What is Requirement of ISO 13485 Documentation for Medical Devices QMS

The ISO 13485 documentation is a very easy process, if it is developed with the basic knowledge of ISO 13485 documents and medical devices in quality management system (QMS). The ISO 13485 Documentation kit include are ISO 13485 quality manual, procedures for quality management system, exhibits and SOPs, sample format and forms maintaining record,  process flow chart as well as ISO 13485 audit checklist templates written in English. Ready to use document toolkit for ISO 13485 certification is as per requirements international standard for Quality Management System in Medical devices manufacturing organizations.

ISO 13485 Manual

The 1st tier of ISO 13485 quality manual documents for requirements medical device manufacturing company is implements quality management system. This manual document includes quality policy, and organization structure and macro level system for medical devices manufacturing in QMS implementation.

ISO 13485 Procedures

ISO 13485 procedures documents which should be designed and develop quality management system for your medical devices company to meet ISO 13485 standard requirements.  The procedures documents helps to the medical devices company to make the best system and quick process improvement. List of procedures below:

  1. Procedure for Management review
  2. Procedure for Document and Data Control
  3. Procedure for Control of records
  4. Procedure for Internal Audit
  5. Procedure for Training
  6. Procedure For Corrective And Preventive Action
  7. Procedure For Control of Monitoring And Measuring Equipments
  8. Procedure for Control of Monitoring of work environment
  9. Procedure for validation of sterilization process
  10. Procedure for Monitoring and Measurement of Processes and more.

ISO 13485 Exhibits

ISO 13485 exhibits documents guidelines for training to the user to implements the process and get detailed ideas for process implementation and improvements.

  • Skill Requirements
  • Disposal of Non–conforming Products
  • Quality Plan
  • Document codification system

ISO 13485 Templates and Format

Following ISO 13485 Templates and format documents require for maintaining record as well as establish control and make system in the organization. List of format below:

  1. Purchase Order
  2. Indent cum Incoming inspection report
  3. Approved Vendor list cum open purchase order
  4. Supplier Registration form
  5. Open Purchase Order
  6. Design And Development Plan
  7. Design Review Minutes Of Meeting
  8. Design Verification Report
  9. Equipment Wise preventive maintenance checkpoints
  10. Customer Complaint report
  11. Medical Practitioner Feedback Form
  12. Validation Of Autoclave By Biological Indicator

ISO 13485 SOP (Standard Operating Procedures)

This ISO 13485 SOPs documents very helpful of any significant aspects issues in the organization. It takes care of all such issues and used as a training guide as well as to establish control and make system in the organization.

  • Measurement Of Temperature And Humidity
  • Validation of Autoclave
  • Microbial Monitoring of Production Area
  • Temperature Monitoring of Sterility Room and Microbiology Laboratory
  • Temperature & Humidity Monitoring
  • Clean Room Condition Monitoring

ISO 13485 Audit Checklist

The ISO 13485 audit checklist documents based on requirements as well as for clause wise questions and department wise question. It will be very helpful tool for the auditor to make audit questionnaire clause wise audit questionnaire while auditing and make effectiveness in auditing.

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ISO 22000 Manual and Procedures Document Templates

The ISO 22000 Documentation for food safety management system is mandatory for proper implementation of ISO 22000 procedures. We help you with preparation of your ISO 22000 Food Safety Manual, Procedures for your food safety management system. The ISO 22000 documents describe a complete, compliant ISO 22000 food safety system, tailored to be unique to your organization.

ISO 22000 Manual

The ISO 22000 Manual is the top level document in the food safety management system. It presents an overview of the processes your organization has implemented to meet the requirements of the food safety standard. Each section references the relevant procedures used to address the ISO 22000:2005 requirements.

ISO 22000 Procedures

This would be a set of professionally written ISO 22000 procedures detailing each process that your company requirements to follow to meet the requirements of the ISO 22000 international standard. These are clearly ISO 22000 food safety procedures documented, easy to follow instructions for your management, food safety leader, food safety team and all employees to follow in the day to day operation of your Food Safety Management System, complying with the requirements of ISO 22000 and FSSC 22000.

  • Procedure for Preliminary Analysis of Production Process.
  • Procedure for Pre-requisite Program
  • Procedure for Hazard Identification
  • Procedure for HACCP Plan
  • Procedure for emergency preparedness and response
  • Procedure for Product Withdrawal
  • Procedure for Management Review
  • Procedure for Document And Data Control
  • Procedure for Correction and Corrective
  • Procedure for Control Of Quality Records
  • Procedure for Internal Quality Audit
  • Procedure for Control Of Monitoring And Measuring Devices
  • Procedure for Control Of Non–Conforming Products
  • Procedure for Training

Key Components of ISO 9001 Quality Manual Templates

The Clause 4.2.2 of ISO 9001 specifies the minimum content of the ISO 9001 quality manual however it doesn’t specify the format and structure. This is a decision that has to be created by every organization throughout the look and implementation section and can often rely on the organization’s size, culture and trade. A high ISO 9001 quality manual template will facilitate by providing an elementary framework for ISO 9001 documentation however a company meets the requirements of ISO 9001. While not a template, the event of the quality manual will simply lose focus and direction.

