Organizations of all kinds may have a need to demonstrate their responsibility for the Quality Management System (QMS) in place and the associated practice of Quality Audit has become a way to satisfy this need. The intention of these systems is to help an organization establish and improve its policies, objectives, standards and other quality requirements.
A set of quality standards have been developed to guide organizations, auditors and their clients, in the common principles for the execution of quality audits. They also provide definitions of quality auditing and other related terms.
So far the series of standards in this field of quality auditing includes:
- The 9000: 2000 standard The 9001: 2000 ISO 9001: 1994.etc.
UNE-EN 30011-1: 1993 Audits UNE-ENE 30011-2.1993 Auditors UNE-ENE 30011-3: 1993 Audit Management Other standards in this series may be prepared in the future.
2 Definitions
Audit Criteria: Policies, practices, procedures or requirements against which the auditor compares the information collected on quality management. The requirements may include standards, norms, specific organizational requirements, and legislative or regulated requirements.
Audit Evidence: Verifiable information, records or statements of fact. Audit evidence can be qualitative or quantitative, it is used by the auditor to determine when the audit criteria are met. Audit evidence is typically based on interviews, document review, observation of activities and conditions, measurement and test results.
Audit Results: Results of the evaluation of the audit evidence collected compared against the agreed audit criteria. The results of the audit provide the basis for the audit report.
Audit Team: Group of auditors, or an individual auditor, designated to perform a given audit; The audit team may include technical experts and internship auditors. One of the auditors on the audit team performs the role of lead auditor.
Audited: Organization that is audited.
Auditor (Quality): Person qualified to carry out quality audits.
Quality audit: Systematic, documented and objective verification process to obtain and evaluate the audit evidence and determine which specific activities, events, conditions, management systems, quality or information regarding these aspects, meet the audit criteria, and the communication of the results of this process to the client.
Lead Auditor (Quality): Person qualified to manage and perform quality audits.
Technical expert: Person who provides the specific knowledge and experience to the audit team, but who does not participate as an auditor.
3 Pre-Work Activities in the Company
3.1. Audit Objectives
The audit must be based on objectives defined by the client. The scope is determined by the lead auditor in agreement with the client to achieve the objectives. The scope describes the extent and limits of the audit.
The objectives and scope should be communicated to the auditee before the audit.
The following are examples of typical objectives:
| to) | Determine compliance with the auditee's QMS audit criteria. |
| b) | Determine when the auditee's QMS has been properly implemented and maintained. |
| c) | Identify areas for potential improvement. |
| d) | Assess the QMS of an organization when there is a desire to establish a contractual relationship, such as that with a potential supplier or business partner. |
A quality audit should focus on clearly defined and documented criteria.
The audit is only carried out if, after consultation with the client, it is the opinion of the lead auditor that:
- There is sufficient and appropriate information on the subject of the audit.
- Adequate resources exist to support and endorse the audit process.
- There is adequate cooperation from the auditee.
3.2. Profile and Responsibilities
3.2.1 Audit Team
The audit team is made up of the lead auditor and the other team members, who may be auditors or technical experts.
To ensure the objectivity of the audit process, its results, and any conclusions, members of the audit team must be independent of the activities they audit, must be objective, and free of any tendency or conflict of interest during the process.
The use of external or internal members of the audit team is subject to the discretion of the client. A member of the chosen audit team within the organization should not be directly responsible for the topic being audited.
Members of the audit team must possess an appropriate combination of knowledge, skills, and experience to fulfill the responsibilities of the audit.
3.2.2. Leader auditor
The lead auditor is responsible for ensuring efficient and effective conduct of the audit within the scope of the audit.
Additionally, the lead auditor has the following responsibilities and activities to fulfill:
| to) | Consult and agree with the client on the scope of the audit. |
| b) | Obtain relevant supporting information such as the details of activities, products, services, in the company and its areas of action, the details of previous audits carried out on the auditee. |
| c) | Formation of the audit team. |
| d) | Direct the activities of the audit team. |
| and) | Prepare communications. |
| F) | Coordinate the preparation of detailed documents and work procedures and assemble the audit team. |
| g) | Represent the audit team in discussions with the auditee, before, during and after the audit. |
| h) | Carry out the audit reports for the client. |
3.2.3. Auditor
The auditor's responsibilities and activities should cover:
| to) | Plan and carry out the assigned tasks, objectively, effectively and efficiently, |
| b) | Collect and analyze relevant and sufficient audit evidence to determine the audit results. |
| c) | Prepare the working documents. |
| d) | Document the individual results of the audit. |
| and) | The writing of the audit report. |
As standardized, each member of the audit team should be assigned specific tasks, or activities to be audited. These appointments must be made by the lead auditor, in consultation with the members of the appropriate audit team.
