The following is a list of commonly asked questions. If you have a question not covered in this section, please send an email to email@example.com.
What if the objective evidence that an assessor requires during a remote assessment cannot be shared electronically due to access or confidentiality issues? +
Assessors require objective evidence, therefore a nonconformity will be assigned to provide the laboratory with the opportunity to submit the evidence as part of the usual nonconformity response process.
Can initial (applicant) assessments be conducted remotely? +
This decision will be made on a case-by-case basis. Factors that will be considered when making the decision include, but are not limited to: the readiness of the laboratory, the geographical location of the assessors in relation to the laboratory, the health and safety of assessors and laboratory personnel, the laboratory’s ability to participate in a remote assessment, and steps that can be taken to mitigate risks to CALA.
My routine reassessment or surveillance visit is being conducted remotely, and I was hoping to add some appendices during the visit. Can this still be done? +
Similar to an abbreviated or accelerated abbreviated visit, this decision depends on whether the new appendices are similar to competencies already demonstrated by the laboratory. In some cases, it may be feasible to perform a remote assessment of new appendices. However, if the area of competency or field of testing is totally ‘new’ to a laboratory, the assessment of these new activities may just have to wait until it is safe for both laboratory staff and assessors to participate in an on-site assessment.
Can an abbreviated or accelerated abbreviated assessment be conducted remotely? +
CALA staff are investigating options to best service our customers and this decision will be made on a case-by-case basis. If the area of competency of the new tests or field of testing is substantively different from the lab’s current competencies, it just may not be possible to conduct the assessment until it is deemed safe for both laboratory personnel and assessors to participate in an on-site visit.
Where do I obtain more information on remote assessments? +
Please see CALA’s Policy on Remote Assessments A140-01.
Our internal audit and/or management review could not be conducted as scheduled; is this a nonconformity? +
It depends! If the laboratory can demonstrate that it carried out these activities in 2019, that they were delayed in 2020 specifically because of issues around COVID-19, that it considered a risk and has an action plan to address the risk (including plans to proceed with normal activities), of course not. However, doing nothing is not an option!
What does a laboratory do if an external supplier of services (e.g., a calibration provider) cannot provide required services to the laboratory? +
It is recognized that calibration service providers (and other service providers) cannot travel and/or gain access to testing laboratories – and may not be able to so for the foreseeable future. Assessors will be asking questions around whether you have considered the risk to the laboratory if anything was done in lieu of a calibration (e.g., an increased frequency of verification checks), and whether there are plans to proceed with normal activities. Doing nothing is not an option!
What if I do not receive or cannot test the option i or option ii PT samples? +
Decisions will be made on a case-by-case basis. Common issues are that the PT provider could not provide samples or that the appropriate laboratory staff could not access the laboratory. Regardless of the reason, CALA requires objective evidence to support the request for exemption from the PT round and if the reason is valid, the laboratory’s accreditation status will not be affected until normal activities resume.
Will the timeframe of 45 days to address nonconformities be extended?+
Decisions to extend the timeframe will be made on a case-by-case basis, pending the impact of the nonconformity on the validity of test results. If a laboratory identifies a risk to addressing nonconformities within 45 days, it needs to have an action plan to address this risk and to ensure that nonconformities are addressed in a timely manner.
Our laboratory has not yet been assessed to ISO/IEC 17025:2017; is there still a requirement for all laboratories to be accredited to this standard by November 29, 2020? +
The International Laboratory Accreditation Cooperation (ILAC) membership has voted in favour of extending the deadline for laboratories to transition to ISO/IEC 17025:2017, to June 1st, 2021.
In the meantime, to help ensure that CALA-accredited laboratories meet any international requirements, CALA is proceeding with a remote assessment of those laboratories that still need to be assessed against the requirements of ISO/IEC 17025:2017 for the first time.
My site visit is scheduled between July 01 and the end of the year. What are CALA’s plans for upcoming site visits? +
Given the uncertainty around COVID-19, CALA has decided to conduct all visits for the remainder of 2020 remotely (i.e., using electronic means), unless CALA deems it necessary to conduct an on-site visit – and that it is safe for assessors and laboratory personnel. CALA does recognize that a remote assessment may not be possible for some laboratories (e.g., access to the facility is prohibited) and, of course, will work with the laboratory to come to the best possible solution.
Where do I obtain more information on remote assessments? +
Please see CALA’s Policy on Remote Assessments A140-01 and Guidance on Remote Assessments for Laboratories A140-02.
Which organization recognizes CALA as being acceptable to accredit Laboratories?+
CALA is formally recognized by the International Laboratory Accreditation Cooperation (ILAC) through evaluations conducted by the Asia-Pacific Accreditation Cooperation (APAC). The website of each organization lists CALA as a signatory member. Please visit their respective websites for details:
What are the necessary steps to becoming accredited?+
In order to become accredited, a laboratory requires a documented Management System that has written test methods and records. It is advisable that laboratories wishing to pursue their first accreditation should perform a gap analysis against the ISO/IEC 17025 standard to evaluate their readiness for accreditation and address any gaps.
