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

The implementation of an ISO 9001 conformance system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) ISO 9001 Internal Audits, (4) control of non-conformities in ISO 9001 Standard, (5) ISO 9001 Standard Corrective Action, and (6) preventative action. A quality manual and several records are also required. The development of other ISO 9001 Standard Procedures, ISO 9001 Standard Work Instructions, and other ISO 9001 Standard documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO 9001 documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.

However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality the ISO 9001 standard documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results. A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process.

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ISO 9001 Standard Youtube video at http://www.youtube.com/watch?v=EsF8_iAeVIA

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. Its similar to the man who chooses not to take the
course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him dont care that he didnt take the exam. It is only those who dont know him that he will have difficulty convincing.

Many organizations were driven to seek ISO 9001 certification by pressure from customers rather than as an incentive to improve business performance and therefore sought the quickest route to certification. The critics called this
coercion and like most command and control strategies, believed it resulted in managers cheating just to get the badge. What was out of character was that suppliers that were well known to customers were made to jump through this
hoop in order to get a tick in a box in a list of approved suppliers. It became a necessary evil to do business. Certainly when perceived as a means to get a badge, the standard was no more than a marketing tool. It could have been
used as a framework for improvement but the way it was imposed on organizations generated fear brought about by ignorant customers who mistakenly believed that imposing ISO 9001 would improve quality. To achieve anything in our society we inevitably have to impose rules and regulations what the critics regard as command and control but unfortunately, any progress we make masks the disadvantages of this strategy and because we only do what we are required to do, few people learn. When people make errors more rules are imposed until we are put in a straightjacket and productivity plummets. There is a need for regulations to keep sharks out of the bathing area, but if the regulations prevent bathing we defeat the objective, as did many of the customers that imposed ISO 9001.

ISO 9001 includes the following standards:
•ISO 9001:2008 Quality management systems Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.
This is the only implementation for which third-party auditors can grant certification. It should be noted that certification is not described as any of the ‘needs’ of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 ‘Scope’) but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 ‘Introduction’).
•ISO 9004:2000 Quality management systems – Guidelines for performance improvements covers continual improvement. This gives you advice on what you could do to enhance a mature system. This document very specifically states that it is not intended as a guide to implementation.
There are many more standards in the ISO 9001, many of them not even carrying “ISO 900x” numbers. For example, some standards in the 10,000 range are considered part of the 9000 group: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: “The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards … Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole”.
Note that the previous members of the ISO 9000 series 9002 and 9003 have been integrated into 9001. In most cases, an organization claiming to be “ISO 9000 registered” is referring to ISO 9001.

To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.

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.
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Step by step

The solution devised by registrar auditing teams was to adopt a practice known as process auditing. For those who don’t know, process auditing is a standardized approach to reviewing  an activity by dividing it into basic components of:

1. Inputs

2. Process steps

3. Outputs

Every activity in an ISO-certified company can be analyzed using this methodology. In order to  better evaluate how well the company had implemented its QMS, registrars also added  standard questions to the audit, asking for knowledge and demonstrations of  process/performance improvement goals for each area of the company. With this approach,  companies became more aware that process improvement wasn’t simply a shop-operations practice; it was everyone’s responsibility. So for the first time, a company’s support activities such as sales, purchasing, engineering and personnel were required to show how they were  working to improve customer satisfaction as well.

ISO 9001:2008 was approved for implementation at the beginning of 2009. For the casual reader, the changes might seem hard to discern. And for the most part, the changes are  only intended to clarify and improve language. However, there is an important change in the wording of the introduction that encourages organizations to consider and use the process approach as a way to improve customer satisfaction and increase value.

From a practical standpoint, what this means is that companies currently using the process approach to auditing should talk to their registrar before making any changes to their QMS. One additional activity that needs to be carried out now that the new standards have been issued is to review all documentation for correct terminology. Failure to upgrade the term ISO 9001:2000 to ISO 9001:2008 might seem like a small thing. But it can become a sticking point if registrars spot it too often.

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