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Stage 1 vs Stage 2 Audits - ISOUpdate.com

A Certification Audit is the first step for your organization once you have decided to undergo an assessment process. Your options include undergoing an assessment with a Certification Body (CB), or Registrar, like The Registrar Company, to determine if your management system complies with the requirements of a given standard (ISO 9001ISO 14001ISO 45001, etc). This Certification Audit is completed in two stages: Stage 1 and Stage 2. These audits differ in many ways: their purpose, duration, information reviewed, and sometimes even location. Therefore it is important to understand the difference between Stage 1 and Stage 2 Audits, and the effect your selection of CB will have on the process.

These audits differ in many ways: their purpose, duration, information reviewed and sometimes even in the location where it will take place.

The objective of a Stage 1 Audit is to determine an organization’s readiness for their Stage 2 Certification Audit.
During the Stage 1, your Certification Body’s auditor will review your management system documented information, evaluate your site-specific conditions, and have discussions with personnel. The auditor will look to see that objectives and key performance indicators, or significant aspects are in place and understood. They will review the scope of the management system and obtain information on your processes and operations, the equipment being used, the levels of control that have been established, as well as any applicable statutory or regulatory requirements. Internal audits and management reviews will be evaluated to ensure they are being planned and performed and the overall level of implementation of your management system will be assessed to determine if your organization is ready to move forward with the Stage 2 Certification Audit.



Your Certification Body will use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Documented conclusions will be given to your organization that will outline your readiness as well as identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit.

A Stage 1 Audit is usually carried out over 1 or 2 days and typically occurs onsite. For organizations with more than 1 location, the audits are usually carried out at your central function location.

The Stage 2 Audit evaluates the implementation and effectiveness of your organization’s management system(s). During the Stage 2 audit, your Certification Body will determine the degree of compliance with the standard’s requirements and report any non-conformances or potential non-conformances that your organization will have to correct before the certification can be issued. If the Stage 2 audit is successful, your organization’s management system(s) will be certified.

The Stage 2 Audit includes:

  • All relevant documented information that evidences your management system’s conformity with all the standard’s requirements;
  • Key performance objectives and targets, looking at performance monitoring, measuring and reporting;
  • Evaluation of internal audits, management review and management responsibility for your organization’s policies;
  • All relevant processes, looking at operational control and the ability to carry them out as planned.

The duration of the Stage 2 Audit is determined in accordance with the relevant IAF Mandatory Documents.  Depending on the size and complexity of the organization this audit can range anywhere from 1 to many days.

Every organization undergoing a certification process should maintain open and clear communication with their Certification Body in order to clarify any questions that may arise before the audits take place. At TRC, customer service is our top priority, with every facet of our organization designed with your satisfaction in mind.

Associating your company with an internationally recognized and trusted certification shows your customers that you hold their satisfaction and expectations above all and adds real value to your bottom line through increased efficiency and reduced risk – and working with the best Certification Body for your unique needs should be top of mind. Certification can be a lengthy process, and you will be working closely with your Certification Body and Auditor for years to come, ensure you pick the best.

 

About the Author

The Registrar CompanyTRC is internationally recognized and trusted. With a large network of auditors, TRC is an international certification body with local benefits. With dedicated Client Service Managers and family-owned and entrepreneurial values, our clients are family. We take the time to understand your business and your unique needs. TRC audits are more than a checklist, we highlight your corporate strengths, and find opportunities for improved processes to ensure you stay competitive and thriving. TRC works with you to ensure minimal disruptions so you receive the highest benefits from the auditing process. Learn about how we can help you today.


Read about The Characteristics of an Excellent Internal Audit



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Organization Knowledge and ISO9001:2015
Organization Knowledge and ISO9001:2015

Guest Contributor John Grosskopf - Founder of DeepGreen ConsultingThis column will cover the background and importance of Auditing Multiple and Integrated Management Systems, the advantages and disadvantages organizations accrue when integrating and when auditing their systems. And adjusting their auditing programs to fit the new reality of multiple and integrated management systems (intMS) increasingly prevalent today.

The adoption of formal Management Systems has risen dramatically the past few decades, and an increasing number of organizations have implemented multiple management systems. Organizations are increasingly recognizing the advantages and efficiencies that accrue by their integration, whether it be full, or partial integration.

