ISO 9001:2015 Quality Management Systems

SO 9001:2015 – Simplified Continuous Improvement

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ISO 9001:2015 Quality Management Systems

The ISO 9001 standard focuses on the quality of an organization’s approach to the design, planning, implementation, and monitoring of its products and services.

Why ISO 9001?

Did you know an ISO 9001:2015 certification can complement other compliance efforts, like ISO 27001? The ISO 9001 standard focuses on the quality of an organization’s approach to the design, planning, implementation, and monitoring of its products and services. It is one of the most beneficial and internationally recognized management system standards. The ISO 9001 Quality Management Standard focuses on improving both operations and management efficacy by ensuring customer requirements are met.

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Consistency and quality are a must to achieve the certification of this standard. Achieving the ISO 9001 certification is a valuable marketing tool, specifically for Software as a Service (SaaS) and Cloud Solution providers, where your customers not only expect but demand a high level of consistency and reliability from their service providers. Achieving ISO 9001 certification assures your organization has a degree of excellence in meeting customer expectations.

Our Process

At our core, we are ‘Information Technology experts’ and ‘Process Improvement advisors’. We understand the continual challenges in safeguarding your assets while building the right processes and controls to meet your customers’ demands. As a result, we have demystified the ISO 9001:2015 standard by extracting the key business activity requirements for each clause.

Most of our clients that have completed our ISO 9001:2015 readiness assessment indicate they were much closer to meeting the requirements of the new standard than they initially thought. Our pragmatic approach begins with leveraging your existing process documentation and understanding your business objectives and your quality management risks as well as opportunities. We then dive into your support channels (resources, infrastructure, capabilities, and constraints) as well as your operations. Each process is mapped to one or more of your business objectives and has at least one key performance indicator to measure the quality of the process. We work with your first, second and third lines of defense to ensure monitoring, measurement, and analysis are built into every process. We end our assessment with a Continuous Improvement Program (CIP) report with recommendations on how to ensure ongoing enhancements are made as your processes evolve and respond to customer demands and business risks.

The following is our simplified Plan-Do-Check-Act (PDCA) approach that is mapped to the key ISO 9001:2015 clauses

Our Services

We can help you cross the ISO certification finish line with our streamlined, plain English templates that have stripped away all the ISO speak and focuses on the core requirements of the standard.

Our approach simplifies the ISO 9001 certification requirements by focusing on the quality of what your organization provides (service or product) from intake, to design, and all the way to customer delivery and post-delivery service follow-up. Our ISO 9001:2015 readiness process is designed to understand what is required and highlight the areas where your business activities may already comply.

ISO9001 Readiness and Remediation

  • Identify Business Objectives (COTO)
  • Determine Scope Statement
  • Gap Assessment
  • Develop Quality Management System (QMS) Manual
  • QMS Implementation Roadmap
  • QMS Implementation Plan
  • QMS Training
  • QMS Risk Assessment
  • QMS Internal Audit
  • Corrective Action Plan (CAP) and Related Maintenance
  • Continuous Improvement Program (CIP) Report

Our customized service and simplified approach guide you through your ISO 9001 certification process. Working with our team of IT control experts and process improvement advisors not only reduces your certification readiness process but also enhances your customer product and/or service delivery.

What is ISO 9001?

The International Organization for Standardization (ISO) is a governing body that develops and publishes international standards covering almost all aspects of technology and manufacturing. ISO 9001 sets the management system standards which are based on a number of quality management principles that focus on customer satisfaction, consistent and quality processes, and continuous improvement.

How to Get ISO 9001 Certified?

It is important to note that ISO does not issue certifications. Achieving an ISO certification requires the engagement of an independent accredited attestation firm (i.e. Certifying Body). There are over a million companies in 170+ countries that are certified bodies for ISO 9001. Certification is not required, and organizations can still implement principles of ISO 9001 informally without obtaining certification. At the end of three years, the ISO 9001 must be recertified.

What are the ISO 9001:2015 Requirements?

ISO 9001:2015 requirements are separated into 11 sections called the ISO 9001 clauses. The clauses have two main components:

  • Non-Mandatory Clauses: Clause 0 introduces the benefits of Quality Management Systems (QMS) as well the overall Plan-Do-Check-Act (PDCA) cycle and Risk-Based Thinking (RBT) concepts. While clauses 1-3 do not have any requirements, they cover information regarding the scope of the standard as well as important terms and definitions.
  • Mandatory Requirements: Clauses 4 – 10 are the mandatory requirements with the exception of clause 8, which can be excluded if the company does not deal with planning or designing its products or services.

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>> This service article was last update on July 24, 2022
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