Internal Audit - The ISO 9001 requirements for internal audits and reviews program

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"What a headache" - that is surely what every employee think to himself, when approaching the massage of an internal audit obtained. There is a reason. You know that is someone to poke their works ... The internal audit is contained in chapter 8.2 - Monitoring and measurement. It 'clear that the purpose of internal control to monitor and measure the lead organization. Internal audits, sometimes called the first part, are conducted by or onName of your organization for internal purposes and may provide the basis for an organization of self-declaration form. The organization must conduct the tests on time to ensure that the Quality Management System:

Managed by ISO 9001
Managed by the needs of a society and audit requirements

What are the criteria for a test? Set of policies, procedures or requirementsa reference.

We believe that the end of the day of the internal control that an internal audit that the organization does. Within the organizational structure, it is difficult for top management to see what's going down the organization. It is not enough to step in production warehouses, distribution centers or service centers and see the staff or goods on the shelves. It 'should monitor the processes and see if they holdbased on predefined criteria. Only high resolution sampling can be done with the real organization of the state. What are the criteria? The ISO 9001 requirements, operating procedures, plans, objectives - the characteristics of the system of quality management.

As internal audit is a very serious and wide, there are all part of one article. This article uses the ISO 9001 for the maintenance of the internal control system with FireReference to ISO 19011 - a guide for standard quality or environmental testing. The standard was published in 2002 and subsequent guidance outlines for the conduct of audits, but also point to the auditor of skills and activities. Unfortunately, the ISO 9001 standard specifies the requirements, but not as we are led to an effective test - one that would cover not only the requirements but also help lead the organization. We use this address in another article(We can not all the secrets in a single article. Sorry. Corporate Policy).

The requirements of ISO 9001 for internal audit audit procedure interanl

ISO 9001 requires to maintain a documented procedure for describing the procedure for conducting an internal audit process. This is not a recommendation but an obligation. The documented procedure must define:

If you must carry out the review - the responsibility for implementing the internal audit process.
What are the organizational units within the scope - Departments, the specific processes, activities, attractions, function, etc.
Description of the process - who met with whom and where and what to bring to all.
The monitoring of internal audit (not upset, we go in detail soon). When the examination of evidence should be documented.

It 'can add an attachment to the evaluation of the plan and all types of forms and documents relating toProcess.

The Auditor

The auditor must be objective in the context of the organizational unit is auditing. This is a difficult thing to achieve if the quality manager is the auditor. It is part of the organization. He will always carry out an audit, its smoke colleagues (who sits and eats with lunch, drink coffee or a cigarette). In addition, consultants for monitoring and documenting the situation properly qualified. Remember, a test is an emotionalEvents where employees are tested on the quality of their services. The examination of the strategy is very important to review progress. In addition to his personal approach, the examination must have a minimum knowledge with the field to assess the processes and quality, which is working procedures (the criteria documented). These types of knowledge and relate to their ability to assess the situation, while he identified any irregularities or errors.As part of ISO 19011 is a specific quality is required for the auditor:

Ethics - credibility, integrity and honesty.
Open Minded - is ready to listen, learn and accept new ideas.
Diplomatic - manners high his colleagues - after all he has to work with people and he is the representative of top management.
Observer - has the ability to recognize what he sees and understands, without questioning.
Perspective - has the ability to assessSituations in appearance, with a broad systematic view of things - has the ability to understand the organizational consequences of his statement.
versatile functions - the ability to mobilize from one situation to another, without direction.
Persistence - has its own goals with perseverance and not be distracted.
Decisive - ready to take the decision
Independent - has its own vision of things and are not influenced by the environment.

We recommend ainfinite patience. During the audit, people would have everything (but everything to divert) the auditor of the subject, try all sorts of reasons: they want to hide their activities, they are afraid or just not like when other people through their moves. The investigator must always remain patient and wait for his question answered. In most cases the customer to respond to completely different answers. At some point things go hand in arguments and disputes. The auditor must remaincold, patience - it was said, be "business as usual" - the test should make it clear, the test is not performed for all subjects, but a decision by top management. The auditors must have a target - with the leaders of the real state of the organization. Can not be on schedule, and interested. This is only a tool and not the destination.

Audit program

The organization should maintain a documented plan for conducting the tests. The program9001 must be documented according to ISO. This is not a recommendation but a requirement! The purpose of this program is to ensure that the tests be carried out as planned. So first, you need a program. The ISO 9001 standard requires the implementation of the tests and the final deadline. This ensures that employees knew that the test is part of the quality management system and not an arbitrary decision is currently the top management. Thisrecommended publishing the lists of control. And for the "Surprise checks - you must not set time to publish easily. The testing program must include:

quality plans for products - for any request for product manufacturing, you should consider running as expected. The best way is to try. Select the product you require to plan their quality and whether the product was made according to the plan. Document the results then.
The ISO 9001 requirementsRequirements including documentation (customer complaints, purchasing information, CAPA, training, etc.). The investigation must have all organizational units that are linked to the achievement of product or group carried out the quality scale. Each unit must be tested at least once a year.
Evaluate processes and procedures - the audit and whether the processes that are related to product manufacturing will be done as required. It might be a correlation with the qualityFloors. But usually a sample to test and evaluate their performance.
Quality Objectives - The audit must examine whether the organization in achieving its quality objectives. It evaluates the objectives - be they related to the product, and assess the results. Where has shown that the targets are reached - will be presented with reasons and measures.

It is not easy for an auditor. There are so simple, they say, without some of the aboveto help.

Audit evidence and results

After the audit, the auditor must provide a separate report on the audit evidence and results. The report must include:

Who were the participants - you should document who participated in the test. The aim is that top management would do its investigation - would know who to approach.
The head - the organization or unit, were examined.
to illuminate General Detailson the basis of verified: How many employees, special projects, specific recent events - information that would be the test.
Check reference to prior investigation and findings before - the examiner must ensure that all defects that during the last tests were found, the treatment was documented and removed, especially, they are not repeated.
Evidence based on test results - that what the auditors discovered and, as it indicates the criteria: good, requiresImprovement requires action or corrective measures (in this article, we would not address the classification of results). In fact, this is the most important part of the report. It defines what the examiner saw and how it was. The investigator should document the test as accurately as possible.
Recommendations - to a determination of the audit may be paid his recommendation.

A sum of all deficiencies identified during the examination - the aim is for this reason: to collect all deficiencies fortop management review to monitor the corrective action for the next audit This amount will be a report of corrective action - but that's another topic. Remember - This report is for top management and the role, responsibility for the organization being called. This report is a tool for him to understand the state. It is therefore recommended that the report would be in a format that is easy to understand for him.

Summary

The purpose of the review is tothat the Quality Management System according to ISO 9001 and the proper maintenance, are required.
You are required to maintain a procedure that specifies the internal review process.
The examiner has a great responsibility. Therefore, he must have a vision for the environment and control, have the ability to evaluate and test, have a broad view of things.
The examiner must politely with high morals, be patient and persistent. The test isto meet an easy task. The organization must maintain an audit program. The purpose of the program is to ensure that the tests be carried out as planned.
After the audit, the auditor must submit a specific report on our audit. This report is the function that is called for the head.