Integration was more difficult prior to the harmonization of the ISO Standards – now guided by ISO’s Annex SL – the high-level structure that provides identical structure, text, and common terms and definitions for management system standards of the future. This will ensure consistency among future and revised management system standards and make their integration, and integrated use simpler. This is highlighted in the recent adoption of ISO 9001 and ISO 14001: 2015, and ISO 45001, ISO’s Occupational Health and Safety Management System Standard, and ISO’s newest.

With the addition of each management system, auditing resources necessary to ensure their effectiveness could, without integration and streamlining efforts, roughly double. Those organizations with a QMS, EMS, and HSMS could triple the auditing resources – including time, utilized over that of a single system.

For the commonly used 2-3 auditors per system, 6-9 auditors may be necessary for those with a QMS, EMS, and HSMS. For those using 3 or more audit team members, imagine the audit army this creates, let alone the time necessary to audit separate systems, and the disruption to the organization.

Considering all the other financial, customer, supply chain, and other audits organizations are subjected, and you can understand why many organizations are ‘audit weary’!

Integrated Audits

Professionals who have conducted integrated audits recognize how much more efficient they can be. The process under review, along with all its controls; environmental, health, safety, and quality; has to be evaluated only once.

There is less duplication of effort during the planning, execution, and even follow-up phases of the audit. Other efficiencies, often unforeseen, are uncovered or revealed once an organization begins an integrated management system pathway, and is yet another advantage to integrated auditing.

Typically, management systems integration allows the organization to minimize duplication and redundancy of effort, streamline or leverage the use of its limited resources, and reduce or eliminate overlapping responsibilities. This is true of integrated systems in general and is especially true regarding the audit function. minimizing duplication and redundancy of efforts translates to significant cost savings, productivity increases, risk reductions, and enhanced effectiveness and efficiency that the intMS are designed to achieve.

When it comes to intMS registration, Registrars should confer savings when auditing and certifying intMS through the same efficiencies and streamlining efforts organizations achieve internally.

Disadvantages of Integrated Audits

While there are many advantages to implementing and auditing intMS, it is important to recognize that there are disadvantages as well.

If an organization is seeking third-party registration to one or more standards, a non-conformance against a requirement of one standard may carry over to another standard. In the worst case scenario, if the non-conformance is major, all registrations could be at risk unless effective corrective action is taken.

Another disadvantage is the learning curve and attendant training that will likely be an adjustment for staff members, many of whom will not be familiar with the requirements of all the management systems involved in the IntMS.

For example, Quality staff may be intimately familiar with ISO 9001 requirements, while needing extensive and perhaps costly training on ISO 14001. The same will be true of OHSMS staff, and vice-versa for each staff function.

In the next installment of this column, we will dive into the mechanics and logistics of intMS auditing, as well as provide tips and techniques to help improve intMS audit team effectiveness and efficiency.

About John Grosskopf: Since a Dr. Deming led quality and environmental paradigm shift at General Dynamics in the late 80’s, John has been a strong management systems (MS) advocate. He has pioneered advances in auditing, integrating MS, a chief contributor to two national MS Standards, and has led the development, implementation, and improvement of hundreds of MS in the public and private sectors. He is an accredited EMS, HSMS, and QMS auditor (accreditations pending), a published author, instructor/trainer, and has presented widely on MSs. Through his firm, DeepGreen Consulting, he is currently assisting clients to improve their triple bottom line through a combination of MS, best practices, collaboration, and leadership

Reference: Auditing Integrated Management Systems: Considerations and Practice Tips, November 2008, Journal of Environmental Quality Management, John Grosskopf, with co-author Jennifer Kraus.



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The Process of Managing Outsourced Suppliers in accordance with ISO 14001:2105  

Following the release of the ISO 14001:2015 standard, organizations had to incorporate multiple changes and activities into their EMS (Environmental Management System) and enable to meet the terms of the ISO 14001:2015 standard. One of the changes that might not seem so obvious is the process by which one’s organization manages outsourced services and suppliers, ensuring that they are aligned with the standard’s terms. By mentioning “outsourced suppliers,” the standard denotes third parties who are contracted to perform critical parts of one’s process and service normally, but not always outside one’s own facility. What does one need to understand and what actions does one need to take in order to ensure that one’s EMS remains compliant? 

