What Are The Documentation Requirements Of ISO 9001?

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

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

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

1. Organization charts

2. Process maps/flow charts/process descriptions

3. Procedures

4. Work

5. Test instructions

6. Specifications

7. Documents for internal communications

8. Production schedules

9. Supplier lists

10. Test and inspection plans

11. Quality plans

12. Quality manuals

13. Strategic plans

14. 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

1. For determining context- Clauses 4.1, 4.2

2. For addressing risks and opportunities- Clause 6.1

3. Competence, training and awareness- Clauses 7.1.2, 7.2. 7.3

4. For equipment maintenance- Clause 7.1.5

5. For document control- Clause 7.5

6. Sales procedure- Clause 8.2

7. For design and development- Clause 8.3

8. For production provision- Clause 8.5

9. Warehousing procedure- Clause 8.5.4

10. For the management of nonconformities- Clauses 8.7, 10.2

11. Monitoring customer satisfaction- Clause 9.1.2

12. For internal audit- Clause 9.2

13. 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