Learn How to Get Started With ISO 9001
You can expect to obtain ISO 9001 certification in 12 to 18 months if you follow a proven project plan.
Contents
ISO 9001 History & Definition
ISO 9001 is defined as “the international standard that specifies requirements for a quality management system (QMS).” (Source: American Society for Quality) It is one of the most implemented quality management systems for processes globally.
The ISO 9001 standard was first introduced in 1987 by the International Organization for Standardization (ISO), an agency comprising national standards organizations from over 160 countries.
Although the first version of the ISO 9001 standard dates back to the 1980s, it has seen a few revisions since its inception, the latest being in 2015. For this reason, you may often see the updated ISO 9001 standard referred to as ISO 9001: 2015. Many of these new updates include:
- New terminology
- Reorganized information
- Emphasis on risk-based thinking
- Improvements in service applicability
- Increased leadership requirements
ISO 9001 Methodology
ISO 9001 follows a “plan-do-check-act” methodology. It uses a process-oriented approach to recording and reviewing a company’s structures, responsibilities, and procedures to achieve and improve quality management.
It involves following these necessary steps:
- Design – Planning the QMS structure
- Build – Developing the QMS structure
- Deploy – Educating staff on the new QMS
- Control – Performing routine audits of the QMS
- Measure – Assessing the QMS and its impact
- Review – Analyze the results of audits
- Improve – Use information from the results to maintain and improve QMS
Why Reinvent The Wheel?
ISO 9001 Principles
The ISO 9001 standard, since its formation, has been built on the idea of seven quality principles:
- Customer Focus – Understanding customer needs and striving to meet those needs and exceed expectations
- Leadership – organizational leaders that create a goal-driven environment and embrace the principles outlined in a quality management system
- Engagement of People – Equipping employees with the tools to learn more about improving systems to perform at their best
- Process Approach – Creating and maintaining processes that will enhance efficiency
- Improvement – Making improvement a continual objective and using audits to keep moving in the right direction
- Evidence-Based Decision Making – Using data to improve performance and processes
- Relationship Management – Selecting businesses that prioritize quality and improvement to collaborate with
In order to be certified, companies must follow these requirements. Those who demonstrate that they can provide quality products and services that meet their customers’ needs and regulatory requirements, and continually improve their systems and processes to deliver these products and services consistently.
Choose Your Approach to ISO 9001
Be sure that you have someone on your team or that you find someone who is an expert at ISO 9001. Contact another business owner who has been ISO 9001 certified or invite him in to lay the groundwork.
It is imperative that if you have never completed an ISO 9001 certification before, that you don’t go at it alone. There are many small steps involved, and if even one is missed, your process of being certified for quality management will be delayed.
Firstly, you’ll want to choose your own approach to obtaining ISO 9001 certification. There are three possible options and one extra resource to help you get there.
Each approach differs. The one you choose depends on your expertise, your leader's expertise, and your employees' expertise. Other factors to consider when choosing an approach are cost, effort, and time.
In-house Implementation
The first approach is low-cost for you, the owner, and your ISO 9001 leader. However, your employees will need to exert intense effort, and the whole process will be significantly longer. This ensures that your ISO 9001 system fits every aspect of your business.
This first approach is called in-house implementation. It is for a company with well-equipped internal resources to set up and sustain the ISO 9001 platform. Your in-house resources would be responsible for training. If you have no internal resources, this might not be the best choice.
Consultant Hands-On
The second approach has a rapid turnaround and requires minimal effort. Unfortunately, this approach usually leads to collapse due to the lack of time spent on training and implementation.
This approach is the Consultant Hands-On approach. If it weren’t so unstable, it would be for internal ownership that is ill-equipped to conduct the process. This is why the time frame is short and the efforts are minimal. Due to that, the platform tends to collapse quickly once certification is set in place.
Consultant Hands-Off
The third approach is for a company whose internal resources are either ill or well-equipped but who hold a strong sense of personal responsibility. This approach is very sustainable and dependable, but it requires the most time and money.
This approach is also the Consultant approach but from a "Hands-Off" angle. Efforts from employees are significant, and the time it takes to complete them entirely depends on the amount of personal responsibility from employees. It can range from moderate to long.
The third approach is specifically for business owners who want to improve internal operations while obtaining an ISO 9001 certification.
Use a Template
The final resource you can use before choosing an approach is a Template for your documentation.
A Quality Manual Template is invaluable to any business owner beginning the certification process. It contains everything you need for the documentation and provides information regarding everything you need to do to set up and approach your quality management system. While the efforts required are still high, the technical logistics of setting up are already spelled out for you.