Important Changes in ISO 14001:2015 

The ISO 14001:2015 standard states that the organization shall “determine its environmental requirement(s) for the operational planning and control regarding products and services as appropriate.” While this statement does not seem drastically different compared to the 14001:2004 standard, Annex A provides more information. One is told how an organization should decide on the amount of control needed over its external suppliers based on factors such as the ability to meet compliance, technical aptitude, the significance and the consequences of the product or service for the organization, and the average capability of the organization’s purchasing process of delivery.  

Additionally, Annex A explains that the amount of control exerted by the organization over the delivery of a service or product is variable. However, one thing is certain: one’s organization must assume all final responsibilities for the environmental performances of any outsourced suppliers in the delivery of one’s product or service.  



How would one achieve this? 

Laying down the foundations 

Regarding the ISO 14001:2015 standard, there are several criteria that should be checked: 

  • How likely are one’s suppliers to deliver one’s key environmental performance indicators? 
  • If one’s supplier is not ISO 14001:2015 certified, do they have an environmental policy? If not, do they follow the terms of one’s organization’s environmental policy? 
  • Does one’s supplier have an internal audit policy and results readily available? 
  • Does one’s supplier completely comprehend legislation that pertains to one’s product and its delivery? 
  • Does one’s supplier have evidence of factoring in risks and identifying environmental aspects to mitigate environmental impacts? 

Now, how can an organization guarantee that its supplier has the capability to manage environmental performance in accordance with the ISO 14001:2015 guidelines? Consider: 

  • Insisting on routinely creating key performance indicators for the outsourced supplier. 
  • Ensuring one’s supplier places great emphasis on environmental criteria whenever they make purchases. 
  • Seeing evidence of actions such as assessing risks and identifying environmental impacts that will produce improvement.  
  • Asking for a record of the supplier’s legislation and proof that they comply with environmental laws that pertain to their work 
  • Seeking proof that any environmental accidents or hazards as a result of the supplier will be documented and reported to the organization according to an emergency preparedness procedure and confirm the existence of a procedure whenever authorities, containment, and corrections are involved. It is advised that the supplier is guided as to how this process should operate, given that the organization itself is responsible any outcomes. 
  • Ensuring that one’s organization agrees to a program for the supplier’s regular inspections, where the environmental performance of the supplier is judged. If necessary, the supplier may take action. 

An Organization’s Key Responsibilities 

When managing one’s outsourced suppliers, it is important to remember that one’s organization has the ultimate responsibility for environmental performance and all internal and external environmental impacts caused by the manufacturing of one’s product or service. As a result of the more descriptive Annex A, the more control one’s organization asserts over its supplier, the better one’s general environmental performance. Taking the steps mentioned above will help one ensure that the suppliers’ environmental performance is managed effectively and the terms of ISO 14001:2015 are consistently surpassed. 

 

