ISO 9001 Overview and Guides

ISO 9001 Overview and Guides talk about ISO 9001, a globally recognized framework, part of the ISO/IEC 9000 series, for governing an organization’s quality management program by providing a clear set of requirements for a Quality Management System (QMS).

ISO 9001 helps demonstrate that your company is serious about improving the quality of their products and services and consistently meets their customers’ expectations.

It can be used by any organization to help ensure that customers get consistent, high quality products and services.

Learn more about continuous ISO 9001 compliance with TrustOps for ISO 9001!

What is a QMS?

ISO 9001 requires the creation and documentation of a Quality Management System (QMS). A QMS provides structure and processes that can be leveraged to manage the quality of your product or service. It consists of a set of quality controls, policies, and procedures. All of these are documented, and usage can be verified independently by an auditor.

ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.

ISO 9001 is composed of 10 sections (referred to as “clauses” in ISO 9001 terminology). While the first three clauses are introductory in nature and serve as an overview of the process itself, clauses 4 to 10 are more strategic, providing guidelines for securing the business as a whole. Each clause contains a set of guidelines intended to improve your company’s quality posture We have outlined these below:

1. Clause 4: Context of the organization
   Establish the context of the QMS by outlining and documenting how your organization is structured, your contractual relationships, and the way you run your business.
2. Clause 5: Leadership
   Define the policies that govern your organization, list the roles and responsibilities of team members working on putting the QMS together, ensure that the team has the necessary resources, and conduct regular reviews.
3. Clause 6: Planning
   When planning your company’s long-term goals and upcoming work, it’s critical that quality risks are taken into account. The guidelines in this clause surround the processes for doing so.
4. Clause 7: Support
   Ensure that the appropriate supporting evidence is created, collected, and maintained as you build out your QMS.
5. Clause 8: Operation
   Develop, implement, and control processes around quality.
6. Clause 9: Performance evaluation
   Establish processes to ensure that your QMS is continuously monitored and evaluated.
7. Clause 10: Improvement
   Ensures that once performance is evaluated, all gaps are addressed.

Why Should I Pursue an ISO 9001 certification?

ISO 9001 helps you demonstrate efforts towards mitigating quality risks. The specifics involved in pursuing an ISO 9001 attestation really depend on the market, the needs of the organization’s customers, and any regulatory requirements with which the organization needs to comply.

Organizations in the following industries most typically need ISO 9001:

1. Construction organizations and construction management teams that adhere to ISO 9001 standards are contributing to a significant reduction in waste costs, greater efficiencies and a safer, happier workplace for employees
2. Engineering companies: building quality assurance into the service offering is crucial for engineering firms; it demonstrates an ability to identify potential hazards and inefficiencies and develop plans to mitigate these risks.
3. Manufacturing companies: By implementing quality management systems, manufacturing firms can communicate value to their markets, especially when foreign competitiveness is steadily increasing.

Traditionally, ISO 9001 can cost anywhere from $30,000 to $100,000 when you factor in the cost of the audit firm, as well as internal costs including productivity, staff training, and resources needed to meet specific requirements.

TrustCloud wants to make the readiness and audit processes both affordable and simple. The cost is broken down into two areas:

1. A compliance automation platform. By automating much of the process, platforms such as TrustOps help you reduce and better manage your internal costs. A transparent and straightforward pricing structure to make it easier for you to manage the overall cost of the program.
2. An auditor. TrustCloud has developed strong relationships with a number of audit firms. This means that they are trained on the platform and know how to evaluate your business; they are also able to pass along discounts as a result of a referral from TrustCloud. ISO 9001 audit partners in the TrustCloud network charge between $5,000 and $15,000 for audits, based on the maturity and complexity of the engagement.

How long is the ISO 9001 process going to take?

Given the complex structure of ISO 9001, it can take months, or even a year, to meet all the requirements by putting all the requisite controls, policies, and procedures in place. If you’ve decided to pursue an ISO 9001 attestation, our recommendation is to kickstart this process sooner.

In addition to the months of preparation, an auditor may spend 6 to 12 months going through your QMS, depending on the size of your organization and the complexity of your QMS.

There is a faster way to do your audit preparation, and it involves leveraging automation to implement controls, craft policies, and prove that you’re doing what you say you are.

TrustOps will save you time, resources, and money.

Click on the next article to understand how to get started with ISO 9001!