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FAQ

The following is a list of questions most commonly asked of our staff.  However, if we have not covered your question, do not hesitate to call the CALA office and speak to someone directly (613-233-5300).  Questions are grouped by department.

Accreditation

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:

APAC
ILAC

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 Program Catalogue and the CALA application form, visit the Accreditation Program Requirements portion of the CALA Library.

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, cannabis, food, mineral and petroleum testing. If the appropriate expertise is available, other areas of testing may be considered for accreditation, 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 do I find the procedure to make changes to my CALA scope or Proficiency Testing participation?+

Refer to the second table on the following page: http://www.cala.ca/progdocs.html.

Where can I find a lab accredited for a specific test (i.e., Lead in Paint)?+

A search based on key words 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 csd@scc.ca

What is the target date for all laboratories to be accredited to ISO/IEC 17025:2017?+

ISO/IEC 17025:2017 was published November 29, 2017.

All laboratories must be accredited to ISO/IEC 17025:2017 by November 29, 2020.

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.

Proficiency Testing

What is the difference between Proficiency Testing and Accreditation?+

Proficiency Testing – this program allows Laboratories to test their ability to do specific tests. The Laboratory in question, would register to receive samples for specific tests (2-4 times per year, depending upon the sample), then when they receive the sample they would analyze and submit the results to CALA. CALA will then give them a score to let them know how accurate they are.

Accreditation – Accredited Laboratories not only participate in the Proficiency Testing Program, but are also assessed against ISO/IEC 17025 on a regular basis (two years in a row, then every two years thereafter).

How do I know if I need Proficiency Testing or Accreditation?+

This is dependant on regulators and client needs. CALA encourages you to review appropriate federal, provincial and municipal regulations as well as discuss with your clients what they require.

Why does CALA use whole volume instead of ampoules in its PT Program?+

Laboratories get the most value out of PT when the samples they receive can be processed in a fashion that is as close to that normally used by the Laboratory. Ampoules require a specific dilution procedure that is not used for most client samples.

Since the PT acceptance limits are based on a 95% confidence limit, doesn’t this mean that a Laboratory has a 5% chance of failure due to random chance?+

No. It is true that for any analyte approximately 5% of Laboratories will obtain an unacceptable score, but this is not due to random chance. A Laboratory that has an absolute z score greater than two, means that ~95% of the other participants were closer to the target value.

How does CALA justify the $150 suspension and withdrawal fees?+

In 2009, CALA issued 1,925 corrective action reports to Laboratories due to unacceptable PT scores. There is a significant amount of administrative effort required to issue and review the scores for acceptability upon receipt. Rather than impose a fee for every PT failure, we only charge the fee after two and three consecutive failures by a laboratory.

How are the analyte concentration ranges determined for the PT samples?+

CALA continually reviews all concentration ranges and considers typical analytical capabilities, typical sample concentrations and regulatory limits, where they exist. CALA’s Program Committee participates in the review process that determines these ranges.

How does CALA examine data to ensure that the evaluations are appropriate and defensible?+

In addition to reviewing the characterization analysis performed before and at the end of each study, the reported data is extensively examined. This includes examining reported results with respect to the order of sample production (homogeneity issues). A similar examination is made of reported results and analysis dates (stability issues). In addition, the inter-Laboratory standard deviation is compared to historical deviations.

CALA also reviews all comments entered during PT results reporting. If there are any recurring concerns, the data for the specific analyte or test group will be examined in even greater detail, possibly resulting in exclusion from the study.

Training

In what order should I take CALA training?+

CALA recommends referring to the training flow chart (.pdf) to assist you in selecting your options for training.

Where can I see if an in-class course is being offered in my area?+

You can view the complete CALA Training Schedule Details page to assist you in determining if a particular training 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 training@cala.ca for details and a quote. For more detailed information please visit CALA’s “Reducing the Cost of Training” page.

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.

CALA

Do I need a membership to participate in CALA programs?+

No. Membership is not a requirement to participate in CALA’s programs, however, discounted PT and training fees are offered to CALA voting members.

What is the difference between memberships?+

Institutional (Voting*): 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.

Individual (Voting*): May be held by any person

Associate: May be held by an individual, association or an organization

Student: May be held by any person enrolled in a full time program in a recognized college or university.

*Only voting memberships are applicable for discounted PT and Training fees.

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 info@cala.ca. 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. Please visit our Online Payment page.

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.

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