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    Twenty-two years of experience promoting operational excellence within small and large private sector businesses and US government departments and agencies. Consulted, trained, and audited organizations in a diverse group of industries including basic steel making, plastics, respirator manufacturing, chemical processing, healthcare compliance and healthcare providers, hospitals, real estate management, food and drug manufacturing, food safety and grading, information technology, medical devices, clinical studies, software developers, automotive, service providers including contract management, banking, cashiering, disbursements, payroll, and payment processing, shipping and customs, logistics management, IT customer service, help desk support and call centers, telephone operations, facility maintenance, human resources, architecture and design, munitions, and environmental management. Expert in trouble shooting, root cause analysis, and problem solving under difficult and stressful circumstances. Expert in curriculum development.
    Developed and provided training to more than 7,000 people, as well as, auditing, and consulting services to clients on six continents and twenty-six countries including: North America-United States, Canada, and Mexico, South America-Colombia, Ecuador, Chile, and Brazil, Africa-Senegal and South Africa, Europe-France, England, Denmark, Germany, Italy, Sweden, Poland, and Czechoslovakia, Asia-Ukraine, China, Japan, India, and South Korea, Australia-Australia and New Zealand.
    Specialties: Quality Assurance, Operational Excellence, ISO 9001, AS 9100/9110, Lean Six Sigma, ISO 14001, ISO 22001, ISO 15378, ISO 27001, US FDA cGMP’s, CE Marking, SA 8000, TL 9000, Capability Maturity Model
    Integration (CMMI), TS 16949, 42 CFR 84, 21 CFR 210 and 211, Malcolm Baldrige Award, OHSAS 18001, and ITIL, training, auditing, and consulting, private equity operational due diligence and operational excellence implementation, government contracting.
    EXPERIENCE
    President
    Third party certification body for international standards including: ISO 9001, AS 9100/9110, ISO 14001, ISO 22001,
    ISO 27001, ISO 15378, SA 8000, TL 9000, TS 16949, and OHSAS 18001. Clients include US Department of Veterans
    Affairs, Energy, Defense, and Walter Reed Medical Center. Client focus is on military and government departments and
    agencies along with the private sector contractors servicing these groups. Geographic coverage is worldwide.
    GMCS is accredited by the International Accreditation Service (IAS). IAS is a nonprofit, public-benefit corporation that
    has been providing accreditation services since 1975. It is a member of Asia-Pacific Laboratory Accreditation
    Cooperation (APLAC), International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum
    (IAF), and the Pacific Accreditation Cooperation (PAC).
    Chairman and Founder
    Chairman and Founder of an operational excellence management consulting firm specializing in the implementation of
    industry and global standards and best practices in both private sector and government and military organizations
    utilizing training, auditing, and consulting techniques. One of the only consulting firms that is ISO 9001 registered
    itself.
    Clients include US Departments of Defense, Transportation, Treasury, Homeland Security, Veterans Affairs, Energy,
    Interior, State, Health and Human Services and Agriculture, Postal Service, NYC Metropolitan Transit Authority,
    Federal Reserve Bank, United Nations, National Transportation Safety Board, Particle Technology Labs, KS Bearings,
    Island Peer Review Organization, Cellomics, Cerilliant, Agribuys, Von Roll America/WTI, Metamorphic Surgical
    Devices, Simplot, Con Edison, POMS Corporation, Intellisys Technology Corporation, Steris Corporation, FirstMiss Steel,
    NEW YORK UNIVERSITY 1991 – 1993
    BOSTON UNIVERSITY 1987 – 1991
    FOX CHAPEL HIGH SCHOOL 1983 – 1987
    CERTIFIED QUALITY MANAGEMENT SYSTEM LEAD AUDITOR 03 / 1995
    ASQ SENIOR MEMBER 01 / 1995
    LEAN SIX SIGMA MASTER BLACK BELT (PENDING)
    PRIVATE PILOT 08 / 1999
    KRAV MAGA ORANGE BELT 09 / 2011
    Automated Liquid Packaging, International Filler Corporation, The Valspar Corporation, Tissue International, Georgia
    Tissue Bank, Insituform East, Unique Pharmaceuticals, Rozinn Electronics, Allegheny Performance Plastics, WMMC,
