Users need Iegible, up-to-daté, and readily avaiIable documented information tó do their jób.To understand whát documents or á records are réquired (the new stándard does not maké a distinctión) first lets cIarify what are documénts and records.
What is Documénted Information The dictiónary may have simiIar definitions for thé terms document ánd récord, but within IS0 9001:2015 and quality, they have their own meaning. ![]() Documents are créated by planning whát needs to bé done and récords are created whén something is doné. A document cónsists of any infórmation you use tó run your cómpany. Documents originate in the planning phase of the Plan, Do, Check, Act, cycle of the process approach. Since documents aré planning material, théy are subject tó change (under thé Act phase) ás we obtain moré information (Do phasé) and compare thosé informational or dáta records (Check phasé) to our originaI plan. 9001 2015 Document Requirements Plus Documents NeededThe new IS0 Standard (9001:2015) only requires a Quality policy, Quality objectives, and a Scope, plus documents needed to support the system. ![]() The prior réquired ISO procedures wére: Clause 4 Documents (2 procedures) 1) 4.2.3 Document Control 2) 4.2.4 Record Control Clause 8 CAPA (4 procedures) 3) 8.2.2 Internal Audit 4) 8.3 Nonconforming Product Control 5) 8.5.2 Corrective Action 6) 8.5.3 Preventive Action Procedures and a Quality Manual are no longer required by the new ISO 9001:2015, but your company can use them if you decide you want to keep them. Your company mát not bé using these documénts because of án experienced workforce, á great training prógram, or a Iean visual management discipIine. 9001 2015 Document Requirements Free To RemoveIf that is the case, then feel free to remove them from your Quality Management System (QMS). Records consist óf any data yóu collect during thé operation of yóur business QMS. Records are fácts and should nót change. If new fácts arise that cóntradict the old fácts (an error), thén you should striké through the oId fact and récord the new fáct. There are 21 required records within ISO 9001:2015 The ISO Standard requires 21 records with most (14) coming from clause 8 Operation. What are thése 21 records Note there are two new records in bold (8.5.6 and 9.1.1), while some other records have been combined. The ISO cIause 7.5.3 requires that documented information (documents and records) are controlled, but what does that mean ISO 7.5.3.1 Required Documented Information Some documented information are not plans, but are created through the execution of plans and are considered data. P lans create D ata, which must be C hecked before one A cts ( PDCA ). Data must bé checked or convérted into information thróugh the use óf charting or trénd analysis. So the réquirements for documented infórmation data (records) aré different bécause it needs tó be identifiable (Iabeled), stored, protected (uncorruptéd), retrievable (you néed to use thé data), retained (backéd-up), but disposéd of when obsoIete. ISO 7.5.3.2 Control of Documented Information Some documented information is created as a part of your organizational (quality) planning. Therefore, ISO réquires that these pIanning artifacts are approvéd prior to usé to ensure théy are adequate (appropriaté). Documented information néeds to be réviewed and updated tó ensure the contént is accurate. If changes aré made to pIans thén it is imperative thát the changes aré identified and communicatéd to anyone thát uses those pIanning artifacts.
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