Archive for December, 2009
Document Review In ISO 9000 Standards
ISO 9000 Document Control Procedures
Develop Quality Management System Documentation In ISO 9000 Standards
Develop Quality Management System Documentation In ISO 9000 Standards
Documentation is the most common area of non-conformance among organizations
wishing to implement ISO 9000 quality management systems. As one company
pointed out: “When we started our implementation, we found that documentation
was inadequate. Even absent, in some areas. Take calibration. Obviously it’s
necessary, and obviously we do it, but it wasn’t being documented. Another area
was inspection and testing. We inspect and test practically every item that leaves
here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.
Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.
Level A: Quality manual
States the scope of the quality management system, including exclusions and
details of their justification; and describes the processes of the quality
management system and their interaction. Generally gives an organization
profile; presents the organizational relationships and responsibilities of persons
whose work affects quality and outlines the main procedures. It may also
describe organization’s quality policy and quality objectives.
Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in
each department and the checks that are carried out.
Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include
drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.
Create a Documented Implementation Plan In ISO 9000 Standards
Create a Documented Implementation Plan In ISO 9000 Standards
Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.
The implementation plan should be thorough and specific, detailing:
a. Quality documentation to be developed
b. Objective of the system
c. Pertinent ISO 9001:2008 section
d. Person or team responsible
e. Approval required
f. Training required
g. Resources required
h. Estimated completion date
These elements should be organized into a detailed chart, to be reviewed and
approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.
Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning.
Conduct Initial Status Survey In ISO 9000 Standards
Top Management Commitment In ISO 9000 Standards
Preparing The ISO 9000 Standards Quality Manual
Preparing The ISO 9000 Standards Quality Manual
| The standard requires a quality manual to be established and maintained that includes the
scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system. ISO 9000 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the manual be a response to the requirements of ISO 9001. 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 9000 :2008, were no more than 20 sections that paraphrased the requirements of the standard. 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. This requirement responds to the System Approach Principle. A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as : a means to communicate the vision, values, mission, policies and objectives of the organization a means of showing how the system has been designed a means of showing linkages between processes a means of showing who does what an aid to training new people a tool in the analysis of potential improvements a means of demonstrating compliance with external standards and regulations When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages. The requirement provides the framework for the manual. Its content may therefore include the following: 1 Introduction (a) Purpose (of the manual) (b) Scope (of the manual) (c) Applicability (of the manual) (d) Definitions (of terms used in the manual) 2 Business overview (a) Nature of the business/organization – its scope of activity, its products and services (b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.) (c) The context diagram showing the organization relative to its external environment (d) Vision, values (e) Mission 3 Organization (a) Function descriptions (b) Organization chart (c) Locations with scope of activity 4 Business processes (a) The system model showing the key business processes and how they are interconnected (b) System performance indicators and method of measurement (c) Business planning process description (d) Resource management process description (e) Marketing process description (f) Product/service generation processes description (g) Sales process description (h) Order fulfilment process description 5 Function matrix (Relationship of functions to processes) 6 Location matrix (Relationship of locations to processes) 7 Requirement deployment matrices (a) ISO 9001 compliance matrix (b) ISO 14001 compliance matrix (c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.) 8 Approvals (List of current product, process and system approvals) |
ISO 9000 Total Quality Management
TQM is infinitely variable and adaptable. Although originally applied to manufacturing operations, and for a number of years only used in that area, TQM is now becoming recognised as a generic management tool, just as applicable in service and public sector organisations. There are a number of evolutionary strands, with different sectors creating their own versions from the common ancestor.
Help Solving Global Warming Problem by ISO 14001 Standards
Global Warming! What can be done? Can ISO 14001 Standards – Environmental Management System Help??
One of the front page headlines in the Monday, June 13, 2005 edition of USA Today read: The debates over: Globe is warming. The sub-title paragraph declared: Politicians, corporations and religious groups differ mainly on how to fix the problem.
While there will always be hold-outs, fewer and fewer knowledgeable people are denying that global warming is a reality resulting from an increase in the amount of greenhouse gases being generated. What remains in debate are the causes of this phenomenon. Is it man-caused, perhaps a by-product of the growing demand for energy, much of which is produced from fossil fuels? Is it a product of natural events like volcanic eruptions or the digestive processes of animals? Is deforestation part of the problem? Is it a combination? Are there other, yet undefined factors at work?
Much work needs to be done to answer these questions. Depending upon the answers, environmental scientists will then turn their focus from cause definition to mitigating the effects of global warming, and instituting corrective and preventive action. Does this sound like the same language used by those involved in quality and/or environmental management system? Of course it does! Quality and environmental professionals have been using the tools of problem prevention and corrective action for years to predict problems before they occur and to correct problems if and when they occur and institute actions to prevent recurrences.
As individuals, each of us can contribute to the solution. As a start, we can choose to drive vehicles that are more fuel-efficient. We can plant more trees. We can recycle where practicable. We can take stock of our energy consumption practices and try to reduce them by some factor.
But, what steps can your organization take to help? The answers are varied, depending upon the size of the organization and the related environmental aspects and impacts. But no matter how simple or complex the business, each can benefit from the implementation of a management system based on ISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organizations processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm. In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.
Environment Awareness – Implement Environmental Management System
Save OUR EARTH!!! Go For ISO 14001 Standards – Environmental Management System. If all companies implement ISO 140001 Standards – Environmental Management System in the organization, it will help us to protect our environment.