ISO 9001 Definition

ISO 9001 Definition: ISO 9001 is a set of internationally agreed standards that provide guidelines for a Quality Management System. If you are interested in the history of the standard, read this.

If your organization meets ISO 9001-2015 then you can become certified to the standard. Interestingly, ISO 9001-2015 can apply to any type of organization. This includes manufacturing, service, software or even non profit organizations

Certification Benefits

• States to your customers that you have certain key Quality Assurance Systems in place and you are following these systems.
• Some customers may only do business with ISO 9001 companies.
• The ISO 9001 definition provides the basis for other certifications such as IS0 14000 (environmental), TS 16949 (automotive), and AS9100 (aircraft).
• It drives improvement within your company.
• It could reduce customer audits of your facilities, processes and systems.
• It drives and changes your company to systematic method of management and work.

If you are getting ready to select an ISO 9001 auditor, review this first.

7 ISO 9001 Principles

ISO 9004 (a supporting standard of 9001) dictates the 7 principles that the ISO 9001 definition is based on. These are:

1. Customer Focus Organization
2. Leadership
3. Engagement of People
4. Process Approach
5. Continual Improvement
6. Evidence Approach to Decision Making
7. Relationship Management
   

More on the ISO 9001 Definition

As mention above the standard can be used for any type of organization. The standard is generic and universal. Third party registrars use the standard as a basis for auditing. It requires top level management commitment to achieve the certification.

The ISO 9001 standard does not determine your company’s quality goals. It does not put numbers on defect levels or other quality characteristics. It is not a measurement tool.

The standard lets you prescribe your systems but you must meet the intent of the standard. Your Quality Management Systems will look different then other organization’s systems. To achieve certification you must “walk the talk”. Within this website you will find recommendations for these systems.

Mandatory Documents
See the mandatory document list for ISO 9001 certification.

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ISO 9001 Main and Key Elements

ISO 9001 Definition: Quality Management System key elements

• General Requirements
• Quality Manual
• Document Control
• Quality Records Control
• Measurement Analysis and Improvement

Management Responsibility key elements

• Management Commitment
• Customer Focus
• Quality Policy
• Quality Objectives
• Quality Responsibility and Authority
• Management Representative
• Internal Communication
• Management Review Inputs and Outputs

Resource Management key elements

• Training and Competency
• Infrastructure
• Work Environment

Product Realization key elements

• Planning
• Product requirements determination
• Product requirements review
• Customer communication
• Design and Development planning, inputs, outputs, review, verification and validation
• Controlling Design and Development changes
• Purchasing process
• Purchasing information control
• Purchase Product Verification
• Process validation for production and service
• Identification and traceability
• Customer property control
• Preservation of Product
• Control of monitoring and measuring equipment

Measurement Analysis and Improvement key Elements

• Continuous Improvement
• Customer Satisfaction
• Internal Audits
• Process and Product monitoring and measurement
• Nonconforming product control
• Data Analysis
• Corrective Action
• Preventive Action

ISO 9000 Quality Audit

Review this page for the 5Ws of the ISO Quality Audit.

Interaction Chart

For ISO 9001  registration, your QA manual will need a process interaction chart. Please subscribe to QA solutions for an example of a process interaction chart and other freebies

Flowcharting

When writing ISO Documentation, it is best to start with flowcharting your systems and processes.

Knowledge Management and ISO 9001:2015

Company Knowledge Management