Preparing a small business for ISO 9001 certification might appear an expensive, complex and daunting undertaking. You may think that certification is only for large enterprises.
In reality, ISO 9001 uses what an organization already has in place for quality practices, makes improvements and documents them effectively. When applied practically, it’s easier to implement than it at first seems.
Is ISO 9001 certification worth it for your small business?
Any move towards implementing quality principles and systems, like those outlined by the ISO 9001 standard, benefits a small business.
This is true even if the business isn’t seeking ISO certification because it creates an opportunity for improved processes, business development and scalable growth.
Depending on your current systems, implementing a QMS can be low cost and low maintenance. Also, it demonstrates your commitment to continuous improvement and quality processes.
ISO 9001:2015 is a globally recognized standard that helps businesses implement quality management procedures and practices.
If your small business is deciding whether to invest in certification, consider these benefits of ISO 9001:2015 accreditation:
What’s involved in preparing for ISO 9001 certification
There’s work to be done to prepare for ISO 9001 certification. These six steps are a guide to what your small business must do.
Step 1. Purchase a copy of the standard, read it thoroughly and familiarise yourself with the requirements.
Step 2. Perform a gap analysis to identify the operations and processes in your business that fall short of ISO standards.
Step 3. Start formal documentation of processes, procedures and ongoing plans for improvement.
Step 4. Launch your QMS to implement the standards and procedures across the business.
Step 5. Conduct an internal audit to review your business’s performance and verify it meets ISO 9001 standards.
Step 6. Apply for certification by selecting a body to conduct an external audit.
Quick overview of ISO 9001 requirements
For small to medium businesses, compliance shouldn’t be about creating new processes from scratch. It’s about aligning and managing existing quality processes – and improving them where necessary.
There are 10 clauses in the ISO 9001:2015 standard. They appear lengthy and complex, but all you need to do is read the standard carefully and understand the principles and objectives of each clause.
They describe the mandatory elements in a QMS, but not how to implement them. You can implement a QMS that works around the way your business operates.
The latest version of ISO 9001:2015 offers more simplified criteria, making certification easier for small businesses.
Here’s what’s involved in each of the 10 clauses (and related sub-clauses) that make up the standard.
The first three clauses, unlike the last seven, don’t contain mandatory requirements or actions. They provide general information, but they must be understood.
1. Scope of the standard
This clause explains the scope of the standard and highlights what quality management intends to achieve.
Businesses must create processes that ensure consistent product and service output and ensure customer satisfaction through conformity to these processes.
2. Normative references
To comprehend the words and terms used in 9001:2015, normative references provide relatable comparisons to the vocabulary used in the 9000:2015 standard.
Businesses must only interpret these terms as directed in this document.
3. Terms and definitions
As with clause 2, you must reference ISO 9000:2015 to fully understand the technical meaning of terms and definitions in ISO 9001:2015.
4. Context of the organization
Each business is unique and operates within a specific environment. It’s not independent of what customers want or regulators define.
This clause requires a business to regularly determine, review and update information relating to external and internal issues that impact the business in setting and meeting its objectives.
Issues might arise from local and global contexts, including legal, technological, competitive, markets, cultural, social and economic environments. It includes meeting the needs and expectations of interested parties that interact with the QMS.
5. Leadership and commitment
This clause outlines the requirements of senior management in developing leadership, commitment and customer focus.
Leadership must establish its commitment to quality and ensure the quality policy is effective.
6. Planning for the QMS
The clause sets out the requirements for working with risk and opportunities when you’re planning your QMS.
A process for mitigating risks and improving desirable effects must be developed.
7. Support and resource management
No business can work without support, such as human resources, infrastructure, work environment and organizational knowledge.
This clause ensures the right support is in place for the QMS to be successful. It requires management to provide and monitor competent and appropriate support and resources.
8. Operational planning and control
This clause concerns the planning for your product or service. Requirements include determining and reviewing product design, development, purchasing, manufacturing, delivery and supply.
The final requirements deal with quality control and product or service non-conformances.
9. Performance evaluation
The requirements in this clause are a system of evaluating, monitoring and reviewing all aspects of the business, from operational performance to customer satisfaction and the performance of suppliers.
It also includes the needs for internal audits, monitoring, analysis and management reviews.
10. Improvement actions
This clause is about the steps for improving your QMS through corrective actions and continuous monitoring and improvement.
A way for SMEs to simplify ISO 9001 compliance
If you’re preparing a small business for ISO 9001 certification, isoTracker’s quality management software can help.
At isoTracker, we offer modular, cloud-based quality management software that’s specifically designed to help simplify ISO 9001 compliance for small to medium businesses.
The software is easy to install and easy to use. There are six modules, for document control and the management of audits, risks, complaints, non-conformances, and training.
Each module can stand alone or integrate seamlessly with other modules to provide a complete quality management system.
Contact us at isoTracker to find out how our cloud-based software can help in preparing a small business for ISO 9001 certification or sign up for a free 60-day trial.
