Step 1: Preparation
The first step addresses how to properly prepare the implementation of ISO 9001 at your small or midsize company. It's not a difficult step but it's important and should not be missed.
Get an Understanding of ISO 9001:2015
The ISO 9001 quality management system focuses on a large variety of business activities - not merely on quality control. Implementing ISO 9001 will, in some way, affect virtually all of your business processes. Before setting target dates and diving into the actual ISO 9001 implementation, it is important to understand the ISO 9001:2015 requirements and the implementation steps. The following sources of information will give you the needed understanding of ISO 9001.
Our ISO 9001 Certification Support Kit (which is included in our ISO 9001 Certification Package) contains a good summary and overview of ISO 9001:2015. It's often used to brief top management on ISO 9001 for small businesses and midsize companies.
The websites of ISO and the 9001 Council contain much information on ISO 9001, how to implement it, and how to get ISO 9001 certification.
You may also want to consider taking our concise online course ISO 9001:2015 Foundation Training which provides an introduction and overview of the standard and its benefits, as well as information on the implementation project.
And in case you don't have a copy of the ISO 9001:2015 standard yet, you will need to obtain one and read through it. See More Recommended Resources on where to download a PDF version.
Note that ISO 9001:2015 is the newest revision of ISO 9001, and that the terms "ISO 9000", "ISO 9001" and "ISO 9001:2015" are used interchangeably but all refer to the current ISO 9001:2015 standard.
ISO 9001 Management Representative
First, appoint the "ISO 9001 Management Representative". This is typically a quality manager or other member of top management of your company; it needs to be somebody who has sufficient authority to change operational processes and the way that your company works. This person will be responsible for implementing ISO 9001 processes.
Companies with more than one physical location may appoint a "local" Management Representative for each physical location or for each business unit in order to allow individual locations or business units a degree of autonomy to implement processes and direct ISO 9001 compliance. A "corporate" Management Representative would then coordinate among the local Management Representatives and ensure that corporate policies and processes are implemented. This setup will ensure both flexibility and simplicity. Note that we offer all our ISO 9001 templates, forms and implementation products in both, a single-site version and a multi-site version. A "Role Description" for the Management Representative is included in the ISO 9001 Certification Package.
We wrote this short guide on how to get ISO 9001 certification under the assumption that you, the reader, will be the Management Representative.
Note that the term "ISO 9001 Management Representative" is no longer used in the ISO 9001:2015 standard. However, the term is generally well accepted and understood, so we continue to use it (as will most ISO 9001 certified companies).
The new ISO 9001:2015 places emphasis on training and awareness programs. Besides being necessary in order to meet ISO 9001 requirements, proper training will any task easier, faster and smoother. The most obvious candidate for ISO 9001 training is the Management Representative who at this point may still be wondering how to proceed in order to get ISO 9001 certification. There are several training options, ranging from self-study to courses and coaching; choosing the right option depends on the individual situation.
Some Management Representatives may only need on-the-job training. For those, the review of a good sample ISO 9001 quality management manual (a quality manual that includes documented procedures addressing all ISO 9001 requirements) together with detailed customization instructions may be completely sufficient. Others may require a formal course, in which case ISO 9001 online training may be the right choice.
Getting full support from top management, middle managers and employees is crucial for the success of your ISO 9001 quality management system. The earlier you get this support, the better.
First, you will need to ensure that the company executives completely support the ISO 9001 effort. Explain to them the benefits of ISO 9001 certification, including the internal and operational benefits, as well as the marketing benefits that the ISO 9001 certificate can bring. Top management will also want to know what it takes to get ISO 9001 certification as far as resource requirements and costs are involved. Lastly, executives management should also get an understanding on their own expected involvement in ISO 9001. As an option, you may suggest top management take a concise, introductory online course that covers all of those topics.
Next, you should inform all managers and employees about the plan for ISO 9001 and how to get ISO 9001 certification, the benefits to them and their work, as well as the expectations regarding their cooperation. This kind of awareness program is quite important in order to prevent employees from feeling threatened by ISO 9001 and ultimately becoming an obstacle to your ISO 9001 implementation efforts. Gaining manager and employee buy-in is best done in form of department meetings. Presenting a motivational ISO 9001 introduction video is a good and easy choice.
Before jumping into the actual ISO 9001 implementation project, it is best to make a plan for it. In most cases, you won't need a comprehensive plan with Gantt charts but a simple plan with implementation steps and target dates will be helpful. A good project guide book that clearly describes all implementation steps (like the one included with our ISO 9001 Certification Package) will simplify your project plan.
At this point, you should conduct a gap analysis in order to find out to what extent your company is already meeting ISO 9001 requirements and where the emphasis of your implementation efforts should be. Use a checklist to perform the gap analysis. Based on the results of your gap analysis, you will be able to sketch out a plan for your ISO implementation project. Now you will have an understanding and plan on how to get ISO 9001 certification.
