Sample ISO 9001 Internal Auditing Procedure

1. PURPOSE
The purpose of this procedure is to define the steps that follows in planning, performing, reporting, recording, and following up on internal audits.
conducts internal audits to determine whether the quality management system:
- Conforms to planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by (QMS Manual policies, procedures, work instructions, and forms)
- Is effectively implemented and maintained.

2. SCOPE
This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system.

3. DEFINITIONS
None

4. REFERENCES
4.1 Quality Manual,
5. ASSOCIATED DOCUMENTS
5.1 Audit Check List,
5.2 ERC/ERO Procedure,
5.4 Audit Schedule,
5.3 Audit Notebook

6. PROCEDURE
NOTE 1: This procedure is typically initiated about four weeks prior to the execution of an internal audit as called for by ’s audit schedule. The audit schedule is established and maintained by The Quality Assurance Manager.
NOTE 2: Every element in the quality system is audited on a regular basis and at minimum of once per year. Activities are audited more frequently if there are significant changes taking place (i.e., many new hires/high turnover of personnel, modified procedures and work instructions, etc.) or if there is a history of problems in that area.
NOTE 3: Only qualified personnel may perform internal auditing activities. These qualified personnel are classified as internal auditors and have received the following training as a minimum: 1 day training on internal auditing techniques, 1 day training on the ISO 9001 Standard, this training may be performed by previously trained internal auditors.

6.1 AUDIT PLANNING, COORDINATION, AND PREPARATION
6.1.1 The Quality Assurance Manager defines the specific criteria, scope, methods, and objectives for the upcoming internal audit based on the status, maturity, and importance of specific elements in ’s quality system.
Audits shall be carried out to a defined scope and shall be as follows,
a) Planned: as per the internal audit plan
b) Unplanned: arising as a result of,
- Customer complaints
- Following the implementation of actions defined in a corrective action report
- Following the identification of additional or amended procedures for products
NOTE 4: In planning the particular audit, these activities include determining the extent and boundaries of the audit (locations, activities, processes); set of policies, procedures and/or requirements to be audited against; auditing methods; and audit objectives.
6.1.2 The Quality Assurance Manager selects the appropriate auditor to ensure objectivity and impartiality of the audit process.
6.1.3 The Quality Assurance Manager and the auditor review the proposed audit program to ensure that it is consistent with and effective for the defined audit criteria, scope, methods, and objectives.
6.1.4 Prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited.

6.2 INTERNAL QUALITY AUDIT INVESTIGATION

6.2.1 The auditor will contact the personnel in the area being audited at the time indicated on the audit program, and briefly review the audit criteria, scope, methods and objectives with them.
NOTE 5: The checklists only serve as a guide to the auditors, and other areas may be investigated as deemed necessary by the auditors or as requested by the auditee.
6.2.2 When a nonconformance is identified, the auditor presents the nature of the nonconformity and the evidence to the personnel involved for verification, clarification, and addresses any questions or concerns that the personnel may have, as well as to give advice, when requested, regarding any problems which are uncovered.
6.2.3 If the nonconformance is confirmed, then go to step 6.2.5.
6.2.4 If the possible nonconformance requires further clarification the auditor will discuss the situation with the Quality Assurance Manager.
6.2.5 After the facts of the nonconformity are verified (or modified), the auditor either drafts nonconformance statement or documents the necessary information for writing one later.
NOTE 6: The nonconformance statement includes the nature of the nonconformity, the actual evidence obtained, and the nature of the requirement that is not being complied with (i.e., the appropriate ISO 9001 clause number, the appropriate quality system document section/page/paragraph, what the personnel says is the normal practice, contract requirements, statutory regulations, current standards, and any other relevant requirements).

6.3 REPORTING AND FOLLOW-UP
6.3.1 Within 2 weeks of completing the internal audit program, the auditor prepares a brief internal audit report and submits it to The Quality Assurance Manager for review and approval.
NOTE 7: The audit report includes the audit’s criteria, scope, methods and objectives, the names and titles of the audit team members, a summary of general observations (i.e., general degree of compliance and any significant problems encountered), all statements of nonconformities, weaknesses, and/or opportunities for improvement, and verification results for follow-up activities performed during the audit.
6.3.2 The Quality Assurance Manager reviews and approves the internal audit report, and then distributes copies of the report to senior management and the personnel of the audited areas that were directly involved in the audit.
NOTE 8: Any additional comments or observations of the Quality Assurance Manager can be attached to the report, but the auditor’s observations be will not be deleted or modified by The Quality Assurance Manager.
6.3.3 The Quality Assurance Manager request a Engineering Change Request for any nonconformity listed in the Internal Audit Report and for any weaknesses and “opportunities for improvement” identified and documented.
6.3.4 The Quality Assurance Manager updates and maintains the long-range audit schedule based upon the documented results of the audit and the planned corrective and preventive actions.
6.3.5 The Quality Manager shall maintain an audit notebook detailing all internal and external audits carried out.
- Long-range audit schedule
- Internal audit program
- Completed checklists- signed and dated by each auditor
- Audit report

7. REVIEW PROCEDURE
Any suggested improvements or modifications to this procedure are to be passed on to the Quality Assurance Manager for discussion at the next Quality Review Committee meeting.

