4 November 2018
All companies need external resources to achieve ISO 9001 certification, and since this is the most popular and widely-implemented quality standard, there is a buoyant market for support materials and services. In this editorial we'll offer objective, practical guidelines on how to identify the resources that best fit your needs, give comprehensive evaluation advice and provide detailed tips on making the right purchase decisions.
If you are planning to set up an ISO 9001:2015 Quality Management System you will need a copy of the Standard. This is true even if you intend to use a consultant to manage the implementation. Also worth remembering is that auditors generally check to see if you have the Standard available.
The ISO 9001:2015 Standard is available in PDF format and hardcopy from ISO and its national member organizations.
Issues to consider when purchasing the Standard include language, price, and authorized sources. The content of the Standard is identical no matter if published by the International Organization for Standardization (ISO) or by one of its national member organizations. National accreditation bodies often modify the title to include their own name; the subtitle "Quality Management System Requirements" and the content of the Standard remain the same.
The Standard is available in the languages of the member countries of the International Organization for Standardization. Purchase the Standard in the language you understand the best. If the official language used at your company is English and your procedures will be written in English (notwithstanding possible translations), you should also purchase an English-language copy of the Standard.
We recommend you purchase from a reputable source to avoid illegal copies, modified text or obsolete revisions. In addition to your country's own accreditation board, you can purchase from the following authorized sources:
ISO offers downloadable PDF and hardcopy versions (priced in CHF).
ANSI, the accreditation board of the USA, offers a downloadable PDF version and a link to a hardcopy available from Amazon (priced in USD).
BSI, the accreditation board of the UK, offers a downloadable PDF and hardcopy version (priced in GBP).
Since all authorized sources offer the same product, simply choose the cheapest.
Many small business owners initially think of hiring a consultant when confronted with ISO 9001. ISO consultants can be used to manage the entire ISO 9001 project or to assist with distinct tasks like documentation development, staff training, gap analysis and project planning.
There are pros and cons to hiring an outside consultant to design the company’s ISO 9001 quality management system.
High costs, along with other important factors, are reasons why business owners should consider alternatives before hiring a consultant. See our research on the pros and cons of ISO 9000 consultants for more information. Our guide on how to achieve ISO 9001 certification explains different implementation approaches.
Differences between quality management consultants are significant in terms of approach, ability, integrity and pricing. Your decision to hire a particular consultant will have a profound impact on your company's culture, operations and finances, so it's essential to carefully evaluate the consultant before hiring. Factors to consider are detailed below.
In-depth knowledge and understanding of the ISO 9001 Standard and its interpretations are crucial. The more practical experience in ISO 9001 implementation a consultant has, the greater the likelihood he will be able to properly address your company's individual needs. However, we have seen numerous cases in which general management consultants or consultants with different fields of expertise readily take on ISO 9001 implementation tasks. Their lack of relevant experience is often a recipe for inefficient and expensive Quality Management Systems. It is therefore essential to carefully evaluate the consultant's knowledge and experience in ISO 9001 rather than relying on the consultancy's name or success in other fields.
It is important to realize there are countless ways to set up an ISO 9001 system. While consultants should adapt their approach to fit the needs of individual companies, the reality is that most have their own, individual style and preferences, all of which will impact on your company's operations. We recommend assessing your company's current performance, culture, strengths and weaknesses in order to determine what sort of approach your consultant should adopt.
For optimum effectiveness and efficiency, your ISO 9001 Quality Management System needs to be tailored to your company's individual characteristics. Documents not precisely geared to your company' needs will lead to numerous problems, including inefficiencies and increased cost. It is therefore crucial that your ISO 9001 documentation is developed by a company insider or someone with an intimate understanding of your business.
Consultants typically gain the necessary understanding of your company by observing your operations and interviewing staff. Prior to hiring a consultant, we recommend clarifying how much time he'll devote to learning about your business, and to what extent he'll individualize the documentation. Remember that time spent learning will significantly impact the consultant's fees.
