The International Organization for Standardization (ISO) is an independent organization that develops international standards for the technology and manufacturing world. These standards help facilitate international trade, ensure safe workplaces and provide a framework for quality control.
ISO 9001:2015 is one of the most recognized members of ISO’s growing list of standards.
What Is ISO 9001?
ISO 9001 is an internationally recognized standard that establishes the framework for implementing a quality management system (QMS). It’s compatible with other ISO standards, including ISO 14001 and ISO 45001. It’s also the only ISO 9000 standard that has a certification — the other ISO 9000 systems work to support ISO 9001. The ISO periodically updates the standard every few years. ISO 9001:2015 is the most up-to-date version.
Any organization can obtain ISO 9001 certification regardless of size or industry. The ISO states that over one million companies in over 170 countries have active ISO 9001 certifications.
The ISO Standards follow a “Plan-Do-Check-Act” (PDCA) model that encourages continual improvement over time. It works like this:
- Plan: Map out and identify your objectives, necessary resources and all risks and opportunities.
- Do: Implement the system according to the plan.
- Check: Measure the success of your processes according to your plan.
- Act: Implement changes to improve how your system operates.
This process is cyclical, so your organization and its functions will see continuous improvement by following it.
Here are some important frequently asked questions about ISO 9001:
What Is a Quality Management System?
A QMS is a system of processes intended to guide a business toward the continual improvement of its products or services. It helps companies prioritize customer satisfaction and quality control at all levels within the company. Additionally, quality management systems can help businesses to optimize efficiency and productivity and minimize waste and downtime.
Is ISO 9001 Certification a Legal Requirement?
While ISO 9001 can undoubtedly benefit your business, it is not a legal requirement.
Who Should Get ISO 9001 Certified?
Any organization committed to providing quality products and services should look into ISO 9001 certification.
ISO 9001 Requirements Checklist
If you’re looking to obtain certification, you’ll want to make sure you’ve covered all your bases. Companies new to management systems will likely take longer to prepare than those familiar with the concept. Still, it’s essential to set a realistic timeline leading up to your first audits. We’ve designed this free checklist to help you get started:
1. Do Your Research
Before making any changes to your organization, make sure you read and understand the requirements. You can purchase a copy of the standard on ISO’s website. Pay special attention to the first three clauses, as these contain important terms and definitions referenced throughout the standard.
2. Perform a Gap Analysis
Once you know what the standard requires, perform a gap analysis to see what improvements your organization may need to make. Follow these steps to get started:
- Consider where you are: What is the current state of your organization in regards to quality?
- Determine where you want to be: What ISO 9001 requirements does your organization need to meet? Which is the most important to your organization?
- Note the gaps: What is the difference between your current performance and your ideal? How big of a difference is it?
- Make necessary improvements: Why are there gaps between your ideal and your current processes? What steps can you take to close those gaps?
Your list of improvements should aim to eliminate the causes of any issues rather than their symptoms. For example, if customers regularly complain that the arms of a fashion doll are too easy to break off, you could look at your manufacturing process to diagnose why the arms are so fragile. By focusing on the root cause rather than the visible effects, you can prevent similar issues from happening in the future.
Overall, this is an excellent process to follow both before audits and any time you want to change how your organization works.
3. Define Your Scope
To most effectively close the gaps you discovered in your analysis, you want to narrow down precisely what the scope of your changes should be. Your scope should include all the gaps you identified in your analysis and the time in which you plan to fix them. Remember that the more improvements you wish to make, the more time you will need to do so.
Your scope can be as broad or as narrow as you wish. You can apply ISO 9001 standards across your whole company, to single departments or even to individual products if that’s what makes sense for your business. However, experts recommend implementing it throughout your company for the best results.
Outlining your scope is also an excellent way to keep your business organized throughout the certification process.
4. Create and Implement Your QMS Manual
Now that you know what you need to address, begin drafting your new QMS policy. Following ISO 9001 guidelines, document all critical processes and procedures for your organization. This step will take some time.
Once you’ve finished your policy, make sure everyone within your organization is aware of the upcoming changes. A strong commitment from company leadership is crucial to this step’s success, as they will be most able to push the information through all relevant channels.
Implementing the QMS will also require all employees receive training on the new policies. All employees, including new hires, should receive a copy of the manual in either digital or paper format for reference. It will take time to adjust, especially if you make significant changes to existing procedures, so it’s best to expect slow change.
5. Designate an ISO 9001 Management Representative
Although ISO 9001:2015 does not require organizations to have a designated representative, it’s still a good idea to have one on board, as this representative will be responsible for obtaining and maintaining your business’s certification. As your ISO expert, they’re uniquely suited to liaise between your company and external auditors and ensure staff and management follow QMS procedures. Since ISO 9001 is so customer-focused, they can also speak for the customer when others within your company are not sure what to do.
The ideal representative is:
- Able to focus on the big picture
- Excellent at communication
- Knowledgeable about your company and its processes
Typically, this person would be a manager or company executive, but anyone in a leadership position capable of implementing procedural changes can fill the role. Organizations with multiple locations may find it beneficial to have local representatives as well as a head official.
