As the new ISO 9000 standard draws near to publication companies are likely to become increasingly interested in how the proposed changes are likely to affect them. In order to assist companies determine the likely impact Statius has developed a series of three papers.
The objective of this paper is to:
The other two papers support this paper and others wishing to know more about the proposed changes, they are:
The notes in this paper have therefore been created as a document to generate discussion around the following draft standards:
They are not meant to be an exhaustive explanation of the draft standards, should this be required it would be better to read the actual standard or the guidance notes themselves.
The layout of this paper takes the numbering systems from the draft standard as it’s guide. All the headings and numbering sequences from the standard have been reproduced, however in some instances these headings have no further notes beneath them, where this is the case the changes between the existing standard and the current draft are deemed to be non existent or inconsequential.
Quality requirements: Relate to how a process or activity is performed
Quality objectives:Relate to the output or achievement of the process or activity
The organisation needs to identify the key processes in the quality management system. These should then be listed in the quality policy manual and as an index.
The organisation then needs to determine the indicators that they wish to use to demonstrate performance improvement. These indicators and the controls that are in place to take action given over, or under, performance should also be documented. Measures and targets might include:
Documentation may be "in any form or media suitable" for the needs of the organisation.
The quality system shall include:
Management responsibility includes:
The organisation will require a document outlining its business plan and objectives. A procedure may also be required to describe the business planning and objective setting process.
Consideration should be given to:
Clients need to demonstrate commitment to the improvement of the system
This might be shown via:
To define customer and end user needs an organisation should:
Links to business planning process and procedure
Links to business planning process and procedure
Links to business planning process and procedure
Quality planning is now linked to the (quality) objectives of the company.
Quality planning has a much wider implication than has previously been the case and links to the improvement of the quality system not just the plan for a specific order. The new measurement and improvement activities and procedures could deal with this clause.
This links with business planning procedures as the quality management system should address strategic objectives.
The goal of the appointment is to enhance effective and efficient operation of the system. It might be useful to update the persons job description with a statement to this effect.
A procedure needs to describe how communications are managed. Examples might include:
A record probably needs to be introduced that logs:
Procedures need to be updated to include inputs from:
The output should be set in the context of the strategic planning cycle, and should focus on:
The people management processes need to be developed to include:
Processes need to be developed to include:
Training plans should include:
It probably make sense to merge a facilities procedure with "measuring and monitoring
devices@quot; calling it something like "facilities and infrastructure".
The current plant and equipment procedures being decanted into the new "facilities and
infrastructure" procedure.
It might be useful to address work environment as part of the above procedure.
This section is essentially the core of the new "process approach" and as such the
new standard has effectively adopted the traditional "Statius Way" of viewing
organisational processes.
It is however, probably, the second most important change to the standard, so should be read
in detail.
Very briefly a "process" may be viewed as consisting of three components, an input,
the actual process or activity of work itself and the result of that work - the output.
This is represented diagrammatically below.
This idea can be developed further so that the process of "running the business" becomes an ever smaller set of processes as described below. Ultimately, you end up with a flowchart that takes into account the decisions and responsibilities.
The procedures should cover:
This is probably best addressed as the various activities occur as part of the day to day processes. Customer feedback might be addressed as part of "communications" procedure or as part of the customer satisfaction / measurement and monitoring procedures. The decision is likely to be depend on how the host organisation views their processes.
Essentially, no change to the current ISO 9001 requirements.
There is now a requirement to define the need for responding to "non conformance", the response being likely to vary for different types of products and the impact the non conformance is likely to have.
Essentially, no change to the current requirements.
Consideration should be given to:
This area very probably encompasses the largest fundamental change. It moves the standard from being "backward looking" and concentrating on "non conformance" to being "forward looking" and looking far more rigorously at "continuous improvement".
As part of the business planning and objective setting activities, key measures of success should have been developed. The procedure needs to describe the measurement and monitoring of these measures.
Measurement and monitoring practices are likely to be addressed in one of two places:
Again, the decision on how measurement should be addressed is likely to be highly influenced by the client organisation and the processes they are involved with.
It might be useful to introduce a matrix of measures showing:
Customer satisfaction can be measured in a number of ways, examples include:
The above list is not exhaustive. A processes does however need to be in place and a procedure needs to written to describe the process.
The internal audit requirement broadens to include the strengths and weaknesses of the management system. The draft guidance notes also suggest the use of self assessment techniques and suggest a list of useful questions which can be found in Annex A of the draft. The draft guidance notes also suggests a review of other activities and support processes in the organisation.
In addition to documenting non conformities internal auditing should also indicate areas of superior performance. Current procedures needs to be updated accordingly.
Examples of process performance include:
Process measures will need to be developed, added to the procedures and monitored accordingly
Examples of process performance indicators include:
Process measures will need to be developed, added to the procedures and monitored accordingly
Information and data should be used from all parts of the organisation to evaluate overall performance (this suggests a balanced scorecard type of approach), results being used to determine:
The organisation should define and implement a methodology for process improvement that can be applied to all processes and activities. The clause discussing the analysis of data above is likely to be the main driver for this process and as such it would seem to make sense to merge the two into once procedure which also covered corrective and preventive action.
Essentially, no change to the current requirements.
Essentially, no change to the current requirements.