ISO 9001:2015 doesn't require the use of technology or software. But while pen and paper may work best for some companies, others benefit from paper-free environments and specialty software. Corporate culture, current work processes, staff education and numerous other factors determine what benefits, if any, your company will again from increased use of technology.
Some consultants insist on the use of particular software solutions (for example, for document control or audit management) and include requirements for software use in the ISO 9001 procedures. You need to clarify these issues prior to hiring.
ISO 9001 systems don't need to be complex: efficiency is typically associated with simplicity while bureaucracy and loss of productivity tend to be the product of unnecessarily complex processes.
Some consultants, however, intentionally deliver overly complex ISO 9001 systems in an attempt to justify "padded" fees. We suggest you request a sample of previously written ISO 9001 procedures and note your first impression when reading them: are they clear and easy to understand, and would they be easy to implement?
Hands-on vs. hands-off
Hands-off consultants will typically seek to maximize employee involvement during the implementation process and play only a background role in developing a QMS. In contrast, a hands-on consultant will tackle the bulk of the ISO 9001 implementation by himself (and at times micromanage the entire project). Our survey on ISO 9001 consultants found that the hands-off approach tends to create ISO 9001 systems that are easier to operate and better geared to the company's specific needs, while hands-on consultants may deliver a less satisfactory or workable solution.
The integrity of ISO 9000 consultants can often be judged by their marketing techniques. Be wary of consultants who give out free materials that ostensibly reduce or eliminate the need for consultancy services. Many such materials are not designed to provide practical assistance but are marketing tools to covertly steer users towards hiring the consultant later on.
Hiring a consultant is the most expensive way to set up an ISO 9001 system.
Hourly rates vary widely and are not necessarily indicative of the consultant's experience or ability.
While consultants generally provide a proposal for ISO 9001 implementation (price and summary of services, etc), it's not unusual for companies to require additional services, and the consultant may take longer than expected to familiarize himself with the company.
It's for this reason that the cost of hiring a consultant often ends up higher than anticipated.
For more information and a more in-depth review of ISO 9000 consultants, refer to ISO 10019.
Differences between consultants are so significant that the International Organization for Standardization (ISO) has developed an entire Standard devoted to the selection of quality management consultants: ISO 10019. The Standard is available at ISO's website.
Implementation kits are designed to enable company staff to implement ISO 9001 in-house. These kits are now very popular among small business owners due to their relatively low cost and potential operational benefits.
Computer-based ISO 9001 certification kits enable company staff to set up their own ISO 9001 quality management system.
Good implementation packages contain documentation templates, instructions and other materials that enable even those without a background in ISO 9001 to achieve certification. The best ISO 9001 certification packages can be considered a superior alternative to consultants.
The kit you choose will impact your ISO 9001 implementation as well as the operations of your company. While good kits can provide tremendous benefits, inferior kits may have profoundly negative consequences. You therefore need to evaluate and choose carefully. We encourage you to conduct your own reviews according to our guidelines below.
Product descriptions, samples and customer feedback are usually sufficient to form a useful assessment prior to purchase. Many template providers also offer a satisfaction guarantee, allowing you to purchase risk-free and evaluate the entire package.
Most vendors sell documentation templates and individual products, but packages typically offer better value to those who need all ISO 9001 implementation tools (though you may want to calculate yourself). As a first evaluation step, check if all necessary components are on offer:
Number of procedures
ISO 9001:2015 doesn't explicitly require a certain number of procedures. However, complete documentation of a Quality Management System should address all ISO 9001 requirements. This typically results in about 40 procedures. Note that procedures may be in the form of individual documents or combined in an ISO 9001 documentation manual.
Customization instructions are every bit as important as the documentation templates they pertain to. Only comprehensive customization instructions can lead to truly individualized ISO 9001 documentation.
The project guide contains step-by-step instructions on how to conduct all implementation tasks, from project planning through to certification.
Number of forms
While not explicitly required, good forms and checklists simplify compliance and increase efficiency. Check how many forms and checklists are included.
