Whether you aim to improve operational efficiency and streamline processes, or you want to differentiate your organization from the competition, or simply you want to demonstrate your commitment to quality management, implementing the ISO 9001:2015 standard into your business is the answer. In this blog you will find everything you need to know about ISO 9001:2015 and a checklist that will help you on your journey to accreditation.
What is ISO 9001:2015?
By definition, ISO 9001 is the internationally recognized standard for Quality Management Systems. Its main objective is to monitor and measure the performance of your business in order to help you improve processes and deliver quality products and services. This standard was recently revised in 2015 to emphasize a risk-based approach, encouraging businesses to analyze the impact and potential threat to quality when making changes. This standard is used by many companies around the globe and can be attainable by any organization no matter the size or the sector.
Why Becoming ISO 9001 Certified is Important?
ISO 9001 improves your business performance and creates a culture that facilitates sustainable development initiatives.
A certified business gives the impression that it is committed to delivering excellence, by showing that it is quality focused, reliable and safe to do business with. With time this creates customer satisfaction and builds confidence in the brand which will bring long-term success and financial gain. This certification can also open up new opportunities in global markets that may otherwise have been unattainable.
And many other benefits:
- Improve operational efficiency
- Manage risks and create a secure, structured environment
- Save money through improved efficiency and productivity
- Stand out from competitors
- Achieve greater employee satisfaction and engagement
- Win and retain new business
- Define employee roles and responsibilities
- Identify deficiencies in products and services
- Reduce waste, rejected work, and customer complaints
12 Step for achieving ISO 9001
When you decide to start your journey towards ISO 9001 certification, where should you start?
Step 1: Leadership buy-in
Implementing a quality management system that helps you reach your ISO 9001 certification is work that involves your entire organization, and requires a strong leadership team who will be accountable for the implementation and continued success of the Quality Management System.
The main moderator of your ISO 9001 project is usually specified according to the size of your organization, but should ultimately fall to the most senior person, generally, it is the CEO working closely with other stakeholders such as the Head of Quality (Strategy), Senior Management Team, Heads of Department, Internal Audit Team and all owners of the process.
Having the full support of the leadership team up front, will not only ensure that your commitment to quality is led top-down, but will also make it easier to implement change or ask for additional resources when needed. Because it is important to note that resourcing is key to the accomplishment of ISO 9001.
Once the leadership team is set, the next is to identify the roles and responsibilities of each component of the team, and this should be documented in an implemented plan. One more important thing to be attentive to is that you should keep all employees aware of the ISO 9001 certification process so that they understand their responsibility in the Quality Management System.
In the first step ask the following questions:
- Why do we want to achieve ISO 9001 certification?
- How will ISO 9001 impact our business?
- What is the budget for the project?
- What resources do we have available, and will we need additional third-party support?
- Who are the ISO 9001 champions responsible for the project completion?
Step 2: Perform a Gap Analysis (GA)
This step aligns with Clause 4. Performing a gap analysis will enable your business to formally identify the gaps in your current QMS and the remediation required to comply with the standard.
This step can be performed by your internal team, but many organizations outsource it to professional consultants that have a deeper understanding of what auditors are looking for, this might be more effective because a third-party provider is also more likely to have an open mind and provide a clear report.
Another factor to be considered is a risk assessment because auditors tend to take a risk-based approach when reviewing processes.
This step will form a key milestone in your project plan and help you come up with a scope of work which leads us to step 3.
Step 3: The scope
In this step, you need to formulate a scope of work based on the results and recommendations from the Gap Analysis. The scope needs to be specific and should include:
- All actions, tasks, and activities to remediate gaps
- Set out timeframes for changes to be implemented
- Include financials (where infrastructure/resourcing changes are needed)
- Outline roles and responsibilities
- Layout objectives and set measurable
Step 4: Implement the QMS and create the QMS Manual
When talking about a Quality Management System, we are referring to all policies, procedures, and processes that a business must enforce to ensure they deliver quality products and services and improve business performance.
Creating your QMS policy is a very important task, as it must address all regulatory requirements of ISO 9001. It must provide clear, workable instructions that define expectations, responsibilities, and actions because it will be used by every employee from management to administration. You also need to create policies for control and maintenance of the document, along with rules for continual improvement.
Step 5: Internal Communication
As previously affirmed, a QMS Policy needs to be distributed to the wider business after being crafted, by a strong communication plan developed by a well-committed leadership team. They will have to lead by example and make the QMS a part of the business culture.
Also, employees need to be trained continuously on any updated processes, and the leadership team needs to make sure everyone is following the rules.
Step 6: Create an Audit Plan
After implementing your system and when your employees start to feel comfortable following your documented procedures, it is time to start an audit plan. Scheduling internal audits that cover all departments is key to measuring the success of your QMS, it will help you take corrective actions and thus identify shortcomings.
Make sure, to collect evidence that demonstrates you are running your systems effectively in form of records, customer satisfaction results, and employee interviews.
Step 7: Identify roles and responsibilities
In every process, roles and responsibilities should be identified to ensure accountability and consistently high-quality output.
Some of those roles are:
Policy/Process Author – This is the person responsible for documenting the process. They must be notified of any changes so that they can update the policy and ensure the wider business is aware.
Reviewer – There may be several ‘Reviewers’ within any given process. These people are responsible for performing quality checks at specified intervals.
Approver – The Approver will give final sign-off once they feel the product/service/activity has been completed to a high standard. They will be held accountable if the customer is unsatisfied.
Depending on the process, roles that need to be identified change, but strong communication and collaborative culture will always ensure your systems operate seamlessly.
Step 8: Refine the QMS
Never forget to evaluate your system, and do the changes that must be done 2 to 3 months before your external audit. Follow this up with regular Management Reviews to ensure changes are having a positive effect and meeting your quality goals.
Step 9: Internal Audit
Run one last internal audit before committing to the external audit that will be conducted by an independent certification body. It will allow you to evaluate the efficiency and identify opportunities for further improvement.
We advise you to select a group of internal auditors well trained, they will be responsible for determining whether your ISO 9001 QMS is effective.
Step 10: Apply for the Stage 1 Audit
After strategizing, analyzing, implementing, and internal auditing, you will become ready to book your external audit. This might take several weeks to complete the application and get a date for the assessment.
When set, communicate the date with the employees and put a reminder to everyone.
Step 11: The External Audit
While external auditors will be looking for evidence that your business is complying with the QMS, encourage your employees to be open and honest and make sure they are prepared. Auditors know that employees won’t have answers to every question but they expect them to demonstrate how they find answers.
Other helpful tips:
- Prepare the office by ensuring workspaces are tidy and that there are no uncontrolled documents on desks or in common areas
- Make sure documents are available when needed
- Have a copy of the QMS manual ready for the auditor on arrival
- Give them a private space in which to work on their documentation
- Assign someone to go with the auditor and introduce them to the relevant people
Step 12: What to Do After Passing?
After achieving the ISO 9001, plastering it all over your website, and shouting about it to your customers, the hard work begins!
To keep your certification, you must continually review, monitor, measure, evaluate, identify and act on risks to improve procedures. Internal audits should be done constantly to make sure the QMS is adequately resourced.
The external certification body will assess your QMS and renew your certification only if it continues to meet the regulatory standards.
To sum up, whether you want to scale your business, or you are working on introducing a new product line or installing new infrastructure, your QMS is the foundation on which your goals can be attained.
Although it may seem hard work following the ISO 9001 checklist and becoming certified is beneficial on the financial, operational, and cultural levels.