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 which will gradually supersede ISO 9001:2008.
ISO 9001:2008 will remain applicable and its certifications will remain valid until September 2018.
THE NEWEST REVISION OF ISO 9001: ISO 9001:2015
The ISO 9001 standard recently 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 are being valid. In the beginning of the transition period, most companies will focus on ISO 9001:2008 and get certified to the 2008 version, while towards the end of the transition period most new certifications will be to the 2015 version. Companies are encouraged to commence their transition from ISO 9001:2008 to ISO 9001:2015 in early 2018.
ISO 9001:2015 Certification:
Most companies that are currently seeking ISO 9001 certification will make the ISO 9001:2015 certification in a 2-step approach: first ISO 9001:2008 certification and then transition to ISO 9001:2015 in 2018. The reason for this 2-step approach is that it is currently much easier and cheaper to get ISO 9001:2008 certified (most available support materials, tools and training are still for the 2008 version, registrars and auditors have yet to transition to the 2015 version, and common interpretations of ISO 9001:2015 have yet to be established). Once ISO 9001:2015 is universally accepted and there is an extensive selection of good support materials, training, auditors and registrars (and lower pricing that comes with increased supply) available, companies may then make the required changes to their documentation and quality management system using our ISO 9001:2015 upgrade materials (free for all customers who purchased our ISO 9001:2008 materials after October 31, 2014).
ISO 9001 Upgrade Materials:
To make the transition to ISO 9001:2015 easy and quick, we will be publishing ISO 9001:2015 upgrade materials. The upgrade materials will be free for all customers who purchased our ISO 9001:2008 materials after October 31, 2014. We will publish our upgrade materials soon after common interpretations of the new ISO 9001:2015 requirements have been established, probably by mid 2016.
Revision of our Documentation Templates:
Once ISO 9001:2015 has been universally accepted and common interpretations have been established, we will also revise all our ISO 9001 documentation templates to meet the new requirements of ISO 9001:2015. We expect our ISO 9001:2015 materials to become available by mid 2016.
HOW TO IMPLEMENT ISO 9001:2008
As explained earlier, we recommend to focus for the time being on ISO 9001:2008 and only later transition to the new revision. We will, therefore, explain how to implement ISO 9001:2008.
ISO 9001:2008 requires a variety of documents:
1. Create the ISO 9001 required documentation (see below).
2. Implement your documentation (ie., ensure that everybody 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 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 9001:2008
ISO 9001:2008 requires a variety of documents:
(1) Quality Manual
The Quality Manual describes the overall quality management system of the company. Writing your ISO 9001 Quality Manual is usually the first step when 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 your ISO 9001 Quality Procedures is usually considered to be the most difficult part of developing the ISO 9001 documentation. ISO 9001:2008 requires 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 at the company. It is usually a short one- to two-paragraph statement that must meet several requirements. 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.
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 writing 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...
There is no specific requirement for ISO 9001 forms within ISO 9001:2008 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.
OUR TEMPLATES MAKE YOUR ISO 9001 DOCUMENTATION EASY
Most companies consider the documentation requirements the most difficult part of the ISO 9001 implementation. The reasons are that these documents have to meet the many 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.
All our templates, forms and guides are fully compliant with ISO 9001:2008 and its commonly accepted interpretations:
fully compliant with all requirements of ISO 9001:2008
fully compliant with the intent of ISO 9001:2008
the simplified wording of ISO 9001:2008 is reflected in our products making them exceptionally easy to understand
With our products, you will benefit from all aspects of ISO 9001:2008!
Companies that use our approved and successful templates get a big head start as they merely modify the templates to fit their companies:
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 get an excellent ISO 9001 quality 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 already made.
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.
The Certification Package
all you need to get ISO 9001 certified
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All our products (purchased after October 31, 2014) now include a free upgrade to ISO 9001:2015. This way you can implement ISO 9001 now as planned and then upgrade for free after the 2015 version is published in late 2015. You will have three years to transition from ISO 9001:2008 to ISO 9001:2015 while keeping your certification.
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