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ISO 9001:2008
The ISO 9001 :2008 standard is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it wants to achieve customer satisfaction through consistent products and services which meet customer expectations. Third-party auditors may grant certifications that prove that a company meets the stringent ISO 9001:2008 requirements.
The current version
of the ISO 9001 standard is ISO 9001:2008. ISO 9001:2008 was published
on November 14, 2008 as successor to ISO
9001:2000 (which was published in the year
2000). ISO 9001:2008 is expected to remain
valid until 2016 when the next revision is
scheduled.
Certification:
Since the publication of ISO 9001:2008, all new
certifications will be ISO 9001:2008
certificates. Existing ISO 9001:2000 can
be upgraded to ISO 9001:2008 following a
re-certification or surveillance audit.
Templates:
All our templates, forms and guides have been fully revised and updated to be 100% up-to-date with
ISO 9001:2008:
fully compliant with all requirements of
ISO 9001:2008
fully compliant with the intent of ISO
9001:2008
the new and simplified wording of ISO
9001:2008 is reflected in our products
making them exceptionally easy to understand
You will benefit from all aspects of
ISO 9001:2008 with our products!
HOW TO IMPLEMENT ISO 9001:2008
In very general terms, in order to implement ISO 9001, you would...
Create the ISO 9001 required documentation (see below).
Implement your documentation (ie., ensure that everybody follows the documented procedures and instructions).
Hire an external registrar to audit and certify you (our forms include a useful registrar evaluation form).
We make the start easy for you! We recommend that you start out with our ISO 9000 Documentation Package. If you follow the included detailed step-by-step customization tutorial, you will have completed the documentation requirements very quickly - and that's usually seen as the biggest step in the ISO 9001:2008 certification process.
For a very detailed project plan that guides your ISO 9001 implementation until certification, please consider our ISO 9001:2008 Project Guide.
ISO 9001:2008 DOCUMENTATION REQUIREMENTS
ISO 9001 :2008 requires a variety of documents:
(1) Quality Manual
The Quality Manual describes the overall quality management system of the
company. Writing the Quality Manual is usually the starting point of developing the
ISO 9001 documentation. ISO 9001:2008 requires the Quality Manual in section
4.2.2
(2) Six Quality Procedures
The Quality Procedures describe in relatively general terms the overall process flow,
its interaction with related processes, as well as the distribution of authorities and
responsibilities. Writing the Quality Procedures is usually regarded the most difficult
part of developing the ISO 9001 documentation. ISO 9001:2008 requires the Quality
Procedures in the following sections:
ISO 9001:2008 section 4.2.3 (Control of Documents)
ISO 9001:2008 section 4.2.4 (Control of Records)
ISO 9001:2008 section 8.2.2 (Internal Audit)
ISO 9001:2008 section 8.3 (Control of Nonconforming Product)
ISO 9001:2008 section 8.5.2 (Corrective Action)
ISO 9001:2008 section 8.5.3 (Preventive Action)
(3) Quality Policy
The Quality Policy is the top-level policy directive regarding quality and customer
satisfaction. It is usually a short one- to two-paragraph statement. ISO 9001:2008
requires the Quality Policy in section 5.3.
(4) Quality Objectives
Quality Objectives are designed to support the Quality Policy. They are specific and
measurable goals. As the goals are met, new goals are set. ISO 9001:2008
requires Quality Objectives in section 5.4.1.
(5) Process Flowchart
ISO 9001 requires "a description of the interaction between the processes of the
quality management system". Though this description can be in an form, a
flowchart is a very appropriate format. ISO 9001:2008 requires the "description" in
section 4.2.2.
(6) Records
Records provide evidence that the company meets the requirements stated in the
Quality Manual, Quality Procedures, Quality Policy, Quality Objectives and Work
Instructions. There are numerous sections in which ISO 9001:2008 specifically
requires records.
A word about Work Instructions...
Work Instructions are detailed step by step instructions on how to perform a particular work process. Work Instructions are typically written by the personnel performing the actual work; the ISO
9001 Management Representative typically guides the developing of Work Instructions and ensures that the requirements of the Quality Manual and the Quality Procedures are met. ISO 9001:2008 does not include an absolute requirement for Work Instructions; however, section 7.5.1. requires Work Instructions where they add value to the company.
A word about Forms...
ISO 9001 does not specifically require forms but they can be considered both work instructions (before they are filled in) and records (after they are filled in). For this reason, good forms save time and provide many more benefits.
OUR TEMPLATES MAKE THE ISO 9001 DOCUMENTATION EASY
Most companies consider these documentation requirements the most difficult part of the ISO 9001 implementation. The reasons are that these documents have to meet the rather hard-to-understand requirements of the ISO 9001 :2008 standard, and that writing these documents is at the beginning of the ISO 9001 implementation thus presenting a big initial hurdle.
Companies that use our proven and successful templates get a big head start as they merely modify the templates to fit their companies:
You instantly have the entire and complete documentation required by ISO 9001.
Figuring out how to start is often a big roadblock but with our templates you can get a huge jumpstart on your implementation.
Companies that use our proven and successful templates will end up with an excellent ISO 9001 quality system:
Using good and proven templates could lead to a significant improvement of any existing ISO 9001 system.
If you use a good quality manual template, you can actually get a simple and user-friendly ISO 9001 system that improves the efficiency of your company.
Companies that use our inexpensive ISO 9001 templates will save much money, time and corporate resources:
With materials that are proven successful you don't have to make the same mistakes that others have already made.
User-friendly ISO 9001 documentation makes it easy and quick for employees to meet the ISO 9001 requirements, thus allowing you to each ISO 9001 certification more quickly, easily and inexpensively.
A non-bureaucratic ISO 9001 system allows companies to operate efficiently.
