Monday, 26 July 2010

13 Step ISO 9001 Checklist

Implementing ISO 9001 can appear to be a very daunting task for companies where it's often the case that personnel don't have experience of implementing a quality management system. With this 13 step ISO 9001 Checklist, we hope to guide you through.

ISO 9001 isn't difficult to implement but rather that the quality related concepts themselves can be difficult to interpret and therefore difficult to apply in the real world. Concepts such as non-conformances and corrective action systems might seem burdensome at first but the outputs of these concepts are an invaluable source of information that should always be used to drive your corporate objectives.

Some of you might be implementing ISO 9001 in small companies and some might be implementing it in much larger companies, but, in all cases, the principal mode of implementation is identical. In other words, the application of ISO 9001 is scalable and generic; regardless of the size of the organization. The primary goal is to achieve a set of consistent processes that provide a route for enhancing customer satisfaction and to provide the necessary data for meaningful continuous improvement activities.

Begin with the assumption that you are already doing most of what ISO 9001 requires, you probably are! Many people talk about the high cost of implementing ISO 9001 but this is a false assumption. If you do it right and understand the Standard then implementation shouldn't be a problem since 75% of your quality system is already in place.

If you have the expertise in-house, and you have the time and necessary resources, you probably don't need a consultant to implement ISO 9001 - start by constructing your own ISO 9001 Checklist. If you have less resources or expertise, a good consultant can save you time and money and help you avoid any pitfalls whilst providing direction to your implementation project.

Step 1: Find out about ISO 9001:2008
Understand what ISO 9001 means for your organisation, not all requirements of the Standard will necessarily be relevant to all organisations. Under certain circumstances, an organisation may exclude themselves from some specific requirements.

Top management must provide evidence of its commitment to developing and implementing the quality management system, as well as continually improving its effectiveness.
Perform a gap analysis on your existing systems and develop your project plan based on the results of the gap analysis.

Step 2: Top Management to Define the Quality Policy
The only definition of quality that counts is the one which Top Management are in agreement. Clearly if you have a definition that clashes with what your customers, your suppliers, your partners believe, that would be a problem. So you will no doubt listen carefully to these stakeholders before you decide, but the decision is yours.

Step 3: Define your Processes
The process approach promoted by ISO 9001 systematically identifies and manages the processes and their interaction within a quality management system.

Step 4: Select internal auditors
Internal auditors should be chosen from within your organization, they must be impartial, inquisitive and open-minded. It is helpful to provide them with an ISO 9001 Checklist.

Step 5: Train Internal Auditors
They need to understand how the new clause structure and requirements will affect their audit plans. Instead of auditing by clause, your organisation may decide to audit by functional area, either way, you should develop an internal audit schedule and review the progress against your plan.

Step 6: Implement Management Systems
Monitor and measure process performance and start internal auditing. Typically, the auditors should undertake at least one internal audit covering all elements of the quality system which must be followed up by a management review. This enables you to identify non-conformances and to implement corrective actions prior to formal assessment.

Step 7: Select Certification Body
Agree the scope of registration and pay fees and continue the implementation plan and ISO 9001 Checklist.

Step 8: Continue the Implementation Plan
Make any necessary changes, from 7, above. Most certification bodies wish to see at least 3 months of records.

Step 9: Management Review
This review generates decisions on key matters such as process improvement, corrective actions and non-conformances that are discovered during the internal audit process from step 6.

Step 10: Implement any System Changes
Implement any changes to the quality management system that might have arisen from the outputs of previous steps.

Step 11: Certification Body Preliminaries
This a desk-based exercise, carried out by the Certification Auditors. The audit is restricted to the quality manual and related systems and its aim is to ensure that the documentation addresses the requirements of ISO 9001.

Step 12: Certification Day
The emphasis here is placed on finding objective evidence that demonstrates your quality management system has been implemented effectively and that it complies with the Standard.

The first areas generally scrutinised are management commitment (e.g. quality policy, objectives and communication), management reviews, corrective actions taken, continual improvement and changes made as the result of the pre-assessment audit.

Make sure you understand and agree any non-conformances or observations. If not, ask for a second opinion.

Step 13: Maintain and Improve Your Quality Management System
The aim of your continual improvement program is to proactively increase the odds of satisfying your customers.

We're here to help
We hope that with this 13 step ISO 9001 Checklist you can avoid complicating an otherwise simple tool. Only by ensuring a minimal amount of time is spent on administrative tasks, can the true power of your quality system deliver real business benefits. For a more complete ISO 9001 Project Plan, please see:

To learn more please visit ISO 9001 Checklist.