ISO 9001 Standard - ISO 9001:2008 Standards

ISO 9001 Standards Certification

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.

How To Prepare ISO 9001 Standards Audit Check List

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 the ISO 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.

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”.

Preparing ISO 9001 Quality Manual

Preparing ISO 9001 Quality Manual

ISO 9001 Standards defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the ISO 9001Standards Quality Manual be a response to the requirements of ISO 9001 Standards. As the top-level document describing the management system it is a system description describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9001:2008, were no more than 20 sections that paraphrased the requirements of the ISO 9001 standards.
Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.