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ISO Update aims to provide information, resources, and updates around the Standards and Certification industry. We believe that organizational standards can help businesses of all shapes and sizes become more efficient and successful on a local, federal, or global scale.
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Food Safety Standards

An increasing number of organizations in the food supply chain industry are seeking certification with the various GFSI approved certification schemes available.

The 3 most used certification schemes are The BRC (British Retail Consortium), the Food Safety System Certification FSSC 22000 and the Safe Quality Food (SQF) code. These schemes are bench marked against the same criteria and they all need to meet minimum requirements established by the GFSI.

However, because they are owned by different organizations and they vary in terms of the scope, structure, certification process, validity and the reporting and management conducted.

Differences in GFSI Approved Certifications Schemes

System requirements

  • The BRC standard has a focus on quality, food safety and legality.
  • The FSSC 22000 targets its focus on food safety and legal compliance.
  • The SQF code has two levels of requirements: Level 2 focuses on food safety and Level 3 on food safety and quality.

System establishment and implementation

  • The BRC standard has descriptive requirements for process and hygienic control which provide clear guidelines as to how food safety should be addressed.
  • FSSC 22000 provides a good framework against which an organization can develop its food safety management system, as it is not too descriptive and has the flexibility to allow the organization to choose the best way to control its own system.
  • The SQF code requires a combination of SQF system elements and food safety fundamentals based on product category.

Certification process

Closing Non-conformities (NC)

  • For the BRC standard all NC’s root cause analysis and objective evidence must be submitted within 28 days.
  • FSSC 22000 requires that critical or major NC detected in stage 1 audit have to be closed during stage 2 audit, and for minor NC the action plan should be submitted.
  • For the SQF code major NC from stage 1 audit must be closed out before stage 2 audit and the root cause and objective evidence need to be submitted in 14 days for majors NC and in 30 days minor NC.

Certificate validity

  • The BRC and SQF certificate valid for 1 year.
  • The FSSC 22000 certificate is valid for 3 years.

Certification mark

  • Only organizations that attain SQF level 3 certification can use the SQF quality mark on their products

Whichever standard an organization decides to use, being certified by a GFSI approved certification scheme will help them ensure the delivery of safe food to their consumers, increase their processes’ efficiency and provide a platform for continuous improvement of their food safety management systems.

 



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ISO 20000

To meet and improve customer satisfaction, it’s essential to monitor and measure performance by using different indicators. Performance indicators for ISO 9001:2015 are tools used for determining how and to what degree an organization is meeting guidelines, policies, objectives, requirements and targets set in their ISO 9001 QMS.

Note: These performance indicators are set by the organization and they vary from one organization to another. The team at The Registrar Company (TRC) created this list as a tool for organizations to learn from and decide which performance indicators are most suitable to the nature of their industry sector and their objectives.

What should be considered is that these indicators must be measurable and achievable. They must refer to the system’s critical processes, they must accurately represent the target to be measured, and they should be quantifiable, cost-effective, reliable and allow management to review the information in real time.

Cost Indicators

Cost indicators are performance indicators that evaluate the activities that consume economic resources in different processes. For example, the spend on energy consumption or other overhead costs, the percentage return on investments, or the percentage costs of carrying out corrections for errors are all cost indicators. 

Time Indicators

Time performance indicators measure the time consumed by an activity or process and consider the time from the beginning to the end of the selected process or activity.

For example:

  • Percentage number of products or services delivered on time.
  • Percentage number of products or services delivered late.

Productivity Indicators

Productivity performance indicators measure the efficiency of resources in the operation. For example, the percentage of downtown a particular machine or process experiences.

Quality Indicators

Quality performance indicators measure the effectiveness of the development of activities or processes, delivering results based on the number of errors, or the number of perfect and flawless deliveries.

For example:

  • Percentage number of products or services needing rework.
  • Percentage of customers ‘very satisfied’.

Summary

Remember, performance indicators are set by the organization and they vary from one organization to another, and while these indicators may vary, they should serve as a tool for improving the quality of decisions regarding the processes, and the ISO 9001 QMS itself.

The Registrar CompanyLooking to expand your knowledge base? The Registrar Company, TRC, has designed over 500 courses and trained over 10,000 individuals since 1990. Our approach is based on current adult learning principles and uses proven, highly interactive participatory sessions and practical techniques that offer real behavioural change that can be implemented and applied immediately in the workplace. Learn more about training with TRC.

