ISO9001 in 2021 Week by Week - Week 50 - 9.3 Management Review

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

9.3 Management Review

This week’s topic is near and dear to my heart.  Every business I’ve worked with has underutilized this tool.  Many companies do it simply to meet the requirement, and do not fully embrace the idea that this IS the heart and soul of a good management system (business operating system). 

“9.3.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.”  A common theme I’ve seen is that organization’s try to get away with doing this once per year and again, simply to “check the box” and meet the requirement.  The point of management review is to keep a finger on the pulse of the system and respond to its performance trends and its needs.  It’s tough to look backward a whole year and have any type of effective response plan.

“9.3.2  Management review inputs

The management review shall be planned and carried out taking into consideration:”  It’s a good idea, with a new management system, to have management review frequently (even monthly) until a routine is established.  The required inputs also need time to develop and mature.  For example, some performance metrics, once discussed, may need to be refined to satisfy everyone’s needs.

“a)  the status of actions from previous management reviews;”  If metrics are performing poorly, or previous action items are not being dealt with, management review frequency should increase until these issues are solved.

“b)  changes in external and internal issues that are relevant to the quality management system;”  This may include changes to the ISO9001 standard, for example.  Or the addition of a new customer with new requirements.  Or local or federal regulations.

“c)  information on the performance and effectiveness of the quality management system, including trends in:

1. customer satisfaction and feedback from relevant interested parties;

This should be a comprehensive feedback loop of both positive and negative feedback from customers as well as interested parties.  This should tell a story about the context of your organization – who you’re serving, how you’re doing, etc

    2. the extent to which quality objectives have been met;

Keep this simple, but also remember to tie it back to your main quality objectives.  What are your main reasons for having a quality system?  Are your objectives mentioned in your quality policy?  Be sure to report on how well you’re doing in management review.

   3.  process performance and conformity of products and services;

This is an important input to management review, in that if improvements are needed (especially where investment of money or resources is needed), this should be reported into management  review for discussion.

   4.  nonconformities and corrective actions;

Management must be kept abreast of trends in nonconformities and also how effective the corrective action activities are.  For example, if most of your corrective actions identify root causes and corrections to be “training”, there’s a good chance that the corrective action system needs improvement.  This would be because if routinely responding to all issues with giving more “training” doesn’t yield better results, more investigation would be appropriate.  Not only should management understand the individual nonconformities and corrective actions, but the overall performance of the corrective action process should also be known.

   5.  monitoring and measurement results;

Management should take a moment to understand the overall data being collected as well as the results from that data.  This is another opportunity to not only dive into individual issues or areas of interest, but also to take a step back and understand the results overall that are being achieved by each of the processes being monitored.

   6.  audit results;

The results of both internal and external audits should be reviewed regularly as these are important indicators of the effective implementation of the quality system overall.

   7.  the performance of external providers;”

Reliance on external providers introduces risk and must be carefully monitored.  Not only must your organization have systems and controls for the activities it does, but also the activities done outside of the organization.  Their affects on the products and services being offered the customer must be known.  Also, it should be broadly understood throughout the organization any external provider who underperforming, or exceeding expectation, or undergoing changes to their organization or processes.  This is all important information for people making decisions on behalf of the operations of the organization.

These are straightforward metrics the organization must address, and they usually take some discussion to develop fully so that all parties agree on the accuracy of their data sources, and the applicability to the organization.

“d)  the adequacy of resources;” 

This discussion usually results in action items assigned to make organizational changes, add resources, purchase equipment, obtain training, etc.

“e)  the effectiveness of actions taken to address risks and opportunities (see 6.1)” 

This requirement loops back to making sure the organization not only identifies its risks and opportunities, but then prioritizes actions to address them.

“f)  opportunities for improvement.” 

