What are the documentation requirements of ISO 9001?

Last Updated at: May 14, 2020
304
What are the documentation requirements of ISO 9001_

An ISO certification enhances the reputation of your service or product. There are different types of ISO certifications your business can apply for such as ISO 9001, ISO 14001, ISO 5001, etc. Each one is unique in itself. Here, we will discuss ISO 9001. Interestingly, in many cases, customers state that they will do business with only those vendors who are ISO 9001 compliant. It is the quality management standard that organizations follow to provide goods & services. The ISO 9001 allows organizations the flexibility to choose their documentation procedure, enabling them to plan effectively and efficiently and to control and organize their processes. This also helps them stay organized and on top of all their activities. Here’s a look at everything you need to know regarding the documentation requirements of the ISO 9001. 

  1. Why was the ISO 9000 revised?

  2. What is the documented information? 

  3. What are the main objectives of documented information?

  4. What are the Documentation Requirements for ISO:9001?

  5. Benefits of ISO 9001 certification

 

Why was the ISO 9000 revised?

  1. To help small, medium, and large types of organizations develop a simple set of standards
  2. Standardize the amount and detail of documentation that is required
  3. Help in organizing the documentation process of different organizations

What is documented information?

As per ISO 9000 clause 3.8., documented information helps in communicating messages and also to serve as evidence of what work has been completed. It helps organizations study what they had planned, and how much of that they were able to complete. It also serves as a channel for knowledge sharing. The type of documentation depends heavily on the organization’s nature, products, processes, and degree of formality. It also depends on the level of communication within the organization, and what its work culture is generally. Examples of documents include paper, magnetic forms, electronic media, optical computer disc, photographs, and master sample.

What are the main objectives of documented information?

  • Serves as a tool for information communication, transfer, and sharing
  • Evidence regarding work undertaken and completed
  • Disseminate knowledge within the organization
  • Used for technical specification
  • Useful when it comes to product design and development

ISO Certification

What are the Documentation Requirements for ISO:9001?

Clause 4.4- Quality management systems, better known as QMS, must maintain documented information in order to support daily operations and processes and to ensure they are completed as planned.

Clause 7.5.1- This clause explains that QMS documentation must include:

  1. a) Information required by International standard
  2. b) Information organization requires for the effectiveness of the QMS

The extent of documented information differs as per:

  • Organization’s size
  • Activities performed by the organization
  • Processes undertaken by the Organisation
  • Products and services offered by the organization
  • The complexity of  processes undertaken
  • Competence of persons involved

Get iso certification now

Documentation Requirement for QMS

  1. Clause 4.3- Scope of the QMS
  2. Clause 8.4.1- Evaluation and selection of suppliers
  3. Clause 5.2- Quality policy
  4. Clause 6.2- Quality Objectives

Documentation Required for Communication

These are examples of documents which help in adding extra value to the QMS

  • Organization charts
  • Process maps/flow charts/process descriptions
  • Procedures  
  • Work 
  • Test instructions  
  • Specifications  
  • Documents for internal communications
  • Production schedules
  • Supplier lists
  • Test and inspection plans
  • Quality plans
  • Quality manuals
  • Strategic plans
  • Forms

