How to comply with Document and Records Control to Gain ISO 9001 Certification

ISO 9001 is one of the most popular and internationally acclaimed standards for quality management systems. Implementation of an effective ISO 9001 quality management system at your organization can offer you many operational and financial benefits. It is more than a mere management tool. You can use your certification to ISO 9001 as a marketing tool. It can help you promote your business and enjoy an increase in sales and market share. All these benefits are only possible if you properly execute everything related to quality management systems, including document control. Listed below are some expert tips that can help you gain ISO 9001 certification.

1. Gain a Clear Insight into Document Control

Document control assures that only authorized persons can access the current, approved version of a document while unauthorized persons should not be able to access the document. Every day, we need to deal with many documents. These documents may include forms that we fill out; guidelines that we follow; invoice templates, holiday schedules; rate sheets used to bill the customers, and many more. Even a seeming trivial mistake in any document can become a significant issue. That is why ISO has stressed document control and records.

A record is a special type of document that contains data that must be retained. Records can provide you with evidence of activities that your organization has performed. Since a record is proof of actions taken, you cannot revise the entries. There may be different requirements for different records. For instance, some records must be retained for seven years, while other must be retained for a much shorter period. In order to obtain ISO certification, your organization should formalize the specific requirements for records.

ISO 9001 provides guidelines that clearly define how you can manage your documents and records. You should know that document management is an integral part of your business management system. Therefore, as with all other clauses of the standard, you must comply with all elements in order to achieve certification.

2. ISO 9001 Documents that You Need

The ISO 9001 system has a direct impact on your entire company; hence, you need to control all the documents related to your business. You can leave the documents that don’t have any direct or indirect impact on your products or services. How much control you should exercise depends on the individual document. In this context, you should know a couple of things, such as:

• Documents must be approved before you publish them.
• Documents must be identified in some way, either a title and/or a number.
• Documents must be available to the persons that need to view or use the documents.
• Documents should have a revisions number, letter, and/or date.
• If preferred, you could consider keeping a document history.

3. Deal with Document Control Effectively

When it comes to those employees that are responsible for creating documents, or who use the documents on a regular basis, a knowledge of document control becomes important. You should make your employees aware of the rules for documentation, how to find your documents, how to determine if the documents are current and approved, and how to get a document changed and re-approved.

4. Date the Documents Properly

ISO 9001 certification procedure needs you to show the exact date when every individual document was created or updated. The date should be static and should be updated when the document is changed.

5. Control of Forms

ISO 9001 document control includes forms as well. You need to control the forms as long as it has a direct impact on your products or services. These forms start out as documents but become records when they are filled in. At this point, you should take care of the filling, storage, identification or labeling, location, retention times, and of eventual destruction. Some records require different retention times, and if so, your procedures should clearly define how long each document or document type should be retained.

6. Documentation Requirements and Descriptions

For most international management system standards, they are very specific if a procedure or record must be written. For example, ISO 9001 requires the following to be documented:

• The scope
• The quality policy
• The objectives.

Auditors will be grateful to see some kind of guide as to the naming conventions of the different kinds of documents in your organization. There can be policies, procedures, work instructions, forms, standards, guidelines, etc. The difference between the documents typically being the level of detail and its purpose.

7. Content

All documents should fit with your company requirements. They should include all the relevant content and should be written in a uniform and familiar manner. Many use a template on the internet to create a document – Beware – A template by its very nature is generic and does not necessarily fit with your requirements.

Procedures should be process oriented, I.e. they state the required steps in the order the steps must be completed. Subsequent procedures should begin where the last procedure left off.

Procedures should clearly state the expected outputs of the process and any records.

Procedures should state the roles responsible for each step.

8. Prepare for the Final Audit

Once you have successfully implemented the stages discussed above, you need to prepare yourself for the final audit. Before the final audit, you should review all the documents created in order to avoid duplication, mistakes, confusing / mixed messages, and accuracy.
Documents should address the relevant management system’s requirements also, but not just by regurgitating the standard. The standard’s requirements should be addressed in a natural way.

A Final Takeaway

Every business should understand that implementation of ISO 9001 and gaining certification is not a one-time benefit. When you prepare effective documents, you help build consistency, standardization, quality, improvement, and customer satisfaction.