Step 2: Documentation
Writing the quality policy and the many ISO 9001 procedures (previously referred to as "documented procedures") is usually considered the most difficult step when implementing ISO 9001. This is because these documents have to meet all of the numerous technical requirements of the ISO 9001:2015 standard, which are often difficult to understand, interpret and apply to a company's circumstances. Another issue that complicates the ISO 9001 documentation development is the timing as writing these documents needs to happen at the beginning of the ISO 9001 implementation project. Without help and experience, this would be big initial hurdle.
On the other hand, customizing prewritten templates can make the documentation development a rather easy task. The key here is the quality of the template and, importantly, the quality of the customization instructions.
Which Documents Are Required by ISO 9001?
(1) Quality policy
(3) Scope of the quality management system
(4) Process map (flowchart)
(5) Quality objectives
(6) Work instructions
Note that the ISO 9001:2015 requirements for work instructions and forms are not explicit.
Work instructions are detailed step-by-step instructions on how to perform a particular work process. ISO 9001:2015 does not include an absolute requirement for work instructions; however, section 8.5.1 requires having work instructions where they add value to the company.
Forms are not specifically required by 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, well-designed forms and checklists save time and efforts in meeting ISO 9001 requirements, and should, therefore, be part of every ISO 9001 quality management system.
Company-Specific ISO 9001 Documentation
The ISO 9001 documentation is not a generic set of documents that can simply be exchanged among companies. All ISO 9001 documents must be:
Specific to your company
Suitable for your company
Your ISO 9001 documentation will include everything from overall policy to detailed work instructions, including specifics of your company and its operational processes. Most importantly, once you spelled out the requirements in your ISO 9001 documentation, your company will have to follow them. It is, therefore, crucial for your company's performance that your ISO 9001 quality manual, procedures and other documentation do NOT contain bureaucratic requirements, requirements that are not suitable for your company's circumstances, or requirements that cause obstacles to your business operations and productivity. Be sure to always keep user-friendliness and efficiency in mind when writing your ISO 9001 documentation.
Customization of Templates
The secret to easy and business-friendly ISO 9001 implementation at small and midsize companies is the use of high-quality, pre-written, customizable templates, together with detailed customization instructions. The importance of the customization instructions cannot be overstated as they will guide you in modifying the templates to fit your company's circumstances, including its work processes, management style and culture. Without good and detailed customization instructions, the templates couldn't be properly customized and the results likely wouldn't even comply with ISO 9001 requirements. We, therefore, recommend you use our ISO 9001 Certification Package (which includes all documentation templates complete with step-by-step customization instructions), which incorporates the 9001Simplified System to ensure easy implementation of a business-friendly ISO 9001 quality management system.
To create your own, company-specific ISO 9001 documentation that includes the quality manual, quality procedures, quality policy, quality objectives, process flowchart and work instructions, simply customize the ISO 9001 Quality Management Manual (this is the comprehensive ISO 9001 documentation template that is included in the ISO 9001 Certification Package). The ISO 9001 Quality Management Manual comes with extensive customization instructions that guide you in personalizing and modifying the various procedures templates to fit your company's individual circumstances. Simply follow the included detailed customization instructions step by step. And this is how we make the ISO 9001 documentation not only easy for you but - even more importantly - also efficient and suitable to your company.
Once you finished customizing our templates per our instructions, have your new ISO 9001 documentation approved by the president of your company.
Step 3: Implementation
Now it's time to implement your ISO 9001 quality management system throughout your company. During this phase you will introduce any new requirements that you included in your customized ISO 9001 Quality Management Manual to affected company employees, and you will help them adjust their way of working accordingly. To make this step a success, it is most important that your employees understand how the new ISO 9001 requirements will benefit them. Another advantage of our business-friendly and non-bureaucratic ISO 9001 documentation is that your employees will easily recognize the benefits and, thus, readily adopt the new requirements.
One Step at a Time
Take one step at a time in your ISO 9001 implementation process. We recommend that you start with the section on Document Control. Explain the requirements in a meeting or memo, or have the appropriate department managers explain to their staff. As with our other ISO 9001 procedures, the document control requirements are not complicated and their benefits are obvious, making the implementation an easy and rewarding experience.
Training and Work Instructions Go Hand in Hand
As you implement your ISO 9001 quality management system, virtually all employees have to change the way they work at least to some extent. At the same time, ISO 9001:2015 calls for standardization and for work instructions. Our Quality Management Manual points out where work instructions are required. We recommend that you assign the writing of work instructions to those who actually perform the work. Instruct them to think of the best way of doing their work, then document the main steps. If your new ISO 9001 Quality Management Manual includes requirements that call for a change in work processes, introduce those new requirements and make the employees incorporate them into their work instructions. Once they are done, review the work instructions to make sure that they meet the requirements of your new ISO 9001 Quality Management Manual.
