Risk Assessment

Last week’s blog addressed risk management.  This week I will address risk assessments. When addressing risk, your company may have anywhere from no problems to lots of problems.  It is risky to not perform frequent assessments.  If you don’t perform risk assessments, how will you know if you have problems? Your procedure may look like…

Risk Management is new to ISO9001

Risk management isn’t just about people getting injured.  There are many facets to risk management. They extend from making sure that your company stays in business to avoiding costly errors in process or in deeds.  Let’s look at the flood potential in Houston for an example. Likelihood of flooding in Houston There is some flooding…

ISO9001-2015 is about your Customer

Customer Satisfaction ISO9001-2015 is not just about quality management, it is about your company meeting its customer’s requirements.  ISO certification shows that your company is focused on improving its business practices and its customer satisfaction.  ISO certification should improve business for several reasons: Improved quality will increase demand for your product or service ISO certified…

ISO9001-2015 Preparation

As I am working through creating a quality manual with a customer, I will address a few sections. One section is titled ‘understanding your organization and its context’.  In it, ISO 9001-2015 calls for a Documentation Hierarchy and it identifies 3 levels. Level 1 – The Quality Manual The top level is the quality manual…

The Quality Plan

As your company is preparing to be ISO9001 compliant, you will be preparing lots of documentation.  One of those documents will be your quality plan. While quality is your goal, you will need to create a plan that will get you there. Set some target objectives that need to be documented and understood by the…

A Benefit from ISO9001 Compliance

As you are documenting your procedures for ISO compliance, you will learn a lot. Each procedure identifies activities that need to be performed and in what order.  These will be documented as numbered steps where an activity is performed before moving to the next step. Work Instructions You will write work instructions describing how to…

ISO Compliance & Software

ISO Compliance doesn’t require the use of software.  It does require you to manage your documents and processes which can be accomplished in a paper based environment. Paper Based Compliance Document management – Documents must be stored in a secure location.  Access must be restricted by a role, title or name.  Documents must not be…