Documented Information
Documents and Records
Since 2015, ISO 9001 which their standard to no longer use the terms documents and records, but to rather call both “documented information.” Since, IATF 16949 is based off of ISO 9001, this term chance applies to the new automotive quality standard. According to the ISO 9001:2015 Standard the term “documented information” refers to information that must be controlled and maintained, meaning you also must maintain and control the medium as well as the information.
What are the requirements for documentation in the IATF 16949:2016?
Unique requirements set by IATF, include 7.5.1.1 Quality Management System Documentation. In the supplemental requirements, IATF states that the organization’s quality management system must not only be documented but also include a quality manual. The format and structure can be defined by the organization and depends on the organizations size, culture and complexity.
Furthermore, sub-clause 7.5.3.2.1 states that organizations are required to define, document and implement a record retention policy. The control of records must satisfy statutory, regulatory, organizational and customer requirements.
7.5.3.2.2 addresses engineering specifications. Organizations are required to document processes describing the review, distribution and implementation of all customer engineering standards/specifications, and any revisions that are related based upon customer schedules.
ISO 9001 provides the framework for the requirements of the QMS. According to ISO 9001, documented information is required to include documents and records that are required by the standard and are essential for effective operations of your organizations. Documented information is key to your QMS because it is used as evidence of conformance, allows your organization to be consistent, and prevents loss of knowledge and information. The more complex your process is, the more important it is that it is greatly detailed.
The following documented information is required by the standard:
Understanding what information needs to be included in your QMS can be confusing and unclear, making it a time consuming process. Our Quality Manual and Procedures package is a fully documented QMS used by hundreds of companies worldwide to successfully obtain certification. Use this package as the foundation of your system, tailor the documents for your organization and benefit from the professionally designed processes while saving time.
Click here for a full list of all required documents and records.
Integrated-Standards.com has many tools to help you integrate ISO Standards in their existing format, which will be simplified with Annex L.
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