Most organizations use this as an opportunity to solicit input from many different areas in addition to making recommendations based on the performance metrics.  An important distinction to make in your organization is the difference between “corrective action” and “improvement”.  Sometimes the lines get blurry in this area.  If something isn’t working according to plan, or isn’t yielding it’s intended results, it requires “corrective action”.  When something is meeting expectation, but someone has a new idea to level up and make it better, only then, is it improvement.

For example, “Opportunity for Improvement = Need more internal auditors because internal audits are not being completed on time” is not appropriate.  If targets are being missed, this is a corrective action.  HOWEVER,

“Opportunity for Improvement = Need to train more internal auditors to support new initiative.  Training department would like to partner with quality department to use internal audit events as “dual purpose” additional verification of training effectiveness and employee competence” would be appropriate as an improvement project.  Provided that the current system is adequate, but an enhancement will be undertaken, that is appropriate as an improvement project.

“9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:” 

This is usually where management review breaks down, and unfortunately the organization loses out on the “good stuff” that all this effort is supposed to yield.  Many organizations “have the meeting”, but by the time all the inputs are reviewed, everyone has lost interest or gotten lost in the exercise, and the “conclusions” part is forgotten altogether.  If this is an issue in your current system, try to organize and make the meeting more efficient so that this area gets a full measure of focus.  Before the meeting wraps up, there should be a crystal clear understanding of:

“a)  opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs."

I implore you to consider rather than trying to conduct a giant management review activity with all of these required inputs and outputs, take a moment to consider what other meetings already take place and what information is routinely discussed.  As long as there is a vehicle for each of these requirements to be met and clearly understood (with documented evidence of their occurrence), a hybrid collection of topical sections of several different meetings CAN be used to comply with these requirements.  Understanding how the business really operates is key to figuring out how to pick out and answer “yes we do” to each of the requirements in this section.  But, if you can successfully do that without adding another huge meeting to your quality system, you will be a hero in your organization!

“The organization shall retain documented information as evidence of the results of management reviews.” 

Yep, there has to be documentation on this one.  The documented information should include conclusions and recommendations to address each of the outputs listed.

THIS WEEK’S HOMEWORK

Review your management system.  And in that review, it is necessary that you review not only management review, but also loop back to your organization’s context, needs of all interested parties AND the processes you identified as necessary to manage your system.  The requirements specifically reference back to those areas and the expectation is that the entire system be aligned and designed to trail back to the basic needs of the business.  And a continuous consideration of risk in these areas is expected.  Management review should be a basic business review meeting with perhaps a few inputs specific to quality.  It should not be interpreted as being its own standalone thing.

This are will probably require some significant revision, so while you’re at it, I would suggest taking the opportunity to also review your metrics, the structure and frequency of your meeting(s) and/or take the opportunity to understand where each of these issues might be being covered in other meetings that are well ingrained in your culture. 

Also, if you’re trying to get away with a once-per-year full-on review of your entire management system, I’d rethink that.  There are some things, like internal audits, corrective actions and others, that if you only look back once per year, you risk simply seeing a collapse of the system in your rearview mirror, only to have to rebuild from scratch.  This is costly, wasteful and will surely undermine the legitimacy of your quality system overall.  

And finally, get feedback from folks to see what improvements could be made to better engage everyone involved in the process.  Good luck!

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Do you need help with your Management Review process to comply with these requirements?  Connect with us today and we'll help you create a robust but simple management review process that will be easy to manage, but powerful in terms of making decisions to get maximum value from your quality management system.  

But, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE or VIRTUAL for IMPLEMENTATION of ANY or ALL ISO9001 Clauses.  We’ll lead your team and build a fully compliant foundation for your quality system so you and your team can understand the requirements and have the confidence to continue forward on your ISO9001 journey toward BETTER QUALITY.   World Class Quality, ISO9001 certification, lower costs and higher yields are just the beginning of the benefits of a robust quality system.  Connect with us today and LET'S GET STARTED!

Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

Or for targeted, personalized support and coaching, let’s partner together to talk through your issues, learn more about specific tools and applications and enrich your personal development through professional coaching.  Available weekly, monthly or whatever best suits your needs!

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