A common belief is that the standards’ requirements are satisfied if detailed procedures exist to define a system. Additionally, many managers and executives think that the ISO 9001 documented procedures for every element in the company results in better control and accountability. The nature and type of documented information that an organization needs to maintain or retain is dependent on the context and its operating environment. Although no requirements are enumerated in these standards for procedure format, more emphasis is placed on this than on the information contained within the procedures.
ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by the organization and the medium on which it is contained. ISO 9001 documentation process is the way of creating control of documents. To be able to control the usage of correct and current documents, a master list of documents is prepared. It helps in simplifying the documentation requirement and may also lead to creation of an effective cross-referencing documentation system thus further simplifying the processes.
ISO 9001:2015 requires a documented procedure for controlling a nonconforming product. The standard doesn’t describe what the documented procedure should look like, how it should be titled, or even how it should be controlled. ISO 9001 doesn’t state that a scope, purpose, reference documents section, or any other type of format is required. The documented procedure can be a flowchart, a one-page instruction sheet, or a 15-page detailed document. It’s always the company’s requirements, although some of Ready-to-use ISO 9001:2015 document packages are available in the market that helps Organizations and provide good reference material to accelerate the process.
QMS 9001 documentation provides the following benefits and objectives:
- Communication of Information – needed by the organization to plan, operate and control its processes. The type and extent of the documentation will depend on the criteria listed above, as well as the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.
- Evidence of conformity – provides evidence that what was planned and what has actually been done.
- Knowledge reservoir and sharing – to preserve and disseminate the organization’s experiences; business and technical know-how. A typical example would be a technical specification, which can be used as a base for design and development of a new product.
- Training tool – to train personnel in performing their responsibilities
- Consistency of performance – by having all personnel perform to the same method, practice or procedure
- Promote best practice – document the best way of performing activity using internal and external knowledge
ISO 13485 is an effective solution to meet the global requirements for a quality management system (QMS). The adoption of the ISO 13485 standard provides a convenient base for manufacturers to deal with rules and responsibilities and demonstrate a commitment to safety and quality of medical devices.
ISO 13485 is a stand-alone QMS standard, derived from the ISO 9000 quality management standard internationally recognized and accepted standard. ISO 13485 adapts the model based on ISO 9000 process for a regulated environment for medical device manufacturing.
Key Importance of ISO 13485:
ISO 13485 Documents are important for designers, medical device manufacturers and distributors. In addition, suppliers and service providers can improve the marketing of an organization increasingly manufacturers require certification to do business with a supplier.
When it comes to the manufacture of medical devices, patient safety depends greatly on the quality and consistency of medical products, and ensure the efficiency, control and maintenance of your quality management system is essential for customers, stakeholders, patients and users, and regulators.
The value of ISO 13485 is not only in implementation but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. In addition, it can help minimize surprises and failures that could affect patient safety and harm the reputation of a manufacturer.
The beneficial outputs of an effective ISO 13485 are as follows:
- Meaningful feedback on the effectiveness of the quality management system.
- Confidence in regulatory compliance.
- Identification of areas requiring attention.
- Confirmation that the best practice is achieved.
- Detection of areas of non-compliance and risk possible.
- Reports and certification is valuable and recognized.
The 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.
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.
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.
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 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.
The 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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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:
- Procedure for Management review
- Procedure for Document and Data Control
- Procedure for Control of records
- Procedure for Internal Audit
- Procedure for Training
- Procedure For Corrective And Preventive Action
- Procedure For Control of Monitoring And Measuring Equipments
- Procedure for Control of Monitoring of work environment
- Procedure for validation of sterilization process
- 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:
- Purchase Order
- Indent cum Incoming inspection report
- Approved Vendor list cum open purchase order
- Supplier Registration form
- Open Purchase Order
- Design And Development Plan
- Design Review Minutes Of Meeting
- Design Verification Report
- Equipment Wise preventive maintenance checkpoints
- Customer Complaint report
- Medical Practitioner Feedback Form
- 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.
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.
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