In God we trust! all others require a review.

In a direct association to the documents control, we will deal now with the records control requirements. The ISO 9001 Standard requires a definition of what records we must preserve as part of our quality system in order to realize our product.

TYPES OF RECORDS

If you would brows your records I believe that you might be able categorize them according to the next division (more or less):

• Quality guide and policy
• Quality procedures – documents describing the procedures within the quality management system.
• Process diagrams, procedures and work instructions - a definite method to perform activity or a process.
• Specifications – documents that specify requirements for product realization.
• Quality plans – documents which define the procedures and resources required to accomplish a project, a product a process or an agreement.
• A record – a document that declares results or present evidence for activities taken.

The level of documnetation is specified with the next pyramid:

A tip: This pyramid was made with Smart Draw software. Now we know it is not the perfect pyramid that you ever laid your eyes on, but it took us just five minutes to do it. When you need to document your organization's QMS - it sometimes takes hours with the conventional tool (MS tools - including Visio). We know because we have been there. This software is really making our quality managers life much easier. Give it a try. They have a free trial: Smartdraw.com 

Back to business,

A SHORT EXPLANATION ABOUT THE RELATION BETWEEN RECORDS AND THE QUALITY SYSTEM

Why is it so important to define which records to control? Let's presume that tomorrow's morning one of your customers will complain about a product he purchased or service that you provided - not so far away from reality. In order to examine if he is right or not, you must approach your records and investigate.
The documentation is our statement of defense. Let's wish that we would never have to use it. But still, if tomorrow morning we find ourselves in an organizational trouble or if any question arises, the documentation would be our savior.
But how on earth, from all the documentations that lay around the organization, we would know what is relevant to our quality management system? Well, the relation can be measured in various levels:

1. First, you must distinguish whether the document takes part within the product realization process. If there are records in the organization that do not take part in the product realization process – they are not considered as part of the quality management system. Plain as that.
2. Whether the document provides any aspect of product (or service) designing, developing or planning - it is part of the quality management system. For example – specifications, plans and product portfolio. These are quality plans. A record which defines the procedures and resources required to accomplish a project, a product, a process or an agreement. It defines also when it would be done and by whom.
3. A documentation of a working process. For example – measurements form a production line or a review form after an equipment installation. The ISO 9001 Standard does not require preservation of all forms or records but it is recommended to examine for every record of any working process, if recording and saving it would bring added value to your organization. Again, you must not preserve any form, but think twice before you dismiss any record.
4. The record provides evidence for a requirement. Every record that documented a performance for a requirement. In other words evidence for achieving the quality plans. 

1. A legible documentation – that it would be possible to read the information recorded at any time.
2. Identification of records – that it would be possible to attribute a record to its origins. How to attribute? It depends on your organization.
3. Retrieval of records – that it would be possible to trace any record at any given moment. That means to preserve the record. Preservation time is determined according to customer requirements or legal requirements. In any case it would be preserved for a minimum of one year time.

The ISO 9001 Standard requires that all the definitions above would be documented within a written procedure. Again, this is not a recommendation but a requirement. You must maintain a written procedure to define what records are included within your quality system.

All these requirements can be hard to handle in large organizations where a large number of employees are using or documents or when there is a large number of documents at hand. As if it is not complicated enough, the ISO 9001 Standard requires that you would document some of his requirements. Say what? Yes. The Standard has some requirements that must be documented. You must maintain records for these requirements: you must plan, maintain, fill out, and preserve (not in this order). Which requirements?
I will make a list but before that I would like to give a tip: if you would brows through the ISO 9001 Standard you would notice a note that repeats constantly: see 4.2.4
This note actually directs you to paragraph 4.2.4 within the standard: Control of records. Still obscured? Any paragraph that ends with that note means that you must maintain a record of this specific requirement. Go brows.
But like I promised I would try to make it easier on you and make a list of all requirements for records:

• Management review must be recorded – paragraph 5.6
• Employees appropriate education training and skills must be recorded – paragraph 6.2.2
• Product realization planning must be recorded – paragraph 7.1
• Review of requirements related to product Record – paragraph 7.2.2
• Design and development inputs must be recorded – paragraph 7.3.2
• Design and development review must be recorded - paragraph 7.3.4
• Design and development verification must be recorded – paragraph 7.3.5
• Design and development validation must be recorded – paragraph 7.3.6
• Design and development change control must be recorded – paragraph 7.3.7
• Suppliers evaluation results must be recorded – paragraph 7.4.1
• Validation of process must be recorded – paragraph 7.5.2
• Identification and traceability of products or service provision must be recorded – paragraph 7.5.3
• Customer notifications regarding his property must be recorded – paragraph 7.5.4
• The control of Monitoring and measurements devices must be recorded – paragraph 7.6
• A method for conducting Internal audits must be recorded – paragraph 8.2.2
• The results of internal audits must be recorded – paragraph 8.2.2
• Monitoring and measurement of product (or service) must be recorded – paragraph 8.2.4
• Evidence for nonconforming products and actions taken to eliminate must be recorded – paragraph 8.3
• Evidence for corrective actions taken must be recorded – paragraph 8.5.2.
• Evidence for preventive actions taken must be recorded – paragraph 8.5.3 

Yes folks, for any processes of the above (assuming that the process refer to your organization and its activities), you must maintain a record. No one said the ISO is easy..

SUMMARY:

• The ISO 9001 Standard require that we define which records we must preserve as part of our quality system.
• We must define what are the documents included within the quality management system and how we would behave with them during the processes.
• Quality records include: Process diagrams, procedures and work instructions, documents describing the quality management system, Specifications, Quality plans and results or evidences for activities taken.
• The relation between a record and the quality management system is measured in various levels.
• Any record must be maintained according to the ISO 9001 Standard: legible, identified and retrievable.
• You must maintain a written procedure to define which records are to preserve and how.
• The ISO 9001 Standard requires records of some of its requirements. You must maintain records for these requirements. In fact, any paragraph that ends with the note - see 4.2.4 - this is a process that must be recorded.

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