ISO 9001 is the most popular and widely-implemented quality standard, and there is an extensive market for support materials and services. To help you find the best resources we have put together the following lists, based on our own research, professional experience and feedback from Council members.
For small and medium-sized businesses, ISO 9001 implementation packages are an increasingly popular alternative to hiring a consultant. They enable business owners to set up a customized, fully functional ISO 9001 system in-house and reach certification on a relatively small budget. However the differences between implementation kits are significant, making due diligence and careful selection essential.
Should you use an ISO 9001 implementation package?
ISO 9001 implementation packages can offer several benefits depending on your situation and needs. If you haven't decided yet which approach to take, consider the following resources:
Our guide on how to achieve ISO 9001 certification explains the different approaches you could take.
Read our survey on ISO 9000 consultants to learn about the pros and cons of hiring a consultant for ISO 9001 implementation.
Documentation templates form core of ISO 9001 implementation packages. Find out all about ISO 9001 documentation templates.
Reviewed: 3 June 2018
9001Simplified, a pioneer in the field of ISO 9001 implementation kits, offers particularly business-friendly tools that stand out for their efficiency, lack of bureaucracy and ease of use. The "ISO 9001 Certification Package" includes detailed customization guidelines, allowing for adaptability across a broad range of businesses. The included remote consulting (e-consulting) ensures that even the most unusual situations are covered. Automatic product configuration simplifies usage and leads to faster certification.
9001Simplified was one of the first online vendors to market ISO 9001 templates and implementation kits, thereby enabling small businesses to achieve ISO 9001 certification for a fraction of the fees consultants typically charge. The company later simplified its ISO 9001 implementation tools and placed greater emphasis on practical, operational improvements, combined with excellent customer support. More recently the company innovated by introducing a new implementation kit, the "ISO 9001 Certification Package", that can be configured automatically, prior to purchase.
This configuration option is not one we've seen elsewhere and at the time of writing (June 2018) appears to be unique. It's an especially interesting feature insofar as it allows companies to tailor the Certification Package according to their precise needs and individual circumstances. The advantages of this approach are obvious – it makes customization easier, leads to better and more individualized ISO 9001 documentation, reduces certification costs and results in quicker ISO 9001 certification. Again, and at the risk of repeating ourselves, these unique configurations can be made automatically, prior to purchase.
The Certification Package includes everything necessary to implement an ISO 9001 Quality Management System. There are over 40 procedures that address every ISO 9001:2015 requirement, and more than 45 forms and checklists that complement the procedures. Also included is an internal audit package, a certification toolkit and ISO 9001 training. Project guide and customization instructions are detailed but the package also includes unlimited support. The included "ISO 9001 Quality Manual" provides an easy way for companies to showcase their ISO 9001 system to inquiring customers – before completing the implementation. In certain situations this could be extremely beneficial.
We tested the Certification Package in a simulated ISO implementation and found the procedures user-friendly, well-written and jargon-free. All ISO 9001:2015 requirements are met through practical, logical steps. The "process structure" version eliminates duplication by combining some ISO 9001:2015 requirements (this configuration option is preferable for the vast majority of users who are seeking only to implement ISO 9001 and not combine it with another ISO standard). Customization instructions are detailed and allow for easy modification to fit virtually all situations.
Customer service is always a key issue with implementation packages. 9001Simplified includes with their implementation package full, remote consulting (they call it e-consulting) that guarantees access to their team of ISO 9001 professionals for situation-specific consulting without charge. In our opinion, this is an important feature.
Another feature worth highlighting is efficiency: we found no unnecessary steps or requirements, and in our opinion this Certification Package should result in a lean Quality Management System that's easy and inexpensive to maintain. For most companies it should also pave the way to numerous operational improvements.
In summary, we consider 9001Simplified's Certification Package to be an unusually business-oriented implementation kit, and applaud the company for taking this crucial element so seriously. We consider the package ideal not just for easy and fast ISO 9001 certification, but for improving business performance.
Business Value-Added: (95%)
Ease of Use: (90%)
Reviewed: 26 June 2018
Easy9001 offers an "All-In-One Easy 9001 Toolkit" that focuses entirely on easy and quick ISO 9001 certification. Though this approach is problematic in our opinion, we recommend the company for two reasons: the resulting Quality Management System is surprisingly effective, and the "easy and quick" approach may be the only way for some business owners to pursue ISO 9001 certification.
