Mandatory Documents in ISO 9001

Mandatory Documents in ISO 9001

Mandatory Documents in ISO 9001

When implementing ISO 9001 - the following documents are required and shall be audited by the Auditor:

Clause 4: Context of the organization


Document Needed: List of Internal External Issues

4.2 Understanding the needs and expectations of interested parties

Clause  Document Needed Remark
4.Context of the organization    
4.1 Understanding the organization and its context List of internal & external Issues.  
4.2 Understanding the needs and expectations of interested parties
  1. List of Interested parties 
  2. The needs and requirements of the interested parties.
4.3 Determining the scope of the 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

The scope shall also mention justification of any exclusions sought from Cl 4 to Cl 8

4.4 Quality management system and its processes

Quoting "The organization shall determine the processes needed for the quality management system and their application throughout the organization" the auditor shall seek SOPs for all processes within QMS.

Quoting 4.4.1 a to h - The auditor will check if all defined process SOPs have

1. Input & outputs defines

2. Sequence & interaction of Processes

3. Definition of criteria & method for process evaluation and monitoring

4. Resource required & their provisioning.

5. assignment of  the responsibilities and authorities for these processes

6. address the risks and opportunities

7. Evaluation of the processes

8. Improvement of Processes.

5. Leadership    
5.1 Leadership and commitment

 Leadership & commitment is an important auditable elements in ISO 9001. Through this portion, they have sought several things including:

Communicating the importance of effective quality management and of conforming to the quality management system requirements


5.2 Policy    
5.2.1 Establishing the quality policy

1. Documented Quality Policy

2. Quality Policy to mention the purpose of the organization. ( & Context and strategic direction)

3. Policy statement to have mention of "commitment to satisfy applicable requirements"

4. Policy Statement to have a mention of " commitment to continual improvement of the quality management system"


5.2.2 Communicating the quality policy

QP has to be available as Documented information

QP must be communicated (Auditor to seek evidence of Communication)

QP to be made available to "interested parties" (Auditor to seek evidence of this communication.