Documentation Requirement as Evidence or Proof

  1. Clauses 4.4- − Information necessary to ensure processes are carried out as planned 
  2. Clauses 7.1.5.1− Evidence of fitness 
  3. Clauses 7.1.5.2− Evidence for calibration and measurement
  4. Clauses 7.2- − Evidence that people in the organization are competent
  5. Clauses 8.2.3− Results of reviews and specifications of products and services
  6. Clauses 8.3.2- Records demonstrating design and development requirements
  7. Clauses 8.3.3− Records regarding design and development inputs 
  8. Clauses 8.3.4− Records of activities regarding design and development controls 
  9. Clauses 8.3.5- Records of design and development outputs
  10. Clauses 8.3.6- Changes to design and development processes
  11. Clauses 8.4.1- Records of evaluation, monitoring, and selection of activities
  12. Clauses 8.5.2− Evidence of outputs whenever traceability is required
  13. Clauses 8.5.3− Records of property lost or damaged 
  14. Clauses 8.5.6− Results regarding review of changes for production 
  15. Clauses 8.6- Records of the release of products and services 
  16. Clauses 8.7− Records of nonconformities and actions taken regarding the same
  17. Clauses 911− Results of the evaluation of the QMS 
  18. Clauses 9.2.2− Evidence related to the implementation of the audit programme 
  19. Clauses 9.3.3− Evidence regarding the results of reviews 
  20. Clauses 10.2.2− Evidence of nonconformities and results of corrective measures taken

Non-Mandatory Documents and Procedures

  • For determining context- Clauses 4.1, 4.2
  • For addressing risks and opportunities- Clause 6.1
  • Competence, training and awareness- Clauses 7.1.2, 7.2. 7.3
  • For equipment maintenance- Clause 7.1.5
  • For document control- Clause 7.5
  • Sales procedure- Clause 8.2
  • For design and development- Clause 8.3
  • For production provision- Clause 8.5
  • Warehousing procedure- Clause 8.5.4
  • For the management of nonconformities- Clauses 8.7, 10.2
  • Monitoring customer satisfaction- Clause 9.1.2
  • For internal audit- Clause 9.2
  • And, for management review- Clause 9.3

Benefits of ISO 9001 certification

  1. Implies that your products and services meet international standards
  2. Proof of protocol and discipline
  3. Helps to improve and review management processes
  4. Easier to review operational procedures
  5. More organized and controlled performance
  6. Reduces error addition
  7. Enables effective communication
  8. Benchmark for implementing new systems
  9. Achieve consistency in efforts and actions
  10. Brings in transparency

 

0

What are the documentation requirements of ISO 9001?

304

An ISO certification enhances the reputation of your service or product. There are different types of ISO certifications your business can apply for such as ISO 9001, ISO 14001, ISO 5001, etc. Each one is unique in itself. Here, we will discuss ISO 9001. Interestingly, in many cases, customers state that they will do business with only those vendors who are ISO 9001 compliant. It is the quality management standard that organizations follow to provide goods & services. The ISO 9001 allows organizations the flexibility to choose their documentation procedure, enabling them to plan effectively and efficiently and to control and organize their processes. This also helps them stay organized and on top of all their activities. Here’s a look at everything you need to know regarding the documentation requirements of the ISO 9001. 

  1. Why was the ISO 9000 revised?

  2. What is the documented information? 

  3. What are the main objectives of documented information?

  4. What are the Documentation Requirements for ISO:9001?

  5. Benefits of ISO 9001 certification

 

Why was the ISO 9000 revised?

  1. To help small, medium, and large types of organizations develop a simple set of standards
  2. Standardize the amount and detail of documentation that is required
  3. Help in organizing the documentation process of different organizations

What is documented information?

As per ISO 9000 clause 3.8., documented information helps in communicating messages and also to serve as evidence of what work has been completed. It helps organizations study what they had planned, and how much of that they were able to complete. It also serves as a channel for knowledge sharing. The type of documentation depends heavily on the organization’s nature, products, processes, and degree of formality. It also depends on the level of communication within the organization, and what its work culture is generally. Examples of documents include paper, magnetic forms, electronic media, optical computer disc, photographs, and master sample.

What are the main objectives of documented information?

  • Serves as a tool for information communication, transfer, and sharing
  • Evidence regarding work undertaken and completed
  • Disseminate knowledge within the organization
  • Used for technical specification
  • Useful when it comes to product design and development

ISO Certification

What are the Documentation Requirements for ISO:9001?

Clause 4.4- Quality management systems, better known as QMS, must maintain documented information in order to support daily operations and processes and to ensure they are completed as planned.

