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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.


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


Required Documents for ISO 9001 2015

Required documents for ISO 9001 2015 post will help you to know what are the required and mandatory documents for ISO 9001:2015 Certification. ISO 9001 2015 Version has been released. Already many organizations are busy to adopt ISO 9001:2015 in their systems and  processes. If you are new and SME organization then this post will help you to prepare ISO 9001 latest version documentation.

Quality Policy, Quality Objectives, Quality Procedures, Certification Scope, Work Instructions, Work Flow Chart, NC Record, CA Plan, Customer feedback, Internal Audit, Management Review Meeting Risk Analysis etc are required documents for ISO 9001 2015 certification. Visit this page to get those ISO documents now.

Are you worry about to prepare those documents? No problem, Advanced Assessment Services is ready to help you to prepare those 9001 documents by yourself. All are ready.These are word format. You can edit that by yourself. If you have basic knowledge on English then easily you can do that.

Are you worry about price? Do not be in panic. It is not costly. All the documents you can get only by spending several hundred US Dollars. Which is much more cheaper than hiring an ISO 9001 Consultant.

How to purchase that? It is  easy to purchase. International credit card like Master Card, Visa Card can be used to purchase the ISO 9001 2015 documents. If you are Bangladeshi and have local ATM Card or bank account then you can pay from your local bank account to get those mandatory iso documents for 9001:2015 certification.

From ISO Geneva office it is not told what  are the required documents for ISO 9001 2015 Standard certification. It will vary from company to company. However quality consultants around the world are agreed that  Quality Policy, Quality Objectives, Certification Scope, Required Procedures, Risk assessment, Work Instructions, Work Flow Chart, NC Record, CA Plan, Customer Feedback, Internal Audit, Management Review Meeting etc are the required and mandatory documents for all kinds of companies for 9001 certification.

Required documents for ISO 9001 2015 is almost same as 9001 2008 version. However, some terms have been changed and some new terms have  been added. In 9001 latest version employment of MR and quality manual are not mandatory now. So, it is a great advantage for SME organizaiton who are worry about preparing and using of big documents like quality manual.

Quality Manual was the headache to many organizations to prepare and follow. Because it was a big volume documents. Now without quality manual you can get ISO 9001 Certified. But some other   documents which are mentioned earlier of this post are still required. Without those documents you cannot be iso 9001 2015 certified. To get all those Required documents for ISO 9001 2015 simply visit this ISO Shop Page.