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 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.

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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ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

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ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

Kindly go to http://www.e-wia.com for more information.

While usually associated with manufacturing and service activities, ISO 9001 should be considered equally as effective as a management system for education and training programs. If we consider the desired outcome (learning), education and training is just another form of service; the product is the knowledge, skill and/or ability that is achieved by the program attendees. As with other services, the delivery of education and training incorporates the processes of design, development, verification, validation, delivery, subsequent correction and ongoing improvement. Therefore, when we try to apply the requirements of ISO 9001 to education and training activities, we find that it aligns exceptionally well with generally accepted practices.

A fundamental objective of any quality management system is to ensure that customer needs are met. In order to define these needs as they relate to education and training, we must first define the primary customer of this service – the program attendee. I’ve used the term “primary customer” in this discussion, as numerous ancillary customers may also be involved, including the parents of the attendee, the state which provides funding to the institution, and possibly even the country in which the activity is performed (as skill development contributes to the national economy). In the case of corporate training, we must also consider the needs of the individual’s employer, the industry they serve, as well as regulatory bodies or other interested parties. The list of potential customers can be as varied as the number of offerings that are available; identification of both primary and ancillary customers is a critical part of the initial needs assessment process, and is essential to the overall success of any education or training effort.

Once the above customers have been defined, their needs must be translated into terms that can be understood by the organization, and that can be further developed to serve as a measurement of an individual’s competency. Typically, these needs are reflected through the establishment of learning outcome statements, commonly referred to as learning objectives. Upon completion of specific portion of a program (or upon the completion of the program as a whole), the participant should be able to demonstrate a defined level of mastery of the course content, or be able to demonstrate the ability to perform a specific task or activity. To determine if these needs are satisfied, the participants performance throughout this entire process is monitored, and at defined intervals, the individual’s ability to meet a defined learning objective is measured against an established set of criteria (be it quizzes, examinations, demonstrations or other evaluation methods). Once the criteria established for competency is met, the objective is considered to be achieved. This process then continues until all established objectives have been met for the program, at which point a certificate or other form of recognition is awarded.

When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.

System documentation required by the ISO 9001 standard, including a quality manual, and the six “system” procedures required by the ISO 9001 standard – the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.

While the ISO 9001 standard does allow for an organization to take exclusion to the requirements found in Clause 7, there are relatively few instances where such exclusion would be justified. Typical education and training activities encompass Design and Development (instructional design), Purchasing (materials and services) Validation of Processes (pilot programs and peer reviews), Customer property (information) and even the Control of Measurement and Monitoring Devices (quizzes and examinations). While the specific processes used may vary between different organizations and offerings, almost every clause of ISO 9001 could conceivably apply.

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How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA).  This PDCA concept is applied at the Quality Management System and the process levels.

2.  Convert the question to requirement  raised by  QMR or the QMS Committee which derived from theISO 9001 standards.  In this case, several questions can lead to one single requirement.

3.  To edit those questions to suit the process that is to be audited.  For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise.  There is no better way to do that than by developing the audit questions with them.