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ISO 9001 Certification | Requirements | Internal And External Issues

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Understating the organization and its context is very much important for any organization because without addressing the issues of the organization, at any stage of the organization – Either for the Newly set up organization, Planning of a New organization, or the Ongoing operation of the organization

The consideration of the organization’s Internal and External issues as per the Activities of the organization is very much Important. This could help the organization to take the action against Potential matters, which help the organization to prevent any obstacles – during regular operation of the organization and Improves in meeting the customer requirements and Expectations of Customer. The Overall organization performance was enhanced.

As per the requirements of ISO 9001:2015, its specific requirements are said in clause # 4.1 to understand the organization and its context.

So, considering the organization – those who want to Implement the ISO 9001:2015 standard in the organization and seeking ISO 9001 certification from an accredited certification body (i.e OSS Certification )

So for the View of understating the requirements – the Explanation of requirements is given below which could help the organization to understand.

1. Identify the Internal issues – considering the organization’s Activities

2. Identify the External Issues- considering the organization’s Activities

The Possible External issues are (But are not Limited To)


Legal Requirements / Law

Market Competitions

Cultural issue

Social Issues

Economic Condition

National / International

Possible Internal issues(But not Limited)

– the Performance of the organization

-Culture of the organization

– Social issue


Identify the Issues and review the issues and take the necessary action for any significant issues and implement the control after considering its Potential Risk.

set the review frequency to review the issues for the effective operation of the organization

What to do for Implementation of ISO 9001 Certification (9001:2015) Clause# 4.1

First, the organization should Identify – Address the activities of the Organization

For Example –

The organization is in the Business of – Manufacturing, Sheet Metal Products for the Automobile Industry
The product may be – Fuel Tank, Suspension parts, Hinges for the Door of the Car, etc.
Now to meet the Requirement of 4.1 of ISO 9001:2015 
The Context of the Organization – is understood now.

Then Identify, the Internal and External issue  

Develop the Team – of Each Department of the Organization. and Identify the Internal Issue of the organization.

For Example

Production Department
– In-process Rejection is very high in Products at the Press Shop
– Die Loading and Unloading time for New Product Set-up time is very High – which causes an average downtime – of 4 to 6 Hrs
-Knowledge about customer requirements at Supervisor / Worker Level
-‚Delay in Delivery of Product 
– Customer end rejection is Very High
– Frequent Machine Break Down
– Power Wattages – High

Identification of External issues of the organization

Develop the Team from – Top Management, Marketing Department ( Dealing with Clients or Engaged in Business Development ), Representative of the Product Department, Quality Department, Compliance Department, HR, etc

For Example
-Very the Technology used by your own organization and your Competitor – see if your organization is using Old Technology – which could affect the Productivity of the organization, quality of the Product, and Manufacturing Cost of the Product.
 Legal and Regulatory requirements verify the want are Legal r/ and regulatory requirements applicable to the organization are we are complying. if not it could cause a penalty to the organization.
– Market Competition – Verify the market rate of own product VS Competitor Product Cost.  what is the expectation of the Customer etc?

For Implementation of Clause# 4.1  Follow The Steps Given Below

Develop the Policy / Procedure / Instruction 
– Identify the Internal issue and External issue
Set the Frequency for Identification and Review of issues.
Set the Responsibility of the Team 
who are involved in the Identification of issues,
Review Issues
Take the Action on a Significant Issue
Record the issue and its Review Status – Keep this record for Risk Analysis and Management Review meetings.
By doing this implementation the requirements of Clause#4.1  will comply with the effective implementation of ISO 9001 requirements. This will help the organization to demonstrate better compliance with ISO 9001 Certification, along with adding a lot of benefits to the organization. For Process performance and productivity enhancements.

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