Clause 4 IATF context of organization

Clause 4- Context of organization ISO 9001:2015

Clause 4 of ISO 9001 & IATF 16949 talk about context of organization. This is one of the auditable clause. 

Context meaning- It could be a line, word or any paragraph which define the organization meaning, or its business meaning. 

Here we are going to understand this clause in details. Let’s first see what IATF-16949 Manual say about this clause. Topic covered under this clause is explained in below picture.

4.1 Understanding the organization and its context (ISO 9001-2015)

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.

This clause requires the organization to determine its context in terms of the Quality Management System, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements. It gives an organization the opportunity to identify and understand the factors and parties in their environment that support the quality management system.

Firstly, the organization will need to determine external and internal issues that are relevant to its purpose, i.e. what are the relevant issues, both inside and out, that have an impact on what the organization does, or that would affect its ability to achieve the intended outcome(s) of its management system.

From above paragraphs, we collect following highlighted words:-

• Context in term of quality management system
• Determining scope of Quality management system
• Interested parties
• General QMS requirement
• Determining external and internal issues
• Intended results of an organization

We will understand meaning of each lines in details.

Let’s say you are going to run any business. Then you need to define its context for which you need to identify internal and external issues, interested parties like- Customer, suppliers and regulatory that can affect your organization goal, product, process and its business growth.

Well you own a production company which is manufacturing consistent quality products for its customer. They will buy from your company only if you have fixed a goal to provide them quality product. So here organization need to get ISO 9001:2015 certified.

Who can get ISO 9001:2015 certified?

Any company can get certified for ISO 9001:2015, either it is small or big. But company must meet the criteria for achieving and maintaining the ISO 9001 certification.

How to write context of organization as per ISO 9001:2015?

Step-1:- Identify internal and external issues

First thing the organization has to do is identify internal and external issues.  The “issue” covers not only problems which could be the subject of preventive actions, but also important topics for the management system to address, such as any market assurance and governance goals the organization might set.

External Issue: - Legal requirement, social responsibility, environmental issues, ethical concerns, technological challenges and economical aspect.

Internal issues:- Value and culture of the organization, organization structure, organization culture, goal and beliefs of organization, equipment and technology within the organization, employees relation & knowledge and Human resources.

Step-2:- Identify interested parties in the organization

Secondly, an organization will also need to identify the “interested parties” that are relevant to their QMS. These parties could include shareholders, employees, customers, and suppliers, statutory and regulatory bodies. Each organization will identify their own unique set of “interested parties” and over time these may change in line with the strategic direction of the organization.

Interested parties:- Customers, owners, shareholders, employees or people in the organization, suppliers and partners, society, competitor, Government and labor union regulatory.

4.2 Understanding the need and expectation of interested parties (ISO 9001:2015)

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 those 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.

Step3:- Determine scope of QMS (ISO9001: 2015)

Organization must have to determine scope of Quality management system. Other than external or internal issues, there must be defined extent and boundary for which the organization is getting certified. While determining scope of QMS you have to consider all requirements of interested parties  (Customer, Suppliers, Regulatory) explaining that all requirement of ISO 9001:2015 is mandatory and may only be excluded if can not be applied.  Let’s see What ISO 9001:2015 says about this?

4.3 Determining the scope of the quality management system (ISO 9001:2015) 

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

b) The requirements of relevant interested parties

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.

This could include the whole of the organization or specific identified functions. Any supporting outsourced functions or processes will also need to be considered in the organization’s scope if they are relevant to the QMS. You are required to establish, implement, maintain and continually improve the QMS in accordance with the requirements of the standard. This requires the adoption of a process approach and although every organization will be different, documented information such as process diagrams could be used to support this.

The scope of QMS in organization should be available and be maintained as a documented information stating the:-

1. Product and services covered by QMS
2. Justification of any instance where a requirement of this international standard cannot be applied

All most these above 3 steps are important to make context of an organization.

4.3.2 -Customer Specific Requirement

Customer specific requirement shall be evaluate and included in scope organization’s QMS.

The supplier would need some sort of process to evaluate each of their customer’s customer-specific requirements and determine exactly how (and where) it applies to their organization’s QMS, as applicable.

Difference between Customer requirement and customer specific requirement.

Customer requirement is for product quality like- Material composition, Packaging pattern, Metallurgical test, etc. While Customer specific requirement could be Product safety, system implementation for product quality. 

4.4 Quality management system and its processes (ISO 9001:2015)

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 determine following:-

1. Risk and opportunities
2. The input required and output expect
3. The sequence and interaction of these process
4. The criteria, methods, including performance indicator
5. The resources needed
6. The assign of responsibility and authorities

What is process needed for QMS?

Here process is set of interrelated or intersecting activities which transforms inputs into output.

Various types of process in an organization could be:-

• Production Process (Welding, stamping, painting, etc)
• Management process (Audits, HR)
• Support process (Maintenance, warehouse, purchasing)
• Customer process (Sales, customer satisfaction)
• Service Process (Bank Loans, money transfers)

Conformance of product and process:- The organization shall ensure the conformance of all product and process including service parts and that those are outsourced, to all applicable customer, statutory and regulatory requirements.

4.4.1.2- Product Safety (ISO 9001:2015)

Product Safety is a new section in the standard. It has enhanced requirements designed to address current and emerging issues that the automotive industry is facing. The standard now lists the documented processes for the management of product safety-related products and manufacturing processes that an organization is required to have.

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