QMS addresses a gamut of sectors and thus management programs. These management programs are similarly based in ISO 9001; the series for quality management system (QMS). QMS ISO 9001 is not products or services specific, but to the processes that produces product and services. The specification under which an organization can ascribe for certification (or use the term registration) is specifically ISO 9001, and the most recent version is the year 2008. Current Annex SL ISO 9001 addresses an organizations processes and activities in helping organizations to objectively demonstrate its capability to meet customer requirements (and expectations). ISO 9001 is of descriptive nature (not prescriptive) and applies to generic categories of products or services. 2015 version of ISO 9001 includes:

  1. Scope
  2. Norm References
  3. Terms & Definitions
  4. Context of the Organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

ISO 9001 certificate of registration provides organizations with the benefit of an independent and competent assessed quality management system paid by the organization itself. ISO 9001 certificate of registration are issued by a registration - certification body. Registration bodies are typically accredited entities empowered to grant certification. Each country can have a number of accreditation bodies. In turn accreditation bodies for a fee grant conformity  assessment - certification bodies the right to bear their mark in issuing certificates of registration (doing work in their behalf). Thereof, expect that it may be more effective and efficient to interact with an International Registration Body such as those listed...

An effective management system needs to progressively contribute to improve your organizations performance; by competent audit teams applying advance techniques, methods and principles that relate to quality, competitiveness, and managing risk the QMS can be a significant contributor to an organizations objectives. These benefits can be evident by assuring that the necessary elements for competitiveness within a "Knowledge Based Global Economy" concurrently with and enticing reduction of hazards and risksRead-On for ISO 9000 FAQ (also under ISO 9000 FAQ questions, supplemental to this page-portal). Also within this portal we provide information on ISO 9000 variants including; HACCP MS / ISO 22000, ISO 13485 , AS9100, TL 9000, ISO/IEC 17025, ISO/IEC 17024, ISO/IEC 27002 | ISO/IEC 27001, TS 16949 and others.... ISO 9000 Registered Companies - 345,000

Current ISO 9001 propitiates the necessary management principles with a greater scope of requirements to its predecessor with lesser specific (explicit) documentation requirements. For ISO 9001 year 2008 an organization must include the business process and cycle activities as a requirement to define its scope plus demonstrating continual improvements, while focuses relating to clients, markets, and similar. The business cycle may include process activities from marketing to the delivery of the product or service, namely the "supply-chain".

The following are Frequently Asked Questions

Which are the general requirements for the applicable current publication ISO 9001?

It is a managerial scheme enticing organizations to improve performance through processes and activities without the burden of bureaucracy - please note that variants of ISO 9001 may require additional procedural documents such as in the case of AS9100, TS 16949, TL 9000, ISO 13485. For consistency and systematization it is essential that those activities and controls important to the organization's management system be consider within its documentation structure and its implementation. At times, without documentation, it may be difficult to objectively demonstrating an effective management system (and in some industry sectors may be a deterrent to verifying effectiveness), but this is the same documentation that your organization requires legally. ISO 9001 or its variants should not add bureaucracy burden. However, ISO 9001 does require that organizations document those activities and processes that are important (key) to the organization's nature of activities... ISO 9001 requires as absolute minimum to document process relevant to: (1) Control of Documents, (2) Control of Records, (3) Control of Non Conformance, (4) Internal Auditing, (5) Corrective Action, and (6) Preventive Action. Without "key" documentation, the management system is only a series of practices and methods that are at times difficult demonstrating effectiveness in control and improving performance. Without documentation, the practices and methods are conjecture and convenient to time and / or to (some) individuals. Current ISO 9001 requirements for documentation initiate with a quality policy relating and inclusive to a quality manual that address each of the ISO 9001 requirement-clauses and referencing procedures (whether explicit or implicit documents). It is NOT advisable that external to the organization personnel specifically develops, completes, and formalizes these documents comprising the management system.

Of interest to many, integrating management systems after 2015, ISO 9001 concurs with ISO 14001, both rely less on documentation of procedures, and more on procedures (not necessarily documented), objective evidence, training, competence, and awareness / consciousness. And only with the necessary documents to substantiate the effectiveness of the management system focusing on competitiveness (and reduction of risk) thus assisting in the objectives to improve the organization's  objectives / goals of performance.

