ISO 9001:2000 - Clause 8.2.2. Internal Audit (internal audit outsourcing)
Thursday, February 14, 2008
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(Double-click on the image to enlarge) DEFINITIONS 3.9.1 audit
systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which they meet the criteria for audit 1
NOTE Internal audits, sometimes called first-party audits are performed by or on behalf of, the organization for management review and other internal purposes, and may form the basis for the statement conformity of an organization. In many cases, particularly in smaller organizations, independence can be demonstrated to be free the auditor of responsibilities in the activity being audited. NOTE 2
External audits include those generally termed second and third audits party. The second party audits are conducted by parties having an interest in the organization, such as customers, or others on their behalf. Third party audits are conducted by independent external auditing organizations, such as those that provide certification / registration in accordance with ISO 9001 or ISO 14001. NOTE 3 When
audited together two or more management systems, is called "combined audit."
NOTE 4 When two or more auditing organizations cooperate to audit a single auditee, it is called "joint audit." 3.9.2
audit program
set of one or more audits planned for a period of time and directed towards a specific purpose
NOTE An audit program includes all activities necessary to plan, organize and conduct audits. 3.9.3
audit criteria set of policies, procedures or requirements
NOTE Audit criteria are used as a benchmark against which we compare the evidence of the audit.
3.9.4 Audit evidence
records, statements of facts or other information that are relevant to the audit criteria and verifiable
NOTE Audit evidence can be qualitative or quantitative. 3.9.5
audit findings
results of the evaluation of the collected audit evidence against audit criteria
NOTE Audit findings can indicate conformity or nonconformity with audit criteria, or opportunities improvement. 3.9.6
conclusions audit
result of an audit provided the audit team after consideration
objectives of the audit and all audit findings
3.9.7 audit client
organization or person requesting an audit
NOTE The audit client may be audited or any other organization that has
regulatory or contractual rights to request an audit. 3.9.8
audited organization being audited auditor
3.9.9
person with demonstrated personal attributes and competence to carry out an audit
NOTE Attributes relevant personal auditor described in ISO 19011. 03/09/1910
audit team
one or more auditors conducting an audit supported, if necessary, technical experts
NOTE 1 One auditor of the audit team is appointed as auditor leader.
NOTE 2 The audit team may include auditors in training. 09/03/1911
NOTE 1 specific knowledge or experience are related to the organization, process or activity to be audited, language or culture .
NOTE 2 A technical expert does not act as auditor in the audit team. 09/03/1912
audit plan describing the activities and arrangements for an audit
09/03/1913
audit scope
extent and limits of an audit
NOTE The audit scope generally includes a description of the locations, organizational units, activities and processes as well as the time period covered. 09/03/1914
competition
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REQUIREMENT ANALYSIS - INTERNAL AUDIT PROCESS
OBJECTIVE The purpose is to establish an internal auditing program that gives confidence to the organization that the QMS is effectively implemented and conforms to the requirements of ISO 9001:2000
DATA ENTRY
as input to this process we can consider:
* competent auditors, to ensure objectivity and impartiality
* Procedure (s) documented (s ), responsibilities and authorities defined in relation to the audit, list or check verification and formats several
* defined audit criteria and methods for ensuring that all aspects of ISO 9001:2000 8.2.2 a) and b) have been implemented
* Results of previous audits and details of previous nonconformities
* Any analysis of areas and processes of high risk or potential problems
ACTIVITIES
The organization shall identify personnel to meet the competencies required to conduct audits, as indivdual and / or group. This involves considering:
* Knowledge of ISO 9001:2000 QMS and operation
* Knowledge of the audited processes
* Skills audit and, where appropriate, to lead the audit team
comuncar* Skills for the findings of the audits
* Availability, objectivity and impartiality
The organization must create a program audits covering:
* The SGC process
* All functions and relevant areas of the organization
defining the frequency of audits, an organization must consider:
* The relative importance of different processes, functions as well as audited
* The performance history of the organization and any relevant items from previous audits
The degree of implementation, maintenance and compliance of the QMS must be evaluated, therefore the (those) audit criteria and scope should be defined so as to allow such evaluation. Eventually
an organization must meet lso systems to ensure that audit findings are brought out and take any action necessary to confirm that it has achieved the desired result
OUTPUTS
include:
* Procedure (s)
internal audit * audit records
* Reports of non-compliance and corrective actions
* Data for further analysis to identify opportunities for improvement
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MINIMUM REQUIREMENTS (according to 8.2.2 of ISO 9001: 2000 and ISO 14001:2005 4.5.5)
1. Documenting (os) procedure (s) to establish a minimum:
* responsibilities for planning, conducting and reporting the results of internal audits
* criteria, scope, frequency and methods of internal audits
2. Establish an audit program
3. Records of the results of audits
4. Identifying and maintaining the competence of internal auditors
5. Ensure independence and objectivity of the (os) auditor (s).
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INTERNAL AUDIT OUTSOURCING
however, wish to involve personnel with proven skills to help improve your internal audit process, thereby increasing the "value added" of it. Sean
these or other cases, there is a growing tendency to "outsource" or "outsource" the activities of internal audits, an issue which is quite acceptable in policy terms. Many times through this "model" is achieved a greater degree of impartiality and therefore an unsurpassed level of certainty, accuracy and objectivity of the information provided to senior management.
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Wednesday, February 13, 2008
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BPD - GOOD DOCUMENTATION (GDP English-Good Documentation Practice)
With the implementation of management systems or models (quality, environmental or otherwise), have a documentation system (SD) efficiently has become a fundamental need for the proper management and control thereof. In this context the implementation of the Good Practice Documentation (BPD), and a tool can become efficient and helpful.
