• Iso 17025 Quality Manual Template Free Pdf
• Iso 17025 Quality Manual Template Free

Iso17025 quality manual template provides laboratories throughout the world with a package to get iso 17025 accreditation. It is essential to acquire iso 17025 accrediation and compliance. Follow the instructions in iso 17025 template and get hold of iso 17025 laboratory accreditation. Iso17025 quality manual template includes iso 17025 quality manual and iso iec 17025 template.

ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles.^[1]. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.^[2] It is also the basis for accreditation from an accreditation body.

There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the 2000 version of ISO 9001 ^[3]

The 2005 version of the standard comprises five elements; Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.

The 2017 version of ISO/IEC 17025 has modified this structure to be Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements. General Requirements and Structural Requirements are related to the organization of the laboratory itself. Structure Requirements cite those issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results. Process Requirements are the heart of this version of the standard in describing the activities to ensure that results are based on accepted science and aimed at technical validity. Management System Requirements are those steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results.

Predecessors[edit]

Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO/IEC 17025:1999 but could sometimes be exceedingly prescriptive. ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but an auditor (assessor) may require the laboratory to justify using a particular method.

In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.

In common with other accreditation standards of the ISO 17000 series (and unlike most ISO standards for management systems), third party auditing (assessment) of the laboratory is normally carried out by the national organization responsible for accreditation. Laboratories are therefore accredited under ISO/IEC 17025, rather than certified or registered (c.f. ISO 9000 series).

In short, accreditation differs from certification by adding the concept of a third party (Accreditation Body (AB)) attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system, specific to a Scope of Accreditation.

Accreditation bodies[edit]

In order for accreditation bodies to recognize each other's accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO/CASCO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

The first laboratory accreditation bodies to be established were National Association of Testing Authorities (NATA) in Australia (1947) and TELARC in New Zealand (1973).^[4][5] Most other bodies are based on the NATA/TELARC model include UKAS and British Cert.in the UK, FINAS in Finland and DANAK in Denmark to name a few.

In the U.S. there are several, multidisciplinary accreditation bodies that serve the laboratory community. These bodies accredit testing and calibration labs, reference material producers, PT providers, product certifiers, inspection bodies, forensic institutions and others to a multitude of standards and programs. These ILAC MRA signatory accreditation bodies carry identical acceptance across the globe. It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies. ABs include:

• The ANSI-ASQ National Accreditation Board and their recent acquisitions of L-A-B and ASCLD-LAB which are now both [http://www.anab.org/ ANAB
• The American Association for Laboratory Accreditation (A2LA)^[6]
• Perry Johnson Laboratory Accreditation (PJLA)^[7]
• International Accreditation Service, Inc. (IAS)^[8]
• National Voluntary Laboratory Accreditation Program (NVLAP) - technically part of the US government and only accredits a few narrow disciplines
• American Society of Crime Laboratory Directors-Laboratory Accreditation Board (ASCLD-LAB)^[9] which is now ANAB (see above).

In Canada, there are two accreditation bodies:

• The Canadian Association for Laboratory Accreditation^[10]

The accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada (SCC) Program for the Accreditation of Laboratories-Canada (PALCAN), and the National Research Council of Canada (NRC) Calibration Laboratory Assessment Service (CLAS). The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System.

In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for management systems, product certification, laboratory, inspection, personnel and others:

• National Accreditation Board for Testing and Calibration Laboratories (NABL) (India)
• Komite Akreditasi Nasional (KAN) (Indonesia)
• Irish National Accreditation Board (INAB) (Ireland)
• International Accreditation New Zealand (IANZ) (New Zealand)
• Dutch Accreditation Council (DAC) (The Netherlands)
• Bureau of Accreditation (BoA) (Vietnam)
• Korea Laboratory Accreditation Scheme (KOLAS) (South Korea)
• DAkkS (Germany)

See also[edit]

References[edit]

