ISO9001 in 2021 Week by Week - Week 8 – 5.1 Leadership and commitment

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 from our quality management systems. (As an added bonus, I’m now a member of TAG/TC176, the committee responsible for review and revision of ISO9001, which is in discussions for a 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!

This week, we’ll continue with the top-level management and strategic planning theme.  Note, that we are 8 weeks into studying ISO9001 and we are still laying foundational groundwork as we would do with a brand-new business.  We’re not adding layers of inspection, or calibrating our instrumentation or implementing lean or Six Sigma or any other “nerdy quality” stuff yet.  We’re still just describing our business, why we exist and what we intend to accomplish as an organization.  And this is top management’s responsibility – not the quality or operational excellence representative, not the continuous improvement leader, not the “document control coordinator”…but TOP MANAGEMENT’S. 

Now that we’ve done our best to define our context (who we are, what (and who) matters to us, what we do and what processes we use to operate), it’s time to switch gears and start looking at who’s steering the ship.  (And the quality manager SHOULD NOT be the one steering the ship).

To be compliant to this section, an organization will have to not only say they are committed, but also be able clearly demonstrate that their TOP MANAGEMENT:

a) takes accountability for the effectiveness of the quality management system;

b) ensures that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;

c) ensures the integration of the quality management system requirements into the organization’s business processes;

d) promotes the use of the process approach and risk-based thinking;

e) ensures that the resources needed for the quality management system are available;

f) communicates the importance of effective quality management and of conforming to the quality management system requirements;

g) ensures that the quality management system achieves its intended results;

h) engages, directs and supports persons to contribute to the effectiveness of the quality management system;

i) promotes improvement;

j) supports other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

These requirements are key if the QMS is to actually mature and yield the desired results of World Class Quality.  Sustainable quality can only be achieved through good processes and sound management practices.  So, these requirements are paramount.

For each of these above, we must ask, “Which leader is responsible for that?” “How can s/he demonstrate that it is being done?”  With these requirements, the real leaders of the organization must engage and really steer the ship. 

This section also includes 5.1.2 Customer focus, a section guiding management to not only do the things listed above, but to keep those things squarely focused on the customer.  The requirement reads,

“Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

c) the focus on enhancing customer satisfaction is maintained”

So, how will your organization tie all of this together?  The past several weeks, we’ve discussed the use of tools like process maps and SWOT analysis.  A SWOT analysis provides a simple framework to understand our (4.1) “organization and context” and “external and internal issues”, while considering our (4.2) “needs and expectations of interested parties” in order to determine the (4.3) “scope of the quality management system”.  Then, we took the next step to describe our (4.4) “quality management system and its processes”.  What a great foundation we’re starting with!  And now, we continue to build.

Understanding our context, what we want from our QMS, how we want our management to drive us forward, we need to understand where our risks lie.  We needn’t take action on those risks quite yet, but we DO have to identify them.   

If you’ve kept up with your homework, you’re in great shape to breeze through this week’s homework.  Remember, you can use the tips I’m sharing, or use them as inspiration and use whatever tools work best for you.

THIS WEEK’S HOMEWORK (with tons of FREE tips and FREE STUFF)

Review the requirements in 5.1.1.  Who in your organization is specifically responsible for EACH of the bullets (a thru j)?  How is the responsibility assigned and communicated?  Does management KNOW they are responsible?  Does everyone in the organization know who is responsible?  How can each of the persons responsible demonstrate that they do, in fact, do each of these things?  How does the QMS describe who is responsible for what? 

Perhaps the Process Maps indicate who is responsible for each process?  Or perhaps there is a responsibilities matrix somewhere?  Or perhaps it is indicated on an organizational chart?  Take time to ensure the QMS identifies who is responsible for (a thru j) in this section.  This doesn’t need to be complicated, but it does need to be addressed.   

After that, move onto 5.1.2 “Customer focus” and identify who is responsible for each of these commitments (a thru c) and how each of them are met. 

