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Are you ready for ISO certification
ISO 9001
ISO for QMS

Welcome to the 4Z-Pedia. Many people are asking how to get an ISO certification. We explained in another 4Z-Pedia document, the various steps of ISO 9001:2015 certification. But before thinking in contacting a certifying body, it is helpful to know how close you are from the qualification to a formal ISO 9001:2015 certification.



We prepared the following checklist as a guide for that purpose. Please note that this checklist is composed of questions & three possible answers.

Questions are based on the clauses of the international ISO 9001:2015 standard. They cover both mandatory & commonly used clauses required by any ISO certifying body.

Answers are divided into three distinct categories:
  1. Ready: means that you can proof your fulfilment of these clauses by appropriate documentation, thereby ready for the visit of the external audit by the certifying body.
  2. Almost Ready: means that you are ready for the visit of the external audit by the certifying body to inspect you. But you need a small support to complete the required documentation.
  3. Not Really: means that you need extensive preparation before getting ready for the visit of the external audit by the certifying body to inspect you.

At the end of this checklist, you will find further guidance on what to do depending on your answers.

In each question you will be asked whether you think you have fulfilled the criteria of the standard. You have the choice to answer as: Ready, Almost Ready, or Not Really


Readiness Checklist


Please note that cells in (Red) are mandatory documents, while cells in (Blue) are commonly used non-mandatory documents.

(For mobile devices, please use landscape mode for a better experience, or swipe fingers right & left to see the whole table).

