Simplifying ISO 9001 Compliance for Small to Medium Businesses

Simplifying ISO 9001 Compliance for Small to Medium Businesses
May 12, 2022 isowebseousr
iso 9001 for small to medium businesses

The words ISO compliance are enough to send a shudder down any compliance officer’s spine but adherence to ISO 9001 standards doesn’t have to be difficult, especially for smaller businesses.

Simplifying ISO 9001 compliance for small to medium businesses is a lot easier once you understand the clauses and break down the requirements.

Simple explanations of the 10 clauses in ISO 9001

ISO 9001 is a Quality Management Standard that is well suited to small and medium businesses that want to improve customer confidence through improved quality and service.

ISO 9001 contains 10 top-level clauses necessary for achieving certification. Once you understand these 10 clauses, you’ll have a clearer understanding of what the standard requires.

1 | Scope

This clause explains the scope of the standard which highlights what quality management is meant to achieve.

The standard expects businesses to create processes that ensure consistent product and service output and ensure customer satisfaction through conformity to these processes.

2 | Normative references

This clause refers to ISO 9000:2015 which is a reference document. It contains the technical terminology used in ISO 9001.

Businesses must ensure they only interpret these terms as directed by this document.

3 | Terms and definitions

These are references for a better understanding of the technical terms referenced above.

Businesses must refer to ISO 9000:2015 for definitions of the technical terms used in ISO 9001. These definitions can also be found on the ISO website.

4 | Context of the organization

The fourth clause requires the business to identify any external or internal issues that affect service and product quality.

With these, the business can outline the requirements for their entire quality management system within the context of their organization.

5 | Leadership

The owner, CEO or upper management will need to be clearly seen in the development, audits and reviews of the quality management system.

This clause requires demonstration that leadership is closely involved in ensuring the QMS is effective.

6 | Planning

This clause requires the business to identify risks and opportunities that will affect the quality management system’s ability to achieve better service through conformance.

It must include actions to mitigate the risks and seize opportunities for improvement.

7 | Support

This clause ensures the right support systems are in place for the QMS to be successful.

This can mean picking the right team members with the right skills and experience, choosing compatible service providers, offering training and ensuring the necessary resources are available.

8 | Operation

This is a comprehensive plan for how the business will provide products or services and communicate with customers and vendors to achieve the goals of the QMS.

It should include procedures for operations, controls and checks, and recording non-conformances.

9 | Performance evaluation

This clause requires a system of monitoring, measuring and analyzing the new procedures implemented by the QMS to gauge if customer satisfaction has improved.

It also stipulates the need for audits and management reviews.

10 | Improvement

This clause requires evidence of improvement through corrective actions and taking advantage of opportunities identified through planning and reviewing.

Improvement doesn’t need to be continuous but there must be evidence that improvements were made incrementally.

Steps involved in achieving ISO 9001 certification

The procedure for implementing ISO 9001 generally follows these basic steps:

  1. buy the standard and read it
  2. decide if you need an external ISO 9001-certified consultant to assist
  3. compare the ISO requirements to the processes you already have in place
  4. adjust processes that don’t meet the requirements
  5. select a certification registrar to conduct the audit
  6. address non-conformities in order to receive certification.

Mapping out processes in your business

To create a quality management system that doesn’t overlook anything, it helps to map out all the processes in your business that contribute to the final quality of your services or products.

These overviews should detail all the stages of your business processes including inputs, operations and outputs as well as tests and checks and required records where applicable.

This will help you identify any shortcomings or opportunities for improvement as well ensuring that all team members have a clear understanding of how to adhere to the QMS.

How you choose to document this mapping process is up to you, but the processes should be easy to understand and accessible to everyone involved.

Prepare required paperwork

Earlier versions of this standard required quite a lot of paperwork but the 2015 version has been simplified. ISO 9001 now only requires three mandatory pieces of paperwork.

  • the scope of your QMS
  • your quality policy
  • your quality objectives.

This probably won’t be the only paperwork you generate with your QMS and ISO 9001 procedures but these three are the minimum required to achieve certification.

Adopting the Plan – Do – Check – Act model

The recommended approach to implementing ISO 9001 is the well-known “Plan – Do – Check – Act” model. This approach is simple but effective.

Plan: Establish the objective of each step in the system and each team member’s responsibility.

Do: Operate according to the agreed-upon and formalized processes and procedures.

Check: Monitor and evaluate the processes to ensure they meet agreed objectives.

Act: Identify any gaps and take any actions that can improve these processes.

How isoTracker’s QMS software can simplify ISO 9001 compliance

At isoTracker, we offer modular, cloud-based quality management software, specifically designed to help in simplifying ISO 9001 compliance for small to medium businesses.

The software is easy to install and easy to use. It provides:

  • a centralized, always up-to-date (and searchable) repository for documents and records
  • highly customizable fields for ensuring the right data is captured at each point
  • workflows for implementing and managing processes
  • automated notifications, so nothing gets overlooked.

We offer six modules, for document control and the management of audits, risks, complaints, non-conformances, and training. Each module can stand on its own or integrate seamlessly with other modules to provide a complete quality management system.

Our Complaints Management, Audit Management, Training, and Non-Conformance Management modules include built-in CAPA capabilities, for managing, recording and reporting corrective and preventive actions.

Contact us to find out more or to discuss your company’s QMS software and ISO 9001 compliance needs. Alternatively, go ahead and sign up for a free 60-day trial, with complete access to all the modules, as well as free training and support.

Get a free trial now

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Manage compliance for ISO 9001/13485/14001/17025/22000/45001 & IATF 16949.

 

Contains document control, training, complaints, audit, non-conformance, risk & CAPA modules.

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