6. Perform an Internal Audit
You should perform internal audits on a regular basis. Strategically planning when audits will happen and making sure employees are aware in advance builds trust within your company. Plus, internal audits are a great way to practice for the real thing.
Like in the external audit, your auditor should come from outside the departments or activities they will be auditing. That way, you’ll prevent conflicts of interest that can affect your results.
Some important things an auditor should examine in an internal audit include:
- Your organization’s approach and ability to identify problem areas.
- How your organization’s internal audit planning fits into your operations.
- Whether the processes you are implementing are working as anticipated.
Document the results of all internal audits for future reference. These records will be instrumental when it comes time for your external certification audits. Additionally, they can be a reference point for future internal audits when gauging how well your QMS is working.
7. Reevaluate Your QMS
Pay attention to how these changes affect your organization’s workflow. Are they helping make the improvements you wanted to see? If there are any tweaks or changes you’d like to make in the QMS, this is the time to do it. Identify any remaining areas for growth and strategize how to address them.
Once you’re feeling confident, run a final internal audit to ensure you’ve caught everything you can. Finalize remaining procedures and brief all employees on any changes you make.
8. Schedule Your Stage 1 Audit
Book an audit appointment with a certification body (CB) when you feel your organization is ready. Remember that certification can take months to complete.
Here are a few things to keep in mind when selecting a CB:
- Scheduling availability
- Experience in and knowledge of your industry
- Approval to work within your defined scope
- References and recommendations
Out of this list, accreditation is one of the most important aspects of a CB to consider. Make sure your CB has accreditation from a reputable third party, like the United Kingdom Accreditation Service (UKAS) or the ANSI National Accreditation Board (ANAB).
You also want to choose a CB with which you’d feel comfortable maintaining a professional relationship, as you will eventually need to renew your ISO 9001 certification.
9. Prepare for External Audit
Make sure everyone in your organization knows when audits will take place and what to do to ensure success. All staff and management should know what to expect during an audit, so provide specific information.
If you still need to, you should also calibrate your equipment to make sure it’s working correctly. Doing so will keep you in compliance with Clause 7.1.5 and improve your organization’s efficiency.
10. Certification Audits
You will go through two rounds of audits: Stage 1 and Stage 2. During the Stage 1 audit, the auditor will conduct a “desk audit” to examine the following documentation:
- The scope of your organization
- Compliance from staff and management
- Implementation of the system in all relevant areas of the organization
- Staff training procedures
This audit takes place over several days and usually occurs in person, but remote auditing has become more common in recent years. Your auditor will point out anything that could be problematic in the next stage, so you should document any areas of concern the auditor finds and the steps to fix them. If the auditor decides your organization is ready for review, you will advance to the Stage 2 audit.
This round focuses on evaluating how your management system actually functions based on the following aspects:
- Extent of documentation
- Compliance with the management system
- Steps that your business took to solve nonconformities found in Stage 1
- Further nonconformities, if there are any
Once your organization passes the Stage 2 audit, you will become ISO 9001 certified. You’ll need to schedule a surveillance audit per your auditor’s guidance.
Your Certification Body will conduct an annual surveillance audit to make sure you’re maintaining compliance. In the time leading up to your surveillance audit, you should:
- Make sure all documentation is current
- Correctly track your progress with your objectives
- Conduct a management review
- Keep your workplace clean
With surveillance audits, the best thing you can do is commit to following and updating your management system. Like starting a fitness regimen or learning to ride a bike, you will find it becomes habitual over time, leading to continual improvement.
The audit process for recertification is similar to that of surveillance audits. As long as you incorporate the feedback you gain through those audits and continuously work on your management system, you should be well-prepared to maintain your certification.
You should book these appointments well in advance of your certification’s expiration date to account for any last-minute scheduling changes.
Garber Metrology is ISO 9001 Certified
At Garber Metrology, we strive to provide high-quality product weighing and calibration services, and we wanted to show that. That’s why our calibration testing laboratories are ISO 9001 certified. And with our calibration services and weighing equipment, we can help you on your path to certification, too.
You may still be wondering why your organization should apply for certification. Here’s why:
Importance of ISO 9001 Certification
Customers expect businesses to invest in the quality of their products and services. By gaining certification, organizations prove they care, increasing their reputation among clients and stakeholders.
For many, ISO 9001 certification makes a business seem more trustworthy, but for some, certification in ISO 9001 is a necessity. Certification can help broaden your customer base by appealing to people who care about your company’s commitment to high standards.
Other benefits of ISO 9001 certification can include:
- Higher efficiency and productivity
- Reduced waste production
- Better internal management
- More business opportunities
- Higher customer retention rates
- Continual improvement of quality standards
- Increased credibility
In short, certification can make your business stand out from the rest.
Garber Metrology Can Help You Prepare for Your Audit
Regular documented equipment calibration is a crucial step towards earning and maintaining ISO 9001 certification. At Garber Metrology, we calibrate every piece of equipment as precisely as possible to meet or exceed industry standards by maintaining the following Accreditation and Certifications:
- ISO/IEC 17025:2017 Accreditations
- ISO 9001:2015 Certification
- ANSI/NCSL Z540-1 Compliant
If you have an audit coming up, rest assured with the knowledge that we’ve got your back. Click here to learn more about our calibration services, or contact us for a free quote today.