ISO 9001 Document Control Checklist

Article Context:

1. ISO 9001 QMS
2. ISO 9001 Documentation Requirements

ISO 9001

ISO 9001:2015 requires a list of obligatory documents.

The QMS‘s scope will include the following:

• Policy on quality.
• Goals for quality.
• Training, skill, experience, and qualification records
• Records of product/service requirements review

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current revision state of the document. Provide relevant paperwork at sites of use. Ensure that the records are readable and easily identified. Control the dissemination of external documents by identifying them. Prevent unintentional use of obsolete documents. If old papers are kept, use appropriate identification

ISO 9001 enables an organization to adjust the documentation as applicable as long as the overall objectives are met. The change, however, does not decrease the need for accurate documentation. The standard states that “documented information” is required: When information is distributed or shared. To demonstrate (and keep proof of) the completion of a quality procedure and the outcomes.

To keep organizational knowledge such as Processes, Specifications and changes, Expectations, and goals, Monitoring, and evaluation, Analyses, reviews, assessments, validations, and Terminology Negotiations have resulted in decisions. Notifications Authorizations Taken Actions Inventory, assets, and property management Qualifications and job descriptions

ISO 9001 general documentation requirements are:-

Step 1: Obtaining leadership support

Step 2: Conduct a Gap Analysis

Step 3: Define the scope

Step 4: Put the QMS into action and write the QMS manual.

Step 5: Communicate internally

Step 6: Develop an audit strategy.

Step 7: Determine your roles and duties.

Step 8: Fine-tune the QMS and put system modifications in place.

Step 9: Internal audit.

Step 10: Apply for Stage 1 Audit.

Step 11: External auditing

Step 12: Passing the Audit

Document control processes help to understand how an organization maintains documents that may include approved documents, updated or corrected ones, and how changes are tracked. In addition, the process helps keep track of how documents are published for internal or external purposes.

Quality policy and objectives are documented.

ISO establishes the quality policy requirements and mandates documented quality policy. It also specifies the standards for quality goals. Here is a summary of ISO’s general documentation requirements:

• Policy on Quality
• Quality targets
• Quality guide
• Process flow charts
• Process maps and/or process descriptions
• Organizational diagrams
• Specifications
• Instructions for work and/or testing
• Internal communications documentation
• Production timetables
• Lists of approved suppliers
• Plans for testing and inspection
• Plans of high quality