Clause 5

This is Clause 5 of ISO9001:2015

5.1 Leadership and commitment

5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality management system by:

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

b) ensuring 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) ensuring the integration of the quality management system requirements into the organization’s business processes;

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

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

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

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

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) promoting improvement;

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

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

5.1.2 Customer focus

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.

5.2 Policy

5.2.1 Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:

a) is appropriate to the purpose and context of the organization and supports its strategic direction;

b) provides a framework for setting quality objectives;

c) includes a commitment to satisfy applicable requirements;

d) includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the quality policy

The quality policy shall:
a) be available and be maintained as documented information;

b) be communicated, understood and applied within the organization;

c) be available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the quality management system conforms to the requirements of this
International Standard;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;

d) ensuring the promotion of customer focus throughout the organization;

e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

 

Demonstrating your quality

Im a big fan of business theory Ive done alot of courses which have involved reading through numerous books and theories from everything from marketing to HR to quality. One of the better known authors on business theory is Michael Porter whos created a number of tools and concepts that are widely taught across the world.

Reading through his books on competitive advantage is worth doing. Youll find that his books are quoted frequency by thousands of authors because of quality and relevancy of his work.  In one of his books about competitive advantage he makes the point that many companies say they provide fantastic service and brilliant products and that ultimately within their market they provide superior quality. He goes onto say that if you really want to have a competitive advantage based on quality and customer satisfaction you cant just say you are the best you have to prove it and provide evidence of it.

When thinking about this and the ISO9001 standard you can see a link. Specifically if you consider clause 7.4 it relates to communication and what should be communicated. I think that a fantastic way of proving you provide a good service and also communicating it is to take customer feddback and stick it on your website. This isn’t new but what I think you should do it publish the bad feedback. By doing this you are showing you are willing to listen to bad feedback, take it on board and do something about it.

Publishing customer feedback in this way not only allows for 7.4 to be met but will also shows that you are complying with clause 8.2.1 which involves monitoring an measuring customer satisfaction by seeking feedback. To see how Ive put this in place within my firm go to www.malthouseengineering.com and go to blog and youll be able to see the results of our satisfaction surveys that take place each month.

 

Readiness review

If you already have a quality management system in place such like ISO9001:2008 then you have a lot of the foundations in place and will go through what is termed as a transition to ISO9001:2015. This will generally happen after you have gone through what BSI term a readiness review. This may be termed a something else depending on what body you use, my experience is with working with BSI.

I will go through in more detail my experience of a readiness review  in another post. For now to aid in the transition BSI have created the following document that explains transitioning that may be of use.

http://www.iso.org/iso/iso_9001_-_moving_from_2008_to_2015.pdf

Risk based thinking

Risk based thinking has become one of the big topics to be discussed as part of the transition. From what I have read it is being pushed more with the moved to ISO9001:2015 compared to the previous version of the standard. There are a number of clauses which require the application of risk based thinking. Due to this having a good level of awareness of what it is is key. From googling it and reading through a number of sources. I have found some useful information which I have included below.

Transitioning to ISO9001:2015

My firm is in the processing of transitioning to the new ISO9001:2015 standard. Any use info i find i will post here to help anyone else doing the same.

Ive found this really useful, its a video from BSI that goes through frequently asked questions and other useful info that might be of use for anyone else who is transitioning.

How to meet 4-1 understanding the organisations context

What is 4-1 understanding the organisations context

Out of all the clauses in the ISO9001:2015 standard I think this is probably one of the easiest to implement. 4.1 asks that the organisation determines the external and internal issues that are relevant to the company and its strategic direction along with those issues that could impact on its ability to achieve the objectives of the quality management system.

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.

How to meet 4-1 understanding the organisations context

For me the ideal way to achieve this clause is to use the SWOT tool. This enables a firm to identify its strengths, weaknesses, opportunities and threats. Its perhaps one of the best known tools available to a business owner to analyse their company and its really really simple to use. But the main reason I would suggest using it is that the strengths and weaknesses aspect makes you consider the internal aspects of the company while the threats and opportunities make you think about the external issues that are relevant to the company.

 

Notes for clause 4-1

Note 1 reminds you that issues can include positive and negative factors. To be honest I think this is pretty obvious. If you are considering your firms weakness and threats you are going to consider negative factors or conditions and if you are going through strengths and oppotirnies then you will consider positive factors so I don’t know why they have put this note in. Perhaps they were trying to lead you towards the SWOT analysis in a roundabout way.

Note 2 is really just a nudge in the right directon for when you are working the SWOT. It highlights the external issues that you should consider which include  legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Those practices with SWOT will already have an awanress of these for those that don’t it’s this provides some ideas to start the SWOT.

Note 3 is really the same of note 2 but goes through the internal issues to consider including values, culture, knowledge and performance of the organization.

Its worth noting that following clauses will make reference to the factors mentioned in notes 2 and 3 so a good SWOT done for clause 4-1 will save you time and effort when you come on to the later clauses.

Applying 4.1 understanding the organisations context

So you probably came here to learn about how to meet the requirements of the clause. To help with this I have included a few points that its worth considering when you do yours and some of the points I included when I did a SWOT for my firm.

If you’re not sure about how to do a SWOT then here 4-1 understanding the organisations context’s a quick video or if you prefer reading to go the marketing teachers site for a quick explanation of SWOT analysis.

Strengths

  • Number of and modernity of machinery
  • Knowledge of staff and their experience
  • Brand strength and awareness
  • Geographic size and reach
  • Range of material stocked

    Weaknesses

  • Number of staff to cover busy periods in sales/production
  • Could relate to the condition of any old machinery
  • Succession planning could be important for firms with an old workforce
  • Financials – could related to cash flow or working capital

Opportunities

  • New products
  • New Markets
  • Possibility to acquire competitors or other firms
  • Changes in law that could be beneficial

Threats

  • Competitors
  • Potnetially could relate to suppliers

All of these aspect will impact the company and its ability to implement the quality manamgent system and ensure it is sucessfully sustained so when you are work through the swot make sure you keep your mind focussed on the impact of each item on the quality system as any auditors are going to want to see that you have related the swot to the requirements of the clause.

So hopefully this gives you some ideas for what you can do to meet the requirements of 4.3. As ive said its not really difficult, it can be time consuming however if done right it can highlight a number of things that can help to improve your business. Plus you will refer to this when looking at some of the other clauses so its worth spending your time doing it right.

Let me know what you have done in your firm when looking at 4.3. Have you used swot as well?

4 Context of the organisation

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their
relevant requirements.

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.

When determining this scope, the organization shall consider:

a) the external and internal issues referred to in 4.1;

b) the requirements of relevant interested parties referred to in 4.2;

c) the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable
within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as
documented information. The scope shall state the types of products and services covered, and provide
justification for any requirement of this International Standard that the organization determines is not
applicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not
being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.

4.4 Quality management system and its processes

4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve
their intended results;

h) improve the processes and the quality management system.

4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;

b) retain documented information to have confidence that the processes are being carried out as
planned.