7.5.3.1
- The organization shall ensure availability and suitability of documentation required by the QMS and by the ISO 9001 Standard.
- The organization shall control the sufficient and appropriate protection of documented information and will identify risks for its safety and integrity.
7.5.3.2
- Distribution, access, and retrieval activities necessary for the control of documented information shall be determined and maintained.
- Activities for storage and preservation, including activities to ensure that documented information remains legible necessary for the control of documented information, shall be determined and maintained.
- Activities for the control of changes of documented information shall be determined and maintained.
- The different levels of access permissions to and the authority to modify the documented information will be defined and controlled.
- Activities for retention and disposition necessary for the control of documented information shall be determined and maintained.
- Documented information of external origin needed for the planning and operation of the QMS will be identified, controlled, and appropriately distributed.
- Documented information retained as evidence of conformity shall be protected from unintended alterations.
Availability and Distribution of Documented Information
Each document will be distributed and available to the relevant parties (roles or functions) at the appropriate locations and at the appropriate point of use. Defining the availability and distribution of documents must include the following:
- User authorization: who is authorized to use a document
- Location of the document: where must a document be kept before and after use
- Form of availability: paper or magnetic media, for example
Suitability of Documented Information
Suitability of documented information relates to the assurance that it was appropriately designed: it supports the processes and activities, is adequate for working, and will assist the organization in meeting the quality objectives and product requirements. Each document shall be approved for suitability before release for use. Which aspects indicate the suitability of documented information?
- Purpose: The purpose of the documented information must be clear to the person who designs and creates it and to the users who use it.
- Work instruction or documented procedure: Users shall understand what is expected from them.
- A form: Users shall understand the significant of the entries, their flow to another process, and their use as evidence.
- Properties: The properties of the documented information are defined and applied, format and structure of a document maintained, identification applied, and protection measures carried out.
- Effectiveness: The documented information achieves its objectives and the process or activity that it supports is accomplished (and not just a form that needed to be filled up in order to satisfy the internal audit)
Legibility of Documented Information
Legibility of documented information refers to its quality of being understood:
- Documents will be legible enough to be identified.
- Records will be legible, readable, and retrievable for their entire retention time.
When you plan and implement the use of documents in the organization and the creation of records, some factors that may affect legibility must be considered:
- Intactness, clarity, usability, and accuracy: The factors almost directly affect legibility. Documents and records must be handled with care and the personnel are responsible for maintaining accurate and legible records with all the required information filled out and correctly filed; Documented information must bear all the required information and details, I personally recommend recording the date of filling the records. People with problematic handwriting will have to work harder and provide legible data and information on the record.
- Deterioration: The deterioration of media on which the documented information is saved plays an important role. For example, media such as CDs or magnetic tapes do not last forever.
- Update of technology: Changing of technology used to save and access the documented information is a major aspect. The organization must ensure that they may access documented information in the future. A good example is the update of computer operation systems where old files cannot be read with new versions.
- Relevance: It will be possible to submit the documented information to its relevant context, process or specific product or process; On documents, it will be clear to which process and product of part of the QMS they refer, Records shall not carry or store information that is not relevant to them.
- Digitization: Conversion of analog records or hard copies to digital formas can result in loss of information.
This webpage contains only a fragment of the chapter 7.5 – Documented Information from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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