Guidance Check the results. The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with. Standard Operating Procedure Management and Document Control Software Facts. MasterControl Documents has been successfully implemented, validated and inspected in FDA.
Company Name/Logo P001 Document Control Procedure Document No: Page 3 of 6 Contents P001 Document Control. PURPOSE - To understand the controls used for controlling and maintaining management system documents and records at the City of Dallas. SCOPE - All documents. SOP Template and MasterControl. The standard operating procedure template is a document used to describe a standard operating procedure in an organization.
What is a Document Control Procedure? This is a mandatory procedure.
Your document control procedure must define: How you approve documents (e. How you update and re- approve amended documents computer based systems are so much easier to maintain. How you ensure that documents are available where they are needed. How you control documents of external origin.
How you prevent the inadvertent use obsolete documents obsolete- but- still- in- use is the single most common non- compliance. Document definition: a "document" is an instruction of some sort e. Sample documents: quality manual, procedures, project plans, national or international Standards (e. ISO 9. 00. 1), industry specific codes- of- practice, customer specifications, drawings, software, samples of visual standards. Learn more about the difference between Documents and Records in document control procedures.
ISO 9001:2008 Procedures » A proven, efficient system with all the necessary elements in place (ISO 9001:2008). ISO 9001-2008 PROCEDURE PROCESS OWNER Information Technology Management PROCEDURE TITLE: Control of Documents DOCUMENT NUMBER: ISO_4-23 REVISION LEVEL. Why do we need document control? A robust document control process lies at the heart of a quality management system. Resources. Msdn.msn.com; Microsoft Visual SourceSafe for Document Control in ISO 9000 Registration; You May Also Like. The Definition of Records Management.
Why do we need document control? A robust document control process lies at the heart of a quality management system; almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence.
Clause 4. 2. 3 tells us that an organization must control the documentation required by the quality management system and that a suitable document control procedure must be implemented to define the controls needed to; approve, review, update, identify changes, identify revision status and provide access. The document control procedure must clearly define the scope, purpose, method and responsibilities required to implement these parameters. In order to comply with the document control clause, it is essential that all personnel understand: what type of documents should be controlledhow this control should be exercised. To get the most out of your document control procedure it must communicate the steps necessary to ensure that staff and other users of the organisation’s documentation understand what they must do in order to manage that information effectively and efficiently. Departmental managers should always be responsible for promoting good document and record management practices in their area whilst supporting overall compliance to the document control procedure. Individuals and their line managers should be responsible for the documents and records that they create, as well as being responsible for their retention and disposal in line with legislative requirements and organisational procedures and practices. Looking for help with your document control procedure?
Control Of Records Procedure Iso 9000
Many of our ISO Templates include a Document control procedure already documented for you.- view sample document control procedure.
Control of Non- conformances. The ISO Navigator™ database hyperlinks the ISO 9. ISO 9. 00. 1 requirements; and explains them in plain English with practical guidance. ISO 9. 00. 1: Control of non- conformances 8.
No matter how you resolve a non- conformance, you must keep records of each non- conformance and how it was dealt with. By keeping records of your non- conformities and doing data analysis, it is easier to spot negative trends and examine the root cause, and eliminate the cause of your problems. This, in turn, should result in fewer defective products and more satisfied customers. Few other processes require as rigid adherence to procedures as controlling non- conforming products. There can be no room for deviation. Corrective Action. If you have manufactured a product, inspected it and found it to be out of specification, it is most likely to be deemed non- conforming product.
In some instances you will have to scrap the defective product but in other situations you may be able to do some remedial work and bring it back into specification. The re- verification after remedial work might involve testing as well as inspection. The reason is not just to verify that the defect has been removed, but also to assure that fresh defects have not been introduced by the rework. Records would be as appropriate for the re- inspection or re- testing performed. What the clause is telling us; is that the product should then be subject to further inspection to verify that it is now correct. As for records, if you documented the non- conformance there should normally be somewhere to verify that you successfully (or not) cured the problem and that it is now conforming.
Re- verification. Re- verification is equivalent to re- inspection and records could include a signature of approval or a more formal test report.
Whichever format is chosen, it must defined in your control of non- conformances procedure. Re- verification simply means that you cannot assume that because someone tells you they have corrected the problem then it is ok. The clause is asking you to re- verify by whatever means you originally chose. If you used inspection as a method of verification then re- inspect in the same method. If not, use whatever method suits you (or your customer). Just make sure it is ok before it leaves! NCR documentation.
You may need to supply new evidence of conformance to your customer along with any corrective/preventive action documentation if requested. The method that you use in either of these situations should be defined in your QMS and procedures, that way you relieve yourself and your auditor from guessing how you would address them. Controlling non- conformances applies to services just as much as it does to tangible goods. Reports, data, test results and intellectual property, to name just a few service outputs, can all be potentially non- conforming, in which case all the disciplines of this process apply. Non- conformance procedure.
The controls and related responsibilities and authorities for dealing with non- conforming product should be defined in your control of non- conforming product procedure: Develop a procedure to control non- conforming products Define how non- conforming products are identified Define how non- conforming products are dealt with Remove or correcting non- conformities Prevent the delivery or use of non- conforming products Verify how non- conforming products were corrected Provide evidence that corrected product(s) now conform Keep records that catalogue non- conforming products. Looking for ISO 9.
Our quality manual template provides a great foundation for establishing, implementing and documenting the six mandatory procedures that are required by the standard.