Transition to the new ISO/IEC 17025 standard

Kitty P-Riveros and Terri ArsenaultQA Team

Connecticut Agricultural Experiment Station

Tuesday, April 9, 201910:00 AM – 11:00 AM

Crosswalk Transition to ISO17025:2017

• As of November 30, 2017, the official ISO/IEC 17025:2017 standard was released by ISO.

• Received the ISO/IEC 17025:2017 Revision Access, and Transition Memorandum from our AB along with the crosswalk worksheet.

Set a goal (time-line) for each step

1. Use the crosswalk to identify “new” items, and revise documents (quality manual, impartiality, purchasing, etc.)

2. Acquire training

3. Conduct internal audits of the management system and all technical programs

4. Implement changes (revise documents, verify records, etc.)

Use the crosswalk to identify “new” items

Revised documents ( ~ 9 SOPs)• Quality Manual• Impartiality SOP ( new)• Management Review SOP• Continual Improvement Process SOP• Externally Provided Products and Services SOP,

formerly called “Purchasing”• Requests, Tenders and Contracts SOP• Control of Non-conforming work SOP• Receiving and Handling Test Items SOP• Complaint SOP (from internal audit finding)

Acquire Training

• Free Webinar also available through APHL resources

• Hired a trainer from our AB to train the entire staff on the new standard. ( April 2018)

Training: Concentrate on new sections

• 8.5 Actions to address risks and opportunities– Updated SOP and our ACCD (in-house LIMS)

• 4.1 Impartiality – Updated quality manual and the SOP (Codes of

ethic ->Undue pressure and ethical conduct -> Impartiality)

• 7.1.3 Decision rule– Updated our customer contracts

Training: Identify required documents

• Procedures ( Methods)– 6.2.5 Personnel records *

– 6.4.3 Handing of laboratory equipment

– 6.4.10 Intermediate check

– 6.5.3 b) Reference measurement

– 6.6.2 Externally provided products & services

– 7.1.1 Review of requests, tenders & contracts

– 7.2.1.1 Evaluation of measurement uncertainty

– 7.2.2.4 Validation

– 7.4.1 Handling of customer equipment

– 7.7.1 Ensuring the validity of results

– 7.10.1 Nonconforming work

Training: Required documents (cont.)• Documented Process

– 7.9.1 Complaints

• Program– 6.4.7 Calibration – 8.8.2 Internal Audit

• Plans– 6.4.13g Equipment maintenance– 7.2.1.6 Method development – 7.3.1 Sampling– 8.5.2 Risk & opportunities – 8.8.1 Internal audits– 8.8.9 Management review

Training: Identify required recordsRecords:

• 6.6.2 External providers records– defining, reviewing and approving the laboratory’s requirements for externally

provided products and services;

– taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers.

• 7.1.8 Contract reviews and discussions

• 7.3 Sampling data

• 7.8.7.3 Dialog with customer on opinion & interpretations

• 7.11.3e) Information management system failures*

Training: Required records (cont.)

Identify• 4.1.4 Risks to impartiality Define• 5.3 Range of activities• 6.6.2a) Laboratory requirements for external

providers Document• 7.8.6.1 Decision rule• 7.11.2 Laboratory software configuration or

modification of COTS

External provider records

Identify risks to impartiality A staff will be asked about potential conflicts of interest during management review.

Laboratory software configuration or modification of COTS

In-house COTS validation procedures

1. Requirements

2. Design

3. Coding

4. Testing

5. Traceability Matrix

6. References, and Finalization

Laboratory software configuration or modification of COTS

Identifying GAPS: Internal Auditing

Identifying GAPS: Internal Auditing (cont.)

Identifying GAPS: Internal Auditing (cont.)• 10 Internal Audits• 20 Findings: 5 findings are identified as gaps for ISO17025:2017

1. According to ISO17025:2017 section 4.2.3 "Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source." The statement cannot be found in anywhere of our documents and policies.

2. Section 7.9.7 indicates "Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant." This section is new to the 17025:2017 standard. concern: CT Admin 026 does not specifically state that formal notice should be given to the complainant.

3. Data provided by the customer is not clearly identified as required by ISO 17025(2017) section 7.8.2.2

4. The decision rule is not listed in the contract as required by CTAdmin019 rev#04 section 2.3.B(8), and new requirement of the ISO standard (section 7.1.3).

5. Concern#01: In section 3.3 of CT Admin 011 rev#09, some risk evaluation questions are redundant and unnecessary to elevate the overall risk score.

Action taken: finding #1• Section 4.2.3 "Information about the customer obtained from

sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source."

• This statement is added into quality manual:“Most records are subject to disclosure under the Freedom of Information Act. However, the laboratory shall not discuss regulatory status or actions concerning specific test results with the general public or other government agencies unless requested to do so by the customer, or required to do so by the law.”

Action taken: finding #2

• Section 7.9.7 indicates "Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant." This section is new to the 17025:2017 standard. concern: CT Admin 026 does not specifically state that formal notice should be given to the complainant.

• Revised the complaints SOP by adding– Section 5 resolution of Complaints: All complaints are

reviewed and resolved through the CIP.– Section 6 notification of Resolved Complaint: through

CIP via comments section for internal complaint and email for external complaint.

Actions taken: finding #3

• Data provided by the customer is not clearly identified as required by ISO 17025(2017) section 7.8.2.2

• Revised test report format: Data provided by customer are indicated in Italic font.

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Action taken: finding #4

• The decision rule is not listed in the contract as required by CTAdmin019 rev#04 section 2.3.B(8), and new requirement of the ISO standard (section 7.1.3).

• Revise customer contracts to ensure that the decision rule is included in the contract.

Action taken: finding #5

• Risk evaluation questions are redundant and unnecessary to elevate the overall risk score.

• Revised the CIP form in ACCD:

Follow up with the finding and implementation #5 (cont.)

A2LA renewal assessment

• January 15-16, 2019: one finding.

• According to ISO17025:2017 section 6.2.5 b; The laboratory shall have procedure(s) and retain records for selection of personnel.

– Finding: "The current procedure concerning personnel and training does not address the selection of personnel.”

A2LA renewal assessment Add section on “Selection of Personnel” to our training SOP. a. Job descriptions for roles under the scope of accreditation shall be described in CT Admin 002. These descriptions shall include minimum qualifications (including educational requirements and work experience), supervision received and exercised, as well as examples of duties.b. The LD will review the job descriptions in Admin 002 and select staff for roles based on relevant experience. The LD shall consider workloads and available resources when making staff assignments.

Contact Information

Kitty Prapayotin-Riveros and Terri Arsenault QA Team

Connecticut Agricultural Experiment Station

Email: Kitty.Prapayotin-Riveros@ct.govTerri.Arsenault@ct.gov

mailto:Kitty.Prapayotin-Riveros@ct.govmailto:Terri.Arsenault@ct.gov