ISO 20000 Audit Checklists

ISO 20000 audit checklistThe ISO 20000 audit checklist was developed as per global international standard for information technology service management. The international standard additionally reviews style and development specifications for implementing objectives to fulfill business and client requirements. The ISO 20000 checklist is employed as a suggestion to review sections starting from quality management to management responsibility.

Quality Management

The Quality management documents however the organization was created, with methods toward implementing a high quality management system. The audit checklist includes many paragraphs about documentation requirements of company and operational policies, institution of a high quality manual and policy statements, and designing quality management review procedures.

Resource Management

The resource management section of ISO 20000 addresses the availability of human and physical resources. Competency, awareness and training requirements are reviewed at the side of infrastructure, instrumentality and different support services. Work environments are reviewed and analyzed for worker and products support.

Product Realization

This section analyzes the creation and producing of a product in regard to established quality management system pointers. Checklist sections embody things about product ISO 20000 documentation, inspection, costs, client demand and style and development designing. Supplying operations referring to buying and distribution of the merchandise are analyzed.

Management Responsibility

Management responsibility of ISO 20000 includes communication the quality management and processes throughout the organization. Management’s role is to incorporate inside its quality commitment, audit procedures, management reviews and preventive actions to eliminate fraud and waste throughout the organization.

FSSC 22000 Audit Checklist Requirements for Food Safety System Certification

fssc 22000 audit checklistThe FSSC 22000 Audit Checklist required to verifying implemented Food Safety System against FSSC 22000 standard requirements. The audit checklist for FSSC 22000 is also useful to FSSC22000 consultant and while implementation of food safety system and auditing it accurately. The audit checklist designed for FSSC 22000 certification should be prepared in local language that all technical and management staff can understand and accordingly check their gap analysis for FSSC 22000 internal audits.

The FSSC 22000 checklist templates documents designed by Global Certification Consultant is very good tool for the auditors to make FSSC 22000 internal auditing of Food Safety System effective. The FSSC22000 audit checklists documents offered with more than 900 audit questions based on requirements of FSSC 22000 standard. The FSSC 22000 Documentation Kit includes manual, procedures, SOPs, templates etc. along with audit checklists written in English and Microsoft Word format, which are easy customize, user friendly and quick learning process. It can be purchase online and download softcopy via secure online transaction, so any organization can prepare quick documentation and won FSSC 22000 certification in quick time.

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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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How ISO 27001 Checklists Makes Effective ISMS Implementation

The ISO 27001 checklist helps IT organizations develop and maintain an information security program which will forestall info leaks and different information security breaches. The audit checklist covers an array of legal, physical and technical management measures that vary from classifying sensitive information to blackball entry by individuals with malicious intent.

The ISO 27001 audit checklist is to be synchronizing whether or not an organization has an information system security program that’s approved by the management and communicated to all or any company staff. Management has to state its commitment to security and also the organization’s approach to managing info security. The policy should be reviewed at intervals. This can be to confirm continued stability, sufficiency and effectiveness of information system technology.

Information Security Management

Information security activities should be managed by representatives from varied company departments. The organization’s want for confidentiality or non-disclosure agreements should be clearly outlined and often reviewed. Staff should perceive that violation of the non-disclosure agreement has consequences. For such management job of maintaining and verifying ISMS, readymade documents of ISMS checklists are available on websites that helps them to conjointly establish risks free environment to information before granting access to external parties. There are many key objectives of such highly technical ISO checklists that help to make effective Information security management system implementation. Management leaders should be checked and enforced before access is granted to any information stored in Organization’s data. The audit checklist for ISMS also guides them to manage Information that should even be classified in terms of its price and sensitivity to the corporate.

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.