3.2.4. Responsibilities of the client and audited.
Responsibilities must cover:
| to) | Define the objectives of the audit, |
| b) | Provide resources to the appropriate authorities to conduct the audit. |
| c) | Approve the audit plan, |
| d) | Receive the audit report and determine its distribution, |
| and) | Inform employees of the objectives and scope of the audit, when necessary. |
| F) | Appoint responsible and competent personnel to accompany the members of the audit team, to act as guides within the company and to ensure that the auditors are aware of the health, safety and other requirements that are appropriate, |
| g) | Provide access to relevant facilities, personnel, information and records at the request of the auditors. |
3.2.5. Scope of the Audit
The scope describes the entire quality management system, procedures, and all the sections of the quality standard applied for the implementation of the system as well as the information related to legal and administrative documentation of the company by the audit team, in factors such as physical location, organizational activities, and how to make reports.
The scope of the audit must be determined between the client and the lead auditor. The auditee should normally be consulted when determining the scope of the audit. Any subsequent changes to the scope of the audit must be made in mutual agreement between the client and the lead auditor.
The resources entrusted to the auditor must be sufficient in quantity and quality to meet the required scope.
3.2.6. Audit plan
An audit plan must be established and communicated to the client. The client must review and approve said plan.
The plan should include:
| to) | The objectives and scope of the audit, |
| b) | The criteria to be used to carry out the audit, |
| c) | The identification of the organizational and functional units to be audited, |
| d) | The identification of the functions and / or individuals within the organization of the auditee who have responsibilities related to quality aspects. |
| and) | Identification of quality aspects that are of high priority. |
| F) | Identification of reference documents. |
| g) | The expected time and duration for interviews and inspections. |
| h) | The dates and places where the audit will be carried out. |
| i) | The Schedule of meetings to be held with the auditee's management. |
| j) | Confidential requirements. |
| k) | The content, format and structure of the report. |
3.2.7. Work document
The working documents required to facilitate the auditor's investigation must contain:
| to) | The forms that document the evidence and support the results of the audit. |
| b) | The procedures and checklists used to evaluate the elements of the QMS. |
| c) | Meeting records. |
Working documents should be kept at least until the audit is complete, confidential information must be securely safeguarded by members of the audit.
4. Activities to be carried out at the site of the audit
4.1. Initial Meeting
There should be an opening meeting. The purpose of an opening meeting is to:
| to) | Present the members of the audit team to the auditee's management. |
| b) | Review the scope, objectives, and audit plan and agree on the audit time table. |
| c) | Provide a short summary of the methodology and procedures to be used during the audit. |
| d) | Confirm that the resources and facilities needed by the audit team are available. |
| and) | Promote the active participation of the auditee, |
| F) | Review the security and emergency procedures relevant to the audit team. |
4.2 Detection of Evidence
Appropriate information should be collected, analyzed, interpreted, and documented to be used as audit evidence in a verification and evaluation process to determine if the audit criteria are being met.
The audit evidence must be of such quality and quantity that competent quality auditors, each working independently, arrive at audit results similar to the evaluation of the same evidence against the same audit criteria.
The audit evidence should be collected through interviews, document review, and observation of activities and conditions.
Information gathered through interviews should be verified by acquiring supporting information from independent sources, such as observations, records, and results of existing measurements. Statements that cannot be confirmed must be identified as such.
Auditors should examine the basis of relevant sampling programs and procedures to ensure quality control of effective sampling and measurement processes.
4.3. Audit Results
The audit team should review all the audit evidence to determine where the QMS audit criteria are not met. The audit team should then ensure that the results of the nonconformity audit are clearly, concisely documented and supported. by the audit evidence.