Clause 7.5.1- This clause explains that QMS documentation must include:

  1. a) Information required by International standard
  2. b) Information organization requires for the effectiveness of the QMS

The extent of documented information differs as per:

  • Organization’s size
  • Activities performed by the organization
  • Processes undertaken by the Organisation
  • Products and services offered by the organization
  • The complexity of  processes undertaken
  • Competence of persons involved

Get iso certification now

Documentation Requirement for QMS

  1. Clause 4.3- Scope of the QMS
  2. Clause 8.4.1- Evaluation and selection of suppliers
  3. Clause 5.2- Quality policy
  4. Clause 6.2- Quality Objectives

Documentation Required for Communication

These are examples of documents which help in adding extra value to the QMS

  • Organization charts
  • Process maps/flow charts/process descriptions
  • Procedures  
  • Work 
  • Test instructions  
  • Specifications  
  • Documents for internal communications
  • Production schedules
  • Supplier lists
  • Test and inspection plans
  • Quality plans
  • Quality manuals
  • Strategic plans
  • Forms

Documentation Requirement as Evidence or Proof

  1. Clauses 4.4- − Information necessary to ensure processes are carried out as planned 
  2. Clauses 7.1.5.1− Evidence of fitness 
  3. Clauses 7.1.5.2− Evidence for calibration and measurement
  4. Clauses 7.2- − Evidence that people in the organization are competent
  5. Clauses 8.2.3− Results of reviews and specifications of products and services
  6. Clauses 8.3.2- Records demonstrating design and development requirements
  7. Clauses 8.3.3− Records regarding design and development inputs 
  8. Clauses 8.3.4− Records of activities regarding design and development controls 
  9. Clauses 8.3.5- Records of design and development outputs
  10. Clauses 8.3.6- Changes to design and development processes
  11. Clauses 8.4.1- Records of evaluation, monitoring, and selection of activities
  12. Clauses 8.5.2− Evidence of outputs whenever traceability is required
  13. Clauses 8.5.3− Records of property lost or damaged 
  14. Clauses 8.5.6− Results regarding review of changes for production 
  15. Clauses 8.6- Records of the release of products and services 
  16. Clauses 8.7− Records of nonconformities and actions taken regarding the same
  17. Clauses 911− Results of the evaluation of the QMS 
  18. Clauses 9.2.2− Evidence related to the implementation of the audit programme 
  19. Clauses 9.3.3− Evidence regarding the results of reviews 
  20. Clauses 10.2.2− Evidence of nonconformities and results of corrective measures taken

Non-Mandatory Documents and Procedures

  • For determining context- Clauses 4.1, 4.2
  • For addressing risks and opportunities- Clause 6.1
  • Competence, training and awareness- Clauses 7.1.2, 7.2. 7.3
  • For equipment maintenance- Clause 7.1.5
  • For document control- Clause 7.5
  • Sales procedure- Clause 8.2
  • For design and development- Clause 8.3
  • For production provision- Clause 8.5
  • Warehousing procedure- Clause 8.5.4
  • For the management of nonconformities- Clauses 8.7, 10.2
  • Monitoring customer satisfaction- Clause 9.1.2
  • For internal audit- Clause 9.2
  • And, for management review- Clause 9.3

Benefits of ISO 9001 certification

  1. Implies that your products and services meet international standards
  2. Proof of protocol and discipline
  3. Helps to improve and review management processes
  4. Easier to review operational procedures
  5. More organized and controlled performance
  6. Reduces error addition
  7. Enables effective communication
  8. Benchmark for implementing new systems
  9. Achieve consistency in efforts and actions
  10. Brings in transparency

 

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Senior Executive - Content in Vakilsearch | Former TEDxSKCET Licensee | Content Marketing | Psychology | Engineering (IT) | Google Developers Group (GDG) co-organizer | WTM Ambassador