Learn about Performance Indicators in ISO 14001

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ISO Management Systems  consider Interested Parties an essential element in the success of any business. Interested parties, also referred to as Stakeholders must be managed in order to obtain and retain their support. Additionally, many ISO Management Standards including; ISO 9001, ISO 14001, and ISO 45001, require organizations to understand and manage the interests and expectations of their Interested Parties as part of the certification process.



Most organizations have a many Interested Parties. Determining which are the most relevant is critical step towards developing a plan to  prioritize and manage them.

How can an organization begin this process? 

First, it needs to understand the organizational context it works in and its goals regarding the management system being considered. Whoever can affect these goals or who can be affected by them, is considered an Interested Party. The most relevant Interested Parties are the ones who provide risk to the organization’s sustainability if their needs and expectations are not met.

Identify who the Interested Parties are: 

The list may include:

  • Owners / Shareholders
  • Customers
  • Clients
  • Suppliers
  • Partners
  • Employees and their families
  • Regulators / Government organizations
  • Contractors
  • Communities
  • NGO’s
  • Unions
  • Emergency services
  • Media

This list can grow or be reduced depending on the organization’s complexity, its context and goals.

Classify the Role of the Interested Parties 

After listing all the interested parties, it’s useful to categorize them based on how these relate to the organization. For example, do they hold responsibility for the organization, do they influence it, do they depend on it, are they close to the organization’s operations, etc.  Guidance on how to categorize them can be found in ISO 14004.

Prioritize their Relevance 

Not all interested parties will have the same interest and power to influence an organizations decisions and activities. Thus, it is necessary to differentiate the ones that have high interest and high power to influence decisions and activates from those that have low interest and power to influence the organization.

Determine the Needs and Expectations of the Interested Parties 

Depending on the size and complexity of the organization, this can be done by either reviewing formal or informal documents of requests, complaints, or talking directly with them. However, complex and big organizations may require research methods to determine their interested parties’ needs and expectations.

Regardless of the size of the organization, establishing a process to manage Interested Parties is essential. Without a proper plan an organization can easily incorrectly allocate its resources on the less relevant Interested Parties, while failing to meet the needs of a critical Interested Party.



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Top 10 Mistakes Made in Managing an ISO 9001 System - ISOUpdate.com

Here are some of the most common mistakes made by organizations when managing an ISO 9001 system:

Mistake 1. Top management is not committed to the ISO 9001 system.  If top management is not involved in quality, if they don’t provide the resources and mechanism to plan, control and improve their products, services and processes, ISO 9001 can not be sustained over time. It’s essential for top management to take decisions that demonstrate that quality, improvement and customer satisfaction are an important issue.



Mistake 2. Not training key personnel in ISO 9001. Not knowing what ISO 9001 is all about can be a big mistake. It is important for organizations to train key personnel (someone who has a decision-making role) in ISO 9001, in order to understand what ISO 9001 really is and what it requires. Not knowing nor understanding ISO 9001 can take organizations through a path of disappointment and despair.

Mistake 3. Not training all personnel. Everyone must receive training on the important quality aspects of the activities and processes they work in. Everyone must understand the importance of quality and how they can achieve it. The training must be consonant with their responsibilities and the activities they perform.

Mistake 4. Making the system complex. If the organization is working to keep the system alive, it is a sign that it is too complex and all the work of filling out forms and documenting procedures is not adding value to the organization. The system must be kept simple and practical, and it should focus on results and improvements, and not on documents.

Mistake 5. Not using the corrective action process properly. Organizations need to take the time to investigate their problems and involve the right people in the investigation process. Most problems are recurrent, so using the corrective action process correctly will reduce or eliminate their recurrence.

Mistake 6. Not knowing what customers want. One of the objectives of ISO 9001 is to improve or increase customer satisfaction, and if organizations do not take the time to listen to their customers, they will not be able to reach this goal. A long and complicated survey is not necessary nor recommended, just by asking a few key questions will give organizations enough information to determine and plan for changes that will aim to fulfill this goal.

Mistake 7. Rushing into the implementation process. To build a solid ISO 9001 management system takes work and time.Trying to implement the system in a short time will be counterproductive. Organizations need to take the necessary time to plan, do, check and act in order to implement a system that will improve their products, services and processes.

Mistake 8. Not having a trained and experienced internal auditor. In many cases, internal auditors lack the necessary training and experience to distinguish small details from big issues in the QMS. Auditors need to focus on the issues that will help organizations improve their processes and the system itself.

