Step 1: Preparation
The first step addresses how to best prepare for the implementation of ISO 9001 at your small or midsize company - including making a decision on your certification approach. It's an important step that sets the foundation of your certification process and greatly affects the long-term success of your ISO 9001 certification.
Set the Objectives that Benefit Your Business
ISO 9001 can greatly benefit your business, including its internal operations, efficiency and profitability, as well as provide marketing advantages and the ability to tap markets that are only open to ISO 9001 certified companies. Organizations like yours can realize these powerful benefits if they actively pursue them and if they identify and set the right objectives at the start of their ISO 9001 certification process.
Prerequisite for benefiting most from ISO 9001 as well as making the required, initial decisions is your understanding of the ISO 9001:2015 standard and the certification process. We recommend the following sources of information in addition to this guide:
Our free resources are full of important background information and practical tips, including on how to avoid the most common mistakes before and during the ISO 9001 implementation process.
Our free downloads contain practical advice and useful decision making tools.
Subscribers to our newsletter get timely updates on our latest practical tips and in-depth research.
Our ISO 9001 Certification Package contains everything needed to become ISO 9001 certified, including 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 useful information on ISO 9001, how to implement it, and how to achieve ISO 9001 certification.
The concise online course ISO 9001:2015 QMS Awareness provides an introduction and overview of the standard and its benefits, as well as information on the implementation project. It's one of the most efficient ways of learning the basics.
The ISO 9001:2015 standard is - despite its difficulty to read and apply - something you will need when getting ISO 9001 certified. See More Recommended Resources on where to download a PDF version.
Note that people talk about ISO 9001 certification in different ways, some of which are technically incorrect. For example, a company that is seeking to become ISO 9001 certified may announce that they are in the process of gaining ISO accreditation. Once they accomplished their goal, the same company may inform their customers that they achieved ISO 9000 registration and internally celebrate their ISO certification. If you are confused, read up on our detailed explanations.
Choose Your Approach
There are three common certification approaches, each with its own pros and cons. The most popular path to ISO 9001 certification used to be hiring a consultant to 'take care of ISO' but its popularity has been fading for various reasons (including cost, ill-fitting operational processes and inefficiencies, lack of staff acceptance, and eventual loss of certification).
The ideal route for your individual company depends on your particular situation. Our article on the best approach to ISO 9001 certification discusses the different methods in detail, including their pros and cons. A practical decision-making tool may be downloaded free of charge.
Our Approach to ISO 9001 Certification
Most small to midsize companies will find it ideal to pursue ISO 9001 accreditation in-house with the support of a good certification kit.
It is the approach that 9001Simplified has pioneered and on which our unique certification system is based.
Appoint the ISO 9001 Lead Person
Have you decided yet who will drive the ISO 9001 project forward? You will need to appoint the lead person for your ISO 9001 certification project, a role historically referred to as "ISO 9001 Management Representative". This responsibility typically falls on 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.
Those of you who use our ISO 9001 templates, certification kit, or forms may automatically configure them - prior to purchase - to single-site or multi-site version.
We wrote this guide on how to get ISO 9001 certification under the assumption that you, the reader, will be the Management Representative.
Training and Awareness
The ISO 9001:2015 standard places emphasis on training and awareness programs. Besides being necessary in order to meet ISO 9001 requirements, proper training will make any task easier, faster and smoother. At this point, it is important to provide information and ISO 9001 training to three different groups:
Top Management - to set the foundation for support and leadership
Two of the five most common mistakes business make when implementing ISO 9001 are related to the understanding that top management have about ISO 9001. Be sure to avoid these costly mistakes by providing the right information and training.
First, you will need to ensure that the company executives completely support the ISO 9001 effort. In order to achieve this, they will require the following information:
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.
Last but not least, executive management should also get a full understanding of their own expected involvement in ISO 9001.
After having yourself already gained this understanding, you are in a good position to provide the needed information and training to the top management team. An easier option would be for top managers to take a concise, introductory online course that covers all of those topics.
Employees - to generate buy-in
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 and all of your employees.
The third most common mistake during the ISO 9001 implementation process is related to the failure of properly - and early - informing all employees and gaining their support.
Getting full support from all levels of managers and employees is crucial for the success of your ISO 9001 quality management system. The earlier you get this support, the better.
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
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. The easiest - and possibly most effective - option would be presenting a motivational ISO 9001 introduction video to groups of employees.
