When you apply for certification, your application rests on the long list of documents and records that share your processes, procedures, and standards. When the ISO requirements launched, it changed the documentation requirements. At the same time, it can also trip you up: you still need to document every process, procedure, and standard that you identify as necessary regardless of whether the standards explicitly name the docs.
Essentially, your organization is allowed to determine for itself just how you prefer to document your QMS as well as what you believe is the adequate amount of documentation to represent your planning. Your paperwork — not your processes per se — is at the heart of your ISO development journey. Documented information is the meaningful information and data that requires control and that your organization must maintain. The documents can refer to:. Your documented information can communicate messages, serve as evidence of implementation or share knowledge between parties.
When applying for your ISO certification, you will submit two groups of documents to the external auditor:. Ultimately, the documented information is part of the core value of the ISO It encourages you to standardize the processes you already employ and to work towards consistent data collection and data updates to core paperwork like the documents listed above. Outside of the documents listed above, your organization may choose to add documents that contribute to the value of your QMS.
Bettye Patrick. United Plating, Inc. A consultant can save you time by performing a gap analysis for you. They are well versed in all of the ISO requirements, and will help you focus in on the areas of your organization that need improvement to achieve certification. Remote analysis also available.
Find a Consultant to Help Me. ISO Requires that you maintain control of documents. Approve documents for adequacy prior to issue Review, update as necessary, and re-approve documents Identify the changes and current document revision status Make relevant documents available at points of use Ensure the documents remain legible and readily identifiable Identify external documents and control their distribution Prevent obsolete documents from unintended use Apply suitable identification if obsolete documents are retained.
Control of Records Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system. Establish a documented procedure to define the controls needed for records: Identification Storage Protection Retrieval Retention Disposition Keep records legible, readily identifiable, and retrievable.
Having It Your Way Sort Of ISO essentially allows the organization to tailor the completeness or complexity of documentation to its own situation, as long as it still achieves its overall objectives.
To prove and retain that proof that a quality process has been completed and what the results were. To retain organizational knowledge including: Processes Specifications and revisions Goals and expectations Monitoring and measuring Analysis, reviews, evaluations, and validations Terminology Decisions made Negotiations Notifications Authorizations Actions taken Assets, inventories and property management Position descriptions and qualifications So What Is Required?
ISO clause 7. Documenting important, but perhaps less critical information that supports the QMS such as process flowcharts , specific quality and operational procedures , schedules, information collection approaches i. Normally the creator s , editor s and approval team are also included as a reference for any users that have questions or need to submit changes.
Danielle Smyth is a writer and content marketer from upstate New York. She has been writing on business-related topics for nearly 10 years. Share It. Documents should be approved by a relevant team before initial issue to ensure the document is accurate.
Documents should be reviewed, updated and re-approved on a declared timeline. Each document should note the revision number and status, as well as identification of what changes were made in the last revision. Current versions of these documents should be available at their points of use, and users must be notified of updates. Documents should remain legible and readily identifiable. This normally involves a reference code or numbering system and a standard document format.
Any documents of external origin should be similarly identified, managed and controlled.
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