Conducting the required ISO 9001 internal audits can be greatly simplified by using a good audit checklist.
Gap analysis checklist
The gap analysis checklist is a planning tool that allows you to determine what will be needed for your company to achieve ISO 9001 certification.
A quality manual is no longer required by ISO 9001:2015.
Check if the implementation kit includes customer support that provides assistance with the materials and ISO 9001 implementation.
After having gained an overview of the implementation kit and its completeness, each component needs to be evaluated. Product descriptions, along with the samples, will give a good indication of the quality of the components.
The procedures form the core of ISO 9001 documentation. To assess the quality of the procedures templates, look at the product descriptions and sample procedures:
How many ISO 9001:2015 requirements are covered?
If individual procedures are numbered according to the ISO 9001:2015 Standard, you should compare the list of procedures with the Standard. If the procedures are integrated in an ISO 9001 documentation manual, you will need to look at the table of contents (which is hopefully available in the product description or as sample file), or a cross-reference in the case of an documentation manual that follows the "process approach".
How good are the procedures?
Good procedures are complete, strike the right balance between detail and readability, are easy to understand and jargon-free, and structured and laid out in a user-friendly way. Take a look at as many sample procedures as possible and observe:
What is your first impression?
Is the text easy to understand for you and others in your organization (readable and jargon-free)?
Is the procedure structured and laid out in a practical, user-friendly way (rather than a list of numbered and sub-numbered sentences or sentence fragments)?
Are there many references to other ISO 9001 documents? References that require the user to jump from one document to another in order to find needed information create inefficiencies and lead to non-compliances.
Would you and your staff consider the procedures practical instructions? Keep in mind that the procedures still require customization before they can be fully applied to your company. However, high-level descriptions and unstructured processes cannot easily be customized to become useful instructions.
Check sample pages for lack of content: how much meaningful content is there compared to unnecessary formalities.
How are the procedures structured?
Are the procedures structured according to the ISO 9001:2015 Standard (Annex SL high-level structure) or according to a "process structure" (a more intuitive structure)? Companies that plan to integrate ISO 9001 with another ISO standard will benefit from the Annex SL high-level structure, while all other companies will typically find the "process structure" more user-friendly.
Is there unnecessary bureaucracy?
"Unnecessary bureaucracy" is probably the most frequent complaint about ISO 9001 systems. It can manifest itself in countless ways but is difficult to detect without experience. Some clear indicators for bureaucratic ISO 9001 systems can be spotted though:
Check samples for unnecessary formalities, including definitions, abbreviations, and complicated numbering systems (these can often be found in the beginning of procedures).
Are there references to a "master list of documents"? A master list that contains all company documents is not required by ISO 9001:2015, is cumbersome to maintain and impractical to use.
Do references to other documents include complicated document numbers? Most smaller businesses operate more efficiently with a simple document control system that doesn't require the extra layer of an involved numbering system.
Are the templates really new?
The current revision of ISO 9001 (ISO 9001:2015) features new and revised requirements, a new structure and new terminology. It is important to verify that the procedures templates have been specifically created for ISO 9001:2015. In other words, it's essential to avoid older products that have been "tweaked" to look as though they were designed for the latest revision. The following are some tips for spotting potentially outdated products:
The procedures are structured according to the numbering system of ISO 9001:2008 (whose main chapters were 4. Quality management system; 5. Management responsibility; 6. Resource management; 7. Product realization; 8. Measurement, analysis and improvement).
Samples and/or product descriptions include references to ISO 9001:2008. Vendors selling such materials are better avoided.
There is a procedure on preventive action (this procedure was superseded by risk-based thinking in ISO 9001:2015).
Are the documents ISO 9001:2015 compliant?
Verifying compliance requires knowledge and experience in ISO 9001. However, it is possible to determine non-compliance (a major warning signal) using the following indicator:
Do the sample documents show evidence of document control? Look for a revision date (typically in the footer of each page) and a document name (or identifying number).