    New Brunswick Scientific, ManTech, The Solar Group, IBM, and GM.
    Organizations audited against industry standards on behalf of clients include: 3M, Draeger AG, Air Ace Oy, Avon
    Technical Products, Camlock (UK) , Interspiro, Respirex, Scott Health and Safety, Sundstrom Safety, MSA, Japan
    Vilene, San M Packaging, Alpha Pro Tech,Safety Equipment Australia, RPB Safety, Maco Pharma, Supplied Air
    Monitoring Systems, Inc., Sata-Farbspritz, Shigematsu, Koken, Masprot, Nitta, Aearo Safety, Avox, Honeywell, Louis M.
    Gerson Co. Inc., and Venus Safety.
    Leigh Brand has personally conducted more than 150 accredited ISO 9001 Lead Auditor Courses, and conducted more
    than 150 third party audits on behalf of the National Institute of Occupational Safety and Health against 42 CFR 84 on
    6 continents and 30 countries around the world.
    EDUCATION
    Master of Arts (M.A.) , Communications
    Bachelor of Arts (B.A.) , Political Science
    President, Alpha Epsilon Pi Vice President Student Affairs Rugby Football Club President Interfraternity Sorority Council
    Scarlet Key Award Recipient Dean’s List
    INTERESTS
    Cycling, Skiing, Scuba Diving, Pilot, Hiking, Wine, Cooking, History, Travel, Music, Theater, Politics, Education
    ASSOCIATIONS
    American Society of Quality, International Registry of Certificated Auditors
    CERTIFICATIONS
    International Registry of Certificated Auditors (IRCA) · License: A008984
    American Society of Quality (ASQ)
    Federal Aviation Administration
    Krav Maga Association of America and Krav Maga Alliance
    ADVANCED DIVER 03 / 1991
    HARMONIZING THE MEDICAL DEVICE DIRECTIVE, CURRENT GOOD MANUFACTURING PRACTICES, AND ISO
    9001
    03 / 2000
    MUTUAL RECOGNITION AGREEMENTS 11 / 2001
    ISO 9001 EXECUTIVE OVERVIEW COURSE 01 / 1995
    ISO 9001 IMPLEMENTATION COURSE 01 / 1995
    ISO 9001 INTERNAL AUDITOR COURSE 01 / 1995
    ISO 9001 IN HEALTHCARE EXECUTIVE OVERVIEW 10 / 2007
    ISO 9001 V AS 9110 EXECUTIVE OVERVIEW COURSE 05 / 2008
    PROCESS MAPPING AND MANAGEMENT 06 / 2006
    Professional Association of Diving Instructors (PADI)
    LANGUAGES
    English ( Native or bilingual proficiency )
    French ( Elementary proficiency )
    PUBLICATIONS
    Journal of cGMP Compliance · Authors: Leigh Andrew Brand, Allen Bailey · http://www.ivtnetwork.com/
    Article describing method of developing a single Quality Management System meeting the requirements of ISO 9001,
    the European Union Medical Device Directive, and US FDA Current Good Manufacturing Standards.
    Journal of cGMP Compliance · Authors: Leigh Andrew Brand, Allen Bailey · http://www.ivtnetwork.com/
    Article describing the forthcoming Agreements between the US and EU with respect to medical devices and other
    regulated products.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Arthur E. Fitch, Carl V. Scheuplein
    Executive Level Course designed to introduce participants to the ISO 9001 standard. Participants are C-Level and
    executive management who desire a quick (2-4 hour) overview of the requirements of the ISO 9001 standard and how
    the implementation of the standard will benefit their organization.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Arthuer E. Fitch, Carl V. Scheuplein
    Two (2) Day Seminar on how to implement the ISO 9001 standard within one’s own organization.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
    Three (3) Day course designed to train individuals on how to conduct Internal Audits in accordance with ISO 19011
    Guidelines for Auditing Environmental and Quality Management Systems.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
    Introductory course on the applicability of ISO 9001 in a healthcare environment.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Carl V. Scheuplein
    Executive Overview on the differences between ISO 9001 and AS 9110.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
    CORRECTIVE ACTION AND ROOT CAUSE ANALYSIS 06 / 2009
    Two (2) day interactive seminar on mapping processes and the critical control points associated with process
    management.
    Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
    Seminar on problem-solving using the 5 WHY technique and how to develop good corrective action plans designed to
    prevent recurrence of nonconformances and customer complaints.