For general information for applicant laboratories, please download: A107-Guidelines-New_Labs.pdf
For the detailed CALA Program Description, which includes Program Policies, Fee Schedule, Accreditation Requirements, PT Policy and the CALA application form, visit the Accreditation Program Requirements portion of the documents section on the CALA web site.
How long will it take to become accredited?+
The application receipt through to the granting of accreditation can vary significantly from 3 – 12 months. The length of time depends on several factors such as the number of findings from the site visit, the number and type of tests to be accredited, the time of year of the assessment (high or low season) but most importantly, a laboratory’s site visit preparedness and the time a laboratory dedicates following the site visit to address any findings.
As a CALA member, does this automatically mean I am accredited?+
No. A laboratory must go through the accreditation process to gain accreditation. However, membership will grant you the following privileges: members have the right to have a say (vote) in the affairs of the organization; members also have preferred pricing for CALA services, and members are kept informed of key issues, challenges and changes to the laboratory industry, our association and relevant regulations through email and other communiques.
What are CALA’s areas of expertise when it comes to its accreditation program?+
CALA accredits testing laboratories to ISO/IEC 17025. CALA’s main areas of expertise are in environmental, food, occupational hygiene, cannabis, mineral and petroleum testing. If the appropriate expertise is available, other areas of testing may be considered for accreditation, so if something is not listed, please inquire.
Does CALA specify the Test Method required to become accredited for a specific test?+
No. CALA does not specify any particular tests that a laboratory must use to become accredited. The laboratory must decide the appropriate test to use based on client and regulatory needs.
Where can I find a lab accredited for a specific test (i.e., Lead in Paint)?+
A search based on keywords can be performed on our Directory of Accredited Laboratories.
I am already accredited to ISO/IEC 17025 by another accrediting body. Do I also need CALA accreditation?+
Many regulators and customers require accreditation by a body that is signatory to ILAC. As long as the other accrediting body is also signatory to ILAC, this accreditation may be sufficient, however the onus is on the Laboratory to determine client and/or regulatory requirements. If it is decided that CALA accreditation is still required, the Laboratory may qualify for an initial accreditation under P26 – CALA’s Policy on Transfer of Accreditation.
How do I purchase a copy of ISO/IEC 17025:2017?+
Laboratories can purchase a copy of ISO/IEC 17025:2017 by going to http://www.scc.ca/en/standards/buy-standards
Network laboratories may be interested in the option to have an electronic format for distribution on an internal network. For this option, laboratories can request a license to reproduce the standard by contacting firstname.lastname@example.org
What is the target date for all laboratories to be accredited to ISO/IEC 17025:2017?+
As a result of the COVID-19 global pandemic, an extension has been granted. All laboratories must be accredited to ISO/IEC 17025:2017 by June 1st, 2021.
Our lab is being assessed in 2019. How does this impact our assessment?+
All laboratories with an assessment in 2019 will be assessed to the new version of the standard – ISO/IEC 17025:2017. Responses to any nonconformities must be submitted to CALA within 45 days for accredited labs (90 days for new labs).
In general, what are the steps to start this transition process?+
As with any project, the key to a successful transition is planning. Laboratory and quality managers can start planning now, by considering the following steps:
- Plan to purchase the most current version of the standard at http://www.scc.ca/en/standards/buy-standards. All accredited laboratories must have their own copy of the new version of the ISO/IEC 17025.
- Perform a gap analysis between the laboratory’s current system and the new version of the standard. Consider who will be responsible for updating policies and procedures, the time line, and how the time line for updates fits in with your reassessment schedule. IMPORTANT: A gap analysis must be submitted to CALA six (6) weeks prior to a reassessment.
- Update documentation and processes as needed.
- Create a training and communications plan.
- Implement the revised system.
If laboratories do not make the cut-off, what is the impact on them?+
As of November 29, 2020, CALA is not allowed to have certificates of accreditation that state conformance to ISO/IEC 17025:2005. Therefore, if a CALA-accredited laboratory is not accredited to the new standard by this deadline, we may have no choice but to suspend the accreditation until the laboratory demonstrates conformance.