For a management system to be effective, implementation must be consistent with practices and methods, thereof the management system does not need to rely on a specific function such as a "Quality Department" (however, do consider that some of the ISO 9001 variants expect that a specific managerial role... with responsibility on "quality").  Effective documentation and records, in simple terms, propitiates development and advancement of an agile and yet robust management system concurrent with the objectives of the organization. This enhances (facilitates) that a management system operates within the team concept, and one that precludes the burden brought by namely "bureaucracy." An effective management system measures its results through the policy, objectives, effectiveness, and performance in adding value to the customer (improving). Thus, management evaluates and diagnoses the level of effectiveness against market / customer expectations and from thereon improves. Improvement can be address by analysis, market studies, tendencies and trends, corrective action, and better yet through preventative measures. Improving requires identification of  causes and thus a basis for improvement (such that a learning experience happens). It is imperative that organization improve not by merely attacking symptom but by tackling causes, and better yet preventative measures.

Why the need of the International Quality Management System (QMS)?

Now in its 5th Revision, acceptance of QMS ISO 9001 is through a confederation of countries comprised within the International Organization for Standardization (the ISO 9000 series first published in 1987 with its roots going back to post - WW II). Implementing and registering a management system to the criteria and requirements set by the International  (or a variants) has become common practice for industry (including government entities). Your customer may impose or otherwise expects in their effort that yourself control process and activities and improve linking within the customer's supply-chain. Customer organizations wish not to engage in auditing its suppliers, as the focus of their business it is not auditing for controlling suppliers. If your organization provides products or services to the US automotive industry, the automotive initiative based in the ISO 9001 applies as ISO/TS 16949, and other variants addressing specific sectors are; AS9100 (for aerospace / aviation), TL 9000 (Telecommunications), HACCP MS, ISO 22000, FDA cGMP QSR, ISO 13485 for medical devices, ISO/IEC 17025 for laboratories... these assist by:

  • Providing the path for advancing to new levels of competitiveness,
  • It is a contractual requirement,
  • In some regions, the need is to be more competitive and in other preventing exclusion from some business activities,
  • A fundamental management system as a basis for integrating methods and techniques for continual improvement...

An organization that is require abiding to Sarbanes-Oxley may find ISO 9001 a viable tool to maintain internal controls. 

Why consider certification - registration?

There are various reasons why an organization elects / pursue management system certification-registration:

 
  • Marketing strategy, in pursuit of becoming or maintaining a "benchmark" position in a specific market (e.g., manufacturer, hospital, police department... and other service providers).
  • Ascertain that no exclusion affects business and commercial activities.
  • Forced upon to certify to a specific body by a client-organization (Note: could be dubious when no choices are given to select conformity assessment - certification body or a particular scheme).
     
  • Of interest to small organizations; recently a company president and owner... as a means to auto-control "…finally I can go on vacation."
     
  • A requirement set forth by the market for product qualification... advancement... e.g., CE Marking for Medical Devices (e.g. Canada - CMDCAS, EU - MDD 93/42/EEC) applying management systems as a requirement for trade...
     
  • To improve competitiveness and operations activities for higher performance.
     
  • Implementation of management fundamentals thus improvement can strive within an organizations infrastructure, the supply-chain.
     
  • Because of a business alliance.
     
  • Imposition as a contractual requirement by a regulatory entity / authority as in the case of European Union 765/2008, which imposes certification for products and services within the EU from a European Based CAB - CB that is accredited by an European Co-operation for Accreditation that links with funds to the International Accreditation Forum.

Note: Information to our portal sites indicates that imposition of management systems becomes a paper exercise, when organizations voluntarily chooses to implement the benefits and gains are to outperform and benchmark.

What is require to initiate or for transition?

As a business strategy, management must identify the need and provide the resources to implement and achieve certification-registration [to an International  System - Scheme]. And this needs evaluation and assigning responsibilities at onset, including budgeting, understanding top management objective in achieving registration ("viewing" the return-on-investment potential). This benefit and costs relation is important for management to support the implementation and sustaining a management system effort. Thus, the require resources are effectively in place and which in turns states the organization's policy and objectives. For effectiveness of the organization's overall objectives, it is important that the mission and objectives intertwine with those of the management system. The road to implementation and opting to certification-registration may even test the organization's ability in effectively working as "team," improve, and enhance the level of competitiveness (and reducing risk).

