What is a document according to ISO 9001?
A document according to ISO 9001 is a "representation of information in any form that is used for communication, management or control." In other words, documents can come in many shapes and sizes, but all are intended to help an organization achieve its objectives. There are three types of documents in ISO 9001: quality manual, procedures, and records.
The quality manual is the top-level document in ISO 9001. It describes the organization's quality management system (QMS) and sets out its overall policies and objectives. The quality manual should be tailored to the specific needs of your organization, and it should be clear and concise so that everyone who needs to can understand it.
Procedures are step-by-step instructions for carrying out specific tasks or activities in the QMS. They should be tailored to the specific needs of your organization, and they should be easy to follow so that everyone who needs to can use them.
Records are documents that describe how a particular task or activity was carried out. They can help you track progress, identify problems, and verify that the QMS is working as intended. Records can come in many different formats, including electronic files, paper documents, and spreadsheets.
General documentation requirements for ISO 9001
The requirements for ISO 9001 documentation are general and straightforward. The purpose of the documentation is to provide evidence that the requirements of the quality management system (QMS) have been addressed. Documents must be accurate, concise, and easy to follow. They must also be reviewed and updated as necessary to ensure they remain current.
There are two types of documents that are typically required under ISO 9001: policy and procedure manuals, work instructions, and records. Policy and procedure manuals establish the framework of the QMS and guide on how it should be implemented. Work instructions provide specific details on how tasks should be performed, while records document the results of activities and processes.
To meet the requirements of ISO 9001, documents must be:
- Accurate: The information contained in documents must be accurate and up to date.
- Concise: Documents must be concise and easy to follow, without unnecessary detail.
- Up to Date: Documents must be reviewed and updated as necessary to ensure they remain current.
Documented quality policy and objectives:
The quality policy of a company is an important document. It specifies the objectives that the company wishes to achieve concerning quality, and it outlines the measures that will be put in place to attain these objectives. The policy is usually reviewed and updated regularly, to ensure that it accurately reflects the current state of the organization and its quality management system.
A quality policy can be beneficial for several reasons. First, it can help to ensure that everyone within the company is aware of the organization’s quality objectives and understands what is expected of them concerning quality. Second, having a quality policy in place can help to ensure that the company's quality management system is effective and efficient. Finally, a quality policy can provide a framework for monitoring and improving the quality of the products or services that the company provides.
A quality manual is a document that outlines your organization's quality management system. It should describe the policies and procedures that your organization follows to ensure that its products and services meet customer requirements and applicable regulatory requirements. The quality manual should be written in a way that is easy to understand so that it can be used as a reference by all employees.
The quality manual should be registered in the Document Control Register, which is a database of all quality-related documents. This register should include the following information for each document.
- The document titles.
- The document revision number.
- The document authors.
- The document date of issue.
- The document status (active, archived, or rescinded).
- The quality manual should be updated as necessary to reflect changes in your organization's policies and procedures.
Document control is the systematic process that ensures that all documents are identified, recorded, tracked, handled, and disposed of in a controlled manner. The goal of document control is to ensure that only authorized revisions of documents are released and that all copies of documents are consistent. To achieve these objectives, a document control register is used.
The document control register is a list or table that identifies each document and the revision level. It also includes the name of the individual who created the document, the date it was created, and the date it was last revised. In addition, the register includes the name of the individual who approved the document, the date it was approved, and any other relevant information.
A document control register is an important tool in document control because it allows organizations to track and manage revisions to documents. It also helps to ensure that only authorized revisions are released.
Explain Documents needed for effective planning, operation and control of processes in Document Control Register?
Document Control Registers are an important part of ensuring that your company has effective and well-organized documentation practices. By taking the time to list and track all the documents that your company uses, you can more easily keep track of revisions, approvals, and distribution. The following list outlines the key documents that should be included in your Document Control Register:
- Company Procedures Manual.
- Procedure Modification Log.
- Document Control Plan.
- Revision History Log.
- Controlled Copy List.
- Distribution List.
- Approval Form.
List out the benefits of Document Control Register?
Whenever an organization embarks on a new project, big or small, it is vital to put together some form of document control. This can take the form of anything from a basic Word document to a sophisticated enterprise-level content management system. The benefits of document control are many, and they include:
- Increased efficiency - When all stakeholders have access to the most recent versions of project documents, everyone can work more efficiently and avoid potential conflicts caused by misunderstanding or lack of communication.
- Improved quality - By having a controlled process for creating and editing documents, it is easier to maintain a consistent level of quality across all project materials.
- Easier collaboration - With proper document control in place, team members can easily share files and work together online or in person.
The specifics of document control will vary from project to project, but some general tips include:
- Establishing clear rules and procedures for creating, editing, and sharing documents. This will help to ensure that everyone is on the same page and that changes are made consistently.
- Having a single central location where all documents are housed. This makes it easy for team members to find what they need quickly and eliminates the risk of losing or misplacing files.
- Using version tracking software to keep track of changes made to documents. This helps to ensure accuracy and accountability, as well as allowing team members to revert to previous versions if necessary.