ISO 9001 & ISO 14385 Certifications

American Language Services has gone through an intensive and detailed process and has earned both ISO 9001 and ISO 14385 certifications. The ISO 9001 process is a quality management standard. ISO is the International Organization for Standardization. It was set up in 1947 and is located in Geneva, Switzerland. Its purpose is to facilitate and support international trade by developing standards that people everywhere would recognize and respect. ISO achieves this purpose through the participation and support of its member bodies. These member bodies currently come from 150 countries. It applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.

For a Fast and Free Quote Online, Just Visit One Of Our Free Quote Pages:

Overview of the ISO 9001 Process as it Pertains to Translations

The ISO 9001 process in general is establishes a set of standards to be followed and documented. Pertaining to the Translation industry, the ISO 9001 process starts with the evaluation of the individual project, followed by quoting of the project, obtaining client approval, logging the project into a specific system, evaluation of the translators, sourcing the translators, desk top publisher & editors, project management follow up, quality control processes, feedback to correct errors, correction of errors prior to deliver, evaluation of on-time performance, client feedback and implementation of system upgrades and external quality evaluation audits.

The Medical Industry & Medical Device Manufacturing

The ISO 14385 pertains to overall translation expertise and processes in the medical Industry. More specifically, the certification is for Medical Device Manufacturing. The overall process has many similarities to the ISO 9001 process. One cannot obtain this certification unless the ISO 9001 certification is completed first.

ISO standards are developed by technical committees. The people who serve on these technical committees come from many national standards organizations. Consequently, ISO standards tend to have worldwide support. ISO 13485 was developed by ISO Technical Committee 210. ISO/TC 210 is responsible for “quality management and corresponding general aspects for medical devices.”

This extensive process reviews and audits every element of how American Language Services operates in order to ensure superior and constant delivery and technical performance. Outlined below is a summary of each individual aspect of the process.

• Develop Your Quality Management System (Qms)
• Document Your Quality Management System (Qms)
• Manage Quality Management System Documents
• Prepare Quality Management System Manual
• Control Quality Management System Documents
• Establish Quality Management System Records
• Show Your Commitment to Quality
• Focus On Your Customers
• Support Your Quality Policy
• Carry Out Your Qms Planning
• Establish Quality Objectives
• Plan Quality Management System (Qms)
• Allocate Qms Responsibility and Authority
• Define Responsibilities and Authorities
• Create Management Representative Role
• Support Internal Communication
• Perform Qms Management Reviews
• Review Quality Management System (Qms)
• Examine Management Review Inputs
• Generate Management Review Outputs
• Provide Required Qms Resources
• Provide Competent Qms Personnel
• Ensure the Competence of Workers
• Meet Competence Requirements
• Provide Necessary Infrastructure
• Provide Suitable Work Environment
• Control Product Realization Planning
• Control Customer-Related Processes
• Identify Your Unique Product Requirements
• Review Customers' Product Requirements
• Communicate With Your Customers
• Control Product Design and Development
• Plan Product Design and Development
• Identify Design and Development Inputs
• Generate Design and Development Outputs
• Carry Out Design and Development Reviews
• Perform Design and Development Verifications
• Conduct Design and Development Validations
• Manage Design and Development Changes
• Control Purchasing and Purchased Products
• Establish Control of Your Purchasing Process
• Specify Purchasing Requirements
• Verify Purchased Products
• Control Production and Service Provision
• Establish Control of Production and Service
• Identify and Track Your Products
• Protect Property Supplied By Customers
• Control Monitoring and Measuring Equipment
• Establish Monitoring and Measurement Processes
• Carry Out Monitoring and Measurement Activities
• Monitor and Measure Customer Satisfaction
• Plan and Perform Regular Internal Audits
• Identify and Control Nonconforming Products
• Collect and Analyze Quality Management Data
• Make Improvements and Take Remedial Actions
• Improve the Effectiveness of Your Qms
• Correct Nonconformities to Prevent Recurrence

To Place An Order Select One Of The Services Below

Interpretation, translation, and transcription specialists offering professional, worldwide multi-language services to the legal industry.