The ISO 9001 Standard
The ISO 9001 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 large 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 requirements.
The ISO 9001 standard is available for download from ANSI.
ISO 9001:2008 is the revision of ISO 9001 that was published in November 2008. In accordance with the revision schedule of ISO 9001, a new revision of the standard was published in September 2015 and has superseded ISO 9001:2008.
The new ISO 9001:2015
The ISO 9001 standard underwent its periodic revision. The newest version of ISO 9001 was published in September 2015 and is referred to as "ISO 9001:2015".
With the publication of ISO 9001:2015 in September 2015, a 3-year transition period started. During this transition period both ISO 9001:2008 and ISO 9001:2015 remained valid. In the beginning of the transition period, most companies still focused on ISO 9001:2008 and still got certified to the 2008 version. Later on, all new certifications were ISO 9001:2015 certifications.
Transition from ISO 9001:2008 to ISO 9001:2015
We encourage all companies that are currently certified to ISO 9001:2008 to start upgrading their ISO 9001 quality management systems to ISO 9001:2015 without further delay. By now, there are extensive support materials available, ranging from ISO 9001 transition training (online courses available at www.9001courses.com) to our own ISO 9001:2015 upgrade materials.
The transition to ISO 9001:2015 may seem complicated at first glance due to the new requirements in ISO 9001:2015. However, with the right materials, the transition can be quite simple and fast.
ISO 9001 Upgrade Materials
To make the transition to ISO 9001:2015 easy and quick, we published two ISO 9001:2015 Upgrade Packages. Just follow the included guide and customize the included templates.
All companies considering ISO 9001 certification should now implement ISO 9001:2015 directly. Since ISO 9001 is a great tool to improve operational processes and efficiency (besides having invaluable marketing benefits), we encourage you to start your ISO 9001 implementation as soon as possible. Don't worry, it is not difficult when you use our ISO 9001:2015 Certification Package.
How to implement ISO 9001:2015
ISO 9001:2015 certification can be achieved as follows:
1. Create the ISO 9001 required documentation (see below).
2. Implement your documentation (ie., ensure that everybody in your company follows the documented procedures and instructions).
3. Hire an external ISO 9001 registrar to audit and certify your company (our forms include a useful registrar evaluation form).
We make the start easy for you! We recommend that you start out with the ISO 9001:2015 Certification Package. If you follow the included project guide, and customize the included quality manual and procedures templates as shown in the detailed step-by-step customization tutorial, you will reach ISO 9001 certification quicker than you ever thought possible.
Documentation requirements of ISO 9001:2015
At first glance it appears that ISO 9001:2015 doesn't require as many documents as its predecessor did. However, this is a misconception. ISO 9001:2015 doesn't require a so-called "Quality Manual" and so-called "Quality Procedures". However, it still requires documentation of various operational processes as "documented information". Those rather vague requirements are typically interpreted to be requirements for numerous procedures. For all practical matters, the documentation requirements have not been relaxed in ISO 9001:2015.
The Procedures are the core of your ISO 9001 quality management system. The procedures describe the overall process flow, the interaction with related processes, as well as the distribution of authorities and responsibilities. Writing your ISO 9001 procedures is usually considered to be the most difficult part of developing the ISO 9001 documentation. The ISO 9001:2015 standard is rather vague on which clauses require procedures but most auditors will expect procedures for most clauses. To be sure, our templates include procedures addressing each and every clause.
The Quality Policy is the top-level policy directive regarding quality and customer satisfaction at the company. It is usually a short one- to two-paragraph statement that must meet several specific requirements. ISO 9001:2015 requires the Quality Policy in clause 5.2.
ISO 9001 requires "a description of the interaction between the processes of the quality management system". Though this description can be in any form, a flowchart is the format of choice. ISO 9001:2015 requires the process flowchart in clause 4.4.
Records provide evidence that the company meets the requirements stated in the ISO 9001:2015 standard, the Procedures, the Quality Policy and the Work Instructions. There are numerous ISO 9001:2015 clauses that call for specific records.
The Quality Manual describes the overall quality management system of the company in generic terms. The ISO 9001 Quality Manual is typically used in order to provide customers and third parties with a summary of the ISO 9001 quality management system. ISO 9001:2015 does not require a Quality Manual; however, previous versions of ISO 9001 required it and it is now a widely expected document.
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 usually guides the writing of Work Instructions and ensures that the requirements of the ISO 9001:2015 standard and the Procedures are met. ISO 9001:2015 clause 8.5.1 requires Work Instructions where they add value to the company.
There is no specific requirement for forms within ISO 9001:2015 but forms 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. We provide you with all essential ISO 9001 forms.
Our templates make your ISO 9001 implementation easy
Most companies consider the documentation requirements the most difficult part of the ISO 9001 implementation. There are two main reasons for this: first of all, the ISO 9001 documentation must meet the many, rather hard-to-understand requirements of the ISO 9001:2015 standard; secondly, writing the ISO 9001 documentation is at the beginning of the ISO 9001 implementation thus presenting an initial hurdle.
All our templates, forms and guides are fully compliant with ISO 9001:2015 and its commonly accepted interpretations:
fully compliant with all requirements of ISO 9001:2015
fully compliant with the intent of ISO 9001:2015
With our products, you will benefit from all aspects of ISO 9001:2015!
Companies that use our approved and successful ISO 9001 templates get a big head start as they merely modify the templates to fit their individual circumstances:
You instantly get the entire and complete documentation required by ISO 9001.
Figuring out how to start is often a big roadblock but our templates give you the needed jumpstart on your ISO 9001 implementation.
Companies that use our approved and successful quality manual and procedures templates will receive an excellent ISO 9001 quality management system:
Using good and proven templates could lead to a significant improvement of any existing ISO 9001 quality management system.
If you use good templates for your ISO 9001 quality manual and quality procedures, you can actually get a simple and user-friendly ISO 9001 quality management 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 made before you.
User-friendly ISO 9001 documentation makes it easy and quick for employees to meet the ISO 9001 requirements, thus allowing you to reach ISO 9001 certification more quickly, easily and inexpensively.
A non-bureaucratic ISO 9001 quality management system allows companies to operate efficiently.
ISO 9001:2015 Certification Package
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ISO 9001:2015 Upgrade Packages
Use our new ISO 9001:2015 upgrade packages for the easiest way to upgrade your ISO 9001:2008 quality management system to meet the requirements of ISO 9001:2015.
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