What is ISO 9001 2015 & Who Needs To Comply?
What is ISO 9001 2015?
ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). It requires that organizations control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 7.5 which says that an organization is required to: “Maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”
Who Should Use the ISO 9001:2015 Revision?
ISO 9001:2015 applies to organizations, regardless of size or industry, that want to show their ability to meet customer requirements and regulatory obligations through the development of consistent products and services.
Many benefits come from ISO 9001:2015 certification, including:
- Increase in customer satisfaction
- Increase in revenue
- Increase in efficiency
What does an organization need to do for ISO 9001:2015 records compliance?
Organizations must establish a documented procedure to:
- 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
How does LuitBiz DMS & QMS help you become ISO 9001:2015 compliant?
Clause
What it means
How LuitBiz DMS & QMS helps
§4.4
Documented information sufficient enough to provide confidence that a quality management system plan will be executed properly
Quality documents (documented statements of a quality policy and quality objectives, quality manual, documented procedures and records required by this International Standard, etc.) can be stored in LuitBiz DMS & QMS and easily retrieved with it's powerful search functionalities.
§7.1.5.1 & §7.1.5.2
Evidence that revolves around calibrating the monitoring and measuring of various resources
LuitBiz DMS & QMS allows users to store and retrieve calibration and monitoring records of various resources. Additionally, the values of these records can be tagged to the documents in LuitBiz DMS which makes their retrieval easier.
§7.2
Evidence showing the competence of a person(s) that have completed work underneath the control of the organization in charge, directly affecting the performance as well as the effectiveness of the QMS
Complete data about the persons involved in the quality process can be tagged and stored in LuitBiz DMS & QMS that can be easily retrieved
§7.5.1
Operational procedures, work instructions, flow charts, process maps, signs, placards, container markings, labels etc. are all examples of ‘documented information’. Documented information can be in any format and media and from any source.
LuitBiz DMS & QMS allows documents in any format to be stored and retrieved in the system.
§7.5.2
When creating and updating documented information the organization must ensure appropriate identification and description (e.g., a title, date, author, or reference number); format (e.g., language, software version, graphics), and media (e.g., paper, electronic); review and approval for suitability and adequacy.
Proper user ID and password administration capabilities of LuitBiz DMS & QMS ensures that all documents are uniquely identified and that their meta data is adequately collected that helps in easy retrieval of documents. Additionally, documents are stored in their original format in LuitBiz DMS.
§7.5.3
The organization must control the documented information required by the QMS that include document availability, suitability, authentication, access control, security and retention policy
LuitBiz DMS & QMS have all the tools required for controlling documents in accordance to ISO 9001:2015 Clause §7.5.3. The documents in LuitBiz DMS & QMS are encrypted using AES-256 encryption technology.
§8.2.3
Documentation must show the results of reviews, as well as the new list of requirements for products/services
LuitBiz DMS & QMS allows users to store all product/service related test results and documents in separate folders. Access to these folders can be moderated and only given to authorized personnel.
§8.3.2, §8.3.3, §8.3.4, §8.3.5 & §8.3.6
Records & Authorized changes centered around design and development
The built-in version control feature of LuitBiz DMS & QMS ensures that the correct versions of the design and development documents and quality forms are available. LuitBiz DMS provides complete audit trail of the documents, who has performed what operation on the document and when. In LuitBiz document and form approval steps can be designed to support business requirements. Documents are routed and email notifications are sent informing people of their tasks in review, acceptance and sign-off with electronic signature. As files are electronically routed, all approval actions are recorded in the system. Routing is configured to automate tasks based on approval status.
§8.5.2
Evidence that identifies the outputs when traceability is a requirement and ensuring that records are available and suitable for use, where and when it is needed. Records must is adequately protected from loss of confidentiality, improper use, or loss of integrity.
LuitBiz DMS & QMS helps ensure control of all policies, procedures, work instructions, forms, specifications, and other company documents affecting quality or customer satisfaction through user/group based access control, folder-based security and instant email alerts.
§8.5.6
Information including the results of a review as well as suggested actions/changes in both the production and service provision. This documentation also includes a list of those who authorize such changes
LuitBiz DMS & QMS allows group leaders to design workflow templates that can be attached to documents that need review. The authorized persons can review and take actions on the documents and also sign off on them with their password protected electronic signature.
§8.7
Records of all non-conformities, as well as concessions that were obtained. Also included in this is the identification of authority that decides what action will take place as a result of non-conformity
LuitBiz DMS & QMS allows the admin user to maintain nonconformity logs and the corrected action taken ensuring conformity with ISO 9001:2015 standards.
§10.2
Evidence that is based on the nonconformities’ nature, as well as corrective actions that need to be taken. There must also be documentation of the results that come from these corrective actions
LuitBiz DMS & QMS allows users to document any non-conformity and corrective action taken by adding the relevant documents as "Related Documents" tp the main record. This helps in retrieving all documents from the same detail screen and prevent recurrence of nonconformities.