Why TS and Not Just ISO 16949?
The International Organization of Standards (ISO) develops many different types of standards for a variety of industries. Recommendations to ISO for a new standard require a two-thirds majority vote for approval as a Technical Standard (TS) and a three-quarters majority vote to become an ISO standard.
ISO/TS 16949 Requirements and MasterControl Features
For each requirement of the ISO/TS 16949 standard, MasterControl software solutions offer a corresponding benefit to meet each standard:
- Clause 4.2.3 Control of Documents: MasterControl Documents automates routing, escalation, approval and delivery of SOPs, policies and other documentation.
- Clause 18.104.22.168 Training: MasterControl Training programs assignment and monitoring of training tasks and grading of online exams and allows sequencing of training courses.
- Clause 7.1.4 Change Control: MasterControl Change Control streamlines the entire procedure for faster turnaround with reports that provide real-time status updates.
- Clause 7.2.3 Customer Communication: MasterControl Customer Complaints simplifies the complaint-handling process and reduces the life cycle from submission to resolution.
- Clause 8.2.1 Internal Audit: MasterControl Audit automates, updates and manages the audit process. It also provides advanced tracking capability throughout the entire audit process.
ISO/TS 16949 Replaced by IATF 16949
In September 2018, ISO/TS 16949:2009 was replaced by IATF 16949:2016. The new certification from the International Automotive Task Force (IATF) provides an interdisciplinary approach that is more focused on risk management, customer satisfaction, leadership and process. One of the biggest changes from ISO to IATF is the requirement for more documentation and documented evidence. Companies with ISO/TS 16949 certifications will have to conduct an audit in order to acquire IATF 16949 certification, which will continue to be aligned with ISO 9001:2015.
ISO/TS 16949 Certification
The following steps should be considered when implementing ISO/TS 16949 to achieve certification:
- Gap analysis (existing system and ISO/TS 16949 requirements)
- Transformation and development of manuals, procedures, operator instructions
- Implementation of procedures
- Suppliers development
- Internal audits
- Registration audit
MasterControl and ISO/TS 16949
MasterControl solutions help you to meet ISO/TS 16949 and IATF 16949 requirements year after year while keeping compliance costs down. The connectivity of MasterControl solutions software gives you the ability to monitor your entire quality management system (QMS) and continuously improve it to ensure that company quality initiatives are enforced across the enterprise.
MasterControl and the FDA
MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).