Key Components of the ISO 9001 Quality Manual

The ISO 9001 provides guides of however organizations ought to Endeavor to fulfill client requirements and come through satisfaction by maintaining a standardized quality apply. ISO 9001 has several requirements that, once taken along, offer assurance that a system’s output can meet client necessities. Supported these elementary requirements, the QMS template should address, among others, the following:

  • How the quality system interacts with business processes
  • What the iso 9001 documentation requirements are
  • How management responsibility is manifested and communicated
  • What the organization’s quality policy is and the way it’s deployed
  • What the organization’s quality objectives area unit and the way they replicate the standard policy
  • How resources are managed
  • How management reviews are undertaken
  • How product realization results in client satisfaction
  • How product and repair provision is planned
  • How the organization collects and analyses data
  • How non-conformances are addressed
  • How corrective and preventive actions are instigated
  • How continual improvement is enforced

There is no requirements that changes to the quality manual be reviewed throughout management reviews however they are doing ought to be reviewed and approved by the relevant personnel laid out in your document management procedure.

Benefits of Using an ISO 9001 Quality Manual Template

Many organizations realize the task of implementing ISO 9001 quality system troublesome as they merely do not perceive wherever to start. A quality manual template will build it straightforward for any organization to arrange a compliant quality manual while providing the subsequent advantages:

  • Fully editable and customizable
  • Viable various to victimization consultants
  • Cost effective resolution to implementation
  • Saves personnel and resources
  • Reduce overall development time

Documentation Materials List of Environmental Management System 14001

Environmental Management System certification stipulates specific requirements and guidelines that have to be attained before implementing in your firm. One amongst these is EMS 14001 documentation material or all written materials regarding the environmental management system. Such environmental system documentation specifies what your organization intends to try while EMS certification. The Environmental System Documentation is a procedure of meeting goals and objectives. Accreting to Environmental standards guidelines, each organization should documented its policy, plans, and objectives for an environmental management program.

EMS Manual

The EMS 14001 Manual gives steering and act as reminders in closing specific task or activity. Document environmental system manual should state your organization’s environmental policies further because the description of its EMS. The Manual should relate your organization’s activities and product to its environmental management systems and the way your management intends to accomplish the requirements. The environmental manual documents additionally acts a permanent reference for your organization in maintain and implementing the environmental management systems.

Environmental Management System Procedures

EMS System Procedures merely check with however you plan to hold out an activity. EMS 14001 requirements your organization to place in writing an outline of all the processes concerned in achieving your organization’s EMS goals. This could embrace however it intends to regulate each inputs and outputs. Premium analysis cluster restricted suggests that you simply will opt for either a general or an in depth environmental procedure documents. In a very general documented procedure, you merely define your procedures in a very straightforward flow chart or diagram. An in depth EMS procedure documented would need many texts process and explaining however your organization intends to accomplish its EMS goal.

ISO 14001 Environmental Policy

Every business company or organization has set environmental standards that guide its operations towards achieving its goals and objectives. Your company should document its EMS policies. The environmental policies documents outline and description the standards your company intends to follow and abide by.

EMS 14001 Work directions

Every organization desires operational procedures to accomplish its goals and objectives. According to Global certification consultancy, your organization would requirements ISO 14001 documented work instruction that specify what’s to be done, the sequence of operation, the abilities required and relevance codes of conduct that guide the complete EMS program. Generally, your documented work instruction would come with things like pictures, diagrams, flowcharts, writings, computer operation and maintenance, further as work production.

9001 Quality Management system Documentation Structure

The ISO 9001 a standard published by the International Organization for Standardization, has the Quality Management Systems Requirements. The QMS 9001 international standard specifies four levels of QMS 9001 documentation that an organization must observe to document its quality management system. ISO 9001 documents

Quality Manual

The QMS system documentation standard prescribes the minimum requirements for the content of a quality manual. The standard recognizes that the structure and format of the manual will depend on the size, culture and complexity of the organization.

Quality Procedures

The international standard requires quality procedures for the following six tasks: control of documents, control of records, internal audit, and control of nonconforming product, corrective action and preventive action.

Work Instruction

A Work Instruction describes how to undertake a specific part of a function, or activity. It is similar to a procedure but is characterized by increased focus and further detail on a particular task. A work instruction is mandatory, and must be subordinate to a procedure.

Records

Records are a way of documenting that the policies, procedures, and work instructions have been followed. Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.