Clause Question Ready Almost Ready Not Really
4 Have you determined the interested parties that are relevant to the QMS?
4.1 Have you determined external & internal issues relevant to the purpose & strategic direction of your QMS that can affect your ability to achieve the intended results?
Are you monitoring & reviewing information about these external & internal issues?
4.2 Have you determined the interested parties that are relevant to the QMS?
Have you determined the requirements of these interested parties that are relevant to the QMS?
Do you monitor & review the information about these interested parties & their relevant requirement?
4.3 Have you established the scope of your QMS?
Does the scope state the types of products & services covered?
While determining the scope, have you determined the external & internal issues, requirements of your relevant interested parties, products & services?
Is your scope made available & maintained as a documented information?
5 Leadership: top Management are now required to demonstrate a greater direct involvement in your QMS:
5.2 Have the policy & objectives for the QMS, which are compatible with the strategic direction of the organization, been established & communicated?
6 Planning: you are required to consider both your context & interested parties when planning & implementing the QMS. You are also required to identify those risks & opportunities that have the potential to impact (positively or negatively) on the operation & performance of the QMS:
6.1 While planning for the QMS, do you consider the internal & external issues & the requirements of interested parties?
Have you taken actions to address risks & opportunities that are proportionate to the potential impact on the conformity of products & services?
6.2 Have you established quality objectives at relevant functions, levels & processes needed for the QMS?
Have you developed quality objectives that are consistent with the quality policy? are they measurable? do they take into account applicable requirements? are they relevant to conformity of products & services & to the enhancement of customer satisfaction? are they monitored? are they communicated? are they updated as appropriate?
When planning how to achieve quality objectives, have you determined what will be done? what resources will be required? who will be responsible? when it will be completed? how the results will be evaluated?
7 Resources: you need to consider both internal & external resource requirements & capabilities to be able to meet customer & regulatory requirements:
7.1.5.1 Have you determined & provided the resources needed to ensure valid & reliable results when monitoring & measuring is used to verify the conformity of products & services to requirements?
Have you ensured that the resources provided are suitable for the specific type of monitoring & measurement activities being undertaken? are they maintained to ensure their continuing fitness for their purpose?
Have you retained documented information as evidence of fitness for purpose of the monitoring & measurement resources?
7.2 Have you determined the necessary competence of persons doing work under its control that affects the performance & effectiveness of the QMS?
Have you ensured that these persons are competent on the basis of appropriate education, training, or experience?
Have you ensured where applicable, taken actions to acquire the necessary competence, & evaluate the effectiveness of the actions taken?
Have you retained appropriate documented information as evidence of competence?
7.3 Have you ensured that the persons doing work are aware of the quality policy? are they aware of relevant quality objectives? are they aware of their contribution to the effectiveness of the QMS, including benefits of improved performance? are they aware of the implications of not conforming with the QMS requirements?
7.5 Have your QMS included documented information that is required by the ISO 9001:2015 international standard?
Is documented information determined by you, as being necessary for the effectiveness of the QMS?
When creating & updating documented information have you ensured the documented information has an appropriate identification & description? has it an appropriate format? has it been reviewed & approved for suitability & adequacy?
Have you ensured that documented information required by the QMS & by the ISO 9001:2015 standard is controlled to ensure that it is available & suitable for use, where & when it is needed? is it adequately protected (from loss of confidentiality, improper use, or loss of integrity)?
Have you, in order to control documented information, addressed its distribution, access, retrieval, use, storage & preservation, including preservation of legibility, & its control of changes (e.g., version control)? its retention & disposition?
Have you determined documented information of external origin necessary for the planning & operation of the QMS be identified as appropriate, & be controlled?
Have you retained documented information as evidence of conformity & protected it from unintended alterations?
8 Operation: You are required to control not only implementation & planned changes to processes, but also to unintended, unplanned changes. Where unintended changes are made, you will have to demonstrate that you have identified any actual or potential adverse effects & have taken action to mitigate them:
8.2 Have you ensured that communication with customers includes information relating to products & services, handling enquiries, contracts or orders, including changes, customer feedback relating to products & services, including customer complaints, specific requirements for contingency actions, when relevant?
8.2.3.2 Have you ensured that you have the ability to meet the requirements for products & services?
Have you conducted a review before committing to supply product & services?
Have you reviewed the requirements specified by the customer, including the requirements for delivery & post-delivery activities?
Have you reviewed the requirements not stated by the customers but necessary for the specified or intended use when know?
Have you reviewed the legal & regulatory requirements applicable to the products & services, & the requirements specified by you?
Have you reviewed & resolved contract or order requirements differing for those previously defined?
When the customer does not provide a documented statement of their requirement, do you conform to the customer's requirements before acceptance?
Do you retain documented information on the results of the review & on any new requirements for the products & services?
8.3 Have you established, implemented & maintain a design & development process that is appropriate to the subsequent provision of products & services?
8.3.3 Have you determined the requirements essential for the specific types of products & services to be designed & developed by considering functional & performance requirements, information derived from previous similar design & development activities, legal & regulatory requirements, standards or codes of practice that the organization has committed to implement, potential consequences of failure due to the nature of the products & services?
8.3.4 Have you applied the necessary controls to design & development processes to ensure that the result to be achieved are defined?
8.3.5 Do you ensure that design & development outputs meet the input requirements?
8.3.6 Have you identified, reviewed & controlled changes made during, or subsequent to the design & development of the products & services to ensure that there is no impact on conformity to requirement?
8.4.1 Do you ensure that the externally provided processes, products & services conform to the requirements?
Do you determine the controls needed when the products & services from the external providers are incorporated into your own products & services?
Do you determine the controls needed when the products & services from the external providers are provided directly to the customer by external providers?
Do you determine the controls needed when the process or part of the process is provided by the external providers?
8.5 Have you implemented production & service provision under controlled conditions?
8.5.1 Are there any documented information available that defines the characteristics of the products, services or activities to be performed & the results to be achieved?
Are monitoring & measuring activities being performed at appropriate stages?
Are competent persons (including qualification) being appointed?
Is the infrastructure & environment being used suitable for the operation of processes?
Have you implemented any actions to prevent human error?
Have you implemented any release, delivery & post-delivery activities?
8.5.3 When property belonging to customers or external providers is under your control or being used by you, do you exercise adequate care?
When the property or the customer or external provider is lost, damaged or otherwise, found to be unsuitable for use, do you report this to the customer or external provider?
Do you retain documented information on what has occurred?
8.5.4 Do you preserve the outputs during production & service provision, to the extent necessary to ensure conformity to requirements?
8.5.6 Do you conduct review & control changes for production or service provision to ensure continuing conformity with requirements?
Do you retain documented information describing the results of the review of changes, the person(s) authorizing the change & any necessary actions arising from the review?
8.6 Have you implemented planned arrangements, at appropriate stages, to verify that the product & service requirements have been met?
Do you ensure that the release of product & service proceed only after the planned arrangement is satisfactorily completed or approved by the relevant authority & as applicable by the customer?
Do you retain the documented information on the release of products & services that includes information relating to the evidence of conformity with the acceptance criteria; traceability of the person authorizing the release?
8.7.2 Do you ensure that the outputs which do not conform to their requirements are identified & controlled to prevent their unintended use or delivery?
Is the action appropriate to the nature of the nonconformity & its effect on the conformity of products & services?
Do you also consider nonconforming products & services detected after delivery of products, or during & after the provision of services?
When non-conforming products & services are detected do you take corrective action and/or segregation, containment, return, or suspension of the provision of products & services and/or informing the customer and/or obtaining authorization for acceptance under concession?
Do you retain documented information that describes the nonconformity; the actions taken; any concession obtained; the authority deciding the action in respect of the nonconformity?
9 Performance Evaluation: requirements are better defined when monitoring & measuring are performed & when the results are analyzed & evaluated:
9.1.1 Have you determined what needs to be monitored & measured, methods for monitoring, measurement, analysis & evaluation needed to ensure valid results, when the monitoring & measuring shall be performed, & when the results from monitoring & measurement are analyzed & evaluated?
Are you evaluating the performance & the effectiveness of the QMS?
Have you retained appropriate documented information as evidence of the results?
9.1.2 Can you demonstrate that you have sought out information relating to how customers view your organization as well as your products & services?
9.2 Are you conducting internal audits at planned intervals to provide information on whether the QMS conforms to your own requirements, & the requirements of the ISO 9001:2015 international standard, & is effectively implemented & maintained?
9.2.2 Have you planned, established, implemented & maintained an audit program(s) including the frequency, methods, responsibilities, planning requirements & reporting which takes into consideration the importance of processes concerned, changes affecting you, & the results of previous audits?
Have you defined the audit criteria & scope for each audit?
Have you selected auditors & conducted audits to ensure objectivity & impartiality of the audit process?
Have you ensured that the results of audits are reported to relevant management?
Have you taken appropriate corrective actions without undue delay?
Have you retained documented information as evidence of the implementation of the audit program & the audit results?
9.3 Has top management reviewed your QMS, at planned intervals, to ensure its continuing stability, adequacy, effectiveness & alignment with the strategic direction of your organization?
10 Improvement: this section emphasizes the general need to improve processes, products & services, as well as QMS results, in order to meet customer requirements & enhance customer satisfaction:
10.2 When a nonconformity occurs, including any arising from complaints have you reacted to the nonconformity as applicable & taken action to control & correct it & also deal with the consequences? have you evaluated the need for action to eliminated the cause(s) of the nonconformity, to ensure that it does not recur or occur elsewhere?
10.2.2 Have you retained documented information as evidence of the nature of the nonconformities, any subsequent actions taken, & the results of any corrective action?


