What is ISO 9001?
ISO 9001 establishes the guidelines for a quality management system that can be used by any size company in any industry. It is recognized globally by more than 1 million organizations to indicate that basic requirements of the standard have been satisfied and that the certified company will achieve continual improvement.
ISO 9001 refers to International Organization for Standardization that was originally based on government procurement standards and large organizations requiring standardization within the supply-chain. This standardization eased the burden of customers and suppliers to follow one standard instead of adhering to several varied and nuanced sets of requirements. Additionally, this allowed the streamlining of customers approving suppliers if they were certified to one global standard.
There are several reasons to become ISO 9001 certified and once an organization begins their journey, they find that the enhanced quality management system can create positive impacts on most parts of their business including:
- Gain advantage over competitors;
- New business opportunities;
- Ease to become qualified suppliers for their potential customers;
- Satisfied customers;
- Reduce risk;
- Reduce costs;
- Increase predictability and stability;
- Increase supply-chain management;
- Federal, statutory and regulatory compliance; and
- Discover how internal departments can communicate better.
ISO 9001 is an important addition to any company seeking improvement like better controls, better processes, better relationships with customers and suppliers, and better records management for long-term growth and bigger profits.
Who is Required to Comply?
As a highly sought-after management system standard, many companies realize the benefits of being ISO 9001 certified. Geared with this internationally recognized quality management standard, you are showing that you value your customers and demonstrate credibility. Companies that are in competitive environments and those seeking opportunities in regulated industries should consider certification.
What are the Components of ISO 9001?
ISO 9001:2015 has 10 clauses that follow the Plan, Do, Check, Act cycle in a process-based approach encouraging risk-based management:
- Normative references
- Terms and Definitions
- Context of the organization
- Performance evaluation
- Continual Improvement
How Can We Help You?
Don’t try to manage it all alone! Linqs has extensive experience in ISO compliance and operations. We can assist you with education & understanding, training and help develop your quality management system for ISO 9001:2015 compliance.
Phase 1 – Training, Assessment, and Gap Analysis
- Provide training on ISO 9001:2015 clauses and compliance;
- Review the organization system(s) including internal and external interested stakeholders;
- Review of ISO 9001:2015 requirements based on the organization system(s);
- Identify the gaps where remediation is needed.
Duration: 1 week
Phase 2 – Compliance Program Management and Procedure Development
- Prioritize the gaps which can be closed in a short time frame;
- Develop plan of actions & milestones to obtain ISO 9001:2015 compliance;
- Develop robust documented quality management system;
- Engage with each department involved with quality and operations; and
- Advise on best quality management system practices.
- Quality Policy, Quality Objectives and Quality Scope;
- Risk analysis management in context to stakeholders;
- Develop procedures for the organization’s effective operations;
- Develop document and records controls;
- Develop customer feedback and complaint handling processes; and
- Develop data analysis and continuous improvement processes.
Duration: Varies depending on the size and scope of the organization
Phase 3 – Continuous Compliance Monitoring (Optional)
- Perform Internal Audits;
- Assess and identify the new gaps a result of changes in operations, regulations, and customer focus;
- Updates to the quality management system including revision changes to risk analysis, processes, significant operation developments, quality scope and documentation controls;
- Assistance with customer requirements, customer complaints, and audit findings;
- Assistance with representation during audits;
- Advise on continuous improvement; and
- Continuous education & training for your organization.
Duration: Varies depending on task(s)