1. ^'Principles behind ISO/IEC 17025'(PDF). Canadian Association for Laboratory Accreditation (CALA). Retrieved 27 March 2018.
2. ^Honsa, Julie D.; Deborah A. McIntyre (2003). 'ISO 17025: Practical Benefits of Implementing a Quality System'. Journal of AOAC International. 86 (5): 1038–1044. Retrieved 28 February 2012.
3. ^'ISO/IEC 17025 Comparison - 1999 to 2005'. SAI Global Limited ABN. Retrieved 28 February 2012.
4. ^'NATA - NATA Field and Program Accreditation Criteria - ISO-IEC 17025 Laboratory Accreditation (Applicable to all ISO/IEC 17025 fields)'. www.nata.com.au. Retrieved 2017-04-28.
5. ^'Testing Laboratory Registration Council Of New Zealand'(PDF).
6. ^'About A2LA'. American Association for Laboratory Accreditation. Retrieved 28 February 2012.
7. ^'ISO/IEC 17025:2005 – Laboratory Accreditation Program- PJLA'. Retrieved 29 May 2015.
8. ^'About IAS The International Accreditation Service'. Retrieved 29 May 2015.
9. ^'ASCLD-LAB home page'. American Society of Crime Laboratory Directors-Laboratory Accreditation Board. Retrieved 12 July 2012.
10. ^'CALA'. Retrieved 29 May 2015.

External links[edit]

The ISO 9000 family of quality management systems (QMS) standards is designed to help organisations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.^[1]ISO 9000 deals with the fundamentals of quality management systems,^[2] including the seven quality management principles upon which the family of standards is based.^[2][3][4] ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.^[5]

Third-party certification bodies provide independent confirmation that organisations meet the requirements of ISO 9001. Over one million organisations worldwide^[6] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticised^[7][8] as being wasteful and not being useful for all organizations.^[9][10]

• 7Evolution of ISO 9000 standards
• 10Effectiveness

Background[edit]

ISO 9000 was first published in 1987 by ISO (International Organisation for Standardization).^[11] It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.^[12] However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the United States Department of Defense MIL-Q-9858 standard in 1959, and the UK's Def Stan 05-21 and 05-24. Large organizations which supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded which led the defence industry to adopt mutual recognition of NATO AQAP, MIL-Q and Def Stan standards. Eventually, ISO 9000 was adopted as a suitable option, instead of forcing contractors to adopt multiple - and often similar - requirements.^[13]

Reasons for use[edit]

The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations^{[clarification needed]}, as the basis of contractual arrangements with their suppliers. This helped reduce the need for 'supplier development'^[vague] by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of product, business type (design responsibility, manufacture only, distribution, servicing etc.) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. The adoption of a single Quality Assurance requirement also lead to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.

A few years later, the UK Government took steps to improve national competitiveness following publication of cmd 8621, and Third Party Certification of Quality Management Systems was born, under the auspices of the National Accreditation Council of Certification Bodies (NACCB) which has become the United Kingdom Accreditation Service (UKAS) .

In addition to many stakeholders' benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business.^[14] Corbett et al. showed that certified organizations achieved superior return on assets^[15] compared to otherwise similar organizations without certification.^[16] Heras et al. found similarly superior performance^[16] and demonstrated that this was statistically significant and not a function of organization size.^[17] Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry.^[18] Sharma identified similar improvements in operating performance and linked this to superior financial performance.^[19] Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark.^[20] Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.^[21]

While the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al. (2005)^[16] may suggest it. Other writers, such as Heras et al. (2002),^[17] have suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.

The mechanism for improving results has also been the subject of much research. Lo et al. (2007) identified operational improvements (e.g., cycle time reduction, inventory reductions) as following from certification.^[22] Internal process improvements in organizations lead to externally observable improvements.^[23][24] The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.^[25]

Global adoption[edit]

The increase in ISO 9001 certification is shown in the tables below.

ISO 9000 series Quality Management Principles[edit]

The ISO 9000 series are based on seven quality management principles (QMP)^[33]

The seven quality management principles are:

• QMP 1 – Customer focus
• QMP 2 – Leadership
• QMP 3 – Engagement of people
• QMP 4 – Process approach
• QMP 5 – Improvement
• QMP 6 – Evidence-based decision making
• QMP 7 – Relationship management

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Iso 17025 Quality Manual Template Free Pdf

Principle 2 – Leadership

Iso 17025 Quality Manual Template Free

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization's overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Contents of ISO 9001:2015[edit]

ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Only ISO 9001 is directly audited against for third party assessment purposes.

