ISO 9001

ISO 9001
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ISO 9001 is a standard for Quality Management. ISO 9000 is maintained by ISO, the International Organization for Standard and provides a set of standardized requirements for a quality management system. It is administered by accreditation and certification bodies. The rules are updated, as the requirements changes over time. The ISO 9001:2008 standard provides a tried and tested frameworkfor taking a systematic approach to managing the organization’s processes so that they consistently turn out product that satisfies customers’ expectations. Some of the requirements in ISO 9001:2008 include

a set of procedures that cover all key processes in the business;
monitoring processes to ensure they are effective;
keeping adequate records;
checking output for defects, with appropriate and corrective action where necessary;
regularly reviewing individual processes and the quality system itself for effectiveness; and
Facilitating continual improvement.
How to get ISO 9001?

First one should familiarize oneself with the requirements of IS/ISO 9001:2000 and also content and philosophies given in IS/ISO 9000:2000, IS/ISO 9004:2000 and the Quality Management Principles. One should understand the organization’s activities and processes and appropriately interpret the requirements of the standards. Implement the requirements in the various activities and processes adding value to these processes and activities Create a cross functional team to prepare, implement, maintain and improve the system. Detail the time commitment both before and after implementation. Provide ISO 9001 training for all those assigned to a particular project team. Have core team members to compare the current quality process with the new process. Identify gaps in the current process and change policies or procedures to close them. Automate procedures whenever possible. Conduct a company-wide internal quality audit after 30 days of implementation. If you pass,
contact an ISO 9001 Certification Body to a conduct an independent audit.
Hire a consultant, if required, this will shorten the implementation time or hire a consultant for the initial audit and then once again halfway through the process to ensure you’re on the right track.

Documentation for ISO 9001

The quality management system documentation includes:

documented statements of a quality policy and quality objectives,
a quality manual,
documented procedures and records required by the ISO 9001:2008 International Standard. ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities, Control of documents, Control of records, Internal audit, Control of nonconforming product, Corrective action, Preventive action
documents, including records determined by company to be necessary to ensure the effective planning, operation and control of its processes
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (example corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (example internal audits). Both are acceptable.

Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.

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