Quality system international requirements

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

The revised and adopted module ISO 9001 2000 makes the quality system management requirements extremely clear. The review of Tables 1 and 2, under the heading Correspondence between ISO 9001 (1994) and ISO 9001 2000, reveals that the same processes are specified in both standards, even though they have different names and subheadings. The quality system requirements in ISO 9001 2000 are comprehensively grouped under clause 7 with additional emphasis on customer satisfaction and internal communication. Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to the requirements within clause 7. Such exclusions do not affect the organization s ability or responsibility to provide products that fulfill customer and applicable regulatory requirements. 

The differences with the existing automotive quality system requirements need careful examination. There are additions, deletions, and movements that users of QS-9000 Third Edition, AVSQ 94, EAQF 94, and VDA 6.1 1998 need to be aware of, as they affect not only supplier quality systems but the internal and external auditing practices. As the national requirements are not similarly structured comparisons are impossible to illustrate in a single table. Readers are therefore advised to compare specific text in each to discover the actual differences. The source of the requirements is depicted in the tables that follow. A dash (-) indicates that there is no matching requirement. 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

The standard requires the supplier to investigate the cause of nonconformities relating to product, process, and quality system and record the results of the investigation. The supplementary requirements require the supplier to use problem-solving methods when an internal or external nonconformity occurs. 

The requirement is also somewhat duplicated in clause 4.1.3 on management reviews. You are required to conduct management reviews to ensure quality system effectiveness and conduct internal quality audits to determine the effectiveness of the system. It would appear that the audit collects the evidence and the review ensures that it is collected. 

Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012. One of these schemes was addressed by my QS-9000 Quality S /stems Handbook, published in 1996. In the same year the automakers of the USA and Europe formed the International Automotive Task Force (lATF) which, in cooperation with the technical committee of the International Organization of Standardization (TO 176), produced ISO/TS 16949. Use of and registration to this new standard is currently voluntary. It is intended that following the first revision to incorporate ISO 9000 2000, the ISO/TS 16949 certification scheme will be mandated by all major vehicle manufacturers on their Tier 1 suppliers. As a result, the standard will be cascaded along the supply chain, ultimately reaching all suppliers to the global automotive industry. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

The regular internal auditing of a quality system is a fundamental requirement. These audits should be conducted by persoimel independent of the operational area being audited for example a quality department should not audit its own activities. The results of such audits, together with those from outside inspection bodies, will invariably identify areas for improvement. 

ISO Guide 34 (1996) Quality system guidehnes for the production of reference materials. (Revised March 1998 as ISO/REMCO document No 464 General requirements for the competence of reference material producers . The revised Guide 34 will appear early 2000.) International Organization for Standardization, Geneva. 

This Chapter describes outlines and discusses the regulations applicable to the QA function and unit, structure, function, charter, and application of the unit in the pharmaceutical manufacturing environment. In addition, it discusses additional quality-related responsibilities that may result when manufacturers move toward a quality systems approach to quality that incorporates current quality system models to further improve quality and harmonize with international quality system requirements. 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

International Conference on Harmonization (ICH) (2005), Q10 Pharmaceutical quality systems, final concept paper, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

Manufacture of excipients in compliance with excipient GMP requirements is based upon an International Organization for Standardization (ISO) 9001 compliant quality system as the foundation to which additional GMP requirements are added. If the manufacturer of the excipient chemical has achieved certification to ISO 9001, then the specific GMP requirements can be added to the quality system already in place. Otherwise, all manufacturing-related ISO 9001 requirements should be implemented in an ISO compliant manner. Therefore such ISO requirements as a sound document... 

The ISO 9001 2000 international standard adopted by (company name) specifies requirements for a quality management system to demonstrate the ability to consistently provide products that meet customer satisfaction and applicable regulatory requirements. The objective is to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system. In this quality system manual, the term product applies only to the product intended for, or required by, a customer. It should be noted that no exclusion is permitted in the adopted model. 

The company has revised the existing ISO 9001 quality manual, and the contents of this manual refer to international standard ISO 9001 2000. No exclusions of the quality system requirements are permitted. 

The international standard ISO 9001 2000 specifies quality system requirements for use where a contract between the company and customers requires demonstration of the capability to design and supply the product in compliance with the applicable regulatory requirements and customer satisfaction. The contents of the adopted standard refer to design, manufacture, and final product inspection and testing. No exclusions permitted. 

The contents of the ISO 9001 1994 international standards are described below in correspondence with ISO 9001 2001 to define quality system requirements and management responsibilities. 

Company name) is in compliance with the requirements of an international standard ISO 9002 1994 quality system — model for quality assurance in production and installation. However, the second edition (ISO 9002 1994), together with ISO 9001 1994 and ISO 9003 1994, is cancelled and replaced by a third edition of the ISO 9001 2000 module. It constitutes a technical revision of these documents. The quality manual QM-3 is prepared in accordance with the corresponding changes specified in the third edition of ISO 9001 2000. 

The contents and the elements of this ISO 9002 quality system manual are revised in accordance with the requirements of international standard ISO 9001 2000. 

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