Contents of ISO 9001:2015 are as follows:

• Section 1: Scope
• Section 2: Normative references
• Section 3: Terms and definitions
• Section 4: Context of the organization
• Section 5: Leadership
• Section 6: Planning
• Section 7: Support
• Section 8: Operation
• Section 9: Performance evaluation
• Section 10: Continual Improvement

Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the introduction). The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment and improve the quality management system.^[34][35]

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's requirements are being met, while the external auditor's role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.

Certification[edit]

The International Organization for Standardization (ISO) does not certify organisations itself. Numerous certification bodies exist, which audit organisations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 expired around September 2018). Many countries have formed accreditation bodies to authorize ('accredit') the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021,^[36] while accreditation bodies operate under ISO/IEC 17011.^[37]

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services and processes. The auditor presents a list of problems (defined as 'nonconformities', 'observations', or 'opportunities for improvement') to management. If there are no major nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the organization will present an improvement plan to the certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers.

An ISO 9001 certificate is not a once-and-for-all award but must be renewed at regular intervals recommended by the certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.

Evolution of ISO 9000 standards[edit]

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

1987 version[edit]

ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:

• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
• ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
• ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ('MIL SPECS'), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.^{[citation needed]}

1994 version[edit]

ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.^{[citation needed]}

2000 version[edit]

ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and centre the concept of process management (the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

ISO 9000 Requirements include:

• Approve documents before distribution;
• Provide correct version of documents at points of use;
• Use your records to prove that requirements have been met; and
• Develop a procedure to control your records.

2008 version[edit]

ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

ISO 9001 is supplemented directly by two other standards of the family:

• ISO 9000:2005 'Quality management systems. Fundamentals and vocabulary'
• ISO 9004:2009 'Managing for the sustained success of an organization. A quality management approach'

Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.

2015 version[edit]

In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001,^[38] and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as 'beginning of a new era in the development of quality management systems.'^[39] As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.^[40]

The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.^[41]

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.^[42]

Some of the key changes include:

• High-Level Structure of 10 clauses is implemented. Now all new standards released by ISO will have this high-level structure
• Greater emphasis on building a management system suited to each organization's particular needs
• A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
• Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
• Less prescriptive requirements for documentation: the organisation can now decide what documented information it needs and what format it should be in
• Alignment with other key management system standards through the use of a common structure and core text^[43]
• Inclusion of Knowledge Management principles
• Quality Manual & Management representative (MR) are no longer mandatory

Auditing[edit]

Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to, to find out where it can improve, and to correct or prevent identified problems. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgements.

Industry-specific interpretations[edit]

The ISO 9001 standard is generic; its parts must be carefully interpreted to make sense within a particular organization. Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (United States), professional soccer teams (Mexico), and city councils (UK)—have successfully implemented ISO 9001:2000 systems.

Over time, various industry sectors have wanted to standardise their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

• The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
• AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100D.
• PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.
• ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements. After the new edition of ISO 9001:2015 the ISO/TS 16949:2009 was also completely revised and reissued by IATF (International Automotive Task Force) IATF 16949:2016 is now a stand-alone standard which doesn't include the ISO 9001:2015 requirements but still refer to them and works as additional automotive specific requirement to ISO 9001.
• TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry. The TL 9000 standard is made up of two handbooks: the QMS Requirements Handbook, and the QMS Measurement Handbook. The current versions of the Requirements and Measurements Handbooks are 5.0. Unlike ISO 9001 or other sector-specific standards, TL 9000 includes standardized product and process measurements that must be reported into a central repository, which allows organizations to benchmark their performance in key process areas against peer organizations. It is important to note that TL 9000 R5.0 contains the full text of ISO 9001:2008.
• ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical devices manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
• ISO/IEC 90003:2014 provides guidelines for the application of ISO 9001 to computer software.
• ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
• ISO 22000 Food Safety Management Systems.

Effectiveness[edit]

The debate on the effectiveness of ISO 9000 commonly centres on the following questions:

1. Are the quality principles in ISO 9001 of value?
2. Does it help to implement an ISO 9001-compliant quality management system?
3. Does it help to obtain ISO 9001 certification?

The effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:

1. Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.
2. How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
3. How well the ISO system focuses on improving the customer experience. The broadest definition of quality is 'Whatever the customer perceives good quality to be.' This means that a company doesn't necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer's experience.
4. How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas for improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.

