FAQ

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.

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.

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.

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.

Please see CALA’s  Policy on Remote Assessments A140-01.

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!

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!

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.

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.

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.

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.

Please see CALA’s Policy on Remote Assessments A140-01 and Guidance on Remote Assessments for Laboratories A140-02.

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:

APAC
ILAC

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.

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.

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.

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.

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.

A search based on keywords can be performed on our Directory of Accredited Laboratories.

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.

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 csd@scc.ca

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.

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).

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.

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.

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/

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.

Yes. Please submit the gap analysis six (6) weeks prior to your assessment, with the normal documents and records that are required.

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.

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.

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.