Easy9001 offers two products: a package to upgrade ISO 9001:2008 systems to meet ISO 9001:2015 requirements and an implementation kit, the "All-In-One Easy 9001 Toolkit". In our opinion the Toolkit is very comprehensive: as well as a detailed project guide, there are 45 procedures templates covering the entire spectrum of ISO 9001:2015, and over 60 additional forms and templates. Included training is limited to a PowerPoint presentation.
The Toolkit includes many forms and other documentation templates, but the most important documents are the procedures. We evaluated them for usability, effectiveness and business value-added, and found the "easy" part is definitely noticeable throughout: Easy9001 appears to have designed the procedures for ease of customization and ease of use later on. The customization instructions are well-written and comprehensive, and allow for easy customization in a variety of business situations and industries. All procedures are set up so that they are useful for both service and manufacturing businesses. All in all, we think that the procedures templates and customization instructions should also allow business owners to create an effective ISO 9001 Quality Management System that also adds business value – though this important aspect is apparently not Easy9001's priority. According to Easy9001, the most important goal is to achieve ISO 9001 certification quickly, and subsequent utilization of the QMS will automatically improve business operations. Though we are strong believers in implementing ISO 9001 for its value as a business improvement tool, we acknowledge Easy's approach.
The Toolkit's project guide is complete as well as practical. We think anybody should be able to follow the clear implementation steps. The guide also references the numerous other implementation tools included, making their usage quite obvious. As mentioned, there are lots of other documents, forms and tools, including the documents necessary to set up an internal ISO 9001 audit program, and a PowerPoint presentation for staff training. Several components of the Toolkit are unusual and interesting. The "Insider Secrets for a Successful ISO 9001 Certification Audit", for example, contains information and advice that might alone justify the price of the Toolkit.
The result of our evaluation: we find the Toolkit good for quick and easy ISO 9001 certification, but just acceptable for business value-added. Based on our simulated ISO 9001 implementation at a small manufacturing company, we believe even complete beginners can use this Toolkit to achieve ISO 9001 certification quickly and satisfactorily.
Business Value-Added: (70%)
Ease of Use: (96%)
Reviewed: 28 September 2018
QualityManualTemplates offers its "ISO 9001:2015 Certification Package" at what seems to be an everlasting "promotional" price. It's a decent package that's rather easy to use and leads to a good ISO 9001 quality management system. Qualitatively it doesn't quite match 9001Simplified and Easy9001 but its price makes it an attractive option for some.
QualityManualTemplates offers an "ISO 9001:2015 Certification Package" as well as templates, forms and guides (you can even purchase individual forms). The Certification Package is quite complete, with extensive documentation templates (more than 40 procedures covering all ISO 9001:2015 requirements), an "essential forms package" that includes 23 forms which go hand in hand with the procedures, an audit package, a gap analysis checklist and project guide, and extensive customization instructions for the templates.
We consider the procedures templates well written: their layout is pleasing and clear, and the described processes are straightforward. The procedures generally strike the right level of detail. Only the design-related procedures are a bit lacking, which make this template sub-optimal for companies involved in design activities. Other than that, all procedures are integrated into the "process oriented" ISO 9001 procedures manual – a well structured document that uses a so-called "process structure" instead of following the structure and numbering system of ISO 9001:2015. We found this process structure intuitive and easy to use, but it may not be ideal for companies wanting to integrate ISO 9001 with another ISO standard; for those companies, we recommend QMT's regular quality & procedures manual. The customization instructions are detailed and well balanced, making them easy to use in a wide range of circumstances. We think that most companies (with the exception of those involved in design activities) will be able to customize the templates without difficulty.
The included project guide is a useful tool with clear instructions that even beginners should be able to follow. The guide's extensive appendix is one of the most all-inclusive we have seen – it even includes an executive overview of ISO 9001:2015.
All in all, we consider this to be a comprehensive package. While some forms are missing (design planning and engineering changes, for example), the package can be considered a solid tool with which to set up an ISO 9001 QMS. The price is attractive.