Advantages[edit]

Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.^[44] The quality principles in ISO 9000:2000 are also sound, according to Wade ^[45] and Barnes, who says that 'ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive'.^[46] Sroufe and Curkovic, (2008) found benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management.^[44] According to ISO^[47] the 2015 version of the standard brings the following benefits:

1. By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities.
2. Organizations can identify and address the risks associated with their organization.
3. By putting customers first, organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat customers, new clients and increased business for the organization.
4. Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down.
5. Organizations will meet necessary statutory and regulatory requirements.
6. Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business.

Criticisms of ISO 9001 certification[edit]

A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for a complete implementation, and later when needed; ISO 9001 certification.^[7] Dalgleish cites the 'inordinate and often unnecessary paperwork burden' of ISO, and says that 'quality managers feel that ISO's overhead and paperwork are excessive and extremely inefficient'.^[48] The level of minimum documentation for a minimum scope organization has been greatly reduced, going from ISO 9001:2000 to ISO 9001:2008 to ISO 9001:2015.^{[citation needed]}

According to Barnes, 'Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed'.^[46] Wilson suggests that ISO standards 'elevate inspection of the correct procedures over broader aspects of quality', and therefore, 'the workplace becomes oppressive and quality is not improved'.^[8]

One study showing reasons for not adopting this standard include the risks and uncertainty of not knowing if there are direct relationships to improved quality, and what kind and how many resources will be needed. Additional risks include how much certification will cost, increased bureaucratic processes and risk of poor company image if the certification process fails.^[44] According to John Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.^[9] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard 'helps to mislead companies into thinking that certification means better quality, .. [undermining] the need for an organization to set its own quality standards'.^[45] In short, Wade argues that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in certification before quality.^[9] Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.^[46][49] 'If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business', said ISO's Roger Frost.^[49] Certification by an independent auditor is often seen as the problem area, and according to Barnes, 'has become a vehicle to increase consulting services'.^[46]

Dalgleish argues that while 'quality has a positive effect on return on investment, market share, sales growth, better sales margins and competitive advantage,' 'taking a quality approach is unrelated to ISO 9000 registration.'^[50] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.^[51]

Abrahamson argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad.^[52] How to get a fake victorian drivers licence.

Pickrell argues^{[citation needed]} that ISO systems merely gauge whether the processes are being followed. It does not gauge how good the processes are or whether the correct parameters are being measured and controlled to ensure quality. Furthermore, when unique technical solutions are involved in the creation of a new part, ISO does not validate the robustness of the technical solution which is a key part of advanced quality planning. It is not unheard of for an ISO-certified plant to display poor quality performance due to poor process selection and/or poor technical solutions.

See also[edit]

• Conformity assessment—Containing ISO published standards
• ISO 10006—Quality management—Guidelines to quality management in projects
• ISO 13485—Medical devices—Quality management systems—Requirements for regulatory purposes
• ISO 14001—Environmental management standards
• ISO 19011—Guidelines for quality management systems auditing and environmental management systems auditing
• ISO/TS 16949—Quality management system requirements for automotive-related products suppliers
• ISO/IEC 27001—Information security management
• ISO 39001—Road traffic safety management
• ISO 50001—Energy Audit
• AS 9100—aerospace industry implementation of ISO 9000/1

References[edit]

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Further reading[edit]

• Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN0-8493-2063-1, ISBN978-0-8493-2063-7
• Naveh, E.; Marcus, A. (2004). 'When Does the ISO 9000 Quality Assurance Standard Lead to Performance Improvement? Assimilation and Going Beyond'. IEEE Transactions on Engineering Management. 51 (3): 352. doi:10.1109/TEM.2004.830864.
• Naveh, E. (1999). ISO 9000 survey'99: An analytical tool to assess the costs, benefits and savings of ISO 9000 registration. QSU Publishing Company.
• Bacivarov, Ioan (Coordinating Editor) (2015). Special issue 'ISO9001:2015'. Asigurarea Calitatii - Quality Assurance 21 (83), ISSN1224-5410

External links[edit]

• ISO/TC 176, SC 2 - ISO committee responsible for developing ISO 9000 standards