The backbone of any template-based ISO 9001 kit is the customization instructions. These instructions need to be detailed enough to apply to a broad range of situations, and any organization must be able to use them to create their own, situation-specific ISO 9001 documentation.
Are there separate instructions?
Check if there is a separate document for the customization instructions. Customization tips that are included as highlighted text within the templates are generally insufficient and don't allow for meaningful editing in a broad range of individual situations.
Are the customization instructions detailed?
Look at a sample to see how well the instructions explain the process. Could they be adapted to your own situation? Other indicators for the level of detail are the number of pages and the table of contents.
Step-by-step instructions for the entire implementation project enable even those without experience to achieve ISO 9001 certification. A good project guide is fully integrated in the ISO 9001 implementation package and explains when and in which order to use the various templates and other components.
How comprehensive is the project guide?
Look at samples rather than relying on the product description, and check the table of contents to see if all implementation steps are covered. Also look at the page numbers to see how many pages of text describe each step.
How clear are the instructions?
Review a sample to see if the instructions are clear and easy to understand. Would you be able to follow them and base your ISO 9001 implementation on them?
Are related documents included?
Check if there are related documents needed during the ISO 9001 implementation. Examples are:
a description of responsibilities of the ISO 9001 point person (often referred to as management representative),
tools to select your registrar,
employee newsletters, and
instructions to prepare for the registration audit.
Note that such documents could be separate documents or part of the project guide as an appendix.
Forms and checklists are designed to simplify the numerous ISO 9001:2015 requirements for collecting and recording data, and typically play an important role in any Quality Management System. Good forms are easy to use in both paper-based and paperless environments, are user-friendly and don't require separate instructions.
How good are the forms?
Good forms are easy to understand and easy to fill in. Take a look at as many samples as you can and observe:
What is your first impression?
Do you understand the form and would you be able complete it without further instructions?
Is the form structured and laid out in a practical, user-friendly way?
Is there enough space for all required data?
Can the form be filled out electronically as well as in a paper-based environment?
Are the forms ISO 9001:2015 compliant?
Verifying compliance requires knowledge and experience in ISO 9001. However, it is possible to determine non-compliance (a major warning signal) using the following indicator:
Do the sample forms show evidence of document control? Look for a revision date (typically in the footer of each page) and the name of the form (or identifying number).
Are there references to the now obsolete ISO 9001:2008? Many older forms remain compliant under ISO 9001:2015 so references to a previous standard revision could indicate either noncompliance or sloppiness and lack of attention to detail.
Are customization instructions included with the forms?
Most ISO 9001 forms and checklists require only limited customization. Nevertheless, customization instructions will add value whenever individual circumstances require editing.
Does a user guide accompany the forms?
If a large number of ISO 9001 forms and checklists is included in the package, it may initially not be obvious how to use them. A user guide that explains each form and its application will be helpful when setting up the Quality Management System.
The quality manual used to be a key document but is not required in ISO 9001:2015. If a template for a quality manual is still included, it could be either a relic from a previous version of the Standard or a document created for marketing purposes. A quality manual that is specifically designed for marketing purposes could be useful for companies that need to show (prior to obtaining certification) that they are actively implementing ISO 9001; it could also be used to provide information on the Quality Management System without disclosing operational details.
A quality manual is particularly useful for marketing if it includes an introduction to the company, the quality policy, the scope of the Quality Management System and a description of its main components. We recommend that you review the table of contents and a sample page.
Flowcharts (or flow diagrams) are frequently used for ISO 9001, and are one of the best tools for analyzing processes and their integration in a system. They can also be used in lieu of written work instructions. It is not uncommon for ISO 9001 documentation to include flow diagrams.
Flowcharts can be created with various tools, though creating them without dedicated software is cumbersome and time-consuming; edits are even more difficult without the right program. The best known flowcharting software is Visio, but superior alternatives exist. When evaluating flowcharts included in an ISO 9001 implementation package, there are two important aspects: the design of the flowchart and the file format.
Which file format is used?