Mistake 9. Believing that what works for one organization will work for their own. Every organization is different and what may work for one, may not work for another. Organizations need to focus on their specific context in order to build and develop their management system around it.

Mistake 10. Leaving the responsibility of the QMS to one person. ISO 9001 needs to be the work of an entire organization. If people do not take ownership of the QMS, it will not work out. People need to incorporate quality in their work and activities and an outsider will not achieve that. Guidance and training is needed, but if quality is not done on a daily basis in every process then the system will never add value to the organization.



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What is a Pre-Assessment Audit? - ISOUpdate.com

Defining a Pre-Assessment Audit

A pre-assessment audit is one that is performed before a certification/registration audit takes place. This pre-assessment audit determines the degree of conformance of an organization’s management system(s) with the requirements of a standard (e.g. ISO 9001, ISO 14001, ISO 27001, etc.)

After putting the time and effort to implement a management system and before diving into a certification audit, many organizations choose to contracting the services another organization or person to perform a pre-assessment audit. This is a full audit of a management system against the requirements of a specific standard that allows organizations to identify any nonconformities and implemented corrective actions before the certification audit.



About the Pre-Assessment Audit

A pre-assessment audit is performed with the same independence and objectivity as a certification audit. The auditor(s) will conduct activities such as documentation review, process review, interview of process owners, etc, in order to gather the necessary information that evidence compliance.

Audits are performed on-site and are a complete assessment of the management system against the requirements of the relevant standard. As any other audit, all nonconformities and observations found will be presented in an audit report that will be delivered at the end of the process; this report will serve as a baseline for the organization to improve its processes and implement the necessary corrective actions.

Who Needs a Pre-Assessment Audit?

Any organization that has implemented a management system and wishes to determine its readiness to undergo a certification audit can seek a pre-assessment audit.

What are the Benefits of a Pre-Assessment Audit?

Some of the benefits of performing this audit are:

  • Helps organizations identify any non conformities and implement corrective actions.
  • Contributes in the optimal preparation for the certification audit.
  • An organization can focus its resources on weaknesses that might lead to nonconformities.
  • Depending on the outcome, organizations can decide to postpone a certification audit that has already been scheduled or, on the contrary, face the certification audit with a renewed confidence.
  • Helps organizations avoid unnecessary additional costs.

A Pre-Assessment audit can be conducted by qualified consultants, registrars, or competent individuals with experience and knowledge regarding the relevant industry sector and standard. It is important to remember that, just as an organization carefully chooses  a certification body or any other service, it should also take the time to choose the correct organization or person to perform its pre-assessment audits.



Did you find that article helpful? Continue learning about Audits & how to choose the correct organization or person for your Audit.

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When going about creating a new business and you’re in the stages of being a startup, some startups might gloss over ISO 9001. The price may be a turnoff to people who see themselves only digging a bigger hole if they invest and go along with ISO 9001 implementation and certification. With any part of business, companies have to weigh the benefits and the cons of investing into something – ISO 9001 is no different. We’re here to tell you about the strongest benefits of investing in ISO 9001. You’re investing in yourself first off, and that’s a big help to startups looking to get their foot in the door.



ISO 9001 – The Benefits
The first thing about ISO 9001 is thinking about the cost. Most startup companies may have to consider a lot of things in their starting stages, and the return that can yield from that investment. When looking towards ISO 9001, you’re investing in practicalities and the foundation for a business. With the foundation set for success, all it takes is time and work for you to be on the road to success. Here are a few things that ISO 9001 can bring you.

ISO 9001 offers the process towards getting your product and sending it out towards the people who are interested in it. The process for building any startup up is complex and lot of work is needed. What are all of the things that are needed from the start of the end of this? What is needed at the start to make the product, finalize the product, send the product and make sure that it fits the requirements of what the customer needs from you? When looking at these processes, you cannot just think about it as a whole – each little thing is its own entity. These all come together and make one large thing in the end – the process. All steps in the process must flow smoothly or you may risk an error that can alter everything later on.

Using ISO 9001, you’re also finding a way to plan, act and find a way to interact to people properly. This goes from customers, analyzing your sales and communicating with them through customer service, monitor and reviewing the effect of these practices, and your employees. By setting a proper environment for your employees who will monitor and act properly to ensure the business flows and thrives. By properly managing customers and employees, the environment will feel great and this can help maximize profits and risks early in time.

ISO 9001:2015 also offers a great view into the goals, objectives, and elements for any startup business. With these, businesses will be able to take action against errors and fix them to move onto bigger and better things.



