The Final Steps in Achieving ISO 9001 Certification

Implementing a Quality Management System (QMS) that complies with ISO 9001 requirements can be challenging.  That’s why a useful approach may be to implement the QMS in phases, where you focus on different elements of meeting the ISO 9001 Standard in progressive stages.  So far, in this series, we have covered meeting the requirements of ISO 9001 Clauses 4, 5, 6, and 8 during the first three phases.  Now we will cover the final phase and discuss complying with the requirements for Clause 7.

Get a Handle on Your ISO 9001 Required Records

Clause 7 “Product Realization” (recall that we can substitute “service” anywhere the word “product” occurs) covers the spectrum from product development (literally from the moment an order is taken or a product conceived) until the product is shipped to the customer.

Besides understanding and complying with the “shall statements” in Clause 7 (as we discussed for Clause 5 and Clause 6), a key element to complying with ISO 9001 Clause 7 is getting a handle on the required records.  A lion’s share of the ISO 9001 required records (14 of 21) come from Clause 7.  These include

• Clause 7.1 Planning of Product Realization – 1 record
• Clause 7.2 Customer Related Processes – 1 record
• Clause 7.3 Design and Development – 5 records
• Clause 7.4 Purchasing – 1 record
• Clause 7.5 Production and Service Provision – 3 records
• Clause 7.6 Control of Monitoring and Measuring Equipment – 3 records

Some organizations seem to struggle with all the required realization records.  For example, I recently worked with a company that took great effort and pride in their meticulous record keeping.  The problem was, however, that they did not understand how the records they kept met the record requirements of the ISO 9001 QMS.

As you create a QMS to comply with Clause 7, there are two things to always keep in mind:

1)  What do I need to do to comply with the requirements?
2)  How can keeping these records help my organization?

In order to comply, particularly in terms of records, an organization has to reflect on the specific requirements listed, as well as on how this record fits in with the unique ways each organization fulfills product realization.  Ensuring you comply with the spirit and letter of the ISO 9001 Standard will require taking some time to understand the requirements and to reflect on your realization processes.

Understand Specific ISO 9001 Requirements for Records

As we know, the ISO 9001 QMS requirements are not very detailed or specific when it comes to record keeping.  It is this generic approach that gives ISO 9001 the flexibility to be applied to disparate organizations.  So each organization can define exactly what form the records will take, and what kind of information will be collected.

But there are some specifics associated with each record that one must be aware of in order to comply with ISO 9001 requirements.  For example, Clause 7.3.4 states specifically that the design and development review records shall contain the results of the reviews and any necessary actions.  So, early in the effort to create records to comply with Clause 7, an organization must have a clear picture of what records are needed and what specifically must be included in the record.

Using ISO 9001 Records for Continual Improvement

While compliance is important, the whole goal of implementing ISO 9001 is to improve as an organization.  So how you use the records to help the organization improve is equally important.  The point of keeping records is not because ISO says we need to, or even because auditors want to see them (though it does, and they will…).   In several places of the ISO 9001 QMS requirements (i.e. Clause 4.1e) the standard requires organizations to monitor, measure, and analyze processes.  Records play an important role in that they are used to capture data and information about processes that are used for monitoring, measuring, and analyzing.

This is what record keeping is really about.  Using them to understand your processes and learn ways to improve.  Are we capturing the customer requirements properly and avoiding rework, scrap, and other waste?  Are design reviews generating actions that improve the product and meet requirements?  Are design projects on schedule and budget or do they consistently suffer from scope creep or delays?  Are process objectives being met?

Employ the ISO 9001 Process Approach

One useful way to get a handle on realization records is to consider product realization as a set of processes, and then identify where, as part of the process, a record is generated and what record requirement is fulfilled.  Ideally, realization processes, like all processes, should have key objectives established that measure effectiveness.  The goal should be to collect information in the records that relates to process effectiveness.

Your ISO records should tell you a lot about how effective your processes are operating.  If they don’t, then perhaps you are meeting bare minimum ISO requirements by generating the record, but you’re not meeting the spirit of the ISO standard by using the QMS for continual improvement.  And the continual improvement philosophy applies to the records themselves.  If you find that you are not getting useful information from your records, then change what you are doing.

Try to Simplify ISO Compliance

With so many required records from Clause 7, it also important to look for ways to streamline and simplify the record keeping.  Do you need 14 different forms?  For example, perhaps a general form can be used for all the design and development records.  For the calibrations records, it may be easier to track the calibration of monitoring and measuring equipment electronically in a database or spreadsheet instead of on paper.

As always, the best approach is to start simple and build on it as you identify needs and areas for improvement.  It is easier to build on a basic, simple system than it is to strip unnecessary elements from an overly complex system.

Using and Auditing ISO 9001 QMS

Now we have covered all the clauses of the ISO 9001 QMS that have requirements.  If you build your ISO compliant QMS in phases over a period of time it becomes less daunting.  Obviously, we could not cover all the elements of compliance, but hopefully we have delineated a path to compliance in manageable steps.

If you recall, earlier we only created drafts of some system procedures.  As you use and review your system, you should get the procedures in finalized forms and release them into document control.  To verify and improve the QMS you should regularly audit it (including records, documents, and improvement activity).  But the most important thing you can do with you ISO 9001 QMS is use it.  Communicate the QMS to the staff; involve them with reviewing procedures, keeping records, and conducting process reviews.  Develop an internal auditing staff who understands the requirements and the organizational goals in employing ISO 9901.

Once you feel comfortable that your ISO Quality Management System is operating and functional, you are ready to contact an ISO 9001 Registrar and set up an audit for certification.  If you need help building your ISO 9001 QMS, we have products and consulting services that can help.  We also offer public and on-site ISO 9001 Internal Auditing classes that can help get the most out of your continual improvement efforts.

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Posted on Monday, March 23rd, 2009 under ISO Quality Management

Licensed under a Creative Commons Attribution 3.0 United States License.

Originally published by Bizmanualz, Inc. under the title The Final Steps in Achieving ISO 9001 Certification.

This and more articles like this can be found at www.bizmanualz.com. This article may be reprinted freely as long as this resource box is left intact.