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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OHSAS 18001 Implementation Process Cycles

Following infographics describes how various ailments comprise during the implementation occupational health and safety management system. This image also guides user documentation process, communication requirements as well as customer focuses in organization.

occupational health and safety management system.

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

6 Mandatory Procedures for ISO 9001

The ISO 9001 there are solely 6 procedures that are mandatory, you need to ISO 9001 document these six procedures. This doesn’t mean simply will go away with just these six, the ISO 9001 procedures you wish can abundantly rely upon the scale and complexness of your organization, these six but are those that you simply should have.

What to Cover in Mandatory ISO 9001 Procedures?

iso 9001 procedures

  1. Control of Documents

A mandatory procedure to manage the approval and re-approval of procedures before issue creates as conforming that the present revision standing is displayed. To make sure that ISO 9001 documents are clean which the present versions are offered at purpose of use. To conjointly make sure that obsolete documents are controlled and documents from external parties like your customers.

  1. Control of Records

How do you maintain your records that show your product is acceptable to use, including how you identify, store and protect the records so that they can be retrieved as necessary, for the correct amount of time, and destroyed when no longer needed – but not before?

  1. Internal Audits

The ISO 9001 quality procedure to outline a planned program of audits to make sure that your processes meet each ISO 9001 documents requirements and your own requirements. conjointly for the coverage, follow up and records of those audits.

  1. Control of Non-Conforming Product

What controls are in place, and who is responsible, to make sure that a non-conforming product is not used? Are there terms that can be put in place to allow the use of non-conforming product such as Rework, Repair or Acceptance by Customer? How do you ensure that a corrected product is re-verified, and what records are kept of the process?

  1. Corrective Action

A written quality procedure to make sure that root causes of issues are known and actions taken to correct them, actions should be verified to make sure effectiveness

  1. Preventive Action

A written procedure for corrective action however the organization ought to take steps to spot prospective issues and eliminate them before an issue happens.

How ISO 9001 Impacts on Organization’s Operational Processes

A quality management system will improve a business’ operational processes and, as a result, the standard of its services. A high quality management program additionally makes clear to customers the business’ robust target quality and satisfaction. To the present finish, implementing quality management systems from the extremely revered may be a particularly sensible step for businesses in any business sector or a part of the globe.

Advantages of Quality Management System

The quality standard operative ISO 9001 facilitate to confirm that merchandise and services round the world meet expectations for quality. For businesses who implement QMS, the most advantages as delineated are the association of quality management systems to structure processes and a natural progression toward improved structure performance. Organization certified to ISO 9001 have reduced prices and augmented client satisfaction with improved product and system quality.

Implementation of Quality Management System

Once a company has chosen to use QMS operative procedures, it ought to begin to instill in its workers the Quality Management Principles. Next, the business ought to analyze the standards and conduct a spot analysis to grasp however existing processes may have to be compelled to amendment to go with 9001 Quality. Finally, the organization ought to work the adjustment of existing processes and therefore the development of latest processes to realize compliance with the 9001 quality management standards.

ISO 9001 Certification

While organizations will follow ISO 9001 procedures while not being certified, taking this extra step will facilitate raise an organization’s image and credibleness. ISO doesn’t offer certification; organizations will acquire certifications from specialized third-party auditors that verify compliance to ISO 9001. The organization will then publicize and promote its certification, at intervals tips, as a trademark of its quality commitment.

Learn more about what to document in Procedures for ISO 9001 certification.

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 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.