QMS Auditing


Quality Management System (QMS) audits has always been one of the common manufacturing practices whether it’s getting audited by customers, internally audited or auditing suppliers. In this section, details of quality audits and preparation information will be illustrated based on the cumulative experiences from being audited by OEMs or auditing upstream suppliers.

In general, quality audits will be primary focusing on the following (but not limited) scopes listed below

During the on site audit, the following scopes can be broken down for the audit criteria. In addition, the auditors can refer to the 4M1E approach (Man, Machine, Material, Method and Environment) to audit.

Scopes include quality management system’s risk evaluation implementation, roles & responsibilities, quality goals and policies along with training plan/qualifications. 

But different industries will refer to different QMS application. For instance, automobiles will have IATF 16949 in addition to ISO 9001, medical device would refer to ISO 13485…etc.

Information can include designed specification, design transfer record, billing of material, customer notification for change,  product realization timeline (start from New Product Introduction phase all the way to mass production) .

Verification test plans for product trials and respective results. Reports such as functional test report, dimension report, process capabilities can be considered.

On site production management including 5S, process flowchart,  production equipment maintenance record, production control plan, first article inspection, changeover record…etc.

What suppliers do when nonconformity occurred for production, quality system, customer complaints and inspection. This also review the mechanisms of supplier’s corrective and preventive actions. Also need to verify the effectiveness of the nonconformity handling cycle.

Auditing Techniques

The following process flow summarizes the general scope for QMS audit from very beginning until audit completion.

Quality Audit Preparation

Before auditing, QMS professionals can refer to the following process flow diagram to formulate the necessary questions for respective QMS processes.

QMS Process Flow Diagram

In addition to the questionaires, the following diagram will summarize how audit plan was circulated within the PDCA cycle.

QMS Audit Plan Formulation

When performing on-site audit, the following trail is how audit information and observation are formulated before concluding the audit.

Throughout the audit process, auditors shall keep mutual and fair stance to observe the facts and evidences from the audit findings. And also remember to know that audit is an opportunity to find improvement within the system, so how to communicate with suppliers fairly while respecting supplier’s profession is a mutual balance for auditors as well.

QMS On Site Audit Flow

Additional recording for information such as production record’s integrity and correctness (Good Documentation Practice), review and questioning from operators, production data and process parameter, error proofing function and risk based approach will be the correct methodology to gather necessary information for validating the compliance for audit items.

Based on the following summaries, the following bullet points will summarize the suggested points to ensure the audit is successful and able to help suppliers identify their opportunities to improve.

In conclusion of the audit, audit reports shall be presented and summarized the audit findings along with improvement requirement. The following bullet points will be the key points to summarize the audit and requesting improvement from suppliers.

Required ISO 9001 Documentation Clauses

The following are the list of clauses for ISO 9001 which required DOCUMENTED records.

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