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      Since 1994 provided training, consulting, auditing to ISO 9001, 14001, OHSAS 18001 & now ISO 45001, and auditor training – ISO 19011.
      Wrote body of skills and knowledge for auditor certification in Canada and US.
      Had the first client registered to integrated management systems in 2003.
      Author of ISO 9001 Guide Book, 2003 Outlined integration of quality, environment, health & safety.
      Author “Driving Sustainability to Business Success”, Wiley, outlines key questions for integrated management systems.

      ISO 9001:2015 represents a major change to the 9001:2008 version. One of these changes regards the Quality Management Systems (QMS) documentation.

      The 2008 version of the standard, uses two separate terms “documents” and “records” to identify its documentation, whereas, in the recently published Draft International Standard of the new revision, both these terms are combined as “documented information”.



      For those familiar with the 2008 version, it can be said that where it refers to “documented procedures” in the new revision it is expressed as a requirement to maintain documented information. Also, where the 2008 version refers to as “records” it is now expressed as a requirement to retain documented information. Below, there’s a list of the documented information that the new standard requires to be maintained and retained.

      Documented information that is required to be maintained with ISO 9001:2015

      • The scope of the QMS, including the products and services it covers and the justification of those requirements that the QMS will not be able to apply.
      • Information that supports the operations of processes.
      • The quality policy.
      • Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

      Documented information that is required to be retained with ISO 9001:2015

      • Information necessary to have confidence that processes are being performed as planned and conform to requirements.
      • Information on the quality objectives.
      • Information as evidence of fitness for purpose of monitoring and measurement resources.
      • Information as evidence of competence.
      • Information describing the results of the review of requirements related to products and services.
      • Information resulting from the design and development process.
      • Information on review of design and development changes.
      • Information of the results of the evaluation, monitoring of performance and re-evaluation of the external providers.
      • Information necessary to maintain traceability when required.
      • Information describing the results of the review of changes, personnel authorizing the change, and any necessary actions
      • Information providing traceability to the person(s) authorizing release of products and services for delivery to the customer.
      • Information on actions taken on nonconforming process outputs, products and services.
      • Results of monitoring and measurement activities.
      • Information as evidence of the implementation of the audit programme and the audit results
      • Information as evidence of the results of management reviews.
      • Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

      As it can be seen from the above list, in the new version of the standard, it will not be required to create and maintain a Quality Manual, which has been around since the creation of ISO 9001 in 1987.



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      Determining the Context of the organization is a new requirements in ISO 45001 and, has already been incorporated in ISO 9001:2015 and ISO 14001:2015.

      Context of the Organisation is about understanding the entire environment in which the organisation operates. The Context can be external or internal. Utilizing SWOT Analysis and PESTLE Analysis (Political, Economic, Social, Technological, Legal and Environmental factors) are two methodologies which can be useful determining context.



      Firstly, the organization needs to determine in internal and external issues which have the ability to affect the outcomes of its Occupational Health & Safety (OH&S) Management System. The internal or external issues can be positive or negative. They can include conditions, characteristics or changing circumstances which can affect the OH&S management system.

      External issues can be:

      • PESTLE (Political, Economic, Social, Technological, Legal and Environmental) etc. factors.
      • New competitors, contractors, suppliers, partners etc.
      • Latest knowledge about products and their ability to affect OH&S.
      • Key drivers and trends relevant to industry.
      • Relationships with external interested parties.
      • Changes in any of the above factors.

      Internal issues can be

      • Organizational structure, and roles.
      • Policies and objectives.
      • Capabilities in terms of Resources such as capital, human and technological.
      • Information systems.
      • Relationship as well as perception of workers.
      • Contractual relationships such as outsourced activities.
      • Working conditions and organizational culture.
      • Working time arrangements.
      • Changes in products, processes, equipment.
      • Changes in any of the above factors.

      Secondly, the organization has to determine the Interested Parties in addition to workers, and their needs and expectations which are relevant to its OH&S Management System.

      Interested Parties can be legal and regulatory authorities, parent organizations, suppliers, contractors and subcontractors, workers representatives, workers organizations such as trade unions and employers’ organizations, customers, medical or other community services, media, business associations and NGO’s, occupational health & safety organizations and practitioners.

      Some needs and expectations are incorporated in to the laws and regulations and are therefore mandatory. Then there are some voluntary requirements which the organization may have subscribed to. The organization addresses the needs and expectations through the planning and implementation of its OH&S Management system.

      Thirdly, the organization has to define the Scope of its OH&S Management System by defining its boundaries and applicability.

      To determine the scope, the organization has to consider the Issues relevant to it. Then it has to consider the interested parties and their needs and expectations. After that it has to take in to account the planned or performed work related activities. The boundaries can include the whole organization or a specific part of the organization. The scope shall not be used to evade its legal and other requirements. Those activities have to be considered that can affect the OH& S performance of the organization. The scope has to be maintained as documented information.

      Fourthly, the organization must establish, implement, maintain and continually improve an OH&S management system according to requirements of ISO 45001 and establish one or more processes that fulfil the requirements of this standard and implement those processes, control them and achieve the intended outcomes. The organization shall also integrate and incorporate the requirements of this standard into its business processes such as design and development, procurement, training and education, human resources, sales and marketing.



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      ISO Certification

      Organizations go through a great deal of work, time and effort to implement management systems such as ISO 9001, ISO 14001, and many others. These management systems are implemented and certified for many reasons, and one of these reasons is recognition. Organizations want their clients, customers, consumers and other interested parties to recognize that their management systems follow specific standards and comply with certain requirements.



      When a certification body is accredited, it means that an accreditation body has verified that it follows a series of standards and requirements that guarantee that their service is impartial, consistent, reliable and recognized internationally. These strict and regular checks that certification bodies undergo provide trust and credibility to the certification. Thus, accredited certification can provide confidence to clients, customers, regulators and other interested parties that the organization is complying with the specific standard, code of conduct or requirement.