Roles & Responsibilities - the Project Manager
After determining your approach, you need to appoint an ISO 9001 Project Manager. This person must be knowledgeable about the quality management standards that you are to set for your company's future.
The main job of your Project Manager is to push the certification project ahead consistently. This role is formally called the “ISO 9001 Management Representative”. They must hold superior knowledge about your company, serve as a manager for any department, and have a history of self-responsibility.
This is the person who will be in charge of implementation. They will create specific plans to apply your new quality standard to each department or section of your company.
If your company has multiple locations, you may appoint several leaders or Management Representatives to head up each location. If this is the case, you must also appoint a “corporate” or “overall” manager to oversee the training and implementation process.
ISO Training
Once you have appointed your leaders, it will be time to conduct training and awareness for your team. Proper training is absolutely and unquestionably required for ISO 9001 certification. It will also boost the sustainability of your platform.
Top Management training
The first place you’ll want to start is with your Top Management or executive team. If any of this will work, everyone involved must be on board.
Hold an informational meeting with your executives. Explain to them ISO 9001 in its basic form and its vast benefits, including improved function internally and operationally and marketing advancements.
You must also inform your Top Management of the approach you have chosen to obtain ISO 9001 certification. Show them what exact resources you will be using, the amount of time in addition to regular work it will require, and the overall estimated costs.
Some of your executive team might be involved with Management Reviews. If so, choose carefully who would be a good fit for the project.
Finally, inform your executive team about what is expected of them during this process. Without their support and contributions, none of this would be possible. They are expected to dedicate the same time, effort, and personal responsibility as everyone else.
Employee Training
After informing your executive team and getting their approval, it is time to hold the same meeting with your employees. This meeting has a slightly different purpose than your previous meeting with your executives.
With your executives, you were simultaneously searching for approval and buy-in. With your employees, searching for approval is no longer a concern. At this point, you are looking to get them on board with the whole project. In other words, you want to “generate buy-in.” Your goal is for them to buy into the entire process.
One of the most common mistakes in the ISO 9001 implementation process is failing to inform employees early and adequately enough. It is essential that you inform all employees and managers of your intentions.
Share with them the planned approach and why you seek ISO 9001 certification. Tell them what they will benefit from it and what you expect from them during the process. Make sure you highlight the time it will take, the required effort, and how you suggest they juggle their daily work with this new process.
ISO 9001 offers an educational introduction video. This could be a valuable resource for your employees, giving them a concise view of this new project you’re bringing into their workplace.
The final step in the initial training and awareness part of your ISO 9001 process is to educate your leader. While your leader may already be instructed in quality management standards, he must be educated on the implementation process.
Take your implementation approach and certification kit and show your leader precisely what he must do to lead effectively.
Construct a Project Plan
The last thing you need to do before starting your ISO 9001 certification process is create a project plan. An ideal plan is clear, achievable, and complete with steps and target dates. Also, include an implementation checklist. This will help you stay on track.
Once you select the best approach for your company, appoint a leader, and create a training plan, you’ll be well on your way to becoming ISO 9001 certified.
Learn the Basic Requirements
After you have solidified an approach, appointed a well-qualified and trustworthy Project Manager, and created an achievable plan for training and implementation, it’s time to tackle the actual requirements for ISO 9001 certification.
These requirements include proper documentation, evidence of successful implementation, and an official internal audit from an ISO 9001 certified auditor.
The Basic Requirements for ISO 9001 Certification
- Proper and official documentation
- Evidence of successful implementation of ISO 9001 quality standards
- An external audit conducted by an ISO 9001-certified auditor
The first requirement for being officially ISO 9001 certified is to write all the necessary documentation. You must write your company’s quality policy, objectives, procedures, and other ISO 9001 documents that meet the platform’s requirements. You must translate ISO 9001 technical jargon into your company’s purposes. Using a Template will significantly help with this.
This translation is important because many companies simply rewrite the technological jargon into their company policy, failing to apply each operation to the document.
You’ll want to avoid reaching the end of the road and being unable to be certified because you failed to apply the standards to your company’s mission.
This error may occur if you hire an outside consultant to write your ISO 9001 policies and procedures. This consultant may not know your company enough to speak on its behalf or determine what it needs. If you want to be thorough, write your policies and procedures yourself.
Overall, your ISO 9001 documentation must fit the needs and circumstances within your company.
It is also essential to avoid having too much or too little documentation. Too much will confuse and overwhelm your readers, while too little may leave them unanswered questions. Be concise yet thorough.