We hope that this "Readiness Checklist" for the ISO 9001:2015, has given you an evaluation of your current business situation. Now you want to know what is the next step upon your own results of the above checklist:


(For mobile devices, please use landscape mode for a better experience, or swipe fingers right & left to see the whole table).

If all, or the majority of the answers have been “Ready”, with “Almost Ready” making up the minority: If the majority of the answers are “Almost Ready”, with a mix of “Ready” & “Not Really” making up the minority: If the majority of the answers are “Not Really”, with “Ready” or “Almost Ready” making up the minority:
Congrats! you are ready to book your external audit with the certifying body. Please get in touch with us for guidance. In this case, you should consider a gap analysis to identify the issues that need to be addressed. If you seek support on how to do it, please contact us, we are here to help you. In this case, it looks like there is still some work to be done. This can be achieved through our training programs that cover ISO requirements. In addition, our numerous consulting packages will enhance your knowledge of the ISO standards; ideally preparing you for your ISO certification. You could also consider a gap analysis to identify areas that deserve your attention & get support on how to solve them. Plase call or email us for help.


Now, if you have any more questions about auditing, checklists, ISO qualification & certification,

Email us today at: support@the4z.com. We will be pleased to answer all your questions about ISO certification.

Call 4Z for Quality today at (also on WhatsApp):
+973 3399 5807 or +90 5050 3040 16.

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