Autor: Martin Dudek Date: March 2016
Česká verze článku ZDE.
Since September 2015 the new issue of the standard ISO 9001 /1/ has been made valid. Personally, I do not think it is a sea change. Nevertheless, there are some new facts and requirements. One of the innovations is “Context of the organization“, discussed in chapter 4.
Even though the standard does not define the conception of the issues, it is possible to understand it as factor, standpoint, account, …
The standard ISO 9000:2015 in chapter 4.1. titled Understanding the organization and its context states: “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 the information about these external and internal issues. “
How to deal with this requirement without complicated documentation?
In my opinion, it can be useful to make up an overview of issues, e.g. in form of a table containing this information:
- Differentiation if it is internal or external
- Impact on the quality management system of the organization, including risks
- Relevance for the quality management system and also for the running of the organization, it should be expressed in figures, per cents or if need be in verbal evaluation
You can find an example of the overview of issues here: see attachment
I recommend to review topicality of survey of issues once a year, e.g. during quality management system review and to state modifications of the issues in the report from management review. By doing this, the requirement of the chapter 9.3.2. of the standard ISO 9001:2015 will be fulfilled.
Needs and expectations of interested parties
The second subchapter of the chapter Context of the organization is the subchapter 4.2 Understanding the needs and expectations of interested parties.
The new issue of the standard ISO 9001:2015 states:
“Due to their effect or potential effect on the organisation’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
- the interested parties that are relevant to the quality management system;
- the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review the information about these interested parties and their relevant requirements.”
The new standard ISO 9001:2015, compared to the previous one, contains in major extent the demand to meet the requirements of laws and regulations. And this is one of the chapters stating this requirement. It is a kind of approaching to reality because the introduction of a product or a service to the market means fulfilment of many legal demands (from purchase and storage of some materials, from requirements for testing and proving of conformity, from customs proceedings to the rules of warranty claim procedure).
To deal with the requirement for designation of interested parties is not complicated either and it suffices to mention them in the Quality Manual (provided you keep it) or to work out a simple list. It is possible to put there these interested parties:
- Clients (end ones and middlemen ones)
- External providers (suppliers of materials, suppliers of repair services, construction or design studios, laboratories and testing labs, etc.)
- Owners (shareholders, parent companies)
- State administration (Customs, Hygienic Stations, Employment Office, Testing Institute, etc.)
Identification, monitoring and review of the requirements of interested parties which are relevant for quality management system, is not “a new requirement or an extra requirement”. It is the requirement every establishment already has been carrying out ordinarily these days. I can mention also some examples:
- Clients´ requirements are reviewed, it is a standard problem. In the original issue of the standard – requirement of the chapter 7.2., new issue of the norm deals with it in the chapter 8.2.3.
- If a supplier of materials has got a five-day delivery time for a certain kind of material or if a minimal off-take quantity is set, the organization takes account of the information while choosing and evaluating the supplier. If the supplier is the only one, the organization must take into consideration quantity and the deadline for the supply of material when planning production and be able to fulfil the required delivery time of the product to the customer. The new issue of the norm deals with it in the chapters 8.4.1., 8.4.2., 8.4.3..
- In companies it is common that if an employee goes to his/her boss and asks him/her for an instrument, better lighting or extension of his/her knowledge, it is necessary to check the relevance of the requirement. If it is relevant, fulfilment of the requirement is ensured after that. If you are able to prove you do it like this, you can use the achievements as evidence you fulfil the requirements of the chapters 7.1.2., 7.1.3., 7.1.4. and 7.2. of the new issue of the standard.
Context of the organization and quality policy
Quality policy remains a required document also in the new issue of the standard. The standard states:
“Top management shall establish, implement and maintain a quality policy that:
- is appropriate to the purpose and context of the organization and supports its strategic direction
- provides a framework for setting quality objectives;
- includes a commitment to satisfy applicable requirements;
- includes a commitment to continual improvement of the quality management system.”
The new issue of the standard left out the requirement for the review from the point of view of suitability. It was usually solved within the review carried out by the management.
Newly, it is necessary to consider the context of the organization when setting up quality policy.
How to deal with all that? The standard states it very generally. It does not state whether to focus on all the issues or only on the selected ones, e.g. important issues. Simply, it should be suitable also for the context of the organization.
I recommend to organize Quality policy as follows:
Head – it contains strategic intentions of the organization
Body – it contains principles and commitments of the organization with regard to important selected issues. I recommend to divide them into spheres that provide with an elegant framework to create the quality objectives. When choosing the structure, it is possible to take into consideration the interested parties.
Foot – it contains the commitment to fulfil the requirements resulting from the laws and regulations and the commitment to endeavour for continuous improvement of quality management system.
You can find an example of Quality policy here: see attachment
The policy of integrated system can be set up in this structure too. It means that one policy (as one document) can be common for systems according to the standards ISO 9001, ISO 14001, ISO 22 001, ISO 27 001, OHSAS 18001, ISO/TS 16949, etc. It is only necessary to take account of the requirements of these standards.
Quality policy arranged in this way then enables to set up easily the quality objectives that are clearly arranged for customers, employees, auditors, …
You can find an example of the quality objectives here: see attachment
Context of the organization is one of the innovations in the new issue of the standards ISO 9001. Nevertheless, it is not so complicated. It is not necessary to create because of that any complicated documents that would be unintelligible for most people in the company and that would serve only for auditors presentations. It is necessary to approach it in a rational and simple way so that it is intelligible to the employees of the society and so that they can identify with it.
© Martin Dudek
/1/ ISO 9001:2015 Quality management system – Requirements. 2015.