The evidence contrasted during the quality audit will inevitably be only a sample of the information available, partly due to the fact that a quality audit is conducted over a limited period of time and with limited resources. Therefore there is an element of uncertainty inherent in all quality audits and all users of the results, all quality audits must be sure of the collection of evidence and non-conformities, their physical and documentary evidence being contracted.
The quality auditor should consider the limitations associated with the audit evidence found during the audit and the recognition of the reliability of the results and any conclusions of the audit, these factors should be taken into account when planning and executing the audit.
The quality auditor must obtain sufficient evidence so that the individual results of the audit, added to the less significant results, can affect any conclusion reached.
The results of the audit should be reviewed with the auditee's management in order to obtain recognition of the basis of all non-compliance results.
4.4. Final meeting.
After completing the evidence gathering phase and before preparing an audit report, auditors should have a meeting with the auditee's management and those responsible for the audited functions. The main purpose of this meeting is to present the results of the audit to the auditee, so that there is a clear understanding and recognition of the basis of those results.
Disagreements should be resolved, if possible before the lead auditor presents the report, final discussions on the meaning and description of the results of the final audit rest with the lead auditor, however the client may still disagree with the results.
4.5. Post-Work Activities in the Company.
4.5.1. Report.
The results of the audit or a summary of these should be communicated to the client in a written report.
The written report is prepared under the direction of the lead auditor, who is responsible for its accuracy and perfection. The information taken in the audit report must be the ones predetermined in the audit plan.
The information regarding the audit to be included in the report must include, but is not limited to:
| to) | Identification of the audited organization and the client. |
| b) | The agreed objectives and scope of the audit. |
| c) | The agreed criteria against which the audit was performed. |
| d) | The period covered by the audit, |
| and) | The date (s) the audit was performed, |
| F) | The identification of the audit team, |
| g) | Identification of the auditee's representatives who participated in the audit. |
| h) | A summary of the audit process, including any obstacles encountered. |
| i) | The conclusions of the audit. |
| j) | The declarations of confidentiality of the contents. |
| k) | The distribution list of the audit report. |
|
XYZ, SA |
BASED SGMA AUDIT
EN UNE-EN- ISO 9001: 2000 |
VDO-SGC-
10010 |
INTRODUCTION
We could say that in terms of Management Systems, the Quality area has been the pioneer in all types of organizations.
The UNE-EN-ISO 9001 Standard: Quality Systems. Model for quality assurance in design and development, production, installation and after-sales service.
The ISO 9001 standard is the most complete of the three Standards (certifiable) 9001, 2 and 3. It develops, in its chapter 4, twenty requirements.
The definition of Audit according to UNE-EN ISO 8402-145: Methodical and independent examination that is carried out to determine if the activities and results related to quality comply with the previously established provisions, and if these provisions are effectively implemented and adequate. To achieve the objectives.
PRE-AUDIT PROCEDURE
- Pre-audit of documents
- 1. 1.1. Quality Manual 2. 1.2. Quality plan 3. 1.3. Procedures 4. 1.4. Referential documents and files 5. 1.5. Reports of previous audits 6. 1.6. Possible certifications 7. 1.7. Responses to the preliminary questionnaires 8. 1.8. Legal documentation
THE INITIAL MEETING
- 1. plan
- 1. 1.1. Reception 2. 1.2. Personal presentation of auditors and interlocutors from the audited sector, and reference data 3. 1.3. Presentation of the organizations, audited and audited 4. 1.4. Presentation of the audit process (review)
- - - objective– - objectives– - last minute modifications program– - deontology of the auditors– - encouragement for the auditees (progress, increased activity, etc.)
- 5. 1.5. Call for cooperation and transparency 6. 1.6. Confidentiality clause (auditors are obliged to respect professional secrecy) 7. 1.7. Provisions relating to material aspects
REQUIREMENTS OF THE STANDARD TO AUDIT
- 1. Management responsibilities2. Quality system 3. Review of the contract 4. Design control 5. Documentation and data control 6. Shopping 7. Control of the products supplied to the customer 8. Identification and traceability of products 9. Process control 10. Inspection and testing 11. 11 Control of inspection, measurement and test equipment 12. Inspection and test status 13. 13 Control of non-conforming products 14. Corrective and preventive actions 15. Handling, storage, packaging, preservation and delivery 16. Control of quality records 17. Internal quality audits 18. Training 19. After-sales service 20. Statistical techniques
| XYZ, SA | AUDIT PLAN | VDO-SGC-
10010 |
AUDIT PURPOSE: Quality management system audit to determine compliance and objectives of the UNE-EN ISO 9001: 2000 STANDARD
COMPANY: ABC, S. A
CIF: AM-1700785
ADDRESS: The Song of a Duro No. 333333
ACTIVITY: Maintenance of Units for Passenger Transport
TEMPLATE: 1750
WORK CENTERS: 3
TYPE OF AUDIT: External of the Quality Management system, is carried out as established by the Quality Regulations.
