Our "5 Steps to ISO 9001 Certification" is a practical guide to ISO 9001 for small businesses and midsize companies. Our approach is business-oriented and lean; it does not include the many committees, task forces and meetings that consultants and other ISO 9001 products use. Instead, we focus on getting things done - quickly and efficiently.
Please note that these "5 Steps to ISO 9001 Certification" are only a brief summary of our approach. Detailed instructions for each implementation step, as well as all the required materials, are included in the ISO 9001 Complete Package.
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.
ISO 9001:2015 is a worldwide-accepted standard for quality management systems. As such, ISO 9001:2015 focuses on a large variety of business activities – not merely on quality control! Implementing ISO 9001:2015 will affect virtually all of your business processes.
Note: "ISO 9000", "ISO 9001" and "ISO 9001:2015" are used interchangeably but all refer to the ISO 9001:2015 standard.
The following sources of information will give you the needed understanding of ISO 9001:
Our "Implementation Tools" (which are included in the Complete Package) contain 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.
You may also want to consider taking an introductory online ISO 9001 course.
And in case you don't have a copy of the ISO 9001:2015 standard yet, you will need to obtain one and read it. See Resources.
First, appoint the “ISO 9001 Management Representative”. This is typically a quality manager or senior manager 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.
Companies with more than one physical location may appoint a "local" Management Representative for each physical location or for each business unit; a "corporate" Management Representative would then coordinate among the local Management Representatives. This setup will ensure both flexibility and simplicity. Note that all our ISO 9001 templates, our ISO 9001 forms, and our ISO 9001 implementation materials and guides are designed to work for both, companies with a single location and companies with multiple locations.
A “Role Description” for the Management Representative is included in the Complete Package. We wrote these "5 Steps to ISO 9001 Certification" under the assumption that you, the reader, will be the Management Representative.
Next, the Management Representative needs to get some training. A "Training Plan for Management Representatives" is included in our ISO 9001 Forms Collection and in our ISO 9001 Complete Package.
Our Complete Package is designed to provide for on-the-job training; the included materials are excellent training tools, particularly our ISO 9001 Quality Management Manual (which includes many explanations) and the detailed customization instructions will help you understand the ISO 9001:2015 requirements.
For additional ISO 9001 training through training videos, online courses and books for self-study, please see our section on ISO 9001 Training.
Getting full support from management 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. You should explain to them the advantages, requirements and costs.
Next, you should inform all employees. It's important that the employees don't feel threatened by ISO 9001. In our Implementation Tools (which come with the Complete Package) you'll find a brief "Employee Intro To ISO 9001", as well as an "ISO 9001 Summary", both of which will serve small and midsize businesses well when informing all employees.
Optionally, there are some DVD courses and online courses recommended in our section on ISO 9001 Training.
Writing the ISO 9001 procedures (or the quality management manual) and the quality policy is usually the most difficult step when implementing ISO 9001. This is because these documents have to meet all of the many technical requirements of the ISO 9001:2015 standard; in addition, writing these documents without help at the beginning of the ISO 9001 implementation is a big initial hurdle.
However, we make the ISO 9001 documentation easy for you!
Use our ISO 9001 Quality Management Manual as a pre-written template, follow the detailed customization instructions, and you can get your ISO 9001 documentation quickly and at minimal cost! (Note that the ISO 9001 Quality Management Manual is included in our Complete Package.)
(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.
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.
The secret to easy and business-friendly ISO 9001 implementation at small and midsize companies is the use of our pre-written, customizable templates. These unique templates will not only help you set up an efficient quality management system, they will also make the writing of the required ISO 9001 documentation a rather easy task.
Most importantly, the included customization instructions will guide you in modifying our ISO 9001 Quality Management Manual, procedures and templates to fit your company's circumstances, including its work processes, management style and culture.
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 our ISO 9001 Quality Management Manual (also included in the Complete Package). The ISO 9001 Quality Management Manual comes with comprehensive 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 suitable to your company and efficient.
Once you finished customizing our templates per our instructions, have your new ISO 9001 documentation approved by the president of your company.
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 the benefits of the new ISO 9001 requirements. Since you will be using our business-friendly and non-bureaucratic ISO 9001 documentation, your employees will easily recognize the benefits and, thus, readily adopt the new requirements.
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.
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 point out where work instructions are required. We recommend that you assign the writing of work instructions to those who actually do 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 that make sense will not only lead to improved and more efficient work processes but also increase the motivation of your staff.
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 but also periodically after achieving ISO 9001 certification. All internal audits are performed by an employee of your company who has been trained in ISO 9001 auditing; alternatively, you could use a subcontractor. The job of the 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 ISO 9001 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. Our ISO 9001 Forms Collection (also included in the ISO 9001 Complete Package) contains an invaluable Audit Checklist that makes auditing easier.
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.
We recommend that you start Step 4 even before Step 3 has been completed. Audits are an excellent way of training; they will help you implementing ISO 9001! Remember that you don't have to conduct your internal audit in one single event; instead, you can divide your internal audits into many smaller pieces. 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 didn't uncover any significant problems, your company will be ready for the ISO 9001:2015 certification audit.
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 the certification audit. The ISO 9001 certification audit can be performed soon after you have completed your internal audit.
Now it's 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! Start your search on the internet and compare the different registrars. Our Registrar Evaluation Form (included in the ISO 9001 Forms Collection and ISO 9001 Complete Package) will help you select an ISO 9001 registrar that's ideal for your company's individual circumstances.
The ISO 9001 certification audit is similar to your internal audits. The auditor will 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 your employees. There are several typical auditor questions and several ISO 9001 requirements that most auditors will focus on. To help you prepare best, we compiled a collection of valuable Audit Preparation Tips, which exclusively come with the ISO 9001 Complete Package.
If the auditor doesn't uncover any significant problems with your ISO 9001 quality management system, you will receive the ISO 9001 certification. If, however, the auditor finds some significant problems, you will have an opportunity to correct those problems before the ISO 9001 certification is issued.
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 certification 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 certification 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. Our ISO 9001 Complete Package includes useful ISO 9001 Marketing Tips.
The ISO 9001 certification is not a one-time event. Your ISO 9001 registrar will perform a surveillance audit once or twice a year to verify continued ISO 9001 compliance. Your ISO 9001 quality management system is designed to continually improve itself. Make sure it remains implemented, continue your internal audits, and we are convinced you'll see your company's performance improvements at the bottom line!
In section 10.3, ISO 9001:2015 requires to "continually improve the suitability, adequacy and effectiveness of the quality management system". Meeting this requirement is easy with our ISO 9001 Quality Management Manual as the required continual improvement is built-in.
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 Complete Package; it contains the necessary templates and other necessary materials, as well as detailed step-by-step instructions.