Management Review IN ISO 9001 Standard

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Quality Product By ISO 9001 Certification

The International Organization for Standardization (abbreviated to ISO) conducts standards for institutes which are organized in more than 159 countries across the globe. The ISO has its head office in Geneva, Switzerland. In simple terms ISO certification is given to an organization in order to indicate that the organization has good standards and it is working well with its employees and its customers. The International Organization for Standardization is not a Government organization. It acts as a bridge in between the private and the public sector and brings out good standards for many organizations across a variety of industries.

There are many standards that are released by the ISO. One of the standards is the ISO 9001 certification. The reason why an organization may require the ISO 9001 certification is to ensure that the company has a very good quality management system in place and can then confirm this to their customers. Also, if an organization has ISO 9001 certification it can ensure to its suppliers that it is following a good standard regarding it’s quality management system. The main two reasons for going for the ISO 9001 certification are to show how effective a company’s production is as well as helping to give good recognition for other new markets concerning their company standards.

The main aspects of ISO 9001 certification are maintaining good quality of products and also to maintain low cost and high efficiency for the production process. The primary thing that is checked with ISO 9001 certification is to confirm that the quality goals that are set out in the company’s quality management system are met. It is also important that once a company gets its ISO 9001 certification they should be seeking to improve all the time. There should be an increase in productivity as well. The goals of ISO 9001 certification are to increase the efficiency, increase the revenue, establish proper decision making, achieve good supplier relationships and prepare documentation work about the company plans, a regular improvement process should be in place and on the whole a complete customer satisfaction system should be implemented.

The ISO 9001:2008 certifications have a few revised benefits and let us see a few of them in detail. The goals of the ISO 9001 are the same for all year where as a few enhancements will be added for every year. Likewise the ISO 9001:2008 certification’s benefits include cost reduction in the production of goods, greater customer satisfaction, improved product efficiency and improved productivity, reduction in the scrap and waste products. The aim is to prepare a quality product which passes the goals of the quality management system. The ISO 9001 certification itself should result in the reduction of customer claims, a proper delivery to the customer on time, providing great reliability, safety and quality to the products. So on the whole the ISO 9001 certification has many good policies for the organization and they are also ensuring that the quality of the product should be good, efficient and cost effective, with an increase in the productivity.

Kindly visit http://www.iso9001store.com for more information.

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

Continual improvement in the quality management system

Continual Improvement In The Quality Management System
The ISO 9001 standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results and continual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the quality management system means continually increasing the ability of the organization to fulfil its objectives.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:
Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higher
Increase efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources
Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning.
There are several steps to undertaking continual improvement:
1. Determine current performance
2 Establish the need for change
3 Obtain commitment and define the improvement objectives
4 Organize diagnostic resources
5 Carry out research and analysis to discover the cause of current performance
6 Define and test solutions that will accomplish the improvement objectives
7 Product improvement plans which specify how and by whom the changes will be implemented
8 Identify and overcome any resistance to change
9 Implement the change
10 Put in place controls to hold new levels of performance and repeat step one
For more information, please visit http://www.iso9001-standard.us

Scope Of The Quality Management System

Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.
The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.
It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.
For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

Quality Characteristic in ISO 9000

Quality Characteristic In ISO 9000

Any feature or characteristic of a product or service that is needed to satisfy
customer needs or achieve fitness for use is a quality characteristic. When
dealing with products the characteristics are almost always technical character-
istics, whereas service quality characteristics have a human dimension. Some
typical quality characteristics are given below.

Product characteristics
1. Accessibility Functionality Size
2. Availability Interchangeability Susceptibility
3. Appearance Maintainability Storability
4. Adaptability Odour – Strength
5. Cleanliness Operability -Taste
6. Consumption Portability – Testability
7. Durability Producibility Traceability
8. Disposability Reliability – Toxicity
9. Emittance Reparability Transportability
10. Flammability Safety – Vulnerability
11. Flexibility Security – Weight

Service quality characteristics
1. Accessibility Credibility – Honesty
2. Accuracy Dependability Promptness
3. Courtesy Efficiency – Responsiveness
4. Comfort Effectiveness Reliability
5. Competence Flexibility – Security

These are the characteristics that need to be specified and their achievement
controlled, assured, improved, managed and demonstrated. These are the
characteristics that form the subject matter of the product requirements
referred to in ISO 9000. When the value of these characteristics is quantified or
qualified they are termed product requirements. We used to use the term quality
requirements but this caused a division in thinking that resulted in people
regarding quality requirements as the domain of the quality personnel and
technical requirements being the domain of the technical personnel. All
requirements are quality requirements – they express needs or expectations that
are intended to be fulfilled by a process output that possesses inherent
characteristics. We can therefore drop the word quality. If a modifying word is
needed in front of the word requirements it should be a word that signifies the
subject of the requirements. Transportation system requirements would be
requirements for a transportation system, Audio speaker design requirements
would be requirements for the design of an audio speaker, component test
requirements would be requirements for testing components, and management
training requirements would be requirements for training managers. ISO 9000
requirements are often referred to as quality requirements as distinct from other
types of requirements but this is misleading. ISO 9000 is no more a quality
requirement than is ISO 1000 on SI units, ISO 2365 for Ammonium nitrate or
ISO 246 for Rolling Bearings. The requirements of ISO 9000 are quality
management system requirements – requirements for a quality management
system.