ISO 9001 Framework Factory Audit

What is the ISO 9001 Factory

The ISO 9001 Supplier Audit also called In-Depth Factory Audit, Complete Supplier Evaluation or even Supplier Quality Management Assessment is a vendor qualification operation aiming to verify the compliance of your supplier quality management system face to ISO 9001 standard requirement. This audit is performed during the sourcing phase before selecting a vendor.

It aims to verify wether the quality management system of your supplier is really and properly set up according to ISO 9001 standard.

Why use the ISO 9001 Factory Audit

When you perform your sourcing using B2B platform you may find an important number of potential supplier who claim being ISO 9001 certified. It normally means their quality management system has been defined, established, verified and controled. Yet, although having ISO certificate paper, many of them may not really implement ISO 9001 principles and phylosophy on their daily operation. Sometimes they do it partially only.

Sometimes, issue may comes from  not getting updated on the last requirement of the standard, having certificate expired, having the people who was in charge of managing with quality management internally to have quitted (turnover in asian factories may be high)/

In Asia, “under the table gifts” to obtain some certification with some organizations (not all fortunately) are common and having a certificate to show to a potential buyer doesn’t necessarily reflect supplier capability to really implement ISO 9001 principles.

For all those reasons, in order to help you in taking your decision about your supplier appointment for your next order, performing a real assessment of your supplier with a neutral third party like us may give you the advantages to have an objective view of the situation.

When the ISO 9001 Factory Audit is occurring

This ISO 9001 Supplier Audit takes place during your sourcing phase before you place an order and lock this order with a down payment.

Where the ISO 9001 Factory is taking place

The ISO 9001 Supplier Audit will takes place at the vendor premises. If your source is a manufacturer it will be made at the factory premise. If your supplier is a trading company there are chances that the auditor get invited to perform its audit at the manufacturing area which they cooperate with for production.

Who conduct the ISO 9001 Factory

The ISO 9001 Supplier Audit will be performed by a ISO 9001 qualified auditor having a significative experience in the field of your product.

How does the ISO 9001 Factory is performed

During a ISO 9001 Supplier Audit the auditor will visit the premises of your supplier and will assess its capability to comply with the ISO 9001 quality standard on a manufacturing point of view. He will especially follow and analyze your vendor capability to implement the quality management principle of ISO 9001 standard for manufacturing process. This especially include the following:

• Production scope: Supplier has established some target, KPI and threshold for its production, etc.
• Control of records: Capability to control its activities by implementing document included in organizational system
• Quality policy: Existence of an internal quality assurance system supervised by specialized personnel.
• Internal communication: Regular coordination of personnel from all departments regarding progress as a whole.
• Management Review: Assessment of management’s role in implementing and maintaining the required quality policy.
• Human resource management: Competence, training, and awareness of human resource issues.
• Work environment: Maintenance of a safe, sanitary and efficient production facility.
• Purchasing: Maintenance of an organized network of reliable raw material and component suppliers.
• Control of nonconforming product: Isolation and disposal of units that do not conform to the client’s specifications.

What the ISO 9001 Factory is checking

The auditor will especially focus his time on checking the following:

1. Vendor Profile: real name of manufacturer, contact details, business licenses check etc.
2. Employees and Workforce: management organization, QC employees, engineering team, workers on the line etc.
3. Facility Check: real address, premises, equipment inventory, number of production lines etc.
4. Clients and Experience: customers being currently services, samples present on site etc.
5. Documents Verification: business licenses, export license, quality certificates etc.
6. Quality Management System:

• Design Control
• Purchasing Control
• Storage Management
• Incoming Inspection
• Production Control
• Final Internal Product Inspection & Testing
• Control of Measuring & Testing Equipment
• Resource Management
• Continual Improvement
• Social Environment Responsibility

What is the process for the ISO 9001 Factory Audit

The ISO 9001 Audit involves the ISO 9001 qualified auditor to get appointment with your supplier and to analyze the supplier capability to follow the ISO requirement. Normally, at this stage we may send a short questionnaire to your supplier to prepare the audit. Once arrived on site, a quick briefing will explain to the supplier what is the goal of the audit and how it will be conducted.

The auditor will then start auditing into the factory by following the ISO 9001 standard for quality management system. He will especially analyze how your supplier is organized and structured in terms of quality assurance procedure for production. The auditor will give a rate for the adherence to the standard for each sub-category of the process.

At the end of the day, a debriefing will be done with the supplier to explain him his strong and weak point and the ISO 9001 Audit report will be established.

For those supplier who are not perfectly qualified with ISO 9001 standard, we have the option to perform and establish corrective action plan and follow up which would be implemented to tend becoming more compliant with the standard and with the finality to be certified. This extra work is performed during a Quality Consulting mission which may last several months.

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