ISO Compliance
The process of becoming ISO compliant begins with an Organization’s decision to adhere to a set of international quality management standards. ISO compliancy is not compulsory; however, following quality standards when developing and producing products and/or services is good for business. Staying compliant and maintaining accreditation and/or certification requires the Organization follow certain rules and regulations set out by the ISO. While ultimately the Organization is responsible for defining and enforcing quality management processes, FileHold Systems (‘FileHold’) feature-rich document and lifecycle management software can assist by efficiently monitoring, organizing, accessing and distributing artifacts in a manner consistent with ISO standards.
ISO 9001 Principles
The table shows the eight ISO 9001 Principles and discusses how FileHold features may be used to address those particular ISO points.[1]
ISO 9001 Principles |
How FileHold Can Help |
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Customer focus: Understanding the customer’s needs and providing a method for them provide feedback. |
The feature-rich workflow module, electronic forms, and Anonymous Portal, and Courier [2], allow Organizations to securely interact with their external Customers. This access makes it easy to exchange information such as surveys, checklists and other pertinent feedback information. Feedback documents can be securely stored and routed to appropriate personnel within the organization. Would you like to know more? |
Leadership: Understanding the Organization's mission. Encourage and develop a culture where employees know what to do to satisfy customers. |
Using workflow templates, managers can easily disseminate vital customer/supplier relationship information to employees. Electronic signatures can be used to verify that users have read corporate policies, mission statements, and customer satisfaction goals. Document and calendar notifications allow employers to observe customer relationship tasks to ensure employees are following relationship standards. |
Involvement of people: Ensure that everyone has and maintains skills to contribute to the company’s success. |
FileHold can be easily configured to track and retain information about employees’ training and skills. |
Process approach: use processes rather than individual tasks for better efficiency. |
FileHold can be useful in streamlining the Organization’s processes for better productivity and efficiency. Organizations can translate many of their processes into FileHold workflows, which ensure consistency and accountability. |
Systems approach to management: having consistent methods to manage tasks. |
FileHold was designed with ISO in mind. The FileHold Library may be configured for the Organization’s business models with pre-defined lexicons as required for different models. This ensures assets are tagged (classified) in a meaningful and consistent way when added or checked into the software. |
Continual improvement: make improvement an on-going objective. |
FileHold can assist Organizations by ensuring that improvement and/or enhancement requests are tracked and properly disseminated to the correct personnel. Improvement requests can come from any in form: digitized video, photos, whiteboard diagrams, sketches, Visio or PowerPoint diagrams, etc. These improvement suggestions can be routed for review and approval. A Continual Improvement schema can be implemented for working documents. Approved documents can be transferred to portal locations for viewing by appropriate audiences. |
Factual approach to decision making: make decisions based on facts. |
Using a FileHold Library to centrally manage physical as well as electronic artifacts means that users have quick access to critical information. Once the data is found, it may be saved and used for reporting. Reports may be extracted into manipulative format for further analysis and charting. |
Mutually beneficial supplier relationships: understand your suppliers so that you can better work with them. |
The anonymous portal and Courier features allows Organizations to effectively and securely share information with suppliers. This can be in the form of surveys, checklists, improvements, and other electronic forms for obtaining supplier feedback. |
ISO 17025 Elements
The five ISO 17025 elements are shown in the table below and discusses how FileHold features may be used to address those particular ISO points.
ISO 17025 Elements |
How FileHold Can Help |
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Scope: understand what equipment is involved and what the environmental conditions are. |
FileHold can be used to track the Organization’s physical (offline) and electronic assets, as well as all pertinent information about those assets. This information may be stored with relevant metadata tags that allow it to be easily and logically searched. The metadata results may also be converted into a manipulative format, such as Microsoft® Excel® for further analysis. |
Normative References: maintain documents on processes that give the most recent information about every area of the process and equipment standards. |
The robust document management capabilities allow organizations to maintain critical process documents in a secure fashion. Users have easy access to current documents and, if applicable, historical versions. The easy to use interface provides for a familiar and logical means for users search and retrieve documents. |
Terms & Definitions: Ensure that there is a mechanism to track and label equipment, instruments, workstations, employees, and a method for providing defined instructions, protocol, procedure, and safety measures. |
By using offline document schemas and relevant metadata tags, FileHold can assist in tracking physical as well as electronic artifacts. These tags may also be used to associate relevant instructions as well as for reporting. |
Management Requirements: provide document control, service to clients, contract reviews, preventative actions, internal audits, management reviews, etc. |
Enhanced workflow capabilities can be defined to automate the movement of internal and external company documents such as policies, procedures, and so on, in a secure manner. |
Technical Requirements: provide safe working conditions, functional equipment, proper calibration of devices, handling of tests and substances, result reporting etc. |
Organizations can use FileHold to securely store functional and technical requirements data, offline documents allow tracking of physical assets, and relevant metadata tagging allows for easy searching and reporting. |
[1] This document does not discuss all features available with FileHold. The extensive API allows FileHold to be customized to resolve more complex business process that cannot be done with out of the box features. Refer to the FileHold website for more information.