Check the file format and which software can be used to open and edit it. If the flowcharts are saved in Visio format (.vsd, .vsdx), then Visio and several Visio-compatible programs can open and edit them. Other formats may limit you to particular software. Check carefully as some applications require monthly subscription fees (quickly getting expensive) while others may not be available for Apple's Mac operating system. Many software vendors offer free trial versions, but keep in mind that you will likely want to purchase the software for continued use.
Do the included flowcharts add value?
Review samples to verify that the included flowcharts really add value. Diagrams that summarize a process flow and supplement a procedure can foster better and quicker understanding. Diagrams that depict the position of a particular chapter within the quality manual offer no practical value and create unnecessary bureaucracy when changes are made to the QMS.
If a training product is included with the implementation package, review it carefully to verify that it is in fact the training you expect.
If the tuition is provided online, it's important to distinguish between interactive training (which includes multimedia elements) and simple PowerPoint or slideshow presentations that have been uploaded to a website. While interactive online training is effective, engaging and fun, PowerPoint presentations offer less value and can seem rather dull by contrast. Review samples or a demo to determine what sort of online training is being provided. Be wary if you find the words "number of slides" or "number of pages" in the description as this usually indicates the training is nothing more than a simple slideshow
Will YOU be the trainer?
Training included with ISO 9001 kits is not always standalone. Sometimes the training consists of instructions and guidebooks that teach you how to manage the training by yourself with the help of handouts for your learners. Unless you want to be the teacher, avoid this type of training product (which can often be detected by the presence of a "trainer's guide" or similar).
See below for more detailed information on training and tips on.
Good ISO 9001 certification packages are designed for DIY ISO 9001 implementation by beginners. Even if detailed customization instructions and a step-by-step project guide are included, you may encounter difficulties or a situation not addressed by the supporting documentation. Free and unlimited customer support by experts is therefore a highly important component of any ISO 9001 certification kit.
What kind of support?
Verify that full customer support provides assistance with individual products and the actual ISO 9001 implementation. Remote consulting is even better. Technical support (assistance with download issues etc) is generally inadequate.
Who provides the support?
Verify that the support is provided by ISO 9001 professionals and experts who also take part in product development as this combination of experience provides the best foundation for reliable support.
Are there limitations to support?
Verify that customer service is not limited by the number of inquiries or similar. Look for unlimited support.
What are the contact options?
Check how customer support can be reached. Ideally phone support and/or email support is provided, with each option having their own advantages. Phone support is ideal for quick answers and cases where you don't know how or what to ask. Email support is ideal for complex questions that require research, for longer and more detailed answers, for keeping a history of questions and answers, for inquiries outside of office hours and for avoiding spending time on hold.
There are many ISO 9000 stores that merely resell ISO 9001 templates. Even though such stores may offer customer service, the service reps may not be sufficiently knowledgeable in ISO 9001:2015 and the intricacies of the templates to provide meaningful help. Unless you are completely sure, we suggest purchasing from the original publisher rather than an ISO 9000 store.
The increasing popularity of ISO 9001 implementation kits has unfortunately led to unethical or outright criminal marketing techniques. The most common problems are associated with free or inexpensive template offerings are:
Some websites offer counterfeit templates and implementation kits that are copied from legitimate providers. Besides the legal and ethical aspect, the problem with counterfeit products is that they tend to be obsolete, a combination of non-matching products, and incorrectly modified. Using such materials as the foundation of your Quality Management System puts your company at serious risk. The following are warning signals:
The website appears broken with non-working links and missing pages (particularly the contact page). This is the case when the entire website is copied with only rudimentary changes to the logo and text.
It is not possible to receive information about the product from customer service.
Products are offered at an unrealistically low price. Remember that the price of a genuine product needs to support developing, maintaining and updating the various components of ISO 9001 implementation packages, providing customer service and maintaining an informative website.