Why does ISO 9001 matter?

Implementation of ISO 9001 and getting a certification with it can help a startup. With ISO 9001, businesses are given a head start into the world and given a glimpse into what they can be. By pointing out errors, giving tips into what can be and how to go along with doing it, owners are able to maximize their profits, satisfy their customers and please their employees. Although the road to certification can take some time and can certainly be from six months to a year, ISO 9001 offers benefits instantly that can help any business. These habits and guidelines set up a business for success, and give startups access to exclusive markets. ISO 9001 is quickly becoming the normal for those who which to have local and federal contracts with the government – what are you waiting for?



 

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Management systems such as ISO 9001, ISO 14001 and OHSAS 18001 require that internal audits are scheduled at planned intervals; they do not establish a specific frequency nor do they establish that all processes need to have an annual internal audit. Therefore, organizations must establish a frequency which is right for their business. But how often should you be having internal audits for compliance? Audits can be performed monthly, quarterly, twice a year, or once a year. It is important to understand the criteria which should be considered before defining an internal audit frequency, as not all processes should be considered on the same timeline.



Complexity of the Processes

  • Crucial or high-risk processes should be audited on a more frequent basis, perhaps quarterly or twice a year
  • Low-risk processes can be audited just once a year or every other year

Internal Audit Frequency - How Complex is your Process? - ISOUpdate.com

Maturity of the Processes

  • Well established processes that run efficiently can be audited once a year or every other year
  • Newly developed processes should be audited more frequently, for example, quarterly, until they are stable

Internal Audit Frequency - How Mature is your Process? - ISOUpdate.com

Past Experience

  • Processes that have a history of frequent deficiencies or non-conformities, should be audited on a more frequent basis, such as quarterly or twice a year
  • Processes with troubles achieving targets and objectives should also be audited on a more frequent basis, such as quarterly or twice per year

Internal Audit Frequency - What is your Processes History? - ISOUpdate.com
Other factors that may influence the frequency of auditing:

  • Budget for the execution of internal audits
  • Regulatory or customer requirements

There is no need to audit every process all at once; consider spreading out internal audits throughout the year by auditing different processes at different times. Auditing many processes all at once can be exhausting and process deficiencies or areas for improvement may be overlooked.

Internal Audit Frequency - Establish a Rational Schedule - ISOUpdate.com

 

Although most standards do not require that all processes be audited every year, it is a common practice in many organizations. Some organizations with mature and well-established management systems may wish to schedule their audits over a 3-year time plan instead of annually. Every organization needs to take a close look at each of their processes, their management systems, and other applicable requirements to establish a rational schedule which fits their needs and is right for them.

This article was written by The Registrar Company and published with permission.

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Procedures for ISO 9001:2015

ISO 9001:2015 does not identify any required documented procedures, at least not as it was required in the 2008 version of the standard. The new standard refers to requirements of “documented information” and in the clause 7.5 it states that:

The organization’s quality management system must include:

  1. Documented information required by this International Standard;
  2. Documented information determined by the organization as being necessary for the effectiveness of the quality management system.



Throughout the new version of the standard, there are a number of references for organizations to maintain and retain documented information. It can be inferred that where the standard states that the organization is required to maintain documented information sufficient to support the operation of processes it is implying the need of documented procedures.

The specific procedures required for the quality management system will depend on the organization itself. The standard also states that:

The extent of documented information for a quality management system can differ from one organization to another due to the:

  1. Size of organization and its type of activities, processes, products, and services;
  2. Complexity of processes and their interactions;
  3. Competence of persons

Each organization will need to identify which procedures are essential for the correct operation of their processes in order determine which ones they’ll need to create. If an organization does not have any documented procedures, it will need to demonstrate how people know what to do and show acceptable evidence to support that their processes are carried out effectively without them.

Organizations that have already implemented ISO 9001 will not need to throw away the procedures that are in place. If these procedures serve as a useful tool within the organization, they should be maintained. However, the new standard presents an opportunity for organizations to take a second look at the procedures that are part of their management system in order to determine which add value to the system and which don’t.

Organizations wishing to be certified with ISO 9001:2015 must meet all of the requirements within a standard, including those regarding documented information, and they must be able to show evidence that they have all the necessary procedures in place.



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Difference Between Stage 1 & Stage 2 Audits - ISOUpdate.com

Small and large organizations recognize that the implementation of an ISO 9001 quality management system (QMS) in their processes gives them a competitive value. However, the task of implementing and successfully obtaining the certification requires time and money. Therefore, a popular question when deciding to implement is “What is the Cost to Implement ISO 9001?”