ISO 9001 Lead Person - to get ready to lead the ISO 9001 certification process
By now you already got a good understanding of ISO 9001 that allowed you to set objectives and make decisions on your implementation approach. However, you are probably still wondering how to proceed in order to get ISO 9001 certification. Now it's a good time to learn all about it.
You should become familiar with the following:
the ISO 9001:2015 standard and its requirements
the most-widely accepted interpretations of the standard and how to apply them
implementation steps (similar to this guide but in greater detail)
There are several options available to gain the needed knowledge, ranging from self-study to courses and coaching. You may, for example, use a book that explains the requirements and offers interpretations and a guide book that explains the implementation steps. An effective and time-saving alternative is taking an online course. A shortcut may be the guide and instructions included with a good certification kit, which should be sufficient for many of you.
Plan Your Project
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 detailed project guide, as included with a good certification kit, will greatly simplify your project plan.
Many companies find it helpful to conduct a gap analysis to judge the extent to which the company is already meeting ISO 9001 requirements and where implementation efforts should be concentrated. A gap analysis is best performed using a checklist. Based on the results, you will be able to sketch out a better plan for your ISO implementation project and focus your efforts on the most critical areas.
Step 2: Documentation
Writing the quality policy, procedures and other ISO 9001 documents 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 many find difficult to understand, interpret and apply to their company's circumstances.
In addition, the ISO 9001 documentation must fit the needs and circumstances of your company - a crucial issue often overlooked when having a consultant write procedures without being intimately familiar with the company, its operations and culture.
Somewhat complicating the ISO 9001 documentation development is timing as it is at the beginning of the ISO 9001 implementation project. Without experience or assistance (for example, in form of templates and customization instructions), this could present an initial hurdle.
Which Documents Are Required by ISO 9001?
Though ISO 9001 has become less prescriptive regarding the number of required documents, the following are part of any quality management system:
Scope of the quality management system
Process map (flowchart)
You have much flexibility as to the number of procedures, work instructions and forms. In fact, you could theoretically get ISO certified without any of them.
We recommend you create as many procedures as needed to properly describe your ISO 9001 system. Most companies will address all ISO 9001 requirements as they apply to their company. However, you won't need to follow the structure of the standard; instead, your procedures may combine or split up ISO 9001 clauses as appropriate to your business.
Work instructions are detailed step-by-step instructions on how to perform a particular work process. They should be created only where they add value to your company.
Forms and checklists are not specifically required but can be considered both work instructions (before they are filled in) and records (after they are filled in). Well-designed forms and checklists save time and efforts in meeting ISO 9001 requirements, and should, therefore, be part of an efficient 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 your ISO 9001 documents must be:
Specific to your company
Suitable for your company
Your ISO 9001 documentation will range from overall policy to detailed work instructions, all of which must reflect your company, it's culture 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 procedures and other documentation do NOT contain bureaucratic requirements, requirements that are not suitable for your company's circumstances and culture, 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.
How to Write Your Documentation
Good documentation is prepared by company insiders to ensure it is both specific and suitable to your company. There is no required format but a well-designed format and layout makes your documentation more user-friendly. Preparing all your documentation is time-intensive and rather complicated but the rewards are worth it.
Don't worry, there is a shortcut that greatly simplifies your ISO 9001 documentation development: ISO 9001 templates combined with customization instructions. Templates are pre-written ISO 9001 documents that are specifically designed to be modified to fit your company. Customization instructions guide the editing; the more detailed the customization instructions, the more likely it is that they address your company's specific situation, allowing you to create your company's own specific and suitable ISO 9001 documentation.
We already addressed the significance of documentation to the efficiency and bottom line of your company. If you base your documentation on templates (as even consultants do), it is important to choose your templates well. The best templates meet the following conditions:
Efficient processes: Good templates form the basis of efficient processes that are free of bureaucracy and unnecessary paperwork. They create simple and effective processes that minimize required efforts and the possibility for errors.
Clarity: Good templates are easy to understand and easy to use. They should be free of jargon and time-consuming references to other documents.
Layout: Good templates are laid out in a practical and user-friendly way. Lists of numbered sentences should be avoided.
Customization instructions: The importance of customization instructions cannot be overstated. Without good and detailed customization instructions, the templates couldn't be properly customized to fit your company's circumstances, including its work processes, management style and culture, and the results likely wouldn't even comply with ISO 9001 requirements. Good customization instructions are very detailed and in form of a separate document (as opposed to simple tips within the templates). They are also easy to understand and apply to your company's situation.