Some consultants are trying to counter the trend towards in-house ISO 9001 implementation by engaging in aggressive marketing techniques. Be aware of free or inexpensive templates that are designed to steer users into situations in which they cannot continue without increasingly expensive consultancy services. Besides their ethical aspects, such marketing traps lead to severe budget over-runs, negate some of the benefits of in-house implementation and result in a Quality Management System based on an insincere foundation. To avoid becoming a victim, we suggest you consider the following warning signals:
The publisher also sells ISO 9000 consulting services (this is a major warning signal).
Templates and entire implementation kits are made available free of charge.
The publisher downplays their own template kit while simultaneously promotes their consulting services.
Training is an important part of any ISO 9001 implementation. Traditional, classroom-based tuition was once the most popular option but in recent years has been supplanted by customized on-site training, video presentations and online courses.
On-site ISO 9001 training offers many advantages over public classes and can be particularly beneficial as a means of teaching senior management.
The first step is to decide on the appropriate training method. This will be determined by your situation and needs. The second step is to select a training provider and product.
Public training (or classroom-based teaching) is conducted by a specialized teacher and open to the public. Tuition is generally provided at schools, colleges, universities or hotel conference rooms. This traditional method tends to be the most expensive, particularly when taking into account travel expenses, but it is sometimes the only option.
Prior to signing up for a public training course, consider the background of the trainer. While numerous professional instructors provide effective ISO 9001 training, there are also courses whose main (albeit hidden) agenda is to sell a product or service.
Who offers the training?
Specialized training companies tend to offer excellent tuition, while some consultants use training courses to promote their consulting services (for example, by depicting ISO 9001 as too complex for DIY implementation and their consultancy services as the only viable way of achieving ISO 9001 certification).
What is the cost?
Good instructors and training facilities are expensive. If public training courses are offered for free or at a very low price, consider the motivation.
On-site training involves hiring a specialized instructor to provide customized training at the company. The advantage over public training is that tuition can be perfectly matched to the needs of the learners. If the audience is large enough, on-site training can also bring cost savings compared to public classes. On-site training is especially useful for teaching senior management. We recommend you choose on-site trainers from reputable training companies only – avoid consultants due to their interest in selling consulting services.
Multimedia video training (usually in the form of a DVD) is stand-alone training that is conducted through a combination of instruction and examples using films, speech and sound. As well as being an enjoyable training method, it's a very cost-effective since any number of people can be taught by a single DVD. Multimedia training is ideal for introducing employees to ISO 9001.
The market for ISO 9001 multimedia video training is small but courses available are generally very good. However, there are also recordings of public courses that are sold as video training – these materials lack multimedia elements and are therefore less entertaining and effective.
Online training (or e-learning) is a popular and effective option: it is completely flexible and can be taken anytime on any computer with an internet connection; it can be paused and resumed whenever needed. Online training is priced on a per-user basis and is therefore a cost-effective approach when only a small number of company staff require tuition.
The increasing popularity of online training has unfortunately lead to some misrepresentation. The use of the word "online" or "e-learning" does not necessarily guarantee interactive, online training.
Is it real online training?
Online training is interactive and incorporates multimedia elements. A PowerPoint presentation that is placed online is not real, interactive training – but often advertised as such. If there are samples available, look at them to verify that the course is not merely a PowerPoint presentation or slideshow in video format. Look too at the product description and watch out for references to a "number of slides" or a "number of pages". Materials containing these phrases are generally not authentic, interactive experiences.
Is it standalone training?
Real online training is standalone but sometimes supplemented by downloadable materials. Review the description and list of contents to identify training products that consist mainly of downloadable PDF files supplemented by a limited number of online elements.
The "train the trainer" methodology involves teaching a specific individual within the company to conduct all required ISO 9001 training. While this approach can sometimes be an alternative to hiring a professional on-site instructor, keep in mind that effective training requires considerable experience and proven teaching skills. For this reason, we generally recommend one of the other training methods.
We advise you to be wary if you are not looking for this training method. We have seen cases (particularly as part of ISO 9001 implementation kits or audit packages) in which "train the trainer" materials are advertised as internal auditor online training. The giveaway is when the phrase "trainer's guide" is included in the description.