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ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented?

_Jens_

Starting to get Involved
#11
agree. Also, keep in mind there is no "one size fits all" management review process. FDA auditors, and very likely others, too, adjust their expectations towards the frequency, scope and formality of GMP-compliant management review along company- or establishment-specific factors. These factors include company size and scope, product complexity, product risk and health risks. Also, the requirement for documented inputs may be implicit. This is the case in the GMP arena. I do not know whether it is true for ISO, too.
 
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DRAMMAN

Quite Involved in Discussions
#12
Oh...absolutely. This is where the skill and experience of the auditor comes into play. An auditor who came from multi-billion dollar companies can not expect the same level of Management Review detail and evidence from a 20 person generalized machine shop. On the flip side, a multi-billion revenue Pharmaceutical company should not be allowed to pass an ISO audit with a 1 time a year 1/2 hr management review meeting with a 2 slide power point file as the evidence. Of course these things happen all the time and many of us have experienced them first hand.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#13
I have seen management review evidence ranging from basically a dinner napkin to elaborate packages of .ppt and notes. Somewhere in between lies the comfort level in your organization; without something to look at it is very difficult for me to verify things like considerations of trended data and how the inputs made it to decisions to act/not to act, follow up from previous reviews etc.

You can be sure I am looking to see every sub-clause is met, at least during certifications and recertifications. The key is not making it too difficult so it can still be value-added.
:2cents:
 
A

Al Hector

#15
The standard ISO 9001:2015 requires to "Retain documented information as evidence of the results of management reviews". Management reviews has 3 sub-clauses 9.3.1 General;9.3.2 Management review inputs and 9.3.3 Management Review Outputs. There is need to have some documented evidence regarding all 3 sub-clauses. The size of the documented information varies related to the size of the organization. It should add value to the organization and not be to over complicated, but also cannot be "verbally" because this is not an evidence.

Most of the auditors(internal and external) will give a NC if there is missing a basic documented evidence of the management review inputs.
 

Andrej

Involved In Discussions
#16
Dear All,

Maybe we should look at ISO /TS 9002:2016 to find an answer.

ISO/TS 9002:2016 has been developed to assist users to apply the quality management system requirements of ISO 9001:2015

ISO 9002 in clause 9.3.2 Management review inputs states:
»The intent of this clause is to establish the inputs that an organization needs to consider in evaluating the performance and effectiveness of the quality management system.
Management review inputs are directly related to the requirements of other clauses in ISO 9001; this includes the analysis and evaluation of data (see ISO 9001:2015, 9.1.3). The inputs should be used to determine trends in order to make decisions and take actions related to the quality management system.«

ISO 9002 in clause 9.1.3 states:
»The output from analysis and evaluation is frequently in the form of documented information such as trend analyses or reports, balanced scorecards, dashboards, and becomes an input to management review or meetings that consider the output. For this reason, it should be in a format that allows a determination to be made of whether actions are needed to improve the quality management system.«
 
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