Templates are part of ISO 9001 certification packages. We suggest you include the above criteria in your evaluation and due diligence.
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 ISO 9001 documentation to affected company employees, and you will help them to adjust their way of working accordingly. To make this step a success, it is most important that your employees understand how the new processes and requirements will benefit them. Obviously, this requires that your new processes are in fact efficient, non-bureaucratic and user-friendly and that their benefits are clear.
One Step at a Time
Take one step at a time in your ISO 9001 implementation process. We recommend 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 your document control procedure should not be complicated but their benefits immediately obvious, the implementation of this new process will be an easy and rewarding experience.
Work Instructions and Process Improvement
As you implement your ISO 9001 quality management system, virtually all employees need to change the way they work at least to some extent. A prime example is the previously mentioned document control procedure.
At the same time, ISO 9001:2015 calls for process improvement and for work instructions. Per ISO 9001:2015, work instructions are only needed if and where they add business value. Value could be added in various ways, for example by detailing the steps of a rarely performed process, by specifying minute detail necessary in a process, by standardizing a process, or by describing a process so that new staff without experience can perform it.
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. Documentation could be in any format, ranging from text to flowcharts, from pictures or screenshots to videos. The criteria for choosing the format are simple: make the instructions most useful to the user.
If your new ISO 9001 procedures include 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, at least initially you may want to review the work instructions to make sure that they meet the requirements of ISO 9001 and your new procedures.
Training and Work Instructions Go Hand in Hand
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 re-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 one or more employees 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 your new ISO 9001 procedures and work instructions.
Small businesses typically have the ISO 9001 lead person perform internal audits. In this case, the ISO 9001 lead person audits the entire company except for his/her own work, and another employee audits the function of the ISO 9001 lead person. Learning auditing skills and performing internal audits is not difficult with good training (particularly inexpensive online courses) and with a detailed audit checklist.
Many companies appoint and train several internal auditors. This is an excellent opportunity for cross-training, and for identifying and spreading best business practices. In fact, your internal audit program could prove to be one of your most powerful business improvement tools by using some of the rather easy techniques identified by us in a recent article.
Audits as Training Tool
We recommend that you start Step 4 (Internal Audits) 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 an 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, a single process or a single requirement at a time.
Once your entire company has been audited against all ISO 9001 requirements, and the number of nonconformances (problems in meeting requirements) have decreased to a manageable amount, your company will be ready for the 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 certification audit can be performed soon after you have completed your internal audit and after you have collected about two months worth of records using your ISO 9001 processes.
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 a national certification body. Start your search on the internet, compare the different registrars, and evaluate them against your company's specific criteria. A good ISO 9001 certification package should include tools to help with this selection process.
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 procedures and work instructions are being implemented and followed by management and employees.
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.
How to Prepare for the Certification Audit
It's important to prepare your staff for the certification audit. There are several items that should be addressed prior to the day the auditor arrives:
Make staff relaxed - explain what to expect from the audit and the auditor.
Documents - document control is always verified so be sure that there are no outdated or uncontrolled documents floating around.
Questions - practice typical audit questions to ensure staff will understand the auditor. Some of the frequently asked questions include "How do you know that you perform your work correctly" (the auditor wants to know about performance criteria and measurements) and "How do you contribute to the objectives of your company's quality policy?" (checking understanding of the quality policy and its application in daily work).
Answers - employees should answer auditor questions truthfully but without volunteering additional information.
Tidy up - you want to show your best side.
An easy way of preparing staff for this important day is presenting a short multimedia video. Also, good certification kits should include audit preparation tools, ideally including a list of typical auditor questions and issues that most auditors will focus on during the site audit.
Reaping the Marketing Benefits
ISO 9001 is the most widely recognized quality standard worldwide, and your ISO 9001 certificate comes with many marketing benefits. Once you successfully passed the certification audit, you best 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 after which you can close the chapter "ISO 9001". In fact, loosing focus after the certification audit is the fifth most costly mistake business make when it comes to ISO 9001.
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 implemented your ISO 9001 quality management system correctly, it is already designed to continually improve itself. 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 incorporates our unique certification system, and even includes free e-Consulting (our unique remote consultant service) so that you won't get stuck.
We hope that this short guide will give you a good overview of what is required to achieve ISO 9001 certification and maybe even get you started with your very first steps. Please contact us to discuss any questions you may have or any specific issues you may face. We will be happy to help you out and move you forward towards ISO 9001 certification and the benefits that come with it.