ISO 9001:2015 classifies documented information in two types: documents do maintain and documents to retain. Documents to maintain are, for example, manuals, procedures, work instructions and forms. These documents can become obsoletes, can be change to newer versions, can be updated. When we fill a form it becomes a record and a record, like a ...
Documented Information How to maintain & retain your documents & records. Checklists Our checklists will ensure your QMS conforms to ISO 9001 requirements. ... How to maintain and retain your documents and records for ISO 9001. Contents. 1 Procedure - view sample; 2 Process Maps, Turtle Diagrams - view sample;
The most recent release of ISO 9001:2015 requires you to maintain 5 documented information (procedures) and retain 22 documented information (records). What documents must be kept to comply with ISO 9001? Take a look at Clause 7.5.1, documentation requirements, which is nothing more than a section heading: 7.5.1 General
Instead, the term consistently used is “documented information.” In order to clarify in the ISO 14001 standard what type of “documented information” is required, the standard uses “maintain” where the intent is that a document (e.g. documented procedure) is needed and uses “retain” where the intent is that a record is needed.
Something important to note here is the meaning of retain documented information and maintain documented information. Retain – is the evidence or the records that an activity or process has been conducted. Maintain – is the procedure or statement. A procedure will tell you HOW a process or activity is to be conducted and even possibly ...
What’s the difference between retain and maintain documented information? In the High Level Structure implemented in ISO 9001, 14001 and 45001 ‘documented information’ is used for all documented requirements which could be any documentation, documented procedures or records. ... ‘Retain documented information’ – is where records are ...
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.
Retain documented information on the release of products and services, including evidence of conformity and traceability to person authorizing release. none. 8.7.2. Nonconforming products. Retain information on nonconforming products, including description, actions taken, any concessions, and authority deciding on action.
This clause requires an organization’s QMS and processes to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned”. Clause 7.5.1
Documents and Records. The ISO 9001:2015 standard no longer uses the terms “documents” and “records”. Both are now called “documented information”. As per the ISO 9000:2015 definition, the term documented information refers to information that must be controlled and maintained.Therefore, it expects that you also maintain and control the medium as well as the information.
Maintain documented information to the extent necessary to have confidence that processes are carried out as planned (8.2); Retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results (9.1.1); Retain documented information as evidence of the compliance evaluation result(s) (9.1.2);
The shift does not, however, lessen the requirement for proper documentation. As noted in the standard, “documented information” can be required: When information needs to be disseminated or shared. To prove (and retain that proof) that a quality process has been completed and what the results were. To retain organizational knowledge including:
To the extent necessary, the organization shall maintain documented information to support the operation of its processes. 4.4.2 b: QMS and its processes: Record: To the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned. 5.2.2 a: Communicating the ...
Newer versions of this standard have simplified the requirements and group documents and records under one term – documented information. The ISO 9001 quality standard requires that documented information be maintained, retained, or both. What is meant by documented information in ISO 9001? Documented information covers documents and records.
Frequently, the standard uses phrases such as ‘the organization shall retain documented information,’ indicating when a record must be retained. In other instances, ‘the organization shall maintain documented information,’ implying the necessity to keep a particular type of document consistently updated and accessible.
The organisation shall: a) maintain documented information to the extent necessary to support the operation of processes b) retain documented information to have confidence that the processes are being carried out as planned. Notice the key words - 'maintain' and 'retain'. Documented information to 'retain' is what was previously called records.
Retain documented information of these activities and any necessary actions arising from the evaluations. 8.5.2 Identification and traceability: Retain the documented information necessary to enable traceability. 8.5.3 Property belonging to customers or external providers: Retain documented information on what has occurred. 8.5.6 Control of changes
Maintaining a document means that the document must be kept and also kept up to date. ... So there you have it – the difference between “maintain” and “retain”. Only a few letters, but a ...
