Comprehend the IATF 16949 standard's documentation information

The International Standard for Automotive Quality Management Systems is IATF 16949:2016. The International Automotive Task Force (IATF) members collaborated to establish IATF 16949, which was then submitted to the International Organization for Standardization (ISO) for approval and publishing. The document is a general industrial quality system requirement based on ISO 9001 and customer-specific automotive needs. The IATF 16949 standard highlights the development of a process-oriented quality management system that allows for continuous improvement, defect prevention, and the elimination of variance and waste in the supply chain. The goal is to efficiently and effectively address the needs of the customers.

In comparison to TS 16949:2009, IATF 16949:2016 has significantly increased the required documents. To be consistent with other standards based on ISO 9001:2015, IATF 16949 has replaced the terms "documented procedure" and "record" with "documented information" throughout the text. The standard discusses and provides instances of what requirements must be written throughout. The IATF 16949 specification is based on ISO 9001:2015, but with extra requirements to fulfill the needs of the automobile industry.

According to IATF 16949, "documented information" refers to essential information that must be preserved and controlled by both the organization and the device (cloud, hard drive, etc.) that contains it. The Quality Management System (QMS), as well as the IATF 16949 documents, data, and processes contained within it, are recognized to be documented information, according to the standard.

Section 7.5 of IATF 16949 provides the documentation requirements, which encompass several of the prior criteria for documents and records. The QMS must include all documented information required by the IATF 16949 standard, as well as any information deemed critical to the effectiveness of the Quality Management System itself. The QMS should also include information about the organization's size, activities, employee competence, and the complexity of its processes and their interactions.

The standard also includes requirements for the creation and retention of documentation, such as its identification, formatting, modification, review, and approval process. Last but not least, IATF 16949 provides criteria for document management, including its availability and suitability, access and retrieval, adequate protection, storage and preservation, use and distribution, change control, retention, and final disposal. This isn't as difficult as it seems; these criteria are identical to the preceding requirements for papers and records, but they've been consolidated into a single set of requirements.

What documented information is required by IATF 16949?

According to the standard, the following items are required documented information:

Scope of the QMS

Quality Manual

Any documents needed to maintain the operation of processes

Any documents needed to ensure that processes are carried out as intended

Quality Policy

Quality Objectives

Verification that processes are being carried out as intended

Verification that products and services conform to requirements

Results of product and service requirements review

Verification that monitoring and measurement equipment is fit for purpose

Standard calibration benchmarks, if there is no internationally recognized standard

Verification of competence

Necessary data to ensure traceability, if required

Results of any changes to the provision of product and service

Release to the customer of products or services, as well as the employee who authorized the release

Actions are taken about nonconformities in products, services, and process outputs, including any concessions

Monitoring and measurement activities and their results

Verification of audit program implementation, and results of the audit

Results of the management review

Evidence that requirements for design and development have been met

Design and development process outputs

Changes in design and development

Results of the evaluation, performance monitoring, and re-evaluation of third-party suppliers

Product and service descriptions, along with activities to be performed and intended results

Verification of any nonconformities, actions taken to address them, and results of any corrective actions taken

Furthermore, the IATF 16949 standard does not mandate enterprises to alter their existing terminologies to meet the new vocabulary, therefore you are not required to change "documents" or "records" to "documented information." Don't overcomplicate things - if your staff are already familiar with the terminology, don't confuse them by changing it. However, if you believe that replacing two different procedures for document and record control with a single, less-complicated method for documented information would simplify things, go ahead and do so. Remember that the purpose of a QMS is to seek methods to improve business processes and keep appropriate control over them - the IATF 16949 standard isn't designed to get in the way of that.

Iso 13485:2016 Medical Devices Quality Management System