Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000?. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Process Approach In ISO 9001 Standards

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.

Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of

approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for managementsystems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance(ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

Introduction to ISO Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

What does ISO 9000 offer?

What does ISO 9000 offer? For one thing, it offers you continuedbusiness with customers who may be requiring you to register. That isa pretty strong benefit right there.These customers may never question your quality, but these customersdepend heavily on their main suppliers. They know they canimprove their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you couldbe. ISO 9000 mandates a continuous improvement system. Youcan wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9000 helps your organizationadapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9000 bring you? When well implemented, anISO 9000 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9000 process (its inherent deficiencies notwithstanding).When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blowsmoke,stay uninvolved, and starve the system of all but the most essentialresources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9000 registration brings you one more thing that your organizationmay not have today: International credibility. ISO 9000 is deployedand practiced in nearly 100 countries around the world. Intoday’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.