After a firm commitment by executive / top management, consider the following (essentials) on the road to implementation and achieving certification-registration:

  • A Management System Baseline Assessment (includes among its many components a Gap Analysis),
     
  • Define the scope of the activities (and any exclusion to current ISO 9001, clauses of section 7 or otherwise variant of ISO 9001),
  • Commitment (and better yet involvement by top management),
  • Planning,
  • Training and awareness as components leading to "competence",
  • Implement through applying contemporary documentation Techniques and Technology (in tune with technological advances and economical viability),
  • Corrective action & Preventive measures (identifying causes impeding progress and improvement) thus tackling the cause (not the symptoms).

Selection of a Certification - Registration Body?

Do not take lightly selecting a certification body. Why? (1) Its a long-term relationship, and (2) poor selection lead your organization into an incompatibility between your business objectives, goals, and resources. The market where selling products or providing services must be taken in consideration as well as values, mission, and the expertise of the registrar in your process and activity sector. Other key aspects is that the CAB - CB (registrar) be customer-centric and preferably that these are objective legally binding for the protection of consumers and knowledgeable on contemporary techniques relevant to global competitiveness and to contribute in the reduction of risks. Whilst Registrars must follow the same protocol they not all operate equally (or the same) - see our web page for registration bodies and registrars.

    Registrars and Registration Bodies, Note: While not "all" agreeing with us... we consider that a "Registrar" construe as a branch of a registration body (namely registration body), thus the accreditation body may not maintain the same level of surveillance as to the Certification Body. another way of seeing such explanation is looking at the difference between centralized and decentralized operational activities. Thereof the difference in terms we use for Registrar and (International) Registration Bodies.

The selection protocol involves; identification, contact, evaluation of the choices - compare, select, communicate, identify scope, quote, and proceed to the Stage I and Stage II. In addition, CAB - CB - Registrars provide an optional service pre registration auditing which your organization may consider but is not a requirement. From "Stage I" your organization initiates the certification-registration protocol onto Stage II assessment-audit leading to recommendation for certification-registration, achieving registration, and from thereon through surveillance assessment-audits (for most likely) a 3-year agreement. Further, and of key importance, is the selection of the assessment audit team... Organizations in the past have allow external auditors imposing their own view and interpretation regardless of those of the organization's objectives... we recommend that organizations obtain as much information from the to be certification body - registrar on the Assessment Team members as if they where going to be full time employee - an  indicator to effectiveness... are registrars / certification bodies operating under ISO/IEC 17024 is helpful. Finally yet importantly, you may wish to consider that the assessment process includes adding-value analysis (truly adding value, not gimmicks of adding value).

We shall not forget that CAB - CB, certification - registration bodies or registrars are service providers (unless imposed a specific limited bodies to choose from). It is you who selects a certification body that meets your expectations and needed criterion to benefits your organization's effort, and not on the amount or colorfullnes of a brochure or if they are "big" registration body as small bodies can provide a degree of service satisfaction not seen with bigger registration bodies (or those that focus on becoming the biggest...).

Certification-registration for all purpose is the same under one or numerous accreditation, publicity about being big or having the more number of registrations does not mean much to your objectives. Consider a certification - registration body that adds true value through assessments, courteous and which operates ethically and with integrity by not combining certification with consulting, unfortunately some certification services combining consulting are packaged under and permitted through its accreditation partner.

How do I know if registration | certification is important to my company?

Implementation and maintaining a management system on the basis of recognized Internationally management systems (standards) is the "norm" more than an "exception" in many industry (and government) sectors. In some regions it is matter of either survival (in others a matter of competitiveness).

In assisting you we provide some questions for you to consider...

 
  • What is the trend on your customer's voice toward satisfaction? How do you know this? Is it factual or is it purely "gut feeling"?
     
  • Has our organization improved in the last 3 years? Can we provide objective measurable evidence?
 
  • Once registered to an management specification -  such as ISO 9001 how would this affect our national objectives and/or export business objectives? How do we know this?
     
 
  • What regulations or codes apply to our industry group?
     
  • Whether there is a believe that it will assist or not in sustaining and updates to regulatory requirements and legal obligations (e.g., meat packaging, pharmaceuticals, chemical, nuclear regulatory, government)...
     