Business Value-Added: (76%)
Ease of Use: (80%)
Templates play a central role in the development of ISO 9001 documentation. They are at the core of do-it-yourself implementation packages and even consultants use them. Templates can lead to excellent results when developing ISO 9001 procedures, forms and checklists. However the qualitative differences between templates and their included customization instructions are significant, making due diligence and careful selection essential.
Should you use ISO 9001 templates?
ISO 9001 templates can add tremendous value during documentation development or improvement. The key to success when using them is the extent to which they can be customized; the customization instructions are every bit as important as the templates themselves. If you haven't decided yet on the use of templates, consider the following:
9001Simplified offers templates for integrated ISO 9001 documentation (their "ISO 9001 Quality Management Manual" contains over 40 procedures) as well as a large selection of forms and checklists. Note, however, that forms and checklists (with the exception of gap analysis and audit checklist) are only available as part of a package (the "ISO 9001 Forms Collection" contains 46 important forms and checklists). The documentation templates and the forms and checklists come with detailed customization instructions so that they can be adapted to a broad range of situations and businesses. Should the need arise, customer support is prompt and knowledgeable. We recommend the documentation templates if you want to improve upon your existing ISO 9001 system. Forms and checklist can be used independently of the 9001Simplified procedures. For more information on 9001Simplified, please read our review of their implementation package.
QualityManualTemplates offers procedures templates (separate procedures as well as integrated in a "Quality and Procedures Manual") and 23 essential ISO 9001 forms and checklists (available individually as well as in a package). Forms and checklists are simple to customize; instructions are included. We recommend QualityManualTemplates to those in need of only a few forms. Those in need of a complete set of forms or a template for the entire ISO 9001 documentation will find better quality and value at 9001Simplified.
ISO 9001 training programs include traditional classroom-based tuition, customized on-site training, online courses and multimedia videos. The popularity of ISO 9001 online training and multimedia courses in particular is increasing, due mainly to their low cost, "fun factor" and flexibility. Our recommendations will help you navigate what's available and choose the approach best suited to your needs.
What format of ISO 9001 training is ideal?
Each training format has its pros and cons, and choosing the ideal format depends on several factors, including:
Do you need to teach groups? If so, customized training performed onsite may be ideal, and is the preferred option for teaching senior management. An inexpensive multimedia course (usually in DVD format) may also suffice. Multimedia video presentations are ideal for introducing ISO 9001 to staff.
Do you need in-depth training for individuals? Public classes and online training are popular due to their effectiveness and cost. Online training is particular inexpensive and obviates travel costs.
Is flexibility important? Online training and DVD courses can be taken independently at any location; both formats can be paused and resumed as needed.
Do you require customized lessons? Custom on-site training allows you to specify your precise training needs around which your instructor will develop a dedicated lesson plan. Training of this type takes into account the culture and operations of your company, potentially making it extremely efficient.
The TÜV Rheinland Group enjoys an outstanding reputation for its range of ISO 9001 Quality Management training courses. Training spans a number of sectors (industry, service providers, health service and hospitals, for example); formats include seminars, webinars, workshops and events. Tuition is presented by qualified, practicing auditors and other experienced QMS professionals. TÜV Rheinland also works in partnership with selected universities and colleges, and grants licenses to administer its ISO 9001 courses.
Fees are perhaps slightly higher than the industry average, but the payback in terms of quality is well worth the investment. In in our opinion, TÜV Rheinland is one of the leaders in this field and we highly recommend their services.
StandardsCourses is a long-established online vendor with a reputation for high quality, reasonably-priced products. Many of their ISO 9001 training courses have been created by some of the world's most respected QMS professionals The company offers two formats: online training and multimedia DVD courses.
We found the DVD courses informative and enjoyable, and overall surprisingly effective. Course durations range from 20-30 minutes – an appropriate length for use in employee or management meetings. All DVDs are accompanied by learning guides, which allows video presentations to be paused in order that attendees can take notes and maintain records of the training session.
The online courses are designed for individuals. The learner proceeds through the course and the content adjusts as he or she progresses. There are also practical examples that enable the learner to easily connect the ISO 9001 requirements to the operations of their own company, while the summaries and quizzes encourage the learner to retain the study materials.
In summary, we recommended these courses: they are high quality and offer great value for money.
