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What is ISO 9001?

Background - what is ISO 9001?

What is ISO 9001?  That is a question often asked by business managers hoping to participate in the import export to China international trade.  ISO 9001 is an international standard that identifies the requirements for establishing a system to manage your processes and organization to better serve your customers.  The ISO 9001 is a Quality Management System that brings standards and consistency to everyday activities.  Processes within an ISO 9001 organization are monitored and analyzed for continuous improvement.

Over one million companies around the world from small businesses to large corporations have received their ISO 9001 certifications over the past 20 years.  It all began with the business owners and managers asking the question, "what is ISO 9001?".

Benefits of ISO 9001 Certification

The ISO 9001 Quality Management System provides numerous value and benefits to the organization:

Improving a Company's Way of Doing Business

The ISO 9001 helps an organization to bring consistency to its processes using standardized definitions.  By doing so, it will result in fewer defects and greater efficiencies.  Higher return on investment (ROI) will come from fewer defects and waste during manufacturing.

Meeting Customer Demands

Within a global economy, many companies are using ISO 9001 certification as selection criteria for choosing suppliers.  Having the ISO 9001 designation demonstrates that a potential supplier has a quality supply chain.  It is much easier for a company to ask for ISO 9001 certification than having to try to audit the supplier on an ongoing basis.

Solving Problems

The ISO 9001 standards include embedding preventative action processes within the organization to proactively reduce the number of problems from occurring.  If an issue does arise, a standardized corrective action process is implemented to prevent the problem from reoccurring.  

Marketing Differentiation

Having an ISO 9001 designation gives a potential supplier a competitive advantage over companies which do not have it.  Reduction of waste will also free up additional resources for organizations to allocate more funding to marketing activities.

Reduce Waste

Under ISO 9001, companies are required to set objectives, monitor processes, analyze performance and take corrective action.  The requirement for consistency and standards within ISO 9001 results in greater efficiencies and reduced waste.   

Boost Customer Confidence

Possessing ISO 9001 may often be a shortcut to getting acceptance as a supplier whether you are interested in importing from China or exporting to China.  A potential supplier must also demonstrate the ability to consistently meet and exceed customer needs over a long term relationship. The ISO 9001 standards bring structure and processes into the company to ensure its long term success.

ISO 9001: 2008 Quality Management Principles

There are eight Quality Management Principles within the ISO 9001: 2008 standards version which were derived from the ISO 9000: 2005 standards. Such principles facilitate the creation of a management system that continuously improves performance and the meeting of the needs of all parties.  The eight principles include:

  1. Meeting and exceeding customer expectations.
  2. Leadership involvement in creating an internal environment that fosters achieving organization objectives.
  3. Employee involvement at all levels within the organization.
  4. Managing tasks and activities as processes.
  5. Processes are managed together as a system.
  6. Striving for continuous improvement.
  7. Data based decision making.
  8. Building a win win relationship with suppliers.

ISO 9001:2008's Eight Sections

Here is a quick overview of ISO 9001:2008's eight Sections:

Section 1: Scope of ISO 9001: 2008

This section describes the purpose of the ISO 9001: 2008 standard which is to focus on meeting customer requirements.  It is also applicable for achieving legal and regulatory requirements.  The standard is broad covering all industries and products.

Section 2: Normative Reference

The ISO 9001: 2008 normative reference (refers back to) is the ISO 9000: 2005.  It refers to the quality management systems - fundamentals and vocabulary.  The definitions and from ISO 9000 may be used to clarify the ISO 9001 requirements.

Section 3 - Terms & Definitions

This section outlines the key definitions and terms used within the ISO 9001 standard. The key definitions for organizations (the entity implementing the standard), suppliers (from whom organizations buy goods), and customers (to whom organizations serve) are found here. Product is defined as the result of a process.

Section 4 - General Requirements

There is a high level summary of the standard within this section.  The requirements for document and record control are outlined here as well as the specifics on a quality manual.

Section 5 - Management Responsibility

Top level management commitment is required to develop, implement and continuously improve a quality management system. There are 5 additional requirements for top management to engage in: internal communications; appointment of management representative; responsibilities are defined and communicated; quality management system is planned and maintained; and customer requirements are met.

Section 6 - Resource Management

Resources such as equipment, tool and facilities must be planned and maintained.  Training is also required for employees, human resource working on company equipment.

Section 7 - Product Realization

Processes are used to convert resources into goods and services.  This section focuses on production and processes.

Section 8 - Measure, Analyze and Improve

Processes that drive improvements are covered here. Such processes include auditing, analysis, customer satisfaction and corrective or preventative steps.