Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter 9

DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008

Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)

However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.

Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken

However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.

If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.


Questions

What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.