9001Simplified also offers training products in two formats: online training and DVD courses. With the exception of a DVD course that introduces ISO 9001 to Spanish speaking employees, all materials are English language. As with their other products, quality and value for money are excellent. For more information on 9001Simplified, please read our review of their implementation package.
Plexus Training offers public courses at conference centers and hotels, as well as customized courses on-site. The company has an excellent interactive training approach, knowledgeable teachers and a fine global reputation. If you are interested in traditional training classes and custom on-site training, Plexus Training is a thoroughly reliable choice.
Selecting an ISO 9001 registrar that fits your individual circumstances is important. There are many criteria but the most important one is the registrar's accreditation: beware of registrars that offer certification without accreditation – attempting to use such a "certification" for marketing purposes often backfires and exposes the holder of the certificate as untrustworthy. A quick search on Google should turn up numerous ISO 9001 registrars in your nearest large town or city.
When should you hire your ISO 9001 registrar?
We recommend selecting and hiring your registrar as early as possible, preferably at the very beginning of your ISO 9001 implementation. The reason is not only a matter of scheduling your registration audit (some registrars require several months advance notice) but also the various resources offered by many of the larger registrars. Some registrars can provide assistance with the definition of the scope of your QMS and help you decide if certain functional areas of your company should be excluded. Particularly companies that operate multiple physical locations will benefit from discussing multi-site issues and a potentially money-saving sampling approach to audits.
Headquartered in London, BSI Group is the National Standards Body of the United Kingdom and one of world's largest certification bodies. BSI is a non-profit distributing organization and offers global services in the linked fields of standardization, systems assessment, product certification, training and advisory services. As of mid-2018, BSI had 76 offices serving over 80,000 clients in 182 countries
Det Norske Veritas (DNV) is one of the world's largest certification and accreditation companies. We have had excellent experience with their auditors over the years. Also, pricing is very competitive. If your company has operations around the world, you will especially appreciate that DNV has local auditors in many regions and countries.
There are many sources of information about ISO 9001 on the internet, including publishers of ISO 9001 implementation packages, ISO 9001 consultants and registrars. Keep in mind though that much of this information may be (covertly) geared towards marketing products or services. The following resources are ones we recommend (aside from the public and member sections of this website):
Is it necessary to read all information on ISO 9001 in order to get certified?
No, it is not. The sources of information presented in this section can be used to gain a basic understanding on ISO 9001 or get specific questions answered. Generally it is advisable to use ISO 9001 training to gain the needed knowledge and only supplement with the additional information per sources below.
The official website of the International Organization for Standardization (ISO) has ample information on the organization itself, on the ISO 9000 standards series, as well as other ISO standards. You can also find links to national quality bodies, such as ANSI for the USA. The site is a quite hard to navigate at times and some articles are very technical. Here are some useful links:
ISO also publishes a monthly newsletter, ISOfocus, which can be accessed free of charge in PDF format. The newsletter covers a range of topics, is well-written and a pleasure to read. Only a small amount of the content pertains to ISO 9001:2015 (the case studies are especially interesting), but it's a fine resource, nonetheless.
Elsmar Cove is the oldest and best known quality forum. Many of its members are ISO 9001 professionals with years of experience. Numerous discussions on ISO 9001 topics take place at any given time – expect to see technical discussions as well as practical advice. The forum is free to join but you can also follow discussions without registering.
The Quality Forum Online is a less-known forum with two sections devoted to ISO 9001: one covers ISO 9001:2008, the other focuses on ISO 9001:2015 Quality Management Systems. The site isn't particularly active, but the community is friendly and willing to share its knowledge and offer advice. There's no need to join if you simply want to browse some of the threads and read through the archives.
Quora is a website where users can post questions and answers. Questions cover a broad range of topics, including ISO 9001. Be aware that answers are provided by the site's community, none of whom are required to prove any particular skill or expertise. Nevertheless, it's interesting to view existing questions and answers, and possibly even post a question of your own. Registration, which is simple and free, is mandatory.
Wikipedia is a free encyclopedia with content provided and updated by its users. The website provides some interesting information about the history of the ISO 9000 family of standards, the different ISO 9000 revisions, certification and auditing, and industry-specific versions. There is also a discussion on some of the criticism concerning the ISO 9000 series.