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ISO 9001:2015 – Requirements, Internal and External Issues

The 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 New organization or the On-going operation of the organization

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

As per the Requirements of ISO 9001:2015 , its a specific requirements 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 for certification from any third party certification body

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

1. Identify the Internal issues – considering the organization activities

2. Identify the External Issues- considering the organization activities

The Possible External issues are (But not Limited)

Technology

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

-Knowledge

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

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

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

First the organization should Identify – Address activities of the Organization
For Example –
Organization is into Business of – Manufacturing, Sheet Metal Product for Automobile Industry
Product may be – Fuel Tank , Suspension parts , Hinges for Door of 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 Product at the Press Shop
– Die Loading and Unloading time for New Product Set-up time is very High – which cause average down time – 4 to 6 Hrs
-Knowledge about customer requirement to 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 Client or Engaged in Business Development ), Representative of Product Department , Quality Department , Compliance Department , HR etc

For Example
-Very the Technology used by own organization and your Competitor – see if your organization is using Old Technology – which could affect the Productivity of organization , quality of Product , Manufacturing Cost of the Product.
 Legal and Regulatory requirements verify the want are Legal r/ and regulatory requirements applicable to organization are  we are complying . if not it could cause penalty to organization.
– Market Competition – Verify the market rate of own product VS Competitor Product Cost .  what is expectation of 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 Team 
who are Involve in Identification of issue ,
Review issues
Take the Action on Significant issue
Record the issue and it’s Review Status – Keep this record for Risk Analysis  and Management Review meeting.
By doing this implementation the requirements of Clause#4.1  will comply for effective implementation of ISO 9001 requirements.