 
  • What is the competition doing in response to QMS (ISO 9001)? Do we know this through evidence?
 
  • In relation to the requirements of the International  ISO 9001, where does our management system stands?
 
  • What initiatives do we currently have in place to improve productivity and to reduce waste factors (time, money and alike)? What initiatives have we successfully completed? Do we have a continual and/or continuous improvement program?
     
  • Are customers invoke or have expectation of showing evidence of a contemporary and best-in-class QMS (ISO 9001 registration)?

Perhaps a key question is... How long more should your organization wait to implement a robust yet agile operating management system? What priority should we place...?

You may want to consider an ethical International Certification - Registration Body that within its values and mission provides adding-value, protection, help to reduce risks, certifies its own body of assessors-auditor and technical experts (so subcontracting is not an issue of concern), provides for improvement and preventative opportunities for improvement... a true partnership, one who's reputation does not merely rely on number of certifications (certification-paper mills) and does is not marred by conducting consulting openly even under accreditation. And to surprise of many price-cost structures are equivalent the same. Certification bodies vary as their purpose varies.

 

ISO 9000 and OCCUPATIONAL HEALTH, IS THERE A NEW  (ISO 45001?), NO and why not?

Through ISO 9001 (and ISO 14001) any organization can extend the scope of its activities to include reduction of risk and address regulatory requirements such as those related to Occupational Health and Safety , further ISO 9001:2000 invokes throughout its clauses in various sections (including legal requirements). In the USA there is a legal requirement under the OSHA (Occupational Health and Safety Act) and in many countries such as in Italy, USA, Canada... Colombia there are very stringent and enforceable requirements for safety & health comparably equivalent, thus it is a social-fiscal obligation.

    Note: OHSAS 18001 is not ISO 18001 (which does not exist) and is in tune with other management systems protocols such as OSHMS, OSHMS.

ISO 45001, ILO-OSH / OHSAS 18001 / Loss Control are internationally recognizable schemes providing a basis for implementation of Occupational Safety and Health. Whilst ILO-OSH | Loss Prevention and OHSAS 18001 are voluntarily implementation schemes, International Registration Bodies may develop their own occupational health and safety management scheme for and under which an organization registers its own system, such as  Loss Prevention, OSHMS...

Requirements and format structure of OHSAS 18001 and ILO-OSH are compatible with ISO 9001 and ISO 14001. This provides for organizations to integrate management systems as mutually inclusive or mutually exclusive such as; ISO 22000, ISO 9001-ISO 14001-OHSAS 18001, ISO 9001, ISO/IEC 27001 + ISO 14001-OHSAS 18001 / ILO OSH... loss control and any possible other combinations beneficial to the natures and objectives of the organization implementing and registering such standards.

 

What is ISO/IEC 17025... and ISO/IEC 17024?

ISO/IEC 17024 is a management  applicable to laboratories performing tests, assays, analysis and metrology (calibration); ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories. While ISO/IEC 17025 takes from ISO 9001 it does invoke specifies prescriptive requirements relating to competence, uncertainty, reporting and validation of tests. Once a laboratory achieves ISO/IEC 17025 implementation, verifiable by a Third Party Registrar, it indicates that it is an "Accredited" Laboratory, whilst ISO 9001 applies the term "Certification - Registration". ISO/IEC 17025 is of "higher level" and more stringent (than ISO 9001; it requires that the laboratory - organization to address the requirements at a higher level of technical competency - visit the ISO/IEC 17025 page....

ISO/IEC 17024 ... certification of individuals... is the international  that provides specifications for organizations granting - issuing certification of individuals services. For example; an academic institution providing education... providing objective evidence of academic achievements... diploma... can opt to meet ISO/IEC 17024 and thus third party certification is an option objectively demonstrating to others meeting these requirements. It is the intent that International Registration Bodies are require to meet this stringent requirement to assure competence of individuals or otherwise require that auditors be recognized, certified or register under an organization providing such services. However, only a handful of international registration bodies or their branches (namely registrars) meet the requirements of ISO/IEC 17024, visit our Certification Bodies and Registrar List Page as few Registration body meets this criteria. Most certification bodies rely in subcontracting the qualification and competence of assessors or auditors. Combining current ISO/IEC 17024 is current ISO 29990 management system for learning services provider.

 

 

 

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