Importance of ISO 9001 Documents for any Organization

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 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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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.

Requirements of OHSAS 18001 Health and Safety Documents and Sample Forms

The OHSAS 18001 health and safety documents will vary relying of the character and scope of a company’s activity and business, however there are general documents of this kind that need to be ready. To be in conformity with all the relevant laws and rules, such health & safety documents need to be ready by skilled specialists within the legal space.

The OHSAS 18001 health & safety documents and forms that an organization has got to ought to embody the emergency action procedures made public thoroughly, also as an evacuation decide to air the prepared within the event of emergencies thanks to accidents or to natural disasters like earthquakes, floods, etc.

When the corporate uses machinery, the health and safety documents to be ready during this respect comprise the machinery examination and repair logs and documents that area unit proof that the machinery is inspected and repaired as often as necessary and meets the safety requirements for the precise surroundings and activities.

When the corporate uses substances like chemicals and solvents that carry hazards for the health and safety of the staff, the health and safety documents and forms ought to embody an inventory of all the dangerous substances chemicals, solvents, etc. There ought to even be documents that contain directions for the staff that have to work with such dangerous substances throughout the implementation of their duties.

An important a part of the cluster of documents concerning health and safety is that the cluster of reports that area unit proof of presidency and relevant authority’s inspections disbursed. Inspections by the govt. and also the several authorities usually embody the examination of sanitation, the hearth safety conditions, the structural safety of the work surroundings – the premises and buildings and structures, the environmental compliance, also as alternative reports as acceptable for the several scope of business of the precise company.

The OHSAS Health & Safety documentation associated with health and safety may vary counting on the age and standing of the staff of the precise company. There will be additional careful, completely different or supplementary documents and forms concerning workers are young staff, or adolescents are below fifteen years previous. There will be conjointly specific health and safety documents and forms once employers have interaction subcontractors, volunteers, or people that are undergoing on the task coaching. The accident and injury documentation is another part of the documentation concerning health and safety standard: it includes documents that area unit associated with the health and safety of the staff of a selected company.

The importance of the relevant health and safety documents and forms is high, as a result of with the help of such sets of documents entailed by skilled lawyers in conformity with all the applicable laws and rules employers will make sure the safe and healthy surroundings within the geographical point. the provision of such documentation that ensures that everyone the staff are properly schooled and every one the machinery and instrumentality area unit often repaired may be a guarantee that the required measures are taken and area unit taken to avoid grave and expensive accidents. With the help of such documentation employers will make sure the higher retention of employees and to extend the productivity and potency within the geographical point.