Hershal
25th February 2009, 08:55 PM
ISO/IEC 17025:2005 Clause 4.15
This is where we will begin the discussions, and this is typically where I begin an assessment. So, let's get going, and put in your thoughts, experiences, and so forth.
Management Review is - in my opinion - perhaps the single most crucial Clause in the entire Standard.
Management Review is where Management is supposed to review the activities of the accredited laboratory. The Management is supposed to review the laboratory whether the laboratory is independent, or whether the laboratory is a "captive lab" that is, part of a larger organization.
Captive labs in particular often have a challenge with Management Review as the review may be rolled into a review of the parent which the Standard does not prohibit; however if the organization registered to ISO 9001 or has no formal third party oversight at all, the agenda in Clause 4.15 is often not completely reviewed. That is typically documented as a corrective action by almost any accrediting body (AB).
Management Review is partly historical and partly future planning. Clause 4.15.1 has a prescriptive agenda. Many ABs will let the laboratory rename or combine the agenda items provided theycan see that each item is adequately addressed.
Clause 4.15.1 requires a pre-determined schedule and procedure. Often this may be as simple as mentioning an annual meeting in December (or some similar approach) for the schedule. The procedure may well be included in the quality manual but must have some detail, such as including the agenda and the schedule. A simple one-line mention is not sufficient unless it is pointing to a specific procedure where the requirements are addressed.
Management Review must also assure that the laboratory's activities which includes both quality and technical, are adequate and effective.
Clause 4.15.2 is a requirement that if any findings arise from Management Review, that the findings are documented, a time established for them to be resolved, and a follow-up that in fact they are resolved. See also Clause 4.11 (Corrective Action) for detail on the process an AB will look for.
So, what is the agenda, and what Clauses does the agenda address? I have listed that below, with the Clauses that are easily identified. It should be noted that otehr topics that are important for laboratory operations should be reviewed, even if they are not included here.
• the suitability of policies and procedures; (Clause 4.2, 4.3)
• reports from managerial and supervisory personnel
• the outcome of recent internal audits; (Clause 4.14)
• corrective and preventive actions; (Clauses 4.11, 4.12)
• assessments by external bodies;
• the results of inter-laboratory comparisons or proficiency tests; (Clause 5.9)
• changes in the volume and type of the work;
• customer feedback; (Clause 4.7.2)
• complaints; (Clause 4.8)
• Recommendations for improvement
• other relevant factors, such as quality control activities, resources and staff training)
This is where we will begin the discussions, and this is typically where I begin an assessment. So, let's get going, and put in your thoughts, experiences, and so forth.
Management Review is - in my opinion - perhaps the single most crucial Clause in the entire Standard.
Management Review is where Management is supposed to review the activities of the accredited laboratory. The Management is supposed to review the laboratory whether the laboratory is independent, or whether the laboratory is a "captive lab" that is, part of a larger organization.
Captive labs in particular often have a challenge with Management Review as the review may be rolled into a review of the parent which the Standard does not prohibit; however if the organization registered to ISO 9001 or has no formal third party oversight at all, the agenda in Clause 4.15 is often not completely reviewed. That is typically documented as a corrective action by almost any accrediting body (AB).
Management Review is partly historical and partly future planning. Clause 4.15.1 has a prescriptive agenda. Many ABs will let the laboratory rename or combine the agenda items provided theycan see that each item is adequately addressed.
Clause 4.15.1 requires a pre-determined schedule and procedure. Often this may be as simple as mentioning an annual meeting in December (or some similar approach) for the schedule. The procedure may well be included in the quality manual but must have some detail, such as including the agenda and the schedule. A simple one-line mention is not sufficient unless it is pointing to a specific procedure where the requirements are addressed.
Management Review must also assure that the laboratory's activities which includes both quality and technical, are adequate and effective.
Clause 4.15.2 is a requirement that if any findings arise from Management Review, that the findings are documented, a time established for them to be resolved, and a follow-up that in fact they are resolved. See also Clause 4.11 (Corrective Action) for detail on the process an AB will look for.
So, what is the agenda, and what Clauses does the agenda address? I have listed that below, with the Clauses that are easily identified. It should be noted that otehr topics that are important for laboratory operations should be reviewed, even if they are not included here.
• the suitability of policies and procedures; (Clause 4.2, 4.3)
• reports from managerial and supervisory personnel
• the outcome of recent internal audits; (Clause 4.14)
• corrective and preventive actions; (Clauses 4.11, 4.12)
• assessments by external bodies;
• the results of inter-laboratory comparisons or proficiency tests; (Clause 5.9)
• changes in the volume and type of the work;
• customer feedback; (Clause 4.7.2)
• complaints; (Clause 4.8)
• Recommendations for improvement
• other relevant factors, such as quality control activities, resources and staff training)