The ISO 9001 auditor will eventually read your policies and procedures. Upon successful completion of your process, this person will hand you your official ISO 9001 certification.
The Documentation You Need to Write
- Quality policy
- Quality objectives
- Scope of the quality management system
- Procedures
- Process maps (flowchart)
- Forms & Checklists
- Work Instructions
You have plenty of flexibility with these documents. The quality policy, procedures, scope, process map, and quality objectives are entirely based on what your company does, who you have, and what you need.
Work instructions detail every position in your company step-by-step. You should outline exactly what each position’s purpose is and the steps for daily work. Then, apply your new quality standards to it. Outline what it would look like if the employee lived up to those standards daily.
The forms and checklists included with our Quality Manual Template are not explicitly required, but they save a lot of time during auditing. Creating legitimate forms and checklists and keeping them on hand only boosts your legitimacy as a company.
The formatting and organization should be clean and professional. Your certification kit includes all of the required technical elements. But as far as content goes, it should be as unique and individualized as your company.
There is no required format, but creating a creative and easy-to-read format would behoove you in the long run.
When it comes to choosing a template, there are four things to consider:
- Efficient processes
- Clarity
- Layout
- Customization
Efficiency covers the need for your documentation to be concise. Choosing an efficient template will ensure that your documentation is not too extensive. Clarity also technically assists with the need for conciseness. Clarity means the template will be easy to read and free from words the reader won’t understand.
The layout ensures that the documents are not just glorified lists. Your purposes must be outlined and flushed out, not just listed. Finally, customization solidifies your individuality as a business owner. You don’t want your documentation to look like another business. It would be best to stay true to your company and its mission.
Implementation
After you complete the necessary documentation, it’s time to physically apply your new quality standards to your business. The new policies, procedures, and work instructions from your documentation help immensely in this part of the process because you will hand it out to your executives, management, and employees.
This is why your documents must be clear and understandable. Your employees must be able to read them and apply them in their work.
It is widely recommended that you hold another meeting with your whole company and show them a digital version of the documentation. Outline the benefits again, and what is expected of them now that your standards are on paper.
Distribute the new work instructions to the respective departments. Encourage your employees to pin their new instructions near their workspace to ensure they follow your new quality standards.
Your employees will undoubtedly have to adjust their work habits. The adjustment period could be long or short, but it is imperative that they find a rhythm that accurately fits your new quality standards.
Offer more training and an open-door policy for any employees who are struggling with the adjustment. This is especially true if your employee population includes interns.
They may be entry-level or new to a workplace atmosphere. Provide some resources for them to ensure success for all parties.
The Internal Audit
The last step in the implementation process is allowing a certified ISO 9001 auditor to your workplace to oversee your conduct of an internal audit. It is called an internal audit because your company will be evaluating itself while an ISO 9001 representative is present.
Typically, the ISO 9001 Project Manager performs the audit. The PM would use an audit checklist.
You have a couple of options when it comes to audits. You can either complete it once or spread it over several days. This is essentially a one-time audit as opposed to a partial audit.
A partial audit will break up your requirements, allowing you to focus on one area at a time. A one-time audit is an all-day event that requires you to be ready to demonstrate every aspect of your documentation.
Certification Audit (from Registrar)
To complete certification, an outside representative must conduct an ISO 9001 certification audit. An independent, third-party ISO 9001 auditor must physically come to your company and perform an audit. This is an external audit as opposed to the internal audit that was previously conducted.
This official certification audit should occur after all your documentation is composed and collected, and about two months into your new quality standards have been functioning.
Independent auditors come from an ISO 9001 Registrar. This registrar lists independent auditors who can come to your business to conduct the audit. If your employees become certified in auditing, they will join this list. Take caution when choosing your registrar: some auditors are not accredited.
You’ll want to search for a registrar who understands your company best.
The actual audit is something like an evaluation. The auditor will observe all departments of your business and determine whether or not it meets the ISO 9001 standard. If there are no issues and all the standards the auditor follows are met, you will be given your official ISO 9001 certificate following the audit.
However, if the auditor still has concerns about how parts of your company operate, you will be given specifics regarding what needs to be fixed. Once these problems are solved, then you will be given your certificate.
A Template will help you prepare for the external audit. It might include a list of typical questions the auditor may ask and tips for your staff.
Ensure your staff is relaxed and continues the work day as usual. Being evaluated can be pretty nerve-wracking, but remaining calm and not paying any mind to the auditor means your employees will have nothing to worry about.
Once you have obtained certification, the process does not end there. This is why the ISO 9001 commitment is most definitely a long-term one.