What is the purpose of BPD ? Basically set controls to the prevention of communication errors, ensuring that staff follow appropriate procedures, in parallel with the implementation of the BPD facilitates the traceability of products, SD effect proper allows us to reconstruct the history of a product, including the use and disposal of raw materials, inputs and intermediate products, bulk products and finished products.
documentation of our system must be able to demonstrate that products and raw materials associated with their manufacture, were monitored throughout the process. To achieve this requires that all specifications, formulations and manufacturing instructions and procedures and records, are formalized, that is, well written and contain no errors, it is essential therefore to ensure the integrity and readability documents.
In conclusion to implement BPD is achieved:
1) Increase efficiency in the organization of documents.
2) Reduce the effort associated the compliance of various regulatory frameworks.
3) Possible removal of some audits.
4) Improve the effectiveness and scope of training.
5) Increasing efficiency and productivity.
6) Facilitating communication.
2. DOCUMENTS AND THEIR USE
Daily and in almost any context (work, student, etc.). We have contact with a wide range and quantity of documentation. Certainly the management of documents, require no less time for both individuals and businesses, therefore the implementation of the BPD involves optimizing the use of that time.
Concact lies the importance of the documents?, there requirimientos regulatory, legal and / or policy that requires the existence of an SD , consisting of certain documents.
For example, the BPE the WHO Pharmaceutical down that good documentation is an integral and essential part of what is called " system quality assurance, therefore, must be related to all aspects of Practice . ISO standards (9001 and 14001 to name just two) require a manual, policies, objectives and minimum
documented procedures and assuming however possible requsite absence of any kind documetnos demand the use of common sense we can see obvious advantages in applying the BPD :
* Standardize and regulates certain activities
* Minimize the risk of error.
* Increases or strengthens the skills of staff
* Optimize the use of productive time and the training
From the analysis of the benefits we can infer the most common uses for documents, highlighting among others:
* Definition of specifications for materials (reagents, consumables, raw materials, packaging, etc) * Define specifications
tools and methodologies production and inspection / test
* Ensuring the internalizing and handling of the various procedures of the organization.
* Delivery of data used in decision making * Registration information
3. DOCUMENTS (Definition)
1. INTRODUCTION
With the implementation of management systems or models (quality, environmental or otherwise), have a documentation system (SD) efficiently has become a fundamental need for the proper management and control thereof. In this context the implementation of the Good Practice Documentation (BPD), and a tool can become efficient and helpful.
What is the purpose of BPD ? Basically set controls to the prevention of communication errors, ensuring that staff follow appropriate procedures, in parallel with the implementation of the BPD facilitates the traceability of products, SD effect proper allows us to reconstruct the history of a product, including the use and disposal of raw materials, inputs and intermediate products, bulk products and finished products.
documentation of our system must be able to demonstrate that products and raw materials associated with their manufacture, were monitored throughout the process. To achieve this requires that all specifications, formulations and manufacturing instructions and procedures and records, are formalized, that is, well written and contain no errors, it is essential therefore to ensure the integrity and readability documents.
In conclusion to implement BPD is achieved:
1) Increase efficiency in the organization of documents.
2) Reduce the effort associated the compliance of various regulatory frameworks.
3) Possible removal of some audits.
4) Improve the effectiveness and scope of training.
5) Increasing efficiency and productivity.
6) Facilitating communication.
2. DOCUMENTS AND THEIR USE
Daily and in almost any context (work, student, etc.). We have contact with a wide range and quantity of documentation. Certainly the management of documents, require no less time for both individuals and businesses, therefore the implementation of the BPD involves optimizing the use of that time.
Concact lies the importance of the documents?, there requirimientos regulatory, legal and / or policy that requires the existence of an SD , consisting of certain documents.
For example, the BPE the WHO Pharmaceutical down that good documentation is an integral and essential part of what is called " system quality assurance, therefore, must be related to all aspects of Practice . ISO standards (9001 and 14001 to name just two) require a manual, policies, objectives and minimum
documented procedures and assuming however possible requsite absence of any kind documetnos demand the use of common sense we can see obvious advantages in applying the BPD :
* Standardize and regulates certain activities
* Minimize the risk of error.
* Increases or strengthens the skills of staff
* Optimize the use of productive time and the training
From the analysis of the benefits we can infer the most common uses for documents, highlighting among others:
* Definition of specifications for materials (reagents, consumables, raw materials, packaging, etc) * Define specifications
tools and methodologies production and inspection / test
* Ensuring the internalizing and handling of the various procedures of the organization.
* Delivery of data used in decision making * Registration information
3. DOCUMENTS (Definition)
1. Organized form of information that can serve as evidence. This information can be in many kinds of format. James Vesper
2. Information and its supporting medium. ISO 9000:2005
3. * Diploma, letter or other writing concerning about a fact illustrated, mainly from historical data. * Written in reliable data contained or capable of being used as such to prove anything. RAE
4. Information or similar relationship, contained in a medium that allows the duration and use. Author's blog
Therefore a document can be in any medium:
* Paper
* * Computer Audio (electronic - digital) * Visual
result can be considered as documents the following examples:
* Signs, banners, and posters, etc
* Plans, sketches, diagrams, etc.
* computer records, databases, spreadsheets, etc.
* Video security, corporate, advertising, etc. * Memoranda
, fax, email, supplied text messages, conversations via messenger, skype, etc
* Prescriptions, chemical formulas, etc. *
standard operating procedures.
* Log of a team, work books, books by
* decrees, laws, regulations, etc. ------------------------
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gestion_y_calidad@hotmail.com
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