      Additional to having a certification recognized by all the interested parties of an organization, there are other benefits of accredited certification. These are:

      Ensures competency
      Accreditation can guarantee that the certification body is competent in assessing specific standards. Organizations want to make sure that auditors are knowledgeable, experienced and that can provide an impartial assessment in the management system being certified.

      Provides legitimacy

      This legitimacy is based on the participation and recognition of public authorities in the structure of the accreditation body, which follow strict international regulations.

      Ensures equality of criteria

      The regular checks of the certification body can guarantee that over the years the organization’s management system will be assessed by the same criteria. This equality of criteria will assist in the maturity of the management system, by supporting its continuous improvement, innovation and internal prestige. It can also support organizations in focusing on the achievement of proposed goals.

      Reduces risks

      Organizations rely on the outcome of their certification body’s assessment to make important decisions regarding their management system. Thus, it reduces the probability of making bad decisions regarding the management system and misallocating resources.
      In general, with accredited certification it is possible to ensure legal compliance, guarantee objective and impartial assessments, ensure confidence and credibility with interested parties, focus on activities that add value, focus on what is important to the interests of the organization, and improve the assessment of the management system that will consequently support decision making.

      These are the main reasons for choosing accredited certification, however, there could be others. There could be the case that a client or a regulatory body requires an organization to have an accredited certification. Thus, before choosing, organizations need to consider the above benefits and any other that could apply to their particular situation and their specific goals.

      There are many accredited Registrars’ listed on the ISO Update Registrar Directory. Fine one here: http://isoupdate.com/registrar-listing/



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      Even if you have an informal quality management system within your business it is often difficult to implement the requirements of ISO 9001:2015. Depending on the size of your business this could be a task that may take six to twelve months to complete depending on the established current systems. It is vital that your staff are fully trained and engaged to make any implementation a success. The following 10 tips are vital to smoothly and effectively implementing an ISO 9001 management system:

      1. Get senior management commitment; while this may sound a little cliché, without the full commitment of your management team throughout the business it is going to be very difficult to drive home the changes and improvements that are required.
      1. Provide training at all levels in the business. Your staff needs to understand not only about the requirements of ISO 9001 but also the different quality principles that they should strive to implement within their every day work. Training should be provided on an ongoing basis according to perceived needs.
      1. Ensure that you have effective internal communication. Without this you are not going to be able to maintain the constancy of purpose that is required.
      1. Establish an implementation team with the authority to make things happen. You cannot just implement an ISO 9001 management system by assigning a management representative and expecting them to do everything in isolation. You need to identify the staff that will be required at all levels throughout the business to craft your system.
      1. Conduct a Gap Analysis; you need to fully understand where your current system meets or fails to meet the expectations of ISO 9001:2015 so that you can allocate resources accordingly.
      1. Involve customers and suppliers in analyzing your current systems. It is important to understand how others view the effectiveness of what you currently do and what they expect from you to improve things.
      1. Plan your implementation fully; responsibilities, roles and schedule. As with any project, the better that you plan it the more likely you are to have success.
      1. Create clear and concise policies and objectives for quality to provide the company with a common direction. Well communicated and understood these will help your company to move forward together.
      1. Encourage everyone to question and improve. It is not enough to only have auditors looking for issues with the systems; everyone should continually seek better ways to do things.
      1. Conduct regular reviews of your ISO 9001 management system through your auditing process to ensure that you are continually improving how your systems function.

      In addition to the above, foster a good relationship with your certification body. Your auditor is not there to catch you out. They will want to help you to develop and grow a system that will significantly benefit your business, so use them fully.

        by -

        – 30 years of industrial and business experience covering diverse industries including medical, and automotive
        – Audit / implementing ISO 9001, 13485, 14001, 14971, 62366, 21 CFR 820, MDDEV, 93/42/EEC
        – Deployment of Lean, Six Sigma, and training on the same from White and Yellow Belt to Master Black Belt
        – Supply Chain Management and Risk Analysis

        Certifications: Six Sigma Black Belt, CQA, CQE, CQM/OE

        Worked for / with world leading corporations such as Dell, Applied Materials, DuPont, Abbott Labs, and more
        Coached business leaders from small and medium firms to large corporations across the world.

        Author: Ten Mistakes of Risk Management, 5S Foundation for Personal and Business Excellence,
        Do-Magic with Your Business (upcoming), Do-Magic with Your Startup (upcoming)