At what point do labs need to change to 2017 to meet regulatory requirements?+
Our advice is to seek clarification from your respective regulators. That being said, ILAC and ISO have published a joint communiqué noting that during the transition period, both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are equally valid and applicable. To read the full communiqué, go to: http://ilac.org/about-ilac/partnerships/international-partners/iso/
Rather than performing a gap analysis, our laboratory is planning to be assessed to ISO/IEC 17025:2017 and have the assessors provide a list of non-conformances. Provided evidence of conformance is submitted to CALA within 45 days and deemed satisfactory, the laboratory will attain accreditation to ISO/IEC 17025:2017 – Is this correct?+
No. By taking this approach, CALA would be giving accreditation solely on a desk review of responses. Because of the differences between ISO/IEC 17025:2005 and ISO/IEC 17025:2017, some assessment work will be necessary to convert accreditation to the new standard. If you choose the approach you are suggesting, there is a risk that accreditation to ISO/IEC 17025:2017 will not be granted until a verification visit is scheduled. This verification visit will be needed to verify implementation of the responses to any non-conformances identified. Thus, the risk is two-fold: not attaining accreditation to ISO/IEC 17025:2017 immediately, and incurring the cost of a verification visit.
Does my completed gap analysis need to be submitted to CALA?+
Yes. Please submit the gap analysis six (6) weeks prior to your assessment, with the normal documents and records that are required.
I've noted that the format of the new version of ISO/IEC 17025 is completely different from the 2005 version. Do I have to re-write my quality manual, so that it's in the same format?+
Not at all! There are definitely procedures that will need to be updated, and some and procedures may be required. Remember that the documented quality system is for the laboratory personnel and if you want to maintain the format of your current documented system — because personnel are familiar and comfortable with it — you will simply need to update it, create a training and communications plan for laboratory personnel, and then implement the changes.
Is CALA providing interpretive documents? +
A new version of P07 – CALA Application of Requirements in ISO/IEC 17025:2017 is available on the CALA website. Keep in mind that some of the new requirements are new to all stakeholders – including CALA and other accreditation bodies – and that application or interpretation may evolve as we get more familiar with the requirements. As such, it is anticipated that this document will be revised frequently over the next 1-2 years.
If a lab is ISO 9001 certified, my understanding is that their quality system does not need to be assessed? Is this true?+
No. Having a system that is certified to ISO 9001 may result in some efficiency during the assessment, but the laboratory must still be able to demonstrate that the system is capable of supporting and demonstrating the consistent fulfillment of the requirements in Clauses 4 to 7. So, while a CALA assessor may not need to assess document control procedures per se, he/she will still need to at least read them during the document review stage, and confirm that the document control procedure used by the laboratory meets the requirements of the ISO 9001 system.
Where can I see if an in-class course is being offered in my area?+
You can view the complete CALA training schedule in the training section of the web site and determine if a particular course is available in your area.
Where can I check for a list of online courses offered by CALA?+
Please view CALA’s online training schedule.
Where can I register for an online course offered by CALA?+
To register for an online course, visit our training website.
What is the payment policy for CALA training?+
The CALA payment policy can be found in P02-02 Fee Schedule. All training-related fees (online, in-class, publications) are payable prior to the first day of training (online or in-class) or delivery of publications.
How does Hosted Training work?+
A laboratory wishing to host a course should contact email@example.com for details and a quote.
Are CALA courses offered in languages other than English?+
No. Under normal circumstances CALA does not provide training to groups whose first language is not English. In the event that groups whose first language is other than English or French, CALA will charge a premium for simultaneous interpretation during training at a cost of $200.00 per person per day, assuming at least 10 participants. This does not include the translation of any training materials. Final costs are to be negotiated at the time of agreement.
Do I need a membership to participate in CALA programs?+
No. Membership is not a requirement to participate in CALA’s programs, however, discounted training fees are offered to CALA voting members and discounted proficiency testing through Proficiency Testing Canada Inc., is also available.
What is the difference between memberships?+
May be held by a corporation, a department or ministry of the federal or provincial government, a municipality, a university, or any other recognized organization. A corporation includes its wholly and majority owned subsidiaries. A Crown corporation or independent government agency is deemed to be a corporation.
May be held by any person
(*)Only voting memberships are applicable for discounted training and discounted proficiency testing through PTC, Inc.
How do I change my contact information?+
Contact changes must be submitted to CALA in writing, either by fax or email. Emailed changes can be sent to firstname.lastname@example.org. In the near future, contact changes will be made directly online.
How does CALA handle complaints and other feedback?+
CALA welcomes all feedback, both positive and negative, from all parties. The CALA process for examining and addressing feedback is found in CALA Q25 – Feedback within CALA Programs.
How does CALA adjudicate disputes and appeals?+
The CALA processes for receiving, investigating, and adjudicating appeals and disputes is found in CALA Q28 – Disputes and Appeals within CALA Programs.
Can I pay an invoice online?+
Yes. We accept Visa and Mastercard. Instructions on how to pay by credit card can be found on all CALA invoices and in the body of the email that has the invoice attached.
My online credit card payment is not processing?+
Ensure that the cents have been included in the dollar amount. For example, if the invoice total is $100, please enter 100.00.