SCOPE: Maintenance Facilities, Warehouses, Offices, and Service Plants
AUDIT DATE: January 11 and 12, 2002-02-
AUDITOR TEAM: 1 Chief Auditor (JRP) Jenaro Romero Pastor-University Studies
And Auditor in Quality Management Systems.
2 Auditor (APL) Antonio Perez Lopez- University Studies and Auditor of Quality Management Systems.
ACTIVITIES CALENDAR:
|
DATE |
UNE-EN-ISO 9001: 2000, Requirements |
Schedule |
Auditor |
Responsible area |
| 11.01.02 | INITIAL MEETING | 9: 00: 00-9: 30 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | RESPONSIBILITIES OF THE MANAGEMENT | 9:: 30-10: 00 | JRP / APL | D.JR, SE, CSC |
| 11.01.02 | QUALITY SYSTEM | 10: 00-10: 30 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | CONTRACT REVIEW | 10: 30-11: 00 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | DESIGN CONTROL | 11: 00-11: 30 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | CONTROL OF THE DOCUMENTATION OF THE DATA | 11: 30.12: 00 | JRP / APL | D: JR, SE, CSC |
| 11.01.02 | PURCHASES | 12: 00.12: 30 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | CONTROL OF THE PRODUCTS SUPPLIED BY THE CLIENT | 12: 30.13: 00 | JRP / APL | D. JR, SE, CSC |
| 11.01.02 | IDENTIFICATION AND TRACEABILITY OF PRODUCTS | 13: 00-13: 30 | APL | PERSONAL |
| 11.01.02 | PROCESS CONTROL | 13: 30-14: 00 | APL | PERS-, SE, CSC |
| 11.01.02 | INSPECTION AND TEST | 14: 00-14: 30 | JRP / APL | I KNOW |
| 11.01.02 | CONTROL OF INSPECTION, MEASUREMENT AND TEST EQUIPMENT | 16: 00-16: 30 | JRP | D; JP |
| 11.01.02 | INSPECTION AND TEST STATUS | 16: 30-17: 00 | JRP | D, JP |
| 11.01.02 | CONTROL OF NON-CONFORMING PRODUCTS | 17: 00-17: 30 | JRP | I KNOW |
| 11.01.02 | CORRECTIVE AND PREVENTIVE ACTIONS | 17: 30-18: 00 | JRP | D, JP |
| 11.01.02 | HANDLING, STORAGE, PACKAGING, STORAGE AND DELIVERY | 18: 00-18: 30 | JRP | D, JP |
| 11.01.02 | CONTROL OF QUALITY RECORDS | 18: 30-19: 00 | APL | I KNOW |
| 11.01.02 | INTERNAL QUALITY AUDITS | 19: 00-19: 30 | JRP / APL | JP, SE |
| 11.01.02 | TRAINING | 19: 30-20: 00 | JRP / APL | JP, SE |
| 11.01.02 | AFTER SALES SERVICE | 20: 00-20: 30 | JRP / APL | JP, SE |
| 11.01.02 | STATISTICAL TECHNIQUES | 20: 30: 21: 00 | JRP / APL | D, JP, SE |
| 11.01.02 | FINAL MEETING | 21: 00-21: 30 | JRP / APL | D, JP, SE, CSC |
| xxxxxxxxx | xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx | xxxxxxxxxxx | xxxxxxxxxx | Xxxxxxxxxxxxxxx |
Jenaro Romero Pastor-Auditor
AUDIT OF THE QUALITY MANAGEMENT SYSTEM
Contributed by: Jenaro Romero Pastor - Auditor - [email protected]
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