2 Costs of Implementing ISO 9001

There are 2 kinds of costs associated with the implementation of ISO 9001

These are:

  1. The costs for the implementation.
  2. The costs for the certification.



Costs of Implementing ISO 9001

In order to effectively estimate the cost for implementation, an organization will have to go through a gap analysis or assessment.

However, there are 3 main factors that an organization should take into account when estimating cost:

  1. The size and complexity of the organization. Is it a small single location organization? or is it a large company  with processes such as design, manufacture, installation, test, etc.?
  2. The type of quality system that is currently in use. Does it have a structured and disciplined system in place? Is the system documented, and how well?
  3. The time that staff and other members of the organization have to devote to the project. Will the organization create everything with its current members? Will it hire someone to guide them? Or, will it hire an ISO consultant to complete the entire process?

The major cost items that every organization needs to consider when implementing ISO 9001 are:

  • Training managers to get them to understand the requirements of ISO 9001
  • Assessment of current quality control practices and creating additional testing facilities routine if necessary
  • Renew the workspace, equipment, machines, public services, supporting facilities, etc, if necessary
  • Review and revamping arrangements for the handling and storage of raw materials, semi-finished and finished products, as appropriate necessary and safe
  • Review existing procedures / practices and listing of new procedures, checklists and records to be prepared
  • Development of QMS related documents
  • Conduct outreach activities of everyone who has roles and responsibilities for implementing the QMS
  • The various expenses such as word processing, stationery and other supplies necessary for the production of manuals, procedures and the like

Costs of ISO 9001 Certification

Regarding the cost of initial certification and costs associated with maintaining certification the main cost items are:

  • Registration and certification fee payable to the certification for a period of three years
  • Fees for the two-stage audit visit nominated by the certification body
  • Audit Committees regularly monitored by the certification agency nominated
  • Travel, accommodation and meals for auditor(s) of certification

The implementation and consequent maintenance of a QMS based on ISO 9001 is an investment of time and money for any organization. The success of the system will rely mainly in the commitment of all its members, especially on how senior management is committed to making ISO 9001 an effective tool to integrate their processes, continuously improve their QMS, and satisfy their customer’s expectations.



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How to Prepare for a Successful ISO 9001:2015 Audit - ISOUpdate.com

No matter how many audits someone has gone through, knowing that someone will be auditing your work always generates some tension and anxiety. Here are some recommendations from The Registrar Company, a North American Certification Body with over 20 years of auditing experience, to help your organization prepare for a successful ISO 9001:2015 audit.

Prepare Employees

  • Quality Policy – Review the quality policy, refresh it if needed, and make sure everyone understands it. There is no need for workers to memorize the policy, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Quality Objectives – Workers should know what the organization’s quality objectives are and how they themselves contribute to achieving them. Employees should know and be able to explain how their day to day activities can influence these objectives.
  • Training – Ensure that everyone has been properly trained to perform their tasks.
  • Documented Information – Make sure everyone knows where to find current copies of procedures, work instructions, and forms that are relevant to their position.
  • Audit Schedule – Let everyone know the scope of the audit, when they will be audited, and what the auditor may be checking in their areas.
  • Interviews – Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure how to respond during an audit.

Review Documented Information

  • Make sure document and record listings are up-to-date.
  • Check that all documents have been reviewed, approved, communicated, and followed by everyone involved in the process or activity.
  • Ensure obsolete documents have been removed from circulation and are no longer in use.
  • Verify that all records are being used correctly.

Ensure all Processes are Being Performed Correctly

  • Make sure that all procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (the correct way) by everyone.

Review Corrective Action Process

  • Review the findings from previous audits and make sure they have been addressed.
  • All non-conformities must be properly recorded, investigated, and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed should also have been verified for effectiveness.

Organize the Workplace

  • It is difficult for quality control and assurance to take place in an untidy, dirty, or unorganized workplace. Take time to organize the workplace (offices, desks, warehouse, workshop floor, etc.).
  • Make sure records, forms, procedures, and any relevant documents are on-hand or easy to access.

Practice Positivity and Professionalism

  • Make a good first impression – treat auditors professionally and with respect.
  • Do not be predisposed. Auditors are not enemies, they are there to establish conformance and to help your organization uncover any weaknesses so that you can take the necessary actions to improve.

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 Services 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.



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