This can be the case for those that are not familiar with the standard, find themselves backed into a corner by a current customer or It also requires the careful and considerate oversight of your Understand how you can create your quality policy.
By Scott Dawson. February 12, Keeping your QMS Current. A cornerstone of the quality management system QMS is the control of documents. While not a particularly glamorous activity, document control is an essential preventive measure ensuring that only approved, current documentation is used throughout the organization. Inadvertent use of out-of-date documents can have significant negative consequences on quality, costs and customer satisfaction. Less is often better than more.
An ISO structure typically organizes itself into 4 levels:. This logical arrangement clarifies the authority, scope and interrelationships of each document. Lower-level documents must agree with requirements of related higher-level documents. Higher-level documents generally reference lower-level documents for easy navigation. The mixed blessing of cross-referencing It is common for companies to add multiple references to related documents within the body of their documents.
Alternatives to intra-document referencing might include:. Carefully designed document numbering systems A document master list showing parent-child relationships between documents The use of an electronic document management system that helps manage document interrelationships and provides for easy searching of document contents.
The ISO standard includes specific document control requirements that will be subject to all internal and external audits ref. Documents required by the quality management system shall be controlled. Measuring Success. How can you measure the performance of your document control process? Here are some suggested metrics: User satisfaction — Periodically survey your employees regarding the usability of your documentation.
Use the results to improve the format of your documents and training of your authors. Document errors — Track the number of document revisions due to information mistakes in your documentation. Results will often reveal weaknesses in your review and proofreading processes. Up-to-date — Count the number of document revisions or audit discrepancies stemming from a document that is out-of-date.
This will tell you whether your periodic document reviews or obsolete document provisions are effective. Documented information to 'retain' is what was previously called records. Information to 'maintain' is what was called documents. The phrase "to the extent necessary" means you get to decide what is required for your business and what documentation provides value.
This phrase appears in three places:. To work out what documentation is needed or useful for a process in your business, you might use risk based thinking, e. Where exclusions are made, claims of conformity to ISO are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. This standard is also available to be included in Standards Subscriptions. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. Subscription pricing is determined by: the specific standard s or collections of standards, the number of locations accessing the standards, and the number of employees that need access.
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