4 Context of the organization T 15                                pdca p

 

4.1 The organization and its context

External and internal issues that can influence the QMS

Requirements 1 to 2 (see also the quiz)

 4.1

The two most important things in a company do not appear in its balance sheet: its reputation and its people. Henry Ford

To successfully implement a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4), we must understand and evaluate everything that can influence the reason for being and business performancemeasurable and expected results of the management system (see also ISO 9000, 3.7.8). You should think carefully about a few key activities:

The SWOT and PESTEL analyses can be useful for relevant analysis of business context (cf. annex 05). record

A list of external and internal issues is carried out by a multidisciplinary team. Each issue is identified by its level of influence and control. Priority is given to issues with great influence and poor control.

smileyMinute of relaxation. Game: Context of the company

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4.2 Needs and expectations of interested parties

Understand the requirements of interested parties

Requirements 3 to 5

4.2 

There is only one valid definition of a business purpose: to create a customer. Peter Drucker

To understand the needs and expectations of interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3), we must begin by determining those who may be affected by the quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) such as:

A list of interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3) is created by a multidisciplinary team. Every interested partyperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3) is determind by its level of influence and control. Priority is given to interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3) with great influence and poor control.

True story 

The customer is king but we still can fight against rudeness. This example is from the restaurant La petite Syrah in Nice and its coffee prices:

“A coffee”...................................7 €
“A coffee, please”...............4,25 €
“Hello, a coffee, please”....1,40 €

Anticipating the reasonable and relevant needs and expectations of interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3) involves:

When a requirementexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) is accepted, it becomes an internal requirementexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of the QMSQuality Management System.

Quality means including the customer's point of view from design to final recycling

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4.3 Scope of the QMS

Define the scope of the QMS

Requirements 6 to 12 

4.3

In many areas, the winner is the one who is best informed. André Muller

The scope (or in other words, the perimeter) of the quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) is defined. When a requirementexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) cannot be applied, a justification is included in the documented informationany support allowing the treatment of information procedure that is maintained and is available to any interested partyperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3).

The specific context of the company is taken into account to determine the scope of the QMSQuality Management System including:

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4.4 QMS and its processes

QMS requirements, processes and interactions

Requirements 13 to 24

4.4

If you cannot describe what you are doing as a process, you do not know what you're doing. Edwards Deming

The requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of the ISO 9001 standard include:

To do this:

The quality manualdocument specifying the general measures taken by an organization to obtain conforming products or services (see also ISO 9000, 3.8.8) is not a requirementexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of ISO 9001 version 2015, but it is always a possible method to present the companya structure that satisfies a need, its QMSQuality Management System and its proceduresdocument describing the to carry out a process (see also ISO 9000, 3.4.5 and documented information) and processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) (cf. annex 07). record

The ISO guide “The integrated use of management system standards” of 2018, contains relevant recommendations on the integration of management systems.

point Pitfalls to avoid:

The requirements of the ISO 9001 standard are shown in figures 4-1:

 pyramid

Figure 4-1. The requirements of the ISO 9001:2015 standard

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The rest of the T 15v15 ISO 9001 readiness version 2015 training is accessible on this page.

See also the training T 35v15 Internal audit ISO 9001 version 2015 and the training package ISO 9001 version 2015.

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