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List of Mandatory SOP and Records For ISO 22000 2018

The document lists the mandatory documents and records required to be compliant with ISO 9001:2015. The mandatory documents include the scope of the quality management system, quality policy, and quality objectives. Mandatory records include calibration records, training records, product review records, design and development records, and audit results. Some records are only mandatory if certain clauses are not excluded. Non-mandatory documents that are commonly used include procedures for determining organizational context, addressing risks and opportunities, training, equipment maintenance, and document control.

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Mohamed Shabir
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6K views1 page

List of Mandatory SOP and Records For ISO 22000 2018

The document lists the mandatory documents and records required to be compliant with ISO 9001:2015. The mandatory documents include the scope of the quality management system, quality policy, and quality objectives. Mandatory records include calibration records, training records, product review records, design and development records, and audit results. Some records are only mandatory if certain clauses are not excluded. Non-mandatory documents that are commonly used include procedures for determining organizational context, addressing risks and opportunities, training, equipment maintenance, and document control.

Uploaded by

Mohamed Shabir
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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List of Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please
note that some of the documents will not be mandatory if the company does not perform relevant
processes eg. Design and development):
 Scope of the QMS (clause 4.3)
 Quality policy (clause 5.2)
 Quality objectives (clause 6.2)
 Criteria for evaluation and selection of suppliers (clause 8.4.1)
And, here are the mandatory records (note that records marked with * are only mandatory in cases when
the relevant clause is not excluded):
 Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
 Records of training, skills, experience and qualifications (clause 7.2)
 Product/service requirements review records (clause 8.2.3.2)
 Record about design and development outputs review* (clause 8.3.2)
 Records about design and development inputs* (clause 8.3.3)
 Records of design and development controls* (clause 8.3.4)
 Records of design and development outputs *(clause 8.3.5)
 Design and development changes records* (clause 8.3.6)
 Characteristics of product to be produced and service to be provided (clause 8.5.1)
 Records about customer property (clause 8.5.3)
 Production/service provision change control records (clause 8.5.6)
 Record of conformity of product/service with acceptance criteria (clause 8.6)
 Record of nonconforming outputs (clause 8.7.2)
 Monitoring and measurement results (clause 9.1.1)
 Internal audit program (clause 9.2)
 Results of internal audits (clause 9.2) eg audit reports, corrective action plan
 Results (outputs) of the management review (clause 9.3)
 Results of corrective actions (clause 10.1)
 Records of risk analysis for determining strengths and weaknesses and threats and opportunities

Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001:2015 implementation.
However, I find these non-mandatory documents to be most commonly used:
 Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2)
 Procedure for addressing risks and opportunities (clause 6.1)
 Procedure for competence, training and awareness/ Training Need analysis (clauses 7.1.2, 7.2 and
7.3)
 Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
 Procedure for document and record control (clause 7.5)
 Sales and Marketing / customer enquiry and order processing procedure (clause 8.2)
 Procedure for design and development (clause 8.3)
 Procedure for production and service provision (clause 8.5)
 Warehouse management procedure/ product dispatch (clause 8.5.4)
 Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
 Procedure for monitoring customer satisfaction (clause 9.1.2)
 Procedure for internal audit (clause 9.2)
 Procedure for management review (clause 9.3)
Some of the non-mandatory documents can be established or developed as SOP or Work instructions
if the management wants to have one. Or a few statements to describe those activities/ processes in
Quality Manual.

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