ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Softwarewere designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.

Role of Governments in ISO 14001 Standards

Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop the
basic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:
(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and
(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certification
services. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.

Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.

ISO 9001 Standards DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

What Should Be Documented In Quality Management System?

Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records

What Does ISO 9001 Offer?

For one thing, it offers you continued business with customers who may be requiring you to register. That is a pretty strong benefit right there. These customers may never question your quality, but these customers depend heavily on their main suppliers. They know they can improve their quality and through-put, if you improve yours. ISO 9001 mandates a continuous improvement system. You can wriggle and fudge, but if you implement that system and work it conscientiously, you cannot help but improve. Continuous improvement is not just a buzz term. It is an imperative.

Has your industry changed? Has your organization changed? A well-implemented ISO 9001 helps your organization adapt to change. It brings independence of individuals and consistency of practices—two features that tend to resist declines in performance.

What else does ISO 9001 bring you? When well implemented, an ISO 9001 quality system improves organization performance. That is, after all, the whole point. In cases where it does not, the fault tends not to be in the ISO 9001 process (its inherent deficiencies  notwithstanding). When an ISO 9001 system does not provide substantial benefits and improvement in performance, it is usually because management has consciously chosen to cut corners, blow smoke, stay uninvolved, and starve the system of all but the most essential resources. “We’ll do this stupid thing, but we’re sure not going to change the way we operate.”

ISO 9001 registration brings you one more thing that your organization may not have today: International credibility. ISO 9001 is deployed and practiced in nearly 100 countries around the world. In today’s ever-growing international economic climate, this is not a bad emblem to have, however narrow the scope of your market today.

How To Keep ISO 9001 System?

The dreaded “program-of-the-month” syndrome: Here today, with much sound and fury—and, after a slow, embarrassing fade-away—gone tomorrow.

Your ISO 9001 system won’t fade away as long as top management remains committed to it. Top management will remain committed to it as long as they see that it is returning some sort of benefit. That benefit may take one of two general forms:

1. Current business stays as a result of the ISO 9001 system.

2. New business comes as a result of the ISO 9001 system.

Net result: Organization achieves incremental cost savings as a result of the ISO 9001 system. Since most companies get into ISO 9001 due to customer pressure, the first benefit is the most operative one. The second benefit is speculative. The net result, surprisingly, is genuine—ISO 9001 registrants, with virtually no exception, realize proven cost savings—but, like mating elephants, it is accompanied by much roaring and screaming, and takes two years to see the results.

Top management will stay committed to the system if only to maintain existing business and, hopefully, obtain new business. This requires that the organization remain registered. For the organization to remain registered, it must undergo and pass surveillance assessments, usually every six months. This is probably the most potent of the four reinforcement mechanisms of ISO 9001—the attributes that keep the system from fading away as another program of the month.

The second reinforcement mechanism is the Management Review process required by the Standard. Management reviews require that senior management review the ISO 9001 system from top to bottom—its implementation, its suitability, its effectiveness, its results. Management must do this on a scheduled basis. Records must be kept to prove that it is done. The reviews have the effect of forcing management to pay attention to the system. The reviews are also an educational process for management. Over time, they see how useful the ISO 9001 system can be as a management and communications tool.

The third reinforcement mechanism is the internal audit process required by the Standard. Trained, independent employees audit the entire quality system on a scheduled basis and record the results. Corrective actions must be carried out and verified against deficiencies found during these audits. Internal auditing is not only an outstanding implementation tool. It also keeps the entire organization tuned in to the system and improving it on an ongoing basis.

The fourth reinforcement mechanism—and arguably the most important one—is the measurement and analysis processes required by the Standard. If you do a good job of establishing meaningful process and quality measures—and then gather, analyze, and react to the data on a disciplined basis—you will see how well the system is working for you. Word to the wise: Establish the measures early in the implementation, so you have a set of baseline measures to compare with subsequent results.

What Is ISO 9000 Registration?

Registration is documented and objective evidence that an organization’s quality system meets the requirements of ISO 9000. Certification is a term often used interchangeably with registration. In the context of ISO 9000, they mean the same thing. Registration is the technically correct term for verification of compliance to standards of quality systems. Certification usually applies to verification of the quality of products (as opposed to quality systems).

Registration is carried out by independent companies called registrars. These companies are:

_ Wholly independent.

_ Accredited by a recognized international accreditation body.

_ Selected, and paid, by you.

Registration can cover:

_ The sole location of a single-location organization.

_ Multiple locations of a multilocation organization.

_ Only certain parts of a multilocation organization (under certain conditions).

_ Separate locations under separate certificates. (This is a more costly approach.)

The registration body audits your quality system against the requirements of ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances. Major noncompliances must be closed out prior to official registration.

When this has been done, the registration body:

Lists the organization’s name in its book of registered companies— in effect, registers the organization in its book.

Issues a certificate to the registered organization. This registration includes:

— Identity of the organization.

— Location(s) covered by the registration.

— A list of products/services supplied by the registered locations.

— Revision date of the Standard.

— Registration effective dates.

— Name and location of registrar.

Most registrars limit registrations to three years. After that, you must renew your registration by undergoing another complete systems audit. Some registrars do not use the renewal  approach. They simply keep checking the system via surveillance audits. Whichever the scheme, the organization, to keep registration, must undergo a surveillance assessment every so often. Six months is the typical interval. Some registrars offer annual surveillance schemes (not recommended except for firms with exceptionally well-implemented quality management systems). Surveillance assessments are scheduled events (there is no such thing as a “surprise” surveillance audit). Only part of the quality system is checked at each surveillance. Usually, the registrar does not disclose what part will be assessed until the day of the assessment, although some registrars will tell you everything up front.

The entire quality system is usually checked via surveillance audits over the course of three years. There is no way to “fail” a surveillance assessment, just as there is no way to “fail” a registration audit except by refusing to implement corrective action required by the registrar. Normally, registrars allow adequate time, but corrective actions must be done in a timely and agreed upon manner to keep registration.

One final note: As mentioned, each registrar publishes a list of the firms it has registered to ISO 9000. A comprehensive list of ISO 9000 registered firms is available from Irwin Professional Publishing (703-591-9008).

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 9000 Standard 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 9000 requirements 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.

Aligning At ISO 9001 Standard Requirements

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.