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Leadership is the direction from the top management to achieve certain goals in an organization. A good leadership creates good environment for work and motivate staffs to be involved to meet its customer requirements. Leadership is the fifth term and clause of ISO 9001:2015 Standard. A plenty of works have been described in this clause for the top management. Some of the major responsibilities have been described in below:

  • Take accountability of effectiveness of the quality management system
  • Be focused on customer satisfaction
  • Establish, implement and maintain a quality policy and share it to all interested parties
  • Engaging, directing and supporting persons for effective implementation of QMS
  • Work on improvement.
  • Ensure customer and applicable statutory and regulatory requirements are met
  • Identify the risks and opportunity which can affect the products or services it provides
  • The focus on enhancing customer satisfaction is maintained.
  • Assigning the roles and responsibilities and authorities of the staffs
  • Ensure the enough resources are there for effectively implementation of QMS

Context of the organization

It is the fourth clause of ISO 9001:2015 standard. Context means circumstances or condition of the company. So, in this clause details idea of the company should be clarified including what kind of product or services it provides, what are the necessary processes what are the external and internal issues, who are the interested parties what is the scope of the quality management system etc should be mentioned clearly before proceed to certification to ISO 9001:2015.

There are four sub clauses of this principal clause number 4. They are: 4.1 Understanding the organization and its context , 4.2 Understanding the needs and expectations of interested parties, 4.3 Determining the scope of the quality management system, 4.4 Quality management system and its processes

4.1: Understanding the organization and its context : The organization shall determine, regularly monitor & review the external and internal issues. External issues are legal, technological, competitive, market, cultural, social and economic environments, whether international, national etc. Internal issues are organizational values, culture, knowledge, and performance.

4.2: Understanding the needs and expectations of interested parties: Two things are mentioned in this sub clause. That are: determine the interested parties and assess the requirements of those parties which are relevant to its QMS. It can vary company to company. However the common interested parties are: customers, owners, employees, providers, bankers, regulators, unions, partners, community, news media, competitors, law enforcement, emergency responders etc.

4.3: Determining the scope of the quality management system: It is one of the required and mandatory requirements for company and it shall be maintained as documented information. Scope determining time the following things should be considered: a) external and internal issues (see 4.1); b) requirements of relevant interested parties (see 4.2); c) products and services of organization. The organization shall apply all the requirements of this QMS standard 9001:2015. However, provide logical justification if any clause is not applicable in scope of quality management system.

4.4: Quality management system and its processes: Determining the processes and showing their interactions among the processes is mandatory for effective implementation of the qms in the organization. In the processes following things should be included: 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. Documented information and retain documented information for the processes is also necessary. During the audit these documented information and retain documented information will be reviewed by the auditor. Go to read about ISO 9001 Clause number 5 


The first clause of ISO 9001 2015 is scope. Two things have been told in this clause. One is which kind of company needs this quality management system standard and why it is need? If we say who needs then the answer is any kind and any size of organization can adopt this standard

If we go why needs then two answers will come there first of all: If any company wants to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and secondly if any organization wants to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

In the clause 2 and 3 there is references of ISO 9000:2015 for normative reference, terms and definitions. So, there is no more to learn from those two clauses. However to know more about clause number 4 you may visit this post

9001:2015 Clauses

There is 10 major clauses in ISO 9001:2015 Standard and there are many sub and sub sub clauses of those major clauses. Major clauses are mentioned in below:

  • Scope
  • Normative References
  • Terms and Definitions
  • Context of the Organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement

What are New in ISO 9001:2015

ISO 9001:2015 has some new and additional content. This post will help you to know those new items of ISO 9001 2015 Standard:

  • 10 Clauses
  • Introduction is much more informative
  • Interested parties
  • Exclusion
  • Risk based thinking
  • Organization knowledge
  • Context of the organization
  • Documented information
  • External providers
  • Products and services

Description of those items can be found in next posts. Read more about 10 clauses from this post

ISO 9001:2015 Requirement

9001:2015 documents requirements

ISO 9001:2015 Documents

ISO 9001:2015 Standard is a latest version of Quality management system Standard. Tough there is no mandatory documentation guideline but in the clause no 7.5.1 it is told about documentation requirements of ISO 9001:2015 as below:

  1. documented information required by this International standard
  2. documented information determined by the organization as being necessary for the effectiveness of the quality management system

In the above first sub clause of 7.5.1 it is telling that documented information is required by this QMS standard but it is not specifying what are the requirements.

In the second sub clause it is telling documented information is requirement for an organization . The organization will determine what are necessary for effective implementation of quality management system.

According to the second sub clause we can summarize that the documented information will be prepared by the organization by follow the following things:

a) size of organization and its type of activities, processes, products and services;
b) complexity of  processes and their interactions,
c) competence of persons.

All the documented information what are the part of ISO 9001:2015 should be controlled following the 7.5 clause. Now lets know what are said in the sub clause a of 7.5:

  • scope of QMS
  • Process operation related documentation
  • Quality Policy
  • Quality Objectives

In the sub clause of b of 7.5 it is told about the documents are required to communicate information or instruction for successful operation of the processes. According to the clause 4.4 though ISO 9001:2015 does not specify the requirements but following documents may add value in the organization:

Organization charts
Process maps, process flow charts and/or process descriptions
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans
Quality manuals
Strategic plans