ISO 9001 Standard - ISO 9001:2008 Standards

Implementing ISO 9001 Standards

Implementing ISO 9001 standards

If you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 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 9001 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 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 in your organization.

How To Meet Quality Standards With ISO 9001 Standards

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for
everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both
time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements
needed in a good quality system:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

= Using well-defined processes and procedures to build stable processes
= Training in the audit and certification process
= Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification.
Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

Series OF ISO 9001 Standards

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: Leading your company to Successful ISO 9001:2008 Registration

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration

Document Review In ISO 9001 Standards

Document Review In ISO 9001 Standards
The ISO 9001 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment should be disposed of.

Why Is ISO 9001 Important?

Why Is ISO 9001 Important?

ISO 9001 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9001 is important because of its international orientation. Currently, ISO 9001 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.

ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9001 is important.