Strahinja Stojanovic Lately, a hot topic of discussion has been the changes to documented information in the updated revision of ISO 9001, and the ways in which it might impact an IATF 16949 implementation. Some of the common questions include: “Is maintenance of documents and records still required?” and “How about documented procedures – can we eliminate them?” Though ISO 9001 (and, as a result, IATF 16949) has done away with the explicit requirements regarding documented records and procedures, a new requirement has been introduced. The term is now “documented information,” which is meant to include both documents and records.
What is ‘documented information’?
“Documented information,” as defined in IATF 16949, refers to important data that must be maintained and controlled by both the organization itself, and by the medium (cloud, hard drive, etc.) containing it. Additional details provided by the standard state that the Quality Management System (QMS), and the documents, records, and processes therein, are considered to be documented information.
Section 7.5 of IATF 16949 contains the requirements regarding documented information, which include several of the previous requirements for documents and records. The QMS must include any documented information that the IATF 16949 standard requires, as well as that deemed vital to the success of the Quality Management System itself. The QMS should also provide details about the organization’s size, its activities, competence of its staff, and the complexity of its processes and their interactions.
In addition to the above requirements, the standard contains requirements regarding the creation and maintenance of documentation, including its identification, formatting, updating, review, and the approval process. Last but not least, IATF 16949 specifies requirements concerning control of documented information, particularly its availability and suitability, access and retrieval, adequate protection, storage and preservation, use and distribution, change control, retention, and eventual disposal. This isn’t as complicated as it sounds – these requirements are mostly identical to the previous requirements regarding documents and records, only merged into a single set of requirements.
What documented information does IATF 16949 require?
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 monitoring and measurement equipment is fit for purpose
- Standard calibration benchmarks, if there is no internationally recognized standard
- Verification of competence
- Verification that processes are being carried out as intended
- Verification that products and services conform to requirements
- Results of product and service requirements 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
- Necessary data to ensure traceability, if required
- Results of any changes to provision of product and service
- Release to the customer of products or services, as well as the employee who authorized the release
- Actions taken with regard to 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
- Verification of any nonconformities, actions taken to address them, and results of any corrective actions taken
Does this new terminology mean you have to change your documentation?
The IATF 16949 standard does not require organizations to change their existing terms to match the new terminology – so no, you don’t have to change “documents” or “records” to “documented information.” Don’t overcomplicate things – if your employees are comfortable with the terminology already in use, then don’t confuse them by changing the terms.
But, if you feel it would simplify things to replace two separate procedures for document and record control with one single, less-complicated procedure for documented information, then by all means, do so. Keep in mind that the point of a QMS is to look for ways to improve your processes and maintain sufficient control over them – the IATF 16949 standard certainly isn’t meant to stand in the way.
Download a free preview of the IATF 16949 Documentation Toolkit to see the structure for each document mentioned above.
