ISO 9001 Overview and Guides

ISO 9001 is 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.

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 ultimately consists of a set of quality controls, policies, and procedures, all of which are documented, and whose 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 – 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:

• 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.
• 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.
• 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.
• Clause 7: Support
  Ensure that the appropriate supporting evidence is created, collected, and maintained as you build out your QMS.
• Clause 8: Operation
  Develop, implement, and control processes around quality.
• Clause 9: Performance evaluation
  Establish processes to ensure that your QMS is continuously monitored and evaluated.
• Clause 10: Improvement
  Ensures that once performance is evaluated, all gaps are addressed.

Why Should I Pursue an ISO 9001 Attestation?

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 wants or needs of the organization’s customers, as well as any regulatory requirements with which the organization needs to comply.

Companies in the following industries most typically need ISO 9001:

• Construction companies; construction management teams that adhere to ISO 9001 standards are contributing toward the significant reduction in waste costs, greater efficiencies and a safer, happy workplace for employees
• 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.
• 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 between $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.

At TrustCloud, we believe compliance shouldn’t cost an arm and a leg. We want to make the readiness and audit process both affordable and simple. We’ve broken the cost down into two areas:

• A compliance automation platform. By automating much of the process, platforms such as TrustOps help you reduce and better manage your internal costs. We’ve developed a transparent and straightforward pricing structure to make it easier for you to manage the overall cost of the program.
• An auditor. We’ve developed strong relationships with a number of audit firms. Not only does this mean 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 – $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 rather than later.

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

If you’re reading this and find yourself in the depths of despair at how long this is all going to take (maybe because you’ve got a large deal contingent on the attestation report), we’ve got good news! There is a faster way to do your audit prep, and it involves leveraging automation to implement controls, craft policies, and prove that you’re doing what you say you are.

What we’re trying to say is: you should take a look at TrustOps. We guarantee (yes, guarantee!) that it will save you time, resources and money.

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