The International Organization for Standardization (ISO) is an international body of experts who provide standards for a number of industries worldwide. Their focus is to produce and promote good business practices through their standards, covering everything from the food industry to chemical plants. Standardizing business practices helps ensure products meet quality standards, are consistent and that production is safe and efficient. The most well-known and widely-adopted of these standards is ISO 9000, a standard for quality control.
ISO 9000 Standards
ISO 9000 is a family of standards for Quality Management Systems (QMS) that helps organizations provide quality goods and services while following all related laws, codes and requirements necessary to their industry. ISO 9000 itself outlines the fundamentals, vocabulary and philosophy; ISO 9001 addresses the requirements a company must fulfill to comply with the standard. The ISO 9000 family can be easily applied to most businesses, regardless of industry or size.
Quality management systems focus on consistency, efficiency and improvement. They provide a set of tools for keeping a company’s processes consistent with each other. They focus on providing quality and value to the customer and helping employees find redundancies or places to change and improve their daily workload.
ISO 9001 Standards
ISO 9001 includes the requirements for controlled documents, which are at the heart of all quality management systems. Controlled documents are any sort of procedures, policies, records, etc. that have to go through a specific process to be created or modified. As per ISO 9001, there are seven controls that need to be established in order to create and manage a controlled document.
ISO Filing System
The following are ISO filing standards for documents:
- 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.
- Obsolete documents should be removed from access and easily identifiable as different from the current approved versions.
Creating ISO 9000 Procedures
These points should ensure that employees are always accessing the most current, approved version of any procedure or policy. Limiting access to writing and editing these documents is key. Normally a document controller or administrator holds this access; this person (or team) then initiates the reviews, makes the changes to the document or file and resubmits it for approval.
Reviewers in these cases should include the employees who most frequently use the document in question, as they will have the best input on what has changed since the last revision. The approval process may include the eyes of a single individual or a team who needs to review from multiple angles.
Document Naming Convention ISO 9001
Choosing a document control numbering system may seem challenging when faced with a number of different types of documents. There are no requirements in the ISO 9001 standard for document labeling, only that each document is easily identifiable.
Type of document can be differentiated by a prefix, such as SOP for a standard operating procedure, POL for a policy and so on. Numbering can be done either sequentially as created or using a numbering system in which each digit represents something. For example, SOP-1007 could mean the seventh standard operating procedure within the department designated as 1000.
Document labels should also include an easily understood title, as well as an indication of the most recent review and approval date. 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.
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