Where Documented Information is Required in a Quality Management System
Where Documented Information is Required in ISO 9001
Where the ISO 9001 standard historically used terms like “quality manual”, “document”, “documented procedures”, and “records”, ISO 9001:2015 now uses the term “documented information” (clause 7.5) to collectively refer to it all. Clause 7.5 provides guidance while allowing flexibility in the way organizations can choose to document their quality management system (QMS).
If you have a procedure for document control and record control, don’t change the terminology. There is no explicit requirement for a procedure on documented information (clause 7.5), however it is one of the fundamental needs of a QMS to have a defined and structured method to control documentation and records which is near impossible to do without a procedure.*
Maintaining vs. Retaining Documented Information
The term “maintain documented information” is the terminology used by ISO 9001 to mandate that some type of document is required (whether a procedure, form, template, etc.). The term “retain documented information” denotes a record is required as evidence of conformity to the process or to the ISO requirement. Other examples of documented information include: operational procedures, work instructions, checklists, check sheets, forms, templates, flow charts, process maps (with inputs, outputs and linkages), routers, travelers, drawings, specifications, requirements, purchase orders, contracts, signs, container markings, labels etc. Download “Where Documented Information Appears in ISO 9001:2015” to see every clause and requirement in ISO 9001 where some type of document and record is needed. Also determine where “documented information” is required by the ISO 9001 standard and determine whether your organization will need any additional documented procedures to help standardize these processes.
These documented procedures are not explicitly called out, but should be created, and must be referenced from within your Quality Manual. The minimum expected topics to be covered in procedures for ISO 9001 are:
- The control of documented information (formerly known as document and record control). This could be broken into 2 procedures, or combined into one.
- Internal audits
- Non-conforming products
- Corrective Actions. For some companies, especially service companies, it may make sense to combine nonconforming and corrective actions into one procedure.
The size and complexity of your company may dictate the need for more procedures. It is recommended, and better common practice, that procedures be separate documents from the Quality Manual for longer term ease in maintenance and upkeep of the documents.
*Note that Appendix A.1 of the standard explicitly states that there is no requirement in ISO 9001 that you use the same terminology that the standard uses, or the structure clause by clause for the QMS documentation. For better internal adoption, it is better to use the company’s terminology versus ISO 9001 terminology. The ISO 9001 standard is written to be translated into multiple languages, so the terminology used is not always ideal for internal comprehension.
Our simpleQuE experts have created documents as guides to where documents and records are required and to provide clarity on the requirements and the term “documented information”. Below you will find links for these helpful guides for ISO 9001:2015, ISO 14001:2015, IATF 16949:2016 and AS9100:2016. All are free to download so you can use for reference to identify what documents and records must exist per the requirements.
In summary, when preparing to implement a quality management system (QMS), these documents indicate where the term “documented information” occurs in each section of the corresponding standard. When the standard states “maintain documented information”, this is equivalent to having a procedure or being documented somewhere. Where it indicates “retain documented information”, there needs to be some type of record.
Where Documented Information Appears in ISO 9001:2015
Where Documented Information Appears in ISO 14001:2015
Where Documented Information Appears in IATF 16949® and ISO 9001:2015
Where Documented Information Appears in AS9100:2016 and ISO 9001:2015
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