You will see that your employees will almost automatically learn the new ISO 9001 requirements as they incorporate them into their own work instructions. We have seen it over and over again: being able to design their own work processes along ISO 9001 requirements will not only lead to improved and more efficient work processes but also increase the motivation of your staff.
Step 4: Internal Audit
Internal ISO 9001 audits are inspections in which your company evaluates itself to see if all ISO 9001 requirements are being followed. These internal audits are not only conducted when implementing ISO 9001 processes but also periodically after achieving ISO 9001 certification. All internal audits are performed by an employee of your own company who has been trained in ISO 9001 auditing; alternatively, you could use a subcontractor. The job of the internal auditor is to verify that your company meets the requirements of ISO 9001:2015 as they are described in the procedures of your ISO 9001 Quality Management Manual.
Small businesses typically have the ISO 9001 Management Representative perform internal audits. In this case, the Management Representative audits the entire company except for his/her own work, and another employee audits the work of the Management Representative. Learning auditing skills and performing internal audits is not difficult with our training and with our audit checklist (also included in the ISO 9001 Certification Package).
Midsize companies often appoint and train several internal auditors. This is an excellent opportunity for cross-training, and for staff of different departments to learn what other departments are doing.
Audits as Training Tool
We recommend that you start Step 4 even before Step 3 has been fully completed. Audits are an excellent way of training management and staff in the new ISO 9001 processes, so audits will help you implement ISO 9001. Note that you don't have to conduct your internal audit in one single event; instead, you can divide an internal audit into many partial audits. For example, you may only audit a single department or a single requirement at a time.
Once your entire company has been audited against all ISO 9001 requirements, and the internal auditor hasn't uncovered any significant problems, your company will be ready for the ISO 9001:2015 certification audit.
Step 5: Certification
In order to achieve ISO 9001 certification, it will be necessary to have an independent, third-party ISO 9001 auditor visit your company and perform a site audit. The ISO 9001:2015 certification audit can be performed soon after you have completed your internal audit.
Selecting the ISO 9001 Registrar
At this point it is time to select your ISO 9001 registrar. The ISO 9001 registrar is the independent entity that sends the auditor and issues the ISO 9001 certificate. There are many companies offering certification services but please be careful: some are not officially accredited by an ISO 9000 certification body. Start your search on the internet and compare the different registrars, or ask us for a referral. The ISO 9001 Certification Package also includes tools to help you select an ISO 9001 registrar that's ideal for your company's individual circumstances.
The ISO 9001 Certification Audit
The ISO 9001 certification audit is similar to your internal audits. A third-party auditor or audit team will perform a site audit in which they visit some or all departments of your company and randomly verify that the requirements in your ISO 9001 Quality Management Manual, procedures and work instructions are being followed by management and employees. There are several typical auditor questions and several ISO 9001 requirements that most auditors will focus on during the ISO 9001:2015 site audit. To help you prepare best, we compiled a list of audit preparation tips, which are included with the ISO 9001 Certification Package. Another easy method of preparing staff for the site audit is to show a short awareness video (for example, "How To Deal With External Auditors").
Unless the auditor uncovers significant problems with your ISO 9001 quality management system, your company will receive the ISO 9001 certificate shortly after the site audit. If, however, the auditor finds some significant problems, you will have an opportunity to correct those problems before the ISO 9001 certification is issued.
Reaping the Marketing Benefits
ISO 9001 is the most widely recognized quality standard worldwide, and the ISO 9001 certification offers many marketing benefits to small businesses and midsize companies. Once you successfully passed the certification audit, you should, therefore, leverage your new ISO 9001 registration in marketing. You may want to prepare a press release, send notification cards to your customers, print your certification mark on business cards and letterhead, add your ISO 9001 registration mark to your advertisement, display a banner outside your office building and last but not least, recognize your employees for the hard work they put into this effort.
ISO 9001 certification is not a one-time event. Your ISO 9001 registrar will perform a surveillance site audit once or twice a year in order to verify continued ISO 9001 compliance and even improvement of your ISO 9001 quality management system. If you used the 9001Simplified approach, then your ISO 9001 quality management system is already designed to continually improve itself as continual improvement is already built-in. Make sure your ISO 9001 processes remain implemented, continue your internal audits, and we are convinced you'll see your company's performance improvements at the bottom line!
ISO 9001 for small businesses and midsize companies can be both easy and rewarding if done right. We recommend implementing ISO 9001 along these five steps using our ISO 9001 Certification Package; it contains step-by-step implementation instructions, the necessary documentation templates with detailed customization instructions, training resources and many other necessary materials, as well as free e-Consulting (our unique remote consultant service) so that you won't get stuck.
Experience has shown that there are common mistakes that organizations make in their pursuit of ISO 9001 certification. Read our three-part series on how to avoid these costly mistakes.
To learn more about ISO 9001:2015, you may want to review the various articles in our Resources section. Your remaining questions are likely answered in our FAQ section. And if you would like to see who our customers are and what our customers think of us, take a look at the customer reviews.