For 5.1.2 a, who is responsible for ensuring “customer and applicable statutory and regulatory requirements are determined, understood and consistently met”?  How is this done?

For this, you may want to maintain a list of statutory and regulatory requirements, their effective dates, who is responsible, and any necessary ongoing action items.  Or perhaps there is a Process Map for Statutory and Regulatory Requirements indicating how these requirements are discovered, vetted, complied with and maintained?  There are many ways to address this requirement.  Be creative and be sure whatever you decide will add value by ensuring you are always abreast of all applicable requirements and confident the organization will remain in compliance. 

For 5.1.3 b, who is responsible for ensuring “risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed”?  How is this done?

For this, you may want to use a SWOT Analysis along with Process Maps to identify where the risks and opportunities are.  These tools can be very dynamic (and multi-purpose) to your organization.  At this early point, the SWOT is simply used at a high level to identify general points of risk as it relates to external and internal issues.  The SWOT continues to develop and grow with the organization over time.  Process Maps are similar.  They start out simply providing a road map to how expectations are met.  But together, they can be leveraged in a number of scenarios to keep the focus on risks and how to prioritize and mitigate them.

For 5.1.3 c, who is responsible for ensuring “the focus on enhancing customer satisfaction is maintained”?  How is this done?

For this, you could use a Process Map which includes “enhancing customer satisfaction”, or a responsibilities matrix, or a job description, an opportunity on a SWOT analysis or any combination of these tools. 

You may want to use a SWOT analysis, or maybe you don’t.  Remember, this is YOUR organization’s QMS.  The combination of a SWOT analysis and Process Maps are my favorite simple set of tools that I like to use in the beginning, because they tell a big story quickly.  Anyone looking at the system for the first time can see a very concise map of the organization, what it does and where its risk points lie.  Then, I like to use these tools again and again as I build the QMS.  A SWOT analysis and Process Maps can be great spring boards for lean and Six Sigma tools such as Value Stream Maps, Failure Mode & Effects Analysis, Spaghetti plots and more going forward.  Use what works best for you and build your system to suit YOUR needs.

THIS WEEK’S FREE STUFF!  FREE DOWNLOAD!  Want help with this week’s homework?  Use the form below to receive a FREE step-by-step guide to walk you through exactly how to use a typical SWOT template along with an Interactive Process Map to build a clear path describing a simple quality management system with its risk points identified.  Using this approach not only creates the foundation for a robust quality management system, but it also paves the way for future implementation of lean and Six Sigma so your quality system stays lean and simple and adds MORE VALUE! 

With this Week-by-Week series, you’re getting lots of FREE STUFF!  And we’re sharing it, because we believe in these methods, because we’ve seen first hand how they can truly simplify business.

If you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE for 100% VIRTUAL IMPLEMENTATION of ISO9001 Clauses 1-6 (there are only 10 clauses total!).  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!

Here are some other VIRTUAL LIVE options,  Connect with us today and we'll create an exciting and engaging experience for your team on:

• VIRTUAL LIVE SWOT Analysis - We'll facilitate and help your team capture your Strengths, Weaknesses, Opportunities and Threats as the foundation of your quality strategy
• VIRTUAL LIVE Process Maps - We'll help your team learn to create an Interactive Process Map and Subprocess maps to create a roadmap to navigate your entire business

Or perhaps your organization is more advanced and is ready for some training that will transform your organization and start solving problems and diving deep into identifying and reducing your risks:

• VIRTUAL LIVE Problem Solving Training - We'll teach your team 3 powerful problem solving techniques ("5 Why", "Fishbone" and "Pareto") with a workshop to solve one of your organization's REAL LIFE problems
• VIRTUAL LIVE FMEA Failure Mode & Effects Analysis - We'll lead a dynamic, hands-on workshop to teach your team how to perform an FMEA and how that tool can be leveraged to launch powerful lean, Six Sigma and Continuous Improvement

And the options don't stop there